Tuesday, 27 Jul 2021

Vaccination Programme

Questions (2660)

Róisín Shortall

Question:

2660. Deputy Róisín Shortall asked the Minister for Health the number of first and second vaccine doses administered to each vaccine cohort in tabular form. [38672/21]

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Written answers

Minister for Health

The COVID-19 Data Hub has now been restored after being temporarily shut-down in the aftermath of the cyber attack.

The Data Hub provides a breakdown of the number of doses delivered to each cohort. The number of first and second doses as of 19 July are listed below.

Cohort	First Dose	Second Dose
Residents aged 65+ in LTCF	114,567	108,714
Frontline healthcare workers	275,667	266,630
People aged 70 years and older	479,138	455,085
People aged 16-69 years of age at very-high risk of severe COVID-19 disease	282,137	265,435
All people aged 60-69 years	338,396	325,689
People aged 16-59 years with medical conditions at high risk of severe COVID-19 disease	254,194	208,618
All other people aged under 60 years	1,206,796	646,657

Covid-19 Pandemic

Questions (2661, 3242)

Róisín Shortall

Question:

2661. Deputy Róisín Shortall asked the Minister for Health the number of passengers arriving into Ireland from designated states in each of the past eight weeks; the number of these who successfully completed mandatory hotel quarantine; the number deemed exempt from mandatory hotel quarantine; and the number that tested positive for Covid-19 after arriving into the country in tabular form. [38673/21]

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Róisín Shortall

Question:

3242. Deputy Róisín Shortall asked the Minister for Health the number of persons who entered mandatory hotel quarantine from each designated state in each of the past eight weeks; the number who successfully completed their full quarantine period; and if he will make a statement on the matter. [40973/21]

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Written answers

Minister for Health

I propose to take Questions Nos. 2661 and 3242 together.

Mandatory hotel quarantine has been introduced as a key safeguard for public health in response to the COVID-19 pandemic. It aims to protect public health and mitigate the spread of COVID-19 and new variants of concern in Ireland.

Mandatory hotel quarantine is a legal obligation for any person, except an exempt traveller, who has been in, or transited through, a designated State within 14 days of their arrival in Ireland, or any person from a non-designated country failing to comply with the requirement to present a not-detected pre-departure RT-PCR test on arrival, if travel regulations, specify such a requirement is relevant to them, or to the country from which they have travelled.

From the period 17 May to 11 July a total number of 24,380 persons entered this country from Designated States. The following Table provides the list of Top 10 Designated States that persons travelled from during this period.

Top 10 List of Designated States that Persons travelled from during the period 17 May to 11 July 2021

Designated State	Number of Persons
United States of America	6,645
United Arab Emirates	5,541
India	2,259
France	2,095
Qatar	1,974
Turkey	1,100
Pakistan	672
Brazil	632
South Africa	536
Belgium	424
Other Designated States	2,502

The Health (Amendment) Act 2021 provides for a limited number of exemptions from mandatory hotel quarantine, which are outlined on www.gov.ie/quarantine. Those who are fully vaccinated with an EMA approved vaccine, who can provide documentary evidence, are also exempt from mandatory hotel quarantine on arrival in Ireland. The numbers entering hotel quarantine are therefore less that the total number of travellers entering the country from designated States. The table below shows the weekly numbers both entering the state and MHQ.

Week	17-23 May	24-30 May	31-May – 06 Jun	07-13 Jun	14-20 Jun	21-27 Jun	28-Jun – 04 Jul	05-11 Jul
Passengers arriving to Ireland from Designated States	2,098	2,687	3,580	4,342	1,637	2,052	3,843	4,141
Number who exited MHQ accommodation	638	631	498	535	556	569	581	648

During this period (17 May to 11 July) a total of 221 Mandatory Hotel Quarantine residents tested positive for COVID-19.

Covid-19 Tests

Questions (2662)

Róisín Shortall

Question:

2662. Deputy Róisín Shortall asked the Minister for Health the number of persons who tested positive for Covid-19 after entering Ireland from abroad in each of the past eight weeks. [38674/21]

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Written answers

Minister for Health

On 4 June, the HSE launched a test booking facility which allows intending travellers to Ireland to pre-book a RT-PCR test from the HSE, free of charge, five days after their arrival. The test may be booked at a time and place convenient to the address the person will be staying at. In addition, any person wishing to take a test may also present as a walk-in at any of the HSE swabbing centres located around the country, details of which are available on the HSE website.

It is not possible for the Department of Health to provide statistics on tests booked through the platform as the operational responsibility does not lie with the Department.

Disabilities Assessments

Questions (2663)

Pearse Doherty

Question:

2663. Deputy Pearse Doherty asked the Minister for Health when a person (details supplied) in County Donegal can expect an appointment for a cognitive assessment; and if he will make a statement on the matter. [38684/21]

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Written answers

Minister of State at the Department of Health

As this Parliamentary Question relates to an operational issue, it is a matter for the Health Service Executive (HSE). However, members of the Oireachtas are advised that the HSE is currently unable to access the information to answer Parliamentary Questions due to the recent cyber-attack, which has required a temporary shut-down of HSE IT systems. The disruption to service is on-going and the HSE is working hard to restore its IT capacity and to resume normal services.

Members of the Oireachtas will be advised as soon as the HSE is again in a position to provide responses to PQs and are encouraged to resubmit their Parliamentary Questions at that point.

Disability Services

Questions (2664)

Pearse Doherty

Question:

2664. Deputy Pearse Doherty asked the Minister for Health if the intellectual disability service received a multi-disciplinary team proposal for a person (details supplied) in County Donegal; and if he will make a statement on the matter. [38685/21]

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Written answers

Minister of State at the Department of Health

As this Parliamentary Question relates to an operational issue, it is a matter for the HSE. However, members of the Oireachtas are advised that the HSE is currently unable to access the information to answer Parliamentary Questions due to the recent cyber-attack, which has required a temporary shut-down of HSE IT systems. The disruption to service is on-going, and the HSE is working hard to restore its IT capacity and resume normal services. Members of the Oireachtas will be advised as soon as the HSE is again in a position to provide responses to PQs and are encouraged to resubmit their Parliamentary Questions at that point.

Question No. 2665 answered with Question No. 2610.

Question No. 2666 answered with Question No. 2605.

Question No. 2667 answered with Question No. 2605.

Equality Issues

Questions (2668)

Holly Cairns

Question:

2668. Deputy Holly Cairns asked the Minister for Health the progress made towards action 12 of the National Disability and Inclusion Strategy 2017-2021. [38081/21]

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Written answers

Minister of State at the Department of Health

Heads of Bill to provide legislative clarity on the issue of deprivation of liberty safeguards are at a relatively advanced stage. A number of complex legal and policy issues which have arisen during the drafting process remain to be resolved.

Covid-19 Pandemic

Questions (2669)

Fergus O'Dowd

Question:

2669. Deputy Fergus O'Dowd asked the Minister for Health if he will address a matter (details supplied) in relation to the reopening of special needs clubs; and if he will make a statement on the matter. [38195/21]

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Written answers

Minister of State at the Department of Health

As this Parliamentary Question relates to an operational issue, it is a matter for the HSE. However, members of the Oireachtas are advised that the HSE is currently unable to access the information to answer Parliamentary Questions due to the recent cyber-attack, which has required a temporary shut-down of HSE IT systems. The disruption to service is on-going, and the HSE is working hard to restore its IT capacity and resume normal services. Members of the Oireachtas will be advised as soon as the HSE is again in a position to provide responses to PQs and are encouraged to resubmit their Parliamentary Questions at that point.

Covid-19 Tests

Questions (2670)

Alan Dillon

Question:

2670. Deputy Alan Dillon asked the Minister for Health if he will provide the list of companies that manufacture and supply SARS-CoV-2 antigen rapid test kits to Ireland that are fully in compliance with EU regulations and requirements and are authorised for personal use or commercial sale in Ireland; and if he will make a statement on the matter. [38736/21]

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Written answers

Minister for Health

Tests for COVID-19 are regulated under the European In-Vitro Diagnostics Directive (IVDD, Directive 98/79/EC) and must be CE marked before being placed on the market in Ireland or elsewhere in the EU. A CE mark is a declaration that the product complies with the requirements of the relevant European legislation. Any manufacturer can apply a CE mark if they meet the relevant requirements. However, depending on the legislation and class of the device, an external and impartial organisation may be required to independently assess if the manufacturer has met these requirements. This is known as ‘conformity assessment’ and for Medical Devices and IVDs an organisation that performs conformity assessment in Europe is known as a Notified Body.

The National Standards Authority of Ireland is a Notified Body for Medical Devices and IVDs (In-Vitro Diagnostics) in Ireland. It is important to note that in terms of intended use, a rapid antigen detection test (RADT) may be designed by the manufacturer to be used by health care professionals or by lay users. COVID-19 tests which are indicated for use by healthcare professionals are classified as General IVDs and are often referred to as ‘self-declare’. This means that they do not require involvement by a Notified Body regarding conformity assessment. Instead, the manufacturer ‘self-declares’ their conformity to the essential requirements within the IVDD. COVID-19 tests which are indicated for use by lay persons (not medical professionals) are classified as Self-Test. This means they do require Notified Body involvement to assess conformity to the applicable regulatory requirements.

The Directive requires that devices perform safely while achieving the purpose intended by the medical device manufacturer. Medical devices which are appropriately CE marked (i.e., have undergone the appropriate conformity assessment) may be freely placed on the European market. In order to achieve the performances claimed by the manufacturer for the device, the test should be used according to the instructions for use provided by the manufacturer. The Department of Health does not maintain a list of tests that have been CE marked or that are available on the Irish market.

A list of COVID-19 tests available in the EU can be found in the COVID-19 In Vitro Diagnostic Devices and Test Methods Database at covid-19-diagnostics.jrc.ec.europa.eu. However, it should be noted that there is no central approval system for in vitro diagnostic medical devices in the EU and the database does NOT represent a list of authorised or approved devices in the European Union.

Considerable work has been undertaken to date to evaluate the potential use of rapid antigen detection tests (RADTs) in an Irish context and this will continue on an ongoing basis. In the health sector, the HSE has deployed rapid antigen tests for use for specific indications in the acute hospital setting, and as part of the response to outbreaks in the community setting, supported by appropriate clinical governance and operational arrangements. This includes updating the case definition for SARS-CoV-2 to accept notification of positive results from rapid antigen tests undertaken in the public health system and reporting of such cases to the COVID Care tracker and to the Computerised Infectious Disease Reporting (CIDR) information system developed to manage the surveillance and control of infectious diseases in Ireland. The current position of the HSE is to use rapid antigen tests only in settings where there is a CE marked, validated assay for use and where an appropriate clinical care pathway is in place to manage the current limitations of the test.

The HSE has recently published the report of the Antigen Test Validation Project which validated a number of rapid antigen detection tests (ADTS) intended for testing samples for SARS-CoV-2 antigen. The products evaluated were chosen as those expected to represent the best available products based on the manufacturers claims and other available evidence. The recommendations in this report will assist in the consideration of other potential applications of rapid antigen detection tests in the health service to support the overall national testing strategy.

I have established an Expert Advisory Group on Rapid Testing which will be chaired by Professor Mary Horgan, to support and advise Government departments who are responsible for progressing pilots and the rollout of rapid tests to their respective sectors.

On an ongoing basis, the National Public Health Emergency Team considers and reviews how best to target testing to detect, and mitigate the impact of, the virus across the population. This includes keeping Ireland’s national testing and tracing policy under continuing review.

Regulatory Bodies

Questions (2671)

Michael Creed

Question:

2671. Deputy Michael Creed asked the Minister for Health if assistance can be provided in expediting a registration with CORU (details supplied). [38737/21]

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Written answers

Minister for Health

In relation to the particular query raised, as this is an operational matter, I have asked CORU (the Health and Social Care Professionals Council) to respond to the Deputy directly.

Question No. 2672 answered with Question No. 2605.

Health Services