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Gnáthamharc

Tuesday, 27 Jul 2021

Written Answers Nos. 1723-1748

Covid-19 Pandemic

Ceisteanna (1725)

Mattie McGrath

Ceist:

1725. Deputy Mattie McGrath asked the Minister for Health if HIQA has re-examined the emerging evidence regarding the efficacy of ivermectin as a prophylactic and treatment for Covid-19; if not, if he will instruct HIQA to re-examine the matter given the growing evidence of the success of ivermectin; if HIQA will outline the studies it has examined as a basis for its decision on the matter; and if he will make a statement on the matter. [35121/21]

Amharc ar fhreagra

Freagraí scríofa

The Deputy is advised that, previously at the request of the NPHET, HIQA conducted a rapid evidence review to identify studies on the effectiveness of (i) pharmaceutical and (ii) non-pharmaceutical interventions, in the ambulatory setting, aimed at reducing progression to severe disease in individuals with confirmed or suspected COVID-19. This evidence review included a review of relevant studies in relation to Ivermectin.

As confirmed by HIQA’s COVID-19 Expert Advisory Group (www.hiqa.ie/sites/default/files/2021-02/Interventions-to-prevent-progression_Advice.pdf ), evidence regarding the effectiveness of pharmaceutical treatments intended for systemic use, must be subject to the highest standards of rigour. Where a pharmaceutical intervention is recommended in the absence of appropriate supportive evidence, there is a significant potential for harm to the patient. Whereas this risk of harm may be justified in certain circumstances (e.g. the intervention poses minimal risk, or the setting involves patients with high potential to gain due to almost certain risk of severe adverse consequences in absence of any intervention) this is less likely to be the case in the setting of mild disease, where a great number of otherwise well patients would potentially receive the intervention.

HIQA has also advised my Department that several international health technology assessment or guideline development organisations have specifically reviewed the evidence to date on ivermectin in COVID-19 and have cautioned or advised against the use of ivermectin outside the setting of clinical trials on the basis of the current evidence. HIQA has also advised that the pharmaceutical company MSD (Merck, USA), which holds a license in the USA for the use of ivermectin as an antiparasitic agent, on 4 February 2021 published a statement including the following:

“It is important to note that, to-date, our analysis has identified:

- No scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies;

- No meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease, and;

- A concerning lack of safety data in the majority of studies.

We do not believe that the data available support the safety and efficacy of ivermectin beyond the doses and populations indicated in the regulatory agency-approved prescribing information.”

Further research was undertaken by HIQA and updated advice was provided to the NPHET on 12 May: COVID-19 - Interventions and health related factors that prevent infection or minimise progression to severe disease. This document was subsequently published by HIQA on the 23 June 2021:

www.hiqa.ie/sites/default/files/2021-06/Advice-to-NPHET_Interventions-to-prevent-COVID-19.pdf

One of the key findings of the review was that Ivermectin is not currently licensed for the treatment of COVID-19. From this evidence summary, there is currently insufficient information on whether it can be safely used to prevent or reduce the severity of COVID-19. Ivermectin should therefore not be used as prophylaxis outside well-designed, regulated clinical trials as the benefits and harms are not yet clear when taken in the context of COVID-19 treatment.

Low certainty or very low certainty evidence was identified in relation to a small number of interventions. However, HIQA noted the low quality of the evidence available including the high risk of bias, small sample sizes and short durations of follow-up, different trials and advised that results from these studies should not be used to inform decision-making with respect to effectiveness.

HIQA’s overall finding was that there is currently insufficient evidence of either effectiveness or safety to support the use of any pharmaceutical intervention outside of well conducted, well-regulated clinical trials. Furthermore, no evidence was identified for the effectiveness or safety of any non-pharmaceutical interventions.

I trust that the above information satisfactorily addresses your question.

Covid-19 Pandemic

Ceisteanna (1726)

Mattie McGrath

Ceist:

1726. Deputy Mattie McGrath asked the Minister for Health his plans to remove the UAE from the MHQ or to exempt those Irish citizens who have received a vaccine (details supplied) from MHQ considering it is approved by the World Health Organisation; and if he will make a statement on the matter. [35198/21]

Amharc ar fhreagra

Freagraí scríofa

The United Arab Emirates was removed from the list of designated states on Friday, 16 July 2021.

Ireland procures COVID-19 vaccines through its participation in an EU procurement process and their approval is by the Commission following recommendation by the EMA.

At present, the Sinopharm vaccine has not received EMA approval.

COVID-19 vaccines can only be approved and used if they comply with all the requirements of quality, safety and efficacy set out in the EU pharmaceutical legislation. No vaccine will be used until Market authorisation from the European Medicines Agency (EMA) is obtained and any authorised vaccine will be subject to ongoing monitoring in Ireland by the Health Product Regulatory Authority (HPRA).

Passengers who are fully vaccinated in accordance with the table below and have the documents to confirm this are not required to complete mandatory hotel quarantine on arrival in Ireland. Dependents, including children, will also be exempted from the requirement to complete mandatory hotel quarantine.

What 'fully vaccinated' means:

A full course of any one of the following vaccines

Regarded as fully vaccinated after:

2 doses of Pfizer-BioNtech Vaccine: BNT162b2 (Comirnaty®)

7 days

2 doses of Moderna Vaccine: CX-024414 (Moderna®)

14 days

2 doses of Oxford-AstraZeneca Vaccine: ChAdOx1-SARS-COV-2 (Vaxzevria® or Covishield)

15 days

1 dose of Johnson & Johnson/Janssen Vaccine: Ad26.COV2-S [recombinant] (Janssen®)

14 days

Disability Services

Ceisteanna (1727)

Robert Troy

Ceist:

1727. Deputy Robert Troy asked the Minister for Health if it will be ensured personal assistance hours which have been approved are put in place for a person (details supplied). [35199/21]

Amharc ar fhreagra

Freagraí scríofa

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.

Question No. 1728 answered with Question No. 1685.

Health Services Staff

Ceisteanna (1729)

Richard O'Donoghue

Ceist:

1729. Deputy Richard O'Donoghue asked the Minister for Health the number of full-time lymphedema nurses recruited in each of the years of 2019, 2020 and to date in 2021; the hospitals in which the nurses are located; and if he will make a statement on the matter. [35203/21]

Amharc ar fhreagra

Freagraí scríofa

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.

Health Services Staff

Ceisteanna (1730)

Richard O'Donoghue

Ceist:

1730. Deputy Richard O'Donoghue asked the Minister for Health the number of full-time adult intellectual disability and autism spectrum disorder speech and language therapy posts in CHO area 3 in each of the years of 2018, 2019, 2020 and to date in 2021 in tabular form; and if he will make a statement on the matter. [35204/21]

Amharc ar fhreagra

Freagraí scríofa

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.

Health Services Staff

Ceisteanna (1731)

Richard O'Donoghue

Ceist:

1731. Deputy Richard O'Donoghue asked the Minister for Health the number of posts in place for community dieticians in mental health and disability in CHO area 3 in each of the years of 2019, 2020 and to date in 2021, in tabular form; and if he will make a statement on the matter. [35205/21]

Amharc ar fhreagra

Freagraí scríofa

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.

Primary Care Centres

Ceisteanna (1732)

Dara Calleary

Ceist:

1732. Deputy Dara Calleary asked the Minister for Health the status of the progress of a project (details supplied) in County Mayo. [35212/21]

Amharc ar fhreagra

Freagraí scríofa

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 Pandemic

Ceisteanna (1733)

Richard Bruton

Ceist:

1733. Deputy Richard Bruton asked the Minister for Health if the procedure for certifying vaccines by the HSE which will be used for green certificates has the capacity to pick up cases in which persons have had a first vaccine (details supplied) and then opted to obtain an alternative vaccine from their local general practitioner. [35213/21]

Amharc ar fhreagra

Freagraí scríofa

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 ongoing, 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.

Disability Services

Ceisteanna (1734)

Alan Dillon

Ceist:

1734. Deputy Alan Dillon asked the Minister for Health the reason referrals to a service (details supplied) have been ceased for autistic children without an alternative provision being put in place; and if he will make a statement on the matter. [35223/21]

Amharc ar fhreagra

Freagraí scríofa

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.

National Maternity Hospital

Ceisteanna (1735, 1839)

Mairéad Farrell

Ceist:

1735. Deputy Mairéad Farrell asked the Minister for Health the funding spent to date on the national maternity hospital; and if he will make a statement on the matter. [35225/21]

Amharc ar fhreagra

John Lahart

Ceist:

1839. Deputy John Lahart asked the Minister for Health the amount that has been spent to date on the new national maternity project per year since the inception of the project move to St Vincent’s Hospital grounds; and the amount that has been transferred to date to a company (details supplied) or any subsidiary connected or related to that group or owners of the group in tabular form. [35580/21]

Amharc ar fhreagra

Freagraí scríofa

I propose to take Questions Nos. 1735 and 1839 together.

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.

National Maternity Hospital

Ceisteanna (1736)

Róisín Shortall

Ceist:

1736. Deputy Róisín Shortall asked the Minister for Health the precise work done to date in his Department and in the HSE in order to comply with the rules governing spending on large State capital projects in respect of the new national maternity hospital; if business cases have been completed by his Department and the HSE in this regard; the conclusions reached in these business cases; if he will undertake to publish these documents in the public interest; and if he will make a statement on the matter. [35256/21]

Amharc ar fhreagra

Freagraí scríofa

A business case for the national maternity hospital (NMH) relocation project was submitted to the Department of Health by the NMH Project Board in December 2020. This provided a comprehensive overview of the proposed project. However, as a project initiated prior to the updated Public Spending Code (PSC), the Project Board is undertaking additional work to ensure full compliance with the new PSC.

The PSC is designed to ensure that investment decisions are underpinned by a clear policy rationale, and that costs are well understood. In 2019, the PSC was updated and introduced a new project lifecycle, tightening the arrangements for project decision-making, and clarifying the roles of the parties involved including the responsibilities for Sponsoring Agencies and Approving Authorities.

The Department of Health has put in place procedures for evaluating and managing public investment in capital projects, and its responsibilities as an Approving Authority, in line with the updated PSC.

The Department is working with the HSE, as a Sponsoring Agency, to ensure that new capital investment proposals are initiated in line with this new lifecycle approach and through all subsequent stages. For projects that pre-date the updated PSC, the Department, the HSE and project boards are working, with input from the Department of Public Expenditure and Reform, as appropriate, to ensure that these projects can be incorporated into this lifecycle approach.

The specific requirements that must be included in a business case at the various stages of the PSC, and the stages at which these are to be published, are detailed at www.gov.ie/en/publication/public-spending-code/

For the NMH relocation project, an updated business case will be re-submitted to the Department of Health, as Approving Authority, and to the Department of Public Expenditure and Reform for technical review, in due course.

General Practitioner Services

Ceisteanna (1737)

Róisín Shortall

Ceist:

1737. Deputy Róisín Shortall asked the Minister for Health if general practitioners are required to follow the HSE sequencing protocol with regard to spare vaccine doses; if not, the protocol for general practitioners; and if he will make a statement on the matter. [35298/21]

Amharc ar fhreagra

Freagraí scríofa

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 ongoing, 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.

Home Care Packages

Ceisteanna (1738)

Holly Cairns

Ceist:

1738. Deputy Holly Cairns asked the Minister for Health the steps he is taking to fulfil the Programme for Government commitment to increase home care hours and introduce a statutory home care scheme. [35300/21]

Amharc ar fhreagra

Freagraí scríofa

Enabling people with care needs to continue to live independently at home for as long as possible is a priority for the Government. To advance this, the Government is committed to establishing a new, statutory scheme for the financing and regulation of home-support services, which the Department of Health is currently developing. It is envisaged that the new scheme will provide equitable access to high-quality services based on a person’s assessed care-needs.

Work is on-going within the Department to determine the optimal approach to the development of the new scheme within the broader context of the Sláintecare reforms. This work encompasses the development of the regulatory framework for the new scheme; the examination of the options for the financing model for the scheme; and the development of a reformed model of service-delivery. With the aim of ensuring that all service-users are provided with a standard, high-quality level of care which is safe, effective, and person-centred, it is envisaged that the regulatory framework will encompass primary legislation for the licensing of providers, minimum standards, and national quality standards.

The Sláintecare Implementation Strategy and Action Plan 2021–2023 commits to the advancement of the development of the new home-support scheme in 2021 and to the commencement of its implementation in 2022. Funding was secured in 2021 for the HSE to progress the roll-out of interRAI as the standard assessment tool for care-needs in the community; the pilot of a reformed model of service-delivery for home-support; and the establishment of a National Office for Home Support Services.

Mobilisation of the pilot of a reformed model of service-delivery is expected to commence at end of August, supported by the National Office. The pilot will deliver an additional 230,000 hours of home-support over a six month period in four community healthcare network (CHN) sites. The four sites selected for the pilot are: CHO 2 Tuam, Athenry and Loughrea; CHO 4 Bandon, Kinsale and Carrigaline; CHO 7 Ballyfermot and Palmerstown; and CHO 8 East Westmeath. In addition, approximately 130 posts have been funded for the national rollout of the interRAI Ireland system, which the home-support pilot will test as the standard assessment tool for care-needs.

While the new home-support scheme is under development, the Government is prioritising improving access to home-support services. As part of Budget 2021, funding for an additional 5 million hours of home-support was provided. This increased investment will contribute to meeting the Programme for Government commitment to providing equitable access to home-support services.

Covid-19 Pandemic

Ceisteanna (1739)

Holly Cairns

Ceist:

1739. Deputy Holly Cairns asked the Minister for Health his views on the Cork City Council motion calling on the Government to support the waiving of patents on the Covid-19 vaccine in the EU and worldwide; and if he will make a statement on the matter. [35301/21]

Amharc ar fhreagra

Freagraí scríofa

India and South Africa have presented a proposal to the World Trade Organisation (WTO) to allow all countries to choose to neither grant nor enforce any patents and other intellectual property rights related to COVID-19 drugs, vaccines and diagnostics for the duration of the pandemic. The proposers argue that this would allow countries to scale up the manufacture of such products.

International Trade is a competence of the EU under the Treaties and in exercising that competence, the European Commission engages fully with the Member States through a variety of Committees and Working Parties/Groups, including on Intellectual Property.

The EU’s current position on the proposed waiver is that the WTO international agreement on Trade Related Aspects of Intellectual Property Rights (the TRIPS Agreement) allows countries the flexibility to respond to the concerns raised by India and South Africa. Specifically, the TRIPS agreement allows compulsory licensing which is when a government permits someone else to produce the patented product or process without the consent of the patent owner.

The EU position is that manufacturing capacity, access to raw materials and distribution networks are the main obstacles that need to be overcome in the supply of vaccines and that increasing manufacturing capacity may be better attained through voluntary licensing arrangements by disseminating the technology and know-how of those who developed the vaccines. The Commission has set up a Task Force for Industrial Scale-up of COVID-19 vaccine production which aims to support the ramp-up of production capacity and address supply chain bottlenecks.

The EU continues to be committed to an open and comprehensive dialogue with all WTO members to explore how the multilateral rules-based trading system can best support universal and equitable access to COVID-19 vaccines and treatments. Discussions on the proposed waiver are continuing at the WTO.

The EU considers that the COVAX Facility, the international initiative to ensure global access to COVID vaccines, is the mechanism that is best placed to ensure that high-income countries finance the vaccines and support the developing countries to secure their share of global supply.

Ireland has consistently championed collaborative responses to the pandemic, with a focus on ensuring that the needs of the poorest and most vulnerable are served by our collective effort. As a member of the global health community, Ireland continues to play an active role in ensuring fair and equitable access to vaccines for all. This includes supporting the World Health Organization (WHO), the Global Vaccine Alliance and the Global Fund, to develop, produce and equitably distribute effective technologies in the COVID-19 global response.

Food Industry

Ceisteanna (1740)

Holly Cairns

Ceist:

1740. Deputy Holly Cairns asked the Minister for Health if his attention has been drawn to a campaign from a company (details supplied) targeting Irish mothers with email marketing weeks after they give birth; and if he will make a statement on the matter. [35302/21]

Amharc ar fhreagra

Freagraí scríofa

Breastfeeding is important for the health of both mother and infant, and national health policy, including the Healthy Ireland Framework, the National Maternity Strategy 2016-2026, the National Obesity Policy and Action Plan 2016-2025 and the National Cancer Strategy 2017-2026, emphasise the importance of supporting mothers who breastfeed, as well as taking action to increase breastfeeding rates in Ireland.

Encouraging mothers to breastfeed is a priority for the Department of Health. To deliver on this priority, the HSE is working to achieve the aims and objectives of “Breastfeeding in a Healthy Ireland – HSE Action Plan 2016-2021”. Due to the impact of the COVID-19 pandemic on the delivery of some actions, the HSE will extend the implementation of the Breastfeeding Action Plan into 2022 and continue to work on priority outstanding actions.

In May of this year I announced significant investment towards implementing the HSE Breastfeeding Action Plan, with €1.58 million of funding to provide an additional 24 lactation consultants across hospital and community settings.

Implementation of Breastfeeding in a Healthy Ireland – HSE Action Plan includes initiatives in the following areas:

- Improved governance and health service structures

- Breastfeeding training and skills development

- Health service policies and practices

- Support at all stages of the breastfeeding continuum through social marketing, support and advocacy.

The Maternity Strategy states that "in addition to practical supports which can be provided to mothers, such as support to continue breastfeeding on return to the workplace, a broader societal change is required in order to promote a more positive culture around breastfeeding. This should support women to feel confident about their choice to breastfeed". In essence, this means that all mothers should be supported to breastfeed at anytime and anywhere.

The HSE is partnering with key stakeholders to develop the supports that mothers require at all stages of the breastfeeding continuum through social marketing, support and advocacy. The www.mychild.ie website provides pregnant and new mothers and families with a range of information and supports about infant feeding. An Ask Our Expert (AOE) on-line service, provided by International Board-Certified Lactation Consultants, is available to answer mothers’ questions and link them to supports in their local area. The webchat facility and HSE breastfeeding Facebook page is also available. These services provide supportive and practical expert information in a friendly, supportive and non-judgemental manner.

A new Code of Marketing of Breast Milk Substitutes in public health services is in final draft and is due for implementation across all health services in 2021.

The HSE’s National Women and Infants Health Programme, in collaboration with health promotion and improvement and public health services in the HSE, supports the implementation of the WHO/UNICEF 10 Steps to Successful Breastfeeding using a model suitable for the promotion and support of breastfeeding in Ireland.

The Healthy Ireland “We're Breastfeeding Friendly” programme aims to support business, community and public service settings to welcome breastfeeding mothers and families.

Breastfeeding will continue to be a priority for the Department of Health, and the Department and HSE will continue working to achieve the aims and objectives of the HSE Breastfeeding Action Plan.

Vaccination Programme

Ceisteanna (1741, 1915)

Holly Cairns

Ceist:

1741. Deputy Holly Cairns asked the Minister for Health further to Parliamentary Questions Nos. 914, 941, 945, 947, 954, 963, 981, 982, 983, 984, 988, 1002, 1003, 1004, 1005, 1041, 1069, 1078, 1083 and 1087 of 28 April 2021, the status of Covid-19 vaccines (details supplied) receiving EMA approval; and if he will make a statement on the matter. [35303/21]

Amharc ar fhreagra

Patrick Costello

Ceist:

1915. Deputy Patrick Costello asked the Minister for Health if he will work to obtain European Medicines Agency approval of a vaccine (details supplied) given it is already approved by the WHO and many Irish persons in particular those residing in the Middle East have already received this vaccine. [35861/21]

Amharc ar fhreagra

Freagraí scríofa

I propose to take Questions Nos. 1741 and 1915 together.

Ireland is participating in an EU Procurement process with a view to accessing a portfolio of candidate vaccines against COVID-19 which are being negotiated with vaccine manufacturers by the Commission acting on behalf of Member States. Emergency Support Instrument (ESI) funding has been leveraged by the Commission to facilitate its negotiations with vaccine manufacturers, including with regard to production costs and securing a reduced per dose cost for Member States.

This process has provided Ireland with access to vaccines (at a reduced cost) that it would find it difficult to access otherwise within a year after the declaration of a Public Health Emergency of International Concern by the WHO. Four of the vaccines in the EU portfolio have already been awarded Conditional Marketing Authorisation (CMA) by the Commission.

Ireland supports efforts made by the Commission to safeguard the production and delivery of doses of vaccine in the quantities agreed with vaccine suppliers and to ensure that up-front funding provided through ESI has been properly used.

COVID-19 vaccines can only be approved and used if they comply with all the requirements of quality, safety and efficacy set out in the EU pharmaceutical legislation. No vaccine will be used until market authorisation from the European Medicines Agency (EMA) is obtained and any authorised vaccine will be subject to ongoing monitoring in Ireland by the Health Product Regulatory Authority (HPRA).

The delivery of vaccines under APAs that the Commission has negotiated on behalf of Member States are predicated upon a CMA being obtained from the Commission (on the basis of a positive recommendation being awarded by the EMA).

The awarding of a CMA provides a high level of assurance that a vaccine has undergone rigorous testing and has met the requirements of the independent regulatory process as regards demonstrating its quality, safety and efficacy.

The EMA has started a rolling review of the Sputnik V COVID-19 Vaccine but it has not been awarded a CMA to date. The Sinopharm vaccine has not been awarded a CMA to date.

Question No. 1742 answered with Question No. 1541.

Departmental Records

Ceisteanna (1743)

Catherine Connolly

Ceist:

1743. Deputy Catherine Connolly asked the Minister for Health further to Parliamentary Question Nos. 240 of 3 May 2017 and 1112 of 2 June 2017, if the information can now be provided; if he will provide the files that have been retrieved; and if he will make a statement on the matter. [35327/21]

Amharc ar fhreagra

Freagraí scríofa

I understand that an official from my Department contacted your office in relation to this PQ in September of this year. It was agreed by email to process the matter raised as a Freedom of Information request rather than a Parliamentary Question given that it relates to the release of records. The FOI request is currently being processed.

Commissions of Investigation

Ceisteanna (1744)

Catherine Connolly

Ceist:

1744. Deputy Catherine Connolly asked the Minister for Health further to Parliamentary Question No. 2081 of 21 April 2021, when the two substantive interim reports of the Farrelly Commission of Investigation will be published; the reason for the delay in publication; the number of interim reports received to date; the number of interim reports published to date; when the final report of the commission will be published; and if he will make a statement on the matter. [35328/21]

Amharc ar fhreagra

Freagraí scríofa

The Farrelly Commission, which commenced work on 15th May 2017, was established to investigate the care and protection of “Grace” (pseudonym) and others in a former foster home in the South East, which has been the subject of abuse allegations. The Farrelly Commission is a statutory Commission of Investigation and is independent in undertaking its functions under the legislation and its Terms of Reference.

Since its establishment, the Farrelly Commission has submitted a series of interim reports to the Minister for Health, which have been published on my Department’s website, and two Substantive Interim Reports on its investigation, which I received in January and March of this year. My officials have since been engaging with the Attorney General's Office and I hope to be in a position to proceed with the publication of these reports in the near future.

Child and Family Agency

Ceisteanna (1745)

Alan Dillon

Ceist:

1745. Deputy Alan Dillon asked the Minister for Health when an early intervention assessment will take place in the case of a child (details supplied); and if he will make a statement on the matter. [34890/21]

Amharc ar fhreagra

Freagraí scríofa

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 Pandemic

Ceisteanna (1746)

Cormac Devlin

Ceist:

1746. Deputy Cormac Devlin asked the Minister for Health the number of children permitted at wedding receptions; if he will consider exempting them from numbers in this and future phases of the roadmap for reopening the economy and society; and if he will make a statement on the matter. [34437/21]

Amharc ar fhreagra

Freagraí scríofa

As the Deputy will be aware, on 29 June, Government announced the next phase of reopening the economy and society in line with Recovery and Resilience: The Path Ahead.

While significant progress is being made in relation to the roll-out of our vaccination programme, the rapidly increasing prevalence of the more transmissible Delta variant, and the significant risk this poses, in particular to those who are not yet fully vaccinated, meant that a number of higher risk indoor activities did not recommence as planned on 5 July, pending the implementation of a system to verify vaccination or immunity status.

However, as an exception, weddings already planned have been allowed to proceed with the planned increase in the number of guests to 50 at the wedding ceremony and reception with protective measures from 5 July. 50 guests, including children, are permitted to attend. The Fáilte Ireland guidelines on weddings can be found online: covid19.failteireland.ie/operational-guidelines/

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. To protect the gains of recent months we must continue to practice basic preventative behaviours and to follow public health guidelines.

Question No. 1747 answered with Question No. 1685.

Health Services

Ceisteanna (1748)

Chris Andrews

Ceist:

1748. Deputy Chris Andrews asked the Minister for Health the status of an application by a person (details supplied) for respite care; and when they can expect a decision on their case. [35456/21]

Amharc ar fhreagra

Freagraí scríofa

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.

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