Written Answers Nos. 516-535
516. Deputy Éamon Ó Cuív asked the Minister for Health the reason a person (details supplied) is repeatedly requested to provide information that has been fully provided as per their own request; the steps he will take to ensure this matter is resolved expeditiously to ensure that the HSE provide good and efficient service to the public; and if he will make a statement on the matter. [22656/21]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
517. Deputy John Lahart asked the Minister for Health his plans for the introduction of the FreeStyle Libre glucose monitoring system for persons over 21 years of age with type 1 diabetes on the long-term illness scheme. [22657/21]
Amharc ar fhreagraUnder the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the community drug schemes; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
518. Deputy Willie O'Dea asked the Minister for Health his views on whether the potential introduction of a Covid-19 vaccine certificate, vaccine pass or immunity certificate to govern access to services, goods or employment would amount to discrimination against sections of the population; his further views on whether vaccine certificate systems at a national level would lead to a two-tier Ireland, marginalizing those who cannot access, cannot medically receive or may simply object to receiving a vaccine and that this would be an infringement on the fundamental rights of Irish citizens to exercise self-governance without coercion over their own bodily autonomy; if he will address the matter given that he failed to address the issue of potential discrimination in response Parliamentary Question No. 1911 of 21 April 2021; and if he will make a statement on the matter. [22659/21]
Amharc ar fhreagraIt is important to differentiate between a vaccine certificate, the purpose of which is to provide evidence that a particular vaccine has been administered to a certain individual on a certain date, with the notion of an immunity certificate which might exempt people from public health measures on the basis that the person is purportedly immune to SARS-CoV-2.
As well as providing a record of vaccination, vaccine certificates also facilitate follow up of adverse events. The HSE is planning for the production of vaccine certificates at part of its implementation planning for a COVID-19 vaccination programme.
Immunity certificates are problematic on a number of grounds. It is not yet clear if the proposed vaccines for COVID-19 actually stop people getting the virus. It is also not clear whether the thresholds for protective immunity are the same in all groups e.g. older persons or those who are immunosuppressed.
On 17 March 2021, the European Commission published its proposal for a Regulation to introduce a ‘Digital Green Certificate’ to facilitate safe free movement inside the EU during the pandemic.
This proposed regulation lays down a framework for the issuance, verification and acceptance of interoperable certificates to facilitate people’s fundamental right to move and reside freely within the EU. Possession of a Digital Green Certificate shall not be a precondition to exercise free movement rights. Careful consideration is being given to the proposal and its many policy, ethical, infrastructural and operational implications across a number of sectors.
Vaccine/immunity certificates can be used in ways that may conceivably both restrict and promote the exercise of human rights and fundamental freedoms. The Department is currently examining the impact such certificates could have on public trust and solidarity, as well as their potential for discrimination and stigmatisation of certain individuals/groups in society. Questions of national as well as international equity are being considered, as are the privacy implications of introducing such digital certificates. The ethical and human rights issues attendant to this issue will be considered as part of the broader policy position.
519. Deputy Jim O'Callaghan asked the Minister for Health the protections in place for children who are required to quarantine under section 38B of the Health Act 1947 (as amended); and if he will make a statement on the matter. [22666/21]
Amharc ar fhreagraMandatory hotel quarantine has been introduced as one element of Ireland’s public health measures to combat the transmission of COVID-19 variants of concern.
The Health Act 1947, as amended, provides that all persons arriving in Ireland from a designated state, or having travelled through a designated state in the previous 14 days, are required to undergo mandatory quarantine in a designated facility unless they are an exempted traveller under the Act. All applicable travellers must reserve and pay for a place in mandatory hotel quarantine.
Unaccompanied minors who have travelled from or through a designated state in the 14 days prior to arrival in Ireland will not be permitted to enter a mandatory quarantine facility alone. To board a flight/ferry to Ireland, an unaccompanied minor must produce a negative RT-PCR test within the last 72 hours and their passport.
Their adult guardian can enter mandatory hotel quarantine with them, however, if this is not possible a responsible adult collecting the unaccompanied minor must sign a guardian release letter undertaking in writing the legal responsibility for ensuring that, the unaccompanied minor, will complete the mandatory 14-day quarantine at a specified address and that it is possible to effectively isolate at the said address.In instances where an unaccompanied minor is arriving in Ireland to attend boarding school, a school representative must present themselves to Irish Immigration authorities with proper identification and on arrival, they will fill in, sign and return the Guardian Release Letter to the Irish immigration official. It is a criminal offence to give misleading or fraudulent information to an Irish immigration official.
Arrangements are also in place with Tusla (the Child and Family Agency) to provide suitable accommodation for any unaccompanied child arriving from designated states who is required to complete their mandatory 14-day quarantine under Tusla's care.
As of 17th April, passengers who are fully vaccinated and have the documents to confirm this are no longer 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 in this instance. Please note that the 4 EMA approved vaccines currently accepted have specific definitions for when a person would be considered ‘fully vaccinated’. Passengers who are fully vaccinated and exempt from hotel quarantine are still subject to other travel restrictions, such as the need to provide a negative pre-departure PCR test and complete a period of self-quarantine at home or wherever specified in their passenger locator form. Neither I as Minister for Health nor my Department have a role in decisions relating to whether individual persons must enter mandatory quarantine or whether individual persons are exempted travellers. All such decisions are to be determined in accordance with the provisions of the Act.
Further information can be accessed on www.gov.ie/quarantine.
520. Deputy Neale Richmond asked the Minister for Health the current position regarding pregnant women receiving the Covid-19 vaccine; if they will be prioritised for the Covid-19 vaccine given the risk of Covid placentitis; and if he will make a statement on the matter. [22667/21]
Amharc ar fhreagraThe immunisation programme in Ireland is based on the advice of the National Immunisation Advisory Committee (NIAC). The committee's recommendations are based on the prevalence of the relevant disease in Ireland and international best practice in relation to immunisation. It makes recommendations on vaccination policy to my Department. The NIAC review all data relating to COVID-19 vaccines on a rolling basis.
Pregnant women are at similar risk of COVID-19 infection to non-pregnant women of the same age. The overall risk of severe illness in pregnancy is low. However, pregnant women with COVID-19 infection are more likely to develop serious disease or to die than either pregnant women without COVID-19 or similar aged non-pregnant women with COVID-19. Additionally, COVID-19 in pregnancy may increase the risk of adverse pregnancy outcomes, such as preterm birth.
NIAC recommends that pregnant women should be offered mRNA COVID-19 vaccination between 14-36 weeks gestation following an individual benefit/risk discussion with their obstetric care giver.
521. Deputy Jim O'Callaghan asked the Minister for Health when persons who do not wish to take a vaccine (details supplied) may be able to receive a different vaccine; and if he will make a statement on the matter. [22670/21]
Amharc ar fhreagraWhile a person can, of course, refuse any offer of vaccination on religious, conscientious or other grounds, provision of one or other authorised COVID-19 vaccine(s) during the immunisation programme will be based on clinical expert guidance, including from the National Immunisation Advisory Committee, to ensure the optimal stewardship of scarce resources and equitable access to safe and effective vaccine(s) for a given population.
As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
522. Deputy Jim O'Callaghan asked the Minister for Health if it is necessary to seek a waiver of the trade and intellectual property rules for Covid-19 vaccines in order to protect developing countries from the threat of Covid-19; if so, the steps taken to obtain this waiver; and if he will make a statement on the matter. [22677/21]
Amharc ar fhreagra551. Deputy Louise O'Reilly asked the Minister for Health if he has engaged at European Union level regarding the waiving of intellectual property rights on Covid-19 vaccines in order to speed up vaccination production and distribution across Europe and the wider world. [22790/21]
Amharc ar fhreagraI propose to take Questions Nos. 522 and 551 together.
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 EU 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.
523. Deputy Joe Flaherty asked the Minister for Health the details of the planned payment of €800,000 for services (details supplied) to address historical underfunding at the service provider. [22678/21]
Amharc ar fhreagraThe Government is committed to providing services and supports for people with disabilities which will empower them to live independent lives, provide greater independence in accessing the services they choose, and enhance their ability to tailor the supports required to meet their needs and plan their lives.
As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
524. Deputy Michael Healy-Rae asked the Minister for Health the status of an operation for a person (details supplied); and if he will make a statement on the matter. [22681/21]
Amharc ar fhreagraUnder 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.
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.
525. Deputy Brendan Howlin asked the Minister for Health the relative accepted efficacy rate of the authorised vaccines for Ireland (details supplied); the understood effectiveness of each of these vaccines for new variants of Covid-19; and if he will make a statement on the matter. [22688/21]
Amharc ar fhreagraCovid-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. Any authorised vaccine will be subject to ongoing monitoring in Ireland by the Health Product Regulatory Authority (HPRA).
The EMA’s human medicines committee (CHMP) has thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorisation be granted by the European Commission.
Following the recommendation for use of vaccines against COVID-19 by the European Medicines Agency (EMA) and authorisation for use by the European Commission, the National Immunisation Advisory Committee (NIAC) develops guidance for their use in Ireland which is contained in the Immunisation Guidelines for Ireland. These guidelines are continuously updated and includes guidance on all new vaccines as they are approved for use in Ireland.
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 safety and efficacy.
Recently, the Commission has engaged in negotiations with Pfizer/BioNTech with a view to securing a Purchase Agreement for 900m doses of its vaccine on behalf of Member States, with provision for an additional 900m doses, for 2022/2023. Pfizer/BioNTech's vaccine is based upon mRNA technology, providing scope for it to be adjusted to deal with variants of Covid-19.
In conjunction with this, the new European bio-defence preparedness plan against COVID-19 variants called “HERA Incubator” will work with researchers, biotech companies, manufacturers and public authorities in the EU and globally to detect new variants, provide incentives to develop new and adapted vaccines, speed up the approval process for these vaccines, and ensure scaling up of manufacturing capacities.
The WHO weekly Epidemiological Update provides an overview of the global, regional and country-level COVID-19 cases and deaths, highlighting key data and trends; as well as other pertinent epidemiological information concerning the COVID-19 pandemic including the efficacy of vaccines against variants:
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports
526. Deputy Brendan Howlin asked the Minister for Health the recommended time interval between first and second doses as advised by the vaccine manufacturers for vaccines (details supplied); and if he will make a statement on the matter. [22689/21]
Amharc ar fhreagra527. Deputy Brendan Howlin asked the Minister for Health further to his response during a debate in Dáil Éireann on 22 April 2021, if he has re-examined the time interval between doses of a vaccine (details supplied); his views on whether it is contrary to health policy to have less vulnerable groups fully vaccinated before more vulnerable cohorts; his plans to ensure that persons are vaccinated with their first and second doses of the vaccine in accordance with the schedule published; and if he will make a statement on the matter. [22690/21]
Amharc ar fhreagraI propose to take Questions Nos. 526 and 527 together.
Ireland’s COVID-19 vaccination programme strategy is to distribute all available vaccine as quickly as is operationally possible, prioritising those who are most vulnerable to COVID-19.
The programme is based on the principles of safety, effectiveness and fairness, with the objective of reducing severe illness, hospitalisations and deaths from COVID-19 infection.
The immunisation programme in Ireland is based on the advice of the National Immunisation Advisory Committee (NIAC). The Committee's recommendations are based on the prevalence of the relevant disease in Ireland and international best practice in relation to immunisation. It makes recommendations on vaccination policy to my Department. The NIAC review all data relating to COVID-19 vaccines on a rolling basis.
Following the recommendation for use of vaccines against COVID-19 by the European Medicines Agency (EMA) and authorisation for use by the European Commission, the National Immunisation Advisory Committee develops guidance for their use in Ireland which is contained in the Immunisation Guidelines for Ireland. These guidelines are continuously updated and includes guidance on all new vaccines as they are approved for use in Ireland.
You can read the guidelines at:
https://www.hse.ie/eng/health/immunisation/hcpinfo/guidelines/covid19.pdf
The recommended time interval between the first and second doses of Comirnaty (Pfizer) is 21-28 days apart.
The recommended time interval between the first and second doses of COVID-19 Vaccine Moderna is 28 days apart.
Vaxzevria (AstraZeneca) is authorised as a two-dose course 4-12 weeks apart.
As alternative vaccines are available, mRNA vaccines are preferable for those aged under 50 years including those with medical conditions with very high or high risk of severe COVID-19 disease.
- Those who have received a first dose of Vaxzevria:
- aged 50 and older should receive their second dose 12 weeks later as scheduled. A shorter interval of 4 - <12 weeks may be used in exceptional circumstance
- aged under 50 years with a very high risk or high risk medical condition should receive their second dose 12 weeks later as scheduled
- aged under 50 years without a very high risk or high risk medical condition should have their second dose scheduled at 16 weeks, pending the availability of further evidence to permit better assessment of the benefits and risks. However, there may be others aged under 50 years who, fully informed of the very rare risk and symptoms of TTS, wish to receive their second dose after 12 weeks and they should be facilitated where feasible.
528. Deputy Catherine Connolly asked the Minister for Health his plans to review the ongoing attendance and visiting restrictions on partners at maternity hospitals, particularly in view of discrepancies in Covid-19 restrictions between different maternity hospitals nationwide; and if he will make a statement on the matter. [22693/21]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
529. Deputy Catherine Connolly asked the Minister for Health the risk analysis his Department or bodies under the aegis of his Department have carried out into the easing of Covid-19 restrictions in the maternity department of University Hospital Galway in order that partners may visit wards outside of the one hour daily slot currently allocated and may spend more than 30 minutes in the neonatal intensive care unit; the details of the frequency of risk assessments carried out in this regard; the details of the criteria taken into account in these risk assessments; and if he will make a statement on the matter. [22694/21]
Amharc ar fhreagraAs this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
530. Deputy Matt Shanahan asked the Minister for Health the proposed commencement date for construction to commence on the new cath laboratory at Waterford; the scheduled completion date based on the start date provided; the proposed commissioning date and handover date envisaged once building works are completed; and if he will make a statement on the matter. [22700/21]
Amharc ar fhreagraAs the Health Service Executive is responsible for the delivery of public healthcare infrastructure projects, I have asked the HSE to respond to you directly in relation to this matter.
533. Deputy David Cullinane asked the Minister for Health if he will advise on a matter raised in correspondence in relation to accessing a general practitioner (details supplied); and if he will make a statement on the matter. [22713/21]
Amharc ar fhreagraThe issues outlined in the Deputy's correspondence relate to service provision. I have referred the matter to the Health Service Executive, and asked that they respond directly to the Deputy.
534. Deputy Róisín Shortall asked the Minister for Health if he will engage with an institute (details supplied) regarding its offer for members of the institute to be added to the list of authorised persons in regulation 4F of SI No. 698 of 2020 in order to help with the Covid-19 vaccination programme; and if he will make a statement on the matter. [22715/21]
Amharc ar fhreagraThe HSE is building and deploying its workforce in order to be prepared for the requirements associated with rolling out the COVID-19 vaccine programme.
GPs, Pharmacists, doctors, nurses, paramedics, and many healthcare professionals, will have a role to play in the vaccination programme.
In addition, on Tuesday 23 February 2021, the Minister for Health signed the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2021. The purpose of these amending Regulations is to add registered optometrists and registered dentists to the list of professionals who may supply and administer Covid-19 vaccinations.
The vaccine rollout is being conducted on a 7-day week basis and to date, over 12,500 staff have received training to operate as vaccinators. To support the expanded immunisation programme the HSE launched a vaccinator recruitment campaign at the end of February.
The inclusion of additional professions to participate as vaccinators in the programme is currently being considered. A statutory instrument to provide for this will be finalised shortly.
535. Deputy Róisín Shortall asked the Minister for Health the status and timeline for publication of draft changes to the Mental Health Act 2001; and if he will make a statement on the matter. [22719/21]
Amharc ar fhreagraThe Mental Health Act 2001 sets out how people who require inpatient mental health services should be cared for and treated, particularly those who are involuntarily detained in approved centres. The Act also provided for the establishment of the Mental Health Commission, the regulator of mental health services in the State, an Inspector of Mental Health Services within the Commission and safeguards for service users, including the right to a review mechanism through the mental health tribunals process. A 2015 decision by the Government of the day called for a draft general scheme to amend the Act to be produced, in line with the 165 recommendations of the 2015 Expert Group Review report. Among the Expert Group recommendations were proposals on revised criteria for detention, updated definitions of mental illness and voluntary and involuntary patients, the introduction of guiding principles, statutory individual care plans, a greater role for Authorised Officers in involuntary admissions, improved safeguards for service users and shorter intervals for tribunals. The Expert Group also recommended that there be a presumption of capacity for young people aged 16 and 17 to consent or refuse treatment, unless proven otherwise, and the introduction of guiding principles for the care of children under the Act. The Department is now finalising the draft general scheme to amend the Mental Health Act, taking into consideration the recommendations of the Expert Group, relevant domestic legislation such as the Assisted Decision-Making (Capacity) Act 2015, Ireland’s international obligations under the UN Convention on the Rights of Persons with Disabilities, relevant Private Members’ Bills, the Mental Health (Amendment) Act 2018, extensive consultation with key stakeholders such as the Commission and the HSE, and the results of a recently concluded public consultation, which saw 100 submissions received by the Department. A legal review of the draft general scheme is currently underway and is expected to conclude shortly. Final comments from key stakeholders such as the Commission and the HSE are expected by the end of April, and the Department will review these final submissions, as well as any submissions received as part of the legal review process, over the next two months, and will inform the final draft legislation. I expect that Government approval of the draft general scheme will be sought before the Dáil summer recess with a view to it being published as part of the autumn legislative programme.
