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Wednesday, 30 Jun 2021

Written Answers Nos. 287-302

Proposed Legislation

Questions (288)

Jim O'Callaghan

Question:

288. Deputy Jim O'Callaghan asked the Minister for Health if he will address issues relating to assisted human reproduction (details supplied). [28207/21]

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Written answers

As the Deputy will be aware, drafting of a bill on assisted human reproduction (AHR) and associated areas of research, based on the published General Scheme of the Assisted Human Reproduction Bill, is ongoing by officials in my Department, in conjunction with the Office of the Attorney General. This comprehensive piece of legislation will encompass the regulation, for the first time in Ireland, of a very wide range of practices, including domestic altruistic surrogacy.

The General Scheme does not contain provisions to regulate surrogacy arrangements undertaken in other jurisdictions. As issues relating to international surrogacy concern areas of law that intersect across the remits of several Government Departments, my Department is engaging with the Department of Justice and the Department of Children, Equality, Disability, Integration and Youth in respect of this policy area.

Overall, the aim of the AHR legislation is to promote and ensure the health and safety of parents and others involved in the process (such as donors and surrogate mothers), while, most importantly, consideration of the welfare and best interests of children born as a result of AHR is the key principle underpinning all legislative measures in this area.

Covid-19 Pandemic

Questions (289)

Mark Ward

Question:

289. Deputy Mark Ward asked the Minister for Health when gaming arcades will be permitted to open under the current restrictions. [28208/21]

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Written answers

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 adherence by the public to the public health measures in place, and this progress has been sustained during recent phases of reopening in April, May and June.

While significant progress is being made in relation to the roll-out of our vaccination programme and the current situation is broadly stable, the prevalence of the more transmissible Delta variant is rapidly increasing in Ireland and this poses a significant risk, in particular to those who are not yet fully protected though vaccination.

On 29 June, Government announced the next phase of reopening the economy and society in line with Recovery and Resilience: The Path Ahead, with an emphasis on lower risk activities given the risks posed by the Delta variant. Higher risk indoor activities, including organised events, service in bars and restaurants, group training, exercise and dance will not yet recommence, pending the implementation of a system to verify vaccination or immunity status. Indoor settings including gaming arcades are among the settings which will not yet reopen.

As we further ease public health measures, our approach must continue to be cautious, gradual and phased, with sufficient time between any easing of measures to assess the impact. This will be critical to ensure that our progress in controlling the virus is maintained.

Significant and sustained 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.

Disabilities Assessments

Questions (290)

Kathleen Funchion

Question:

290. Deputy Kathleen Funchion asked the Minister for Health when a child (details supplied) can expect an ASD assessment. [28209/21]

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Written answers

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.

Disabilities Assessments

Questions (291)

Kathleen Funchion

Question:

291. Deputy Kathleen Funchion asked the Minister for Health when a child (details supplied) can expect an ASD assessment. [28210/21]

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Written answers

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.

Vaccination Programme

Questions (292)

Kathleen Funchion

Question:

292. Deputy Kathleen Funchion asked the Minister for Health when a person (details supplied) will receive a vaccine; and if the matter will be expedited as a matter of urgency in view of the circumstances. [28211/21]

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Written answers

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. 293 answered with Question No. 271.

Medicinal Products

Questions (294)

Neale Richmond

Question:

294. Deputy Neale Richmond asked the Minister for Health the estimated timeline for the process of adding a new drug to the primary care reimbursement service from product review to inclusion; and if he will make a statement on the matter. [28213/21]

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Written answers

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines.

In line with the 2013 Health Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.

Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (the NCPE). They use a decision framework to systematically assess whether a drug is cost-effective as a health intervention.

As outlined in the IPHA agreement, and in line with the 2013 Act, the HSE will decide, within 180 days of receiving an application (or a longer period if further information is sought from the company), to either add the medicine to the reimbursement list or agree to reimburse it as a hospital medicine, or refuse to reimburse the medicine.

The HSE strives to reach a decision in as timely a manner as possible. However, because of the significant monies involved, it must ensure that the best price is achieved, as these commitments are often multi-million euro investments on an ongoing basis. This can lead to a protracted deliberation process.

When there is a proposed decision by the HSE not to support reimbursement of a medicine, there is an extension in this timeline. This is due to the requirement of the HSE to issue a “notice of proposal”, and to allow 28 days for manufacturers to make representations to reconsider their decision. The HSE must then consider those representations and make a formal decision.

Question No. 295 answered with Question No. 271.
Question No. 296 answered with Question No. 271.

Health Services

Questions (297)

Kathleen Funchion

Question:

297. Deputy Kathleen Funchion asked the Minister for Health when a person (details supplied) will receive the necessary therapies they have been waiting for given the long delays in relation to same. [28216/21]

View answer

Written answers

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

Questions (298)

Pauline Tully

Question:

298. Deputy Pauline Tully asked the Minister for Health the reason that only six and 15 guests can attend a wedding ceremony inside and outside, respectively while 50 guests can attend the reception for the same wedding; if the rationale behind this policy takes into account the size of the location in which the ceremony or reception is to take place; if persons who have been vaccinated can be treated as surplus to the permitted number of guests; and if he will make a statement on the matter. [28217/21]

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Written answers

As the Deputy will be aware, 50 people can currently attend a wedding service (both religious and civil) and 25 people can attend a wedding celebration or reception. On 29 June, Government announced the next phase of reopening the economy and society in line with Recovery and Resilience: The Path Ahead. While a number of higher risk indoor activities will not recommence as planned on the 5th July, pending the implementation of a system to verify vaccination or immunity status, it has been announced that, as an exception, weddings already planned will be allowed to proceed with the planned increase in the number of guests to 50 at the wedding reception with protective measures.

While significant progress is being made in relation to the roll-out of our vaccination programme and the current situation is broadly stable, the prevalence of the more transmissible Delta variant is rapidly increasing in Ireland and this poses a significant risk, in particular to those who are not yet fully vaccinated.

As we further ease public health measures, our approach must continue to be cautious, gradual and phased, with sufficient time between any easing of measures to assess the impact. This will be critical to ensure that our progress in controlling the virus is maintained. Significant and sustained 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.

Covid-19 Pandemic

Questions (299)

Niall Collins

Question:

299. Deputy Niall Collins asked the Minister for Health if the position of mandatory hotel quarantine for incoming visitors from the USA will be clarified as outlined on correspondence by a person (details supplied); and if he will make a statement on the matter. [28236/21]

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Written answers

All adults who enter the State from abroad are subject to the Government's current travel restrictions upon arrival, unless exempted.

As of May 28th, persons arriving from the United States of America are no longer automatically subject to Mandatory Hotel Quarantine. However, they are still subject to other travel restrictions such as home quarantine, supplying passenger locator form information and ensuring they have evidence of a negative RT-PCR test which was taken in the 72 hours before arrival in the State.

Mandatory hotel quarantine is necessary in circumstances where passengers coming from non-designated countries do not provide evidence that they have a negative or ‘not detected’ result from a COVID-19 Reverse Transcription Polymerase Chain Reaction (RT-PCR) test carried out no more than 72 hours before arrival into Ireland.

Vaccination Programme

Questions (300)

Paul Murphy

Question:

300. Deputy Paul Murphy asked the Minister for Health when a person (details supplied) will be called for vaccination. [28243/21]

View answer

Written answers

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. 301 answered with Question No. 280.

Vaccination Programme

Questions (302)

David Cullinane

Question:

302. Deputy David Cullinane asked the Minister for Health if he has engaged with the NIAC in order to consider the possibility of an mRNA vaccine as the second dose for the 60-69 age group; and if he will make a statement on the matter. [28245/21]

View answer

Written answers

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 include guidance on all new vaccines as they are approved for use in Ireland. The current Guidelines state the four COVID-19 Vaccines currently authorised for use in Ireland are not interchangeable. For vaccines that have a two-dose schedule, the same vaccine should be used for both doses.

You can read the guidelines at: www.hse.ie/eng/health/immunisation/hcpinfo/guidelines/covid19.pdf

There is insufficient evidence to recommend a change from the authorised two-dose Vaxzevria® schedule or to support giving an mRNA vaccine instead of a second dose of Vaxzevria®. There is a need for further evidence on the safety and effectiveness of mixed (heterologous)vaccine schedules. Further information is expected in the coming months which may warrant an update of these recommendations.

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