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Gnáthamharc

Thursday, 1 Jul 2021

Written Answers Nos. 386-405

Medicinal Products

Ceisteanna (386)

Neale Richmond

Ceist:

386. Deputy Neale Richmond asked the Minister for Health if he has considered adding a suitable product for those with epilepsy to the Medical Cannabis Access Programme; and if he will make a statement on the matter. [28537/21]

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 (387)

Mattie McGrath

Ceist:

387. Deputy Mattie McGrath asked the Minister for Health the current position in relation to persons travelling to Ireland who have been fully vaccinated with any of the WHO and EMA approved vaccines following the agreement by the European Union in relation to fully re-opening to vaccinated visitors from outside the EU; and if he will make a statement on the matter. [28660/21]

Amharc ar fhreagra

Freagraí scríofa

Under the current public health travel measures, travellers arriving into Ireland from all overseas are required to complete a COVID-19 Passenger Locator Form, to present evidence of a negative / non-detected pre-departure RT-PCR test taken within 72 hours of arrival and to observe mandatory quarantine.

The pre-departure PCR test result is currently required for all overseas arrivals, even vaccinated persons.

The Government has announced revised travel policies to take effect from 19 July in keeping with the EU Digital Covid Certificate. International travel policy is kept under continuous consideration and Government is responding proactively to balancing the risks associated with increased travel with the re-opening of society and non-essential overseas travel.

Covid-19 Pandemic

Ceisteanna (388)

Mattie McGrath

Ceist:

388. Deputy Mattie McGrath asked the Minister for Health the current position in relation to those travelling from Abu Dhabi who have received a vaccine (details supplied); if they will be exempted from MHQ; and if he will make a statement on the matter. [28661/21]

Amharc ar fhreagra

Freagraí scríofa

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.

The following table sets out the definition of ‘fully vaccinated’;

Type of Vaccine

You are regarded as fully vaccinated after

Pfizer-BioNtech

7 days after 2nd dose

Moderna

14 days after 2nd dose

Oxford-AstraZeneca

15 days after 2nd dose

Johnson & Johnson/Janssen

14 days after single dose

Fully vaccinated travellers are still required to have a negative pre-departure RT-PCR test and complete a period of self-quarantine at home or wherever specified in their passenger locator form.

Ireland supports the EU Procurement Process, the purpose of which is to secure safe and efficacious vaccines for EU citizens.

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 safety and efficacy.

The Sinopharm vaccine has not been awarded a CMA to date.

Health Services Staff

Ceisteanna (389)

Martin Browne

Ceist:

389. Deputy Martin Browne asked the Minister for Health the measures he is taking to ensure that hospital staff are supported in doing their work during the extraordinary situation in which they find themselves following the cyber-attack. [28662/21]

Amharc ar fhreagra

Freagraí scríofa

I am grateful for the measures being taken by all public health sector staff in trying to maintain services that have been impacted by the recent cyber attack.

Supporting staff impacted by the recent cyber attack against the HSE is a matter for the HSE to respond on. However, members of the Oireachtas are advised that the HSE is currently unable 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.

Hospital Waiting Lists

Ceisteanna (390)

Martin Browne

Ceist:

390. Deputy Martin Browne asked the Minister for Health the measures he is taking to address the increased waiting lists that will result from the suspension of many procedures due to the recent cyber-attack. [28663/21]

Amharc ar fhreagra

Freagraí scríofa

It is recognised that waiting times for scheduled appointments and procedures have been impacted in the last year as a direct result of the COVID-19 pandemic.

While significant progress was made in reducing waiting times from June 2020 onwards, the surge in Covid-19 cases in the first quarter of 2021, and the resultant curtailment of acute hospital services, is reflected in the current waiting list figures.

On 23 March 2021 the HSE published the “Safe Return to Health Services Plan”, outlining a three phased approach for the proposed restoration of services across Community Services, Acute Hospital Operations, Cancer Services and Screening Services. It sets target times for their safe return and details the conditions and challenges that will have to be met. However, the implementation of this plan has been suspended pending the resolution of the recent ransomware attack, which is having a significant impact on acute hospitals. The HSE is focusing on urgent and time critical appointments and procedures until this incident is resolved. Once the incident is resolved the focus will return to restoring routine elective services.

Due to the ongoing IT issues triggered by the HSE cyber-attack, the National Treatment Purchase Fund (NTPF) has been unable to receive weekly national hospital waiting list data or downloads. The latest available waiting list information was collated by the NTPF on 13th May 2021. This data highlights that the Inpatient/Daycase waiting list increased by 6% to 76,510 since the start of the year, the Outpatient waiting list increased by 4% to 630,270, while the GI Scopes waiting list by 6% to 34,377 in the same period.

My Department does not have full access to information on the impact of this ransomware attack on elective waiting lists but will provide an update as soon as one is available.

My Department, the HSE and the NTPF are putting in place plans to improve access to elective care and reduce waiting times for patients. These plans include increased use of private hospitals, funding weekend and evening work in public hospitals, funding “see and treat” services where minor procedures are provided at the same time as outpatient consultations, providing virtual clinics and increasing capacity in the public hospital system.

An additional €240 million has been provided in Budget 2021 for an access to care fund, €210m of which has been allocated to the HSE and a further €30m to the NTPF. This will be used to fund additional capacity to address the shortfall arising as a result of infection control measures taken in the context of COVID-19, as well as addressing backlogs in waiting lists.

My Department, the HSE and the NTPF are currently in the process of finalising a Multiannual Waiting List Reduction Plan to address waiting lists and bring them in line with Sláintecare targets over the coming years.

Cybersecurity Policy

Ceisteanna (391)

Martin Browne

Ceist:

391. Deputy Martin Browne asked the Minister for Health the measures he plans to take to prevent to the greatest extent possible the reoccurrence of a similar cyber-attack. [28664/21]

Amharc ar fhreagra

Freagraí scríofa

Improved security measures have already been put in place within my Department's IT systems. A complete security review of the ICT infrastructure is currently being finalised and specialised software has been installed to mitigate against malicious software, and to provide early warning notifications of same. The system is fully monitored, providing for a rapid response to any notified incidents.

My Department continues to liaise closely with the National Cyber Security Centre, the Office of the Government Chief Information Officer, our security partner and with colleagues across the Public Service to ensure that best practice is followed as it relates to all aspects of cyber security.

In the wake of the recent ransomware attack, the Health Service Executive has deployed additional expertise, resources and technology to provide enhanced monitoring of systems and networks. This is considered an interim measure as they procure a permanent Security Operations Centre to provide security and threat incidence monitoring and response, including:

- Monitoring and alerting on portals and software;

- Monitoring and incident management of all devices on the network to ensure that all devices are compliant with rules/policies;

- Threat incident response including triage, close and/or escalation

National Maternity Hospital

Ceisteanna (392)

Neale Richmond

Ceist:

392. Deputy Neale Richmond asked the Minister for Health the status of the transfer of the National Maternity Hospital from Holles Street to St. Vincent’s Hospital; the timelines for developing the new national maternity hospital at St. Vincent’s Hospital campus; the estimated costs of construction to date; and if he will make a statement on the matter. [28665/21]

Amharc ar fhreagra

Freagraí scríofa

The Government is committed to the development of the new National Maternity Hospital (NMH) planned for the St Vincent’s University Hospital Campus at Elm Park, as set out in the Programme for Government. Significant progress has been made on the capital project, with planning permission for the hospital secured in 2017 and, in 2018, the awarding of contract for substantial enabling works.

As the Deputy will be aware the ownership and governance arrangements in relation to the new NMH are more complex. The proposed corporate and clinical governance arrangements for the new NMH at Elm Park were set out in the Mulvey Agreement, which was finalised in 2016 following an extensive mediation process between the NMH and the St. Vincent’s Healthcare Group, published thereafter and noted by Government in 2017. The Mulvey Agreement provides for the establishment of a new company - National Maternity Hospital at Elm Park DAC - which will have clinical and operational, as well as financial and budgetary, independence in the provision of maternity, gynaecology and neonatal services. A draft legal framework has subsequently been developed in order to copperfasten these arrangements, and further engagement is anticipated as part of ensuring that the State’s significant investment will be protected and that all legally permissible services will be provided in the new NMH.

A business case for this relocation project was submitted to the Department 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. It will be submitted to the Department, as Approving Authority, and to DPER for technical review in due course.

Timelines for the new hospital are subject both to satisfactory finalisation of the legal arrangements, and approval of the business case, and therefore not yet available. I have been advised that the amount expended to date on construction works only for the new NMH on the St Vincent’s University Hospital campus is €51.2m inclusive of VAT.

Hospital Facilities

Ceisteanna (393)

Neale Richmond

Ceist:

393. Deputy Neale Richmond asked the Minister for Health the status of plans to move four maternity hospitals from their current locations to be co-located with an acute adult hospital: Holles Street, the Coombe, the Rotunda and Limerick Maternity Hospitals; and if he will make a statement on the matter. [28666/21]

Amharc ar fhreagra

Freagraí scríofa

In line with best international practice, it is Government policy, as set out in the National Maternity Strategy, that standalone maternity hospitals will be co-located with acute adult hospitals. In the context of promoting women’s health, the Programme for Government commits to progress the planning, tender and design stages for the relocation of the Coombe Hospital to St James’s, the Rotunda Hospital to Connolly, and Limerick University Maternity Hospital to University Hospital Limerick. The Programme for Government also commits to conclude the governance arrangements and commence the building of the new maternity hospital at St Vincent’s Hospital, Dublin.

The National Development Plan identifies the implementation of the National Maternity Strategy as a major investment programme for the sector to provide an appropriate environment within all our maternity hospitals/units to facilitate the delivery of a modern, safe, quality service where the woman’s need for privacy and dignity is respected. In this regard the four sites for proposed co-location, referenced above, are included in the National Development Plan. The new maternity hospital at the St Vincent’s University Hospital Campus is intended to be the first of these to be developed, and the relocation of the other maternity hospitals will follow in time.

In relation to the relocation of the NMH to the St Vincent’s University Hospital, significant progress has been made on the capital project, with planning permission for the hospital secured in 2017 and, in 2018, the awarding of contract for substantial enabling works. In parallel, work is ongoing in relation to the governance and ownership arrangements for the new hospital, to protect the State's significant investment and to provide assurance that all legally permissible services will be provided in the new hospital.

In addition, a business case for the NMH relocation project was submitted to the Department 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. It will be submitted to the Department, as Approving Authority, and to DPER for technical review in due course. Timelines for the new hospital are subject both to satisfactory finalisation of the legal arrangements, and approval of the business case.

The other relocation projects are at an early stage and all of these project proposals must progress through a number of approval stages, in line with the PSC, including detailed appraisal, planning, design and procurement before a firm timeline or funding requirement can be established. Approval must be received for each individual stage to ensure that the proposal delivers value for money and remains affordable, and that sufficient funding is available to fund the project to completion, including equipping and commissioning costs.

Health Services

Ceisteanna (394, 395)

Mary Lou McDonald

Ceist:

394. Deputy Mary Lou McDonald asked the Minister for Health further to Parliamentary Question No. 781 of 10 March 2021, the status of the work undertaken by CHO6 to reopen the GMHS; the progress made to date regarding the recruitment of permanent staff , administration staff and IT expansion; and if he will make a statement on the matter. [28667/21]

Amharc ar fhreagra

Mary Lou McDonald

Ceist:

395. Deputy Mary Lou McDonald asked the Minister for Health the indicative timeframe for when the GMHS will fully reopen; and if he will make a statement on the matter. [28668/21]

Amharc ar fhreagra

Freagraí scríofa

I propose to take Questions Nos. 394 and 395 together.

The Gay Men's Health Service is a community STI service, managed through HSE Community Healthcare East (CHO6).

The Gay Men's Health Service (GMHS) reopened in January 2021 on a phased basis and in line with Government and HSE guidelines. The GMHS PrEP service has recommenced and is seeing both new and returning service users. The Clinic’s Consultant in Infectious Diseases (GMHS and GUIDE Clinic, St James’s Hospital) and other doctors are providing virtual consultations, and PrEP service users attend GMHS for STI screening, blood testing and treatment as required.

Those with diagnosed STIs or requiring Hepatitis and/or HPV vaccine continue to be treated in GMHS also. A weekly STI clinic has commenced for symptomatic screening and treatment of both new and returning service users and, also, follow up for those who require further treatment or vaccinations. The GMHS Nurse led asymptomatic screening service has also been re-instated, following the recent HSE cyber attack.

The closure of the GMHS in 2020 resulted from the pressures arising from the Covid-19 pandemic and related primarily to the necessary redeployment of increasing numbers of personnel to diverse COVID-19 related duties. Staff in the Gay Men’s Health Service (GMHS) were reassigned, by reason of necessity, to other HSE services. Following the GMHS closure, significant efforts were made to maintain service provision through other locations, including the GUIDE Clinic in St. James’ Hospital.

Prior to the pandemic, the GMHS was staffed by 97% agency staff; this is no longer the case. Funding for the PrEP programme allowed pro-rata recurring funding to be allocated to GMHS in 2020. As a result of pandemic related pressures on staffing, recruitment in 2020 initially focused on the services required to support the Covid-19 pandemic. However, a recruitment campaign to fill the posts for the GMHS PrEP programme commenced in the latter part of 2020 and is progressing well, with the recruitment of additional nurses underway. IT improvements have also been put in place.

HSE Community Healthcare East advises that they have made every effort to restore, and maintain services as far as is possible, given current pandemic related pressures on resources. It should be noted that, in order to ensure compliance with HSE Covid-19 safety measures, capacity at clinics is somewhat reduced, in order to maintain adherence to social distancing protocols.

The GMHS will continue to reinstate services on a phased basis and in line with the HSE's Safe Return to Work Guide. Officials from the Department of Health and HSE Sexual Health and Crisis Pregnancy Programme are in regular contact with CHO6 in order to monitor progress.

The GMHS website is updated regularly, and provides full details of services available, as these are reinstated. It is hoped that GMHS services can be delivered to their full potential and developed further, once pandemic related constraints on health service capacity as a whole can be safely reduced.

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. 395 answered with Question No. 394.

Medicinal Products

Ceisteanna (396)

Jennifer Carroll MacNeill

Ceist:

396. Deputy Jennifer Carroll MacNeill asked the Minister for Health the current status of the prospective reimbursement of a drug (details supplied); the status of same following the meetings which were scheduled to take place in April 2021; when a decision will be made by the HSE on the reimbursement of the drug; and if he will make a statement on the matter. [28669/21]

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.

Vaccination Programme

Ceisteanna (397)

Cathal Crowe

Ceist:

397. Deputy Cathal Crowe asked the Minister for Health if the period between the doses of a vaccine (details supplied) can be reduced for those in the over 60 years of age category. [28670/21]

Amharc ar fhreagra

Freagraí scríofa

On 4 June I announced a shorter interval between doses for the Vaxzevria® (AstraZeneca) vaccine. This follows updated recommendations from the National Immunisation Advisory Committee (NIAC), which have been endorsed by the Chief Medical Officer. NIAC has concluded that those of any age (without any previous COVID-19 infection), who have received their first dose of Vaxzevria® should receive their second dose 8-12 weeks later.

The HSE recently received updated advice from NIAC in relation to reducing the dose interval for the administration of the AstraZeneca vaccine from 12 weeks to 8. Extensive planning has been required to put in place a programme that will now see the remaining, approximately 450,000 people, in receipt of the AstraZeneca vaccine fully immunised through the administration of this second dose by the end of July.

Covid-19 Pandemic

Ceisteanna (398)

Michael Healy-Rae

Ceist:

398. Deputy Michael Healy-Rae asked the Minister for Health if a series of matters in relation to the Covid-19 hub (details supplied) in County Kerry will receive a response; and if he will make a statement on the matter. [28671/21]

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 Tests

Ceisteanna (399)

Michael Healy-Rae

Ceist:

399. Deputy Michael Healy-Rae asked the Minister for Health if he will address a matter (details supplied); and if he will make a statement on the matter. [28672/21]

Amharc ar fhreagra

Freagraí scríofa

Under the current public health travel measures, travellers arriving into Ireland from all overseas are required to present evidence of a negative / non-detected pre-departure RT-PCR test taken within 72 hours of arrival.

There is no requirements given in the relevant Regulation (S.I. 135/2021) that the test must be carried out by a private operator.

Question No. 400 answered with Question No. 372.

Medicinal Products

Ceisteanna (401)

Catherine Connolly

Ceist:

401. Deputy Catherine Connolly asked the Minister for Health the status update on the development of a registry to record women who have been prescribed sodium valproate during pregnancy; and if he will make a statement on the matter. [28674/21]

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.

Question No. 402 answered with Question No. 371.

Health Strategies

Ceisteanna (403)

Catherine Murphy

Ceist:

403. Deputy Catherine Murphy asked the Minister for Health the status of his work on the implementation of action Item 3.13 of the National Breastfeeding Action Plan which pertains to the WHO Code of Marketing of Breast-milk Substitutes. [28788/21]

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.

I can confirm however that 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 23.5 lactation consultants across hospital and community settings.

Medicinal Products

Ceisteanna (404)

Dara Calleary

Ceist:

404. Deputy Dara Calleary asked the Minister for Health if the HSE is actively considering the purchase of the drug partisan for use by sufferers of familial amyloidosis; if there is a projected timeframe for the sanctioning of use; and if he will make a statement on the matter. [28789/21]

Amharc ar fhreagra

Freagraí scríofa

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. 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 (NCPE).

The HSE has advised that it received an application in December 2018 for the reimbursement of Patisiran (Onpattro) for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

In January 2019, a full health technology assessment (HTA) with respect to this indication was commissioned by the HSE. This assessment was completed in February 2020, with the NCPE recommending that Patisiran not be considered for reimbursement unless cost-effectiveness could be improved relative to existing treatments.

The HTA report with respect to Patisiran was reviewed by the HSE Drugs Group in July 2020, along with the outputs of commercial discussions with the applicant which took place in May 2020, and the patient group submission received during the HTA process.The HSE Drugs Group requested patient and clinician input via the Rare Diseases Technology Review Committee (RDTRC) to assist the group in making its recommendation to the HSE Executive Management Team (EMT) regarding reimbursement of Patisiran.The RDTRC convened on 24 September and reviewed the clinical data previously submitted as part of the established pricing and reimbursement process. The Committee also heard from Consultants involved in the specialist management of patients with hATTR amyloidosis.

The RDTRC continued its review of Patisiran at its subsequent meeting on 5 November which included patient input on the impact of hATTR amyloidosis. Following these meetings, the Committee finalised a statement summarising the clinician and patient engagement on Patisiran which was received by the HSE Drugs Group on 26 November.

The HSE has advised that it met with the applicant company in December 2020 and in early January 2021 for further discussions and deliberations on the pricing position. At its January 2021 meeting, the HSE Drugs Group reviewed all the relevant documentation concerning the application, including information provided by the RDTRC. The HSE has advised that, having considered all of the criteria of which is obliged to take account, the HSE Drugs Group was unable to recommend in favour of reimbursement.

The decision-making authority in the HSE is the HSE Executive Management Team (EMT). The HSE EMT decides on the basis of all the demands with which it is faced (across all services) whether it can fund a new medicine, or new uses of an existing medicine, from the resources that have been provided to it in line with the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE has confirmed that it issued notice to the applicant company of the proposed decision of the EMT not to support reimbursement of Patisiran in February 2021.

Where the HSE EMT team has considered a recommendation of non-reimbursement from the HSE Drugs Group and proposes to accept such a recommendation, the HSE is legally required (in line with the 2013 Health Act) to set out in detail a notice of any proposed decision to an applicant company. The HSE is also legally required in such circumstances to provide at least a 28-day period (from the formal written notice of proposal) to enable an applicant company to consider the proposal not to reimburse and to make representations to the HSE. The HSE is legally required to consider any such representations in advance of a formal decision.

The HSE advises that the applicant company submitted representations on 5 March and 12 March, in response to the EMT’s proposed decision. These were considered at the HSE Drugs Group's May 2021 meeting, with a view to making a recommendation to the HSE EMT on the basis of all of the available evidence, in line with the 2013 Health Act.

The application for the reimbursement of Patisiran remains under consideration with the HSE. As decision-making authority, the HSE EMT will, following receipt of the outcome of the HSE Drugs Group's deliberations, make a decision on whether Patisiran will be reimbursed.

Abortion Services

Ceisteanna (405)

Bríd Smith

Ceist:

405. Deputy Bríd Smith asked the Minister for Health the details of his plan for a review of the Termination of Pregnancy Act 2018; the form this review will take; if it will include hearings or submissions from interested parties; when it will be concluded; if the Oireachtas Joint Committee on Health will have a role in this regard; and if he will make a statement on the matter. [28817/21]

Amharc ar fhreagra

Freagraí scríofa

The Health (Regulation of Termination of Pregnancy) Act 2018 was signed into law on 20 December 2018 and commenced on 1 January 2019. Section 7 of the Act states that “The Minister shall, not later than 3 years after the commencement of this section, carry out a review of the operation of this Act."

The review is being progressed this year and will be led by an independent expert. It is anticipated that it will take a three-part approach to reviewing the operation of the Act, with strands focusing on service users, service providers and a public consultation. Research to inform the service user and service provider strands will be commissioned and carried out independently, and a public consultation will be held.

Upon completion, a full report, with any necessary recommendations, will be submitted to me, as Minister, for consideration.

I have held a number of meetings with stakeholder groups to discuss the approach for the review; this will be finalised in due course.

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