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Tuesday, 23 Jul 2019

Written Answers Nos. 1757-1779

Abortion Services Provision

Ceisteanna (1757)

Micheál Martin

Ceist:

1757. Deputy Micheál Martin asked the Minister for Health if he is satisfied that terminations are not being carried out in private clinics; and if he will make a statement on the matter. [33984/19]

Amharc ar fhreagra

Freagraí scríofa

As the Deputy will be aware, the Health (Regulation of Termination of Pregnancy) Act 2018 was passed by the Houses of the Oireachtas on 13 December 2018 and signed into law by the President on 20 December 2018. Services for termination of pregnancy commenced on 1 January 2019.  

Sections 26 to 28 of the Act provide universal access to termination of pregnancy services for people who are ordinarily resident in the State (i.e., services are provided free of charge). However, women - from both within and outside the State - may also access the service on a private basis should they so choose, although they will have to pay a fee to do so. There is no requirement for a termination of pregnancy to be carried out in a particular location.

Abortion Services Provision

Ceisteanna (1758)

Micheál Martin

Ceist:

1758. Deputy Micheál Martin asked the Minister for Health if his attention has been drawn to maternity hospitals that may have breached section 20 of the Health (Regulation of Termination of Pregnancy) Act 2018; and if he will make a statement on the matter. [33985/19]

Amharc ar fhreagra

Freagraí scríofa

As the Deputy is aware, under section 20 of the Health (Regulation of Termination of Pregnancy) Act 2018, a notification of each termination of pregnancy carried out under the legislation must be notified to the Minister for Health within 28 days of it being carried out. 

I assume the Deputy’s question has been raised in relation to the recent case concerning termination of pregnancy in the National Maternity Hospital.  I am, of course, aware of it but it would be inappropriate for me to comment on an individual case.   

Our overriding concern at this time must be for the couple involved.   

I have been advised that steps are being taken to have an independent review of this case undertaken.  It is important to await the results of that review, which will allow for a better understanding of what has occurred. It will also allow for any learning that may emerge to be disseminated throughout the health system.

Abortion Services Provision

Ceisteanna (1759, 1760)

Micheál Martin

Ceist:

1759. Deputy Micheál Martin asked the Minister for Health if his attention has been drawn to an organisation (details supplied) being approached to carry out an independent assessment of a termination case in the National Maternity Hospital, Holles Street, recently; and if he will make a statement on the matter. [33986/19]

Amharc ar fhreagra

Micheál Martin

Ceist:

1760. Deputy Micheál Martin asked the Minister for Health his views on whether it is acceptable that the National Maternity Hospital, Holles Street, will only communicate through a senior counsel to a couple that had their baby terminated under circumstances that may have breached current legislative protocol; and if he will make a statement on the matter. [33987/19]

Amharc ar fhreagra

Freagraí scríofa

I propose to take Questions Nos. 1759 and 1760 together.

I assume the Deputy’s question has been raised in relation to the recent case concerning the termination of a pregnancy in the National Maternity Hospital.  I am, of course, aware of this matter it but it would be inappropriate for me to comment on an individual case. 

Nonetheless, as I have previously made clear, when a serious incident that requires investigation occurs within the health service, I am strongly of the view that the establishment of an independent review is the appropriate way forward in order to ascertain the facts of the case.

I have been advised that steps are now being taken to have an independent review of this case undertaken.  I understand that the organisation the Deputy has referred to was approached by the National Maternity Hospital and identified international experts to act as chair and co-chair of the review.  A panel of external experts has been appointed and includes members with the appropriate medical expertise to allow for a full understanding of the facts to be developed. The review is being chaired by a clinical expert from outside the jurisdiction.  My Department has been advised that the review panel also includes a Senior Counsel among its membership to provide input regarding the specific requirements of Irish law in relation to termination of pregnancy. The importance of enabling the participation of patients in any such review is also well established and the panel includes a patient representative.

In accordance with the HSE's Incident Management Framework 2018, the review panel provides the highest level of independence under that Framework, in that the panel members are all external to the National Maternity Hospital and Hospital Group.  Furthermore, the majority of panel members are external to the Irish health service.

It is important that the family concerned are at the centre of the review process and I expect that the couple involved to be facilitated in engaging with the review and communicating directly with the chair of the review panel if they so wish, as would be normal practice in such reviews. 

It is imperative now that the review panel progresses its work as expeditiously as possible.  I would like to take this opportunity to appeal to all members of the House to await the results of that review, which will allow for a better understanding of what has occurred. It will also allow for any learning that may emerge to be disseminated in our maternity services and more widely throughout the health system.

Medical Disclosure Code

Ceisteanna (1761)

Micheál Martin

Ceist:

1761. Deputy Micheál Martin asked the Minister for Health if he has considered an alternative short-term approach to admitting error in certain medical or obstetric cases in the absence of legislation on medical disclosure; and if he will make a statement on the matter. [33988/19]

Amharc ar fhreagra

Freagraí scríofa

As the Deputy will be aware, both the Department of Health and the HSE are absolutely committed to upholding the principles of open disclosure, and a variety of policy and legislative measures to support its operation are in place, with further developments being planned.  

Open disclosure is an integral element of patient safety incident management and learning.  It is about an open, honest and consistent approach to communicating with patients and their families when things go wrong in healthcare. The background to the legislative provisions to support open disclosure lies in the Commission on Patient Safety and Quality Assurance (July 2008) which recommended that legislation be enacted to provide legal protection/privilege for open disclosure of adverse events to patients.

The Civil Liability (Amendment) Act 2017 which was passed by the Oireachtas in November 2017 provides the legal framework to support voluntary open disclosure. Part 4 of the Act applies to all patient safety incidents, including near misses and no-harm events, and provides provisions to create a safe space for staff to be open and transparent with patients in order that they can be given as much information as possible, as early as possible, including an apology where appropriate. The Act of 2017 provides legal protection for the information given following a serious patient safety incident, and ensures that any apology cannot be interpreted as an admission of liability or used in litigation against the provider. Of course, a patient subject to harm will still have the right to seek redress under the law, based upon the circumstances of the case and their medical records. Part 4 of the Act of 2017 and the Civil Liability (Open Disclosure) (Prescribed Statements) Regulations 2018 came into effect on 23 September 2018.  

This legislation is an additional support to health professionals undertaking an open disclosure, and it is important that they in turn engage compassionately with patients, listen to the patient’s experience and their individual requirements, and respond in a meaningful and proactive way.  

During the Report Stage debate of these provisions, I also committed to examining how legislation could be expedited to provide for mandatory open disclosure to patients of serious incidents. The general scheme for the Patient Safety Bill, approved by Government on 5 July 2018, provides the legislative framework for a number of important patient safety issues, including mandatory open disclosure of a list of serious patient safety incidents and the notification of same externally to the Health Information Quality Authority and the Mental Health Commission to contribute to national learning and system wide improvements. The Bill will also contain provisions in relation to clinical audit and the extension of the Health Information and Quality Authority's remit to private hospitals.  

The Bill is part of the broader programme of legislative changes and policy initiatives being taken by the Department so as to improve the ability of the health service to anticipate, identify, respond to and manage patient safety issues. Creating a culture of open disclosure and learning from the things that go wrong is the bedrock of making services safer.  

The general scheme of the Patient Safety Bill underwent pre-legislative scrutiny at the Oireachtas Joint Committee on Health on 26 September 2018. The Bill will build on the foundations provided for by the Houses of the Oireachtas in relation to open disclosure as set out in the Civil Liability (Amendment) Act 2017. Officials of my Department and the Office of the Parliamentary Counsel are continuing to progress this legislation. It is intended that the Patient Safety Bill will be introduced in the Autumn Dáil session.

HSE Funding

Ceisteanna (1762)

Louise O'Reilly

Ceist:

1762. Deputy Louise O'Reilly asked the Minister for Health the way in which funding for each area will be decided under the new regional health areas and community health networks; and the way in which it will be allocated and distributed at regional level. [33989/19]

Amharc ar fhreagra

Freagraí scríofa

Following last week’s announcement of the Government decision approving the six future regional health areas and publication of the map of the regions, my Department will continue to progress work on the development of detailed policy proposals on reconfiguration of the HSE, including the establishment of regional health bodies.  In parallel, the published Sláintecare Implementation Strategy and Action Plan also include workstreams to develop new models for funding and resource allocation.

These newly identified regional areas will now have clearly defined populations allowing the future bodies to plan, resource and deliver health and social care services for the needs of its population.  It will also empower frontline staff and allow for the devolvement of decision-making power from the HSE to each local region.

The regions will be funded using population-based resource allocation models and will be accountable for achieving population health outcomes within this funding.

The regions will have a “one budget, one system” approach, providing improved accountability and governance in terms of finance and performance, equitable resource allocation, and increased clinical governance compliance requirements.

Hospital Groups

Ceisteanna (1763, 1764)

Louise O'Reilly

Ceist:

1763. Deputy Louise O'Reilly asked the Minister for Health if, under the new regional health areas and community health networks, hospital groups will be reconfigured to align hospitals by region; the way in which this will be done; and the timeframe for same. [33990/19]

Amharc ar fhreagra

Louise O'Reilly

Ceist:

1764. Deputy Louise O'Reilly asked the Minister for Health if, under the new regional health areas and community health networks, community health organisations will be reconfigured to align by region; the way in which this will be done; and the timeframe for same. [33991/19]

Amharc ar fhreagra

Freagraí scríofa

I propose to take Questions Nos. 1763 and 1764 together.

Following last week’s announcement of the Government decision approving the six future regional health areas and publication of the map of the regions, my Department will work with the HSE and current Community Healthcare Organisations and Hospital Groups to put in place processes for improved collaboration and integrated performance management at a regional level to ensure benefits of increased integration can be achieved in advance of returning to Government with full reconfiguration proposals. This will include interim changes to current administrative structures, where appropriate.

The new HSE Board and the Chief Executive Officer of the HSE have been given a strong mandate to support Sláintecare implementation, including the transition to new structures and the Department will engage with the HSE leadership at all stages of this process.

There will also be continued engagement with all key stakeholders to ensure that structural changes do not unduly cause disruption and loss of focus on service delivery and the roll-out of the broader reform programme. The proposed changes to health structures are only one element of broader reform plans arising from the Sláintecare report. These proposals must be seen as part of the broader proposals in the 2019 Action Plan to support and develop a better health and social care service based on clinical and service integration, enhanced service capacity and delivery and improved governance, accountability and patient safety arrangements.

Therefore, the focus of Sláintecare reform will continue to be on improving population health and healthcare delivery with revisions to structures being just one task among many, rather than an end in itself.

Medical Aids and Appliances Applications

Ceisteanna (1765)

Louise O'Reilly

Ceist:

1765. Deputy Louise O'Reilly asked the Minister for Health if his attention has been drawn to the fact that a number of men have now presented to the health service reporting adverse effects of surgical mesh; and his plans to help the those affected by way of mesh removal. [33992/19]

Amharc ar fhreagra

Freagraí scríofa

Surgical mesh devices are synthetic medical devices used to provide additional support to weakened or damaged tissues in a number of different surgical procedures. 

All medical devices carry certain benefits and risks and there are known complications associated with the use of surgical mesh. Surgical mesh devices are regulated medical devices and therefore the overall risk benefit ratio associated with their use is considered to be positive. Patients undergoing surgery involving mesh should be fully informed about their individual different treatment options and the associated risks and benefits.

As with any surgical procedure, patients who experience adverse effects following surgery involving the use of mesh devices should seek advice from their treating clinicians about their specific circumstances and the treatment options most suited to them.

Proposed Legislation

Ceisteanna (1766)

Louise O'Reilly

Ceist:

1766. Deputy Louise O'Reilly asked the Minister for Health his plans to update the Pharmacy Act 2007. [33998/19]

Amharc ar fhreagra

Freagraí scríofa

The Regulated Professions (Health and Social Care) (Amendment) Bill 2019 contains a number of proposed amendments to the Pharmacy Act 2007 including amendments to interpretations in Part 1, in Part 2 relating to the functions of the Pharmaceutical Society of Ireland, in Part 3 relating to the functions of the PSI Council, in Part 4 relating to the Pharmaceutical Registration System, in Part 6 in relation to Complaints, Inquiries and Discipline, in Part 7 relating to Powers of Investigation and in Part 8 relating to Miscellaneous and General provisions.

My Department has recently engaged in preliminary discussions with the Pharmaceutical Society of Ireland regarding other possible amendments to the Act.

Hospitals Patronage

Ceisteanna (1767, 1776)

Micheál Martin

Ceist:

1767. Deputy Micheál Martin asked the Minister for Health the status of the ownership model that will be introduced for the new maternity hospital at St. Vincent’s Hospital, if the process for same is finalised; and if he will make a statement on the matter. [33999/19]

Amharc ar fhreagra

Fiona O'Loughlin

Ceist:

1776. Deputy Fiona O'Loughlin asked the Minister for Health the status of the ownership of the proposed new national maternity hospital; and if he will make a statement on the matter. [34021/19]

Amharc ar fhreagra

Freagraí scríofa

I propose to take Questions Nos. 1767 and 1776 together.

My Department continues to engage with St Vincent’s Healthcare Group and the National Maternity Hospital to develop a legal framework to protect the State’s significant investment in the new maternity hospital on the St Vincent's University Hospital campus.  St Vincent’s Healthcare Group has agreed to provide the State with a 99-year lease of the land upon which the new maternity hospital will be built, and this will allow the State to retain ownership of the new facility.  The State will, in turn, provide an Operating Licence to the NMH DAC and the St. Vincent’s Healthcare Group to enable the provision of health services in the newly constructed building.  

The overall framework being put in place will unequivocally copper-fasten the principle that patient care in the new hospital will be delivered without religious, ethnic or other distinction and that any medical procedure which is in accordance with the laws of the land will be carried out there.

Question No. 1768 answered with Question No. 1399.

Cancer Screening Programmes

Ceisteanna (1769, 1770, 1773, 1774)

Micheál Martin

Ceist:

1769. Deputy Micheál Martin asked the Minister for Health if he will report on the most recent information he and his officials have on the low risk over delayed test results for the 800 women that were missed due to a computer glitch; the number of women who have now been informed; the number that need future follow-up; and if he will make a statement on the matter. [34001/19]

Amharc ar fhreagra

Micheál Martin

Ceist:

1770. Deputy Micheál Martin asked the Minister for Health if he will report on the reported 52 women (details supplied) among those at the centre of the latest CervicalCheck controversy who now face the low risk of their conditions progressing as they show low grade cytological changes; the supports being made available to them, if it is through their general practitioners; if they have been informed; and if he will make a statement on the matter. [34002/19]

Amharc ar fhreagra

Micheál Martin

Ceist:

1773. Deputy Micheál Martin asked the Minister for Health the way in which groups of women in the most recent CervicalCheck controversy, 52 out of 800, are being reassured as he indicated on 16 July 2019; the assurances he has been given regarding the way in which this is being done; and if he will make a statement on the matter. [34005/19]

Amharc ar fhreagra

Micheál Martin

Ceist:

1774. Deputy Micheál Martin asked the Minister for Health if he and his officials were given information regarding the way in which the computer glitch occurred in the most recent CervicalCheck controversy; if he or his officials have met those in charge of ICT; the safety mechanisms put in place to prevent this from occurring again; and if he will make a statement on the matter. [34006/19]

Amharc ar fhreagra

Freagraí scríofa

I propose to take Questions Nos. 1769, 1770, 1773 and 1774 together.

In late 2018, Quest Diagnostics informed the HSE of a number of HPV tests done outside the manufacturers' recommended timeframe. While the clinical risk was low, as advised by the HSE, around 4,000 women who had previously tested HPV negative were invited for a further smear test as a precaution.

In addition, a number of women affected by this issue had their existing samples retested with a different type of HPV test, the HPV DNA test, which has a longer expiration period. Both tests are acceptable and are used in international screening programmes. The use of this test meant that women were not required to attend their GPs for a repeat smear test.

The HSE advised the Department on 10 July that the IT system in the laboratory undertaking these retests required updates to ensure electronic issuing of results letters and that, as these updates could not be completed in time, letters were to issue manually to GPs. Regrettably, this had not happened in all cases.

The HSE has apologised for this issue, and has affirmed that the clinical risk to the women affected is low. This issue related to approximately 850 women, although it should be noted that final figures remain to be confirmed by the HSE in association with Quest.

Within this, approximately 52 women tested positive for the HPV virus on retest. This meant they required a different care pathway than if they had tested negative. The HSE has advised that these women's GPs received the women's results in February, and that it has been in contact with the GPs of all of these women and affirmed they are on an appropriate care pathway.

In regard to the remaining women, who have had no change to their results or care pathway, the HSE has advised it will write to them apologising for the delay in advising them that their HPV results remain unchanged.

These retests were undertaken by Quest Diagnostics at a quality assured laboratory in Chantilly, which is approved by the HSE for HPV testing for CervicalCheck work, including the retests in question, and which forms part of the additional capacity secured by CervicalCheck to meet the programme's needs on an ongoing basis. The HSE advises this facility currently provides only HPV testing for CervicalCheck, which is one part of the overall cervical screening test process.

In regard to the way in which this IT issue occurred, and mechanisms to prevent a re-occurrence, the HSE CEO has commissioned an immediate rapid review of this incident, and appointed Professor Brian MacCraith as the independent external chairperson. The review is expected to be complete and provided to the HSE by 2 August, and the HSE has indicated its intention to publish the report. The rapid review will provide a report to the HSE’s CEO setting out the facts relating to the incident and to make recommendations for any appropriate further actions and future learning.

A HSE Serious Incident Management Team (SIMT) is in place to manage the response to this incident, and is continuing to engage with Quest Diagnostics to ensure final confirmation of the numbers affected by any delay in issuing results letters, to ensure all necessary communications to women and/or their GPs have taken place, and to report at the conclusion of the incident.

Home Help Service Provision

Ceisteanna (1771)

Micheál Martin

Ceist:

1771. Deputy Micheál Martin asked the Minister for Health the status of the implementation of the 800,000 extra home help hours in 2019; the way in which they have been allocated; and if he will make a statement on the matter. [34003/19]

Amharc ar fhreagra

Freagraí scríofa

As this is a service matter I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.

Home Help Service Data

Ceisteanna (1772)

Micheál Martin

Ceist:

1772. Deputy Micheál Martin asked the Minister for Health if the outsourcing of home help hours costs have actually reduced the number of actual home help hours being made available to patients; and if he will make a statement on the matter. [34004/19]

Amharc ar fhreagra

Freagraí scríofa

As this is a service matter I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.

Questions Nos. 1773 and 1774 answered with Question No. 1769.

Medicinal Products Licensing

Ceisteanna (1775)

Fiona O'Loughlin

Ceist:

1775. Deputy Fiona O'Loughlin asked the Minister for Health the progress made on the granting of licences for medicinal cannabis; and if he will make a statement on the matter. [34019/19]

Amharc ar fhreagra

Freagraí scríofa

As the Deputy may be aware, on 26th June I signed legislation which allows for the operation of the Medical Cannabis Access Programme (MCAP) on a pilot basis for five years.

This new legislation means that commercial medical cannabis suppliers whose cannabis products meet the specified requirements set out in the legislation and which have been listed in Schedule 1 of the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations will be able to supply these products to the Irish market.

Once suitable medical cannabis products are made available by suppliers, the Access Programme will make it possible for a medical consultant to prescribe, in line with the published clinical guidance, a listed cannabis-based product for a patient under his or her care for the following medical conditions, where the patient has failed to respond to standard treatments:

- spasticity associated with multiple sclerosis;

- intractable nausea and vomiting associated with chemotherapy;

- severe, refractory (treatment-resistant) epilepsy.

It should be noted that currently no medical cannabis products are available for use under the MCAP as it is expected that it will take some time for suppliers to arrange to have their products made available on the Irish market.

Up to date information relating to the MCAP, which includes a FAQ (Frequently Asked Questions) document, is available on the Department's website.  

Pending full operation of the MCAP, and for medical indications not included in the MCAP, doctors may continue to utilise the Ministerial licencing route to prescribe medical cannabis for their patients, should they wish to do so. In line with the Chief Medical Officer's advice, the granting of a licence for cannabis for medical purposes must be premised on an appropriate application being submitted to the Department of Health, which is endorsed by a consultant who is responsible for the management of the patient and who is prepared to monitor the effects of the treatment over time. 

To date Ministerial licences have been issued in respect of twenty-five individual patients.

Question No. 1776 answered with Question No. 1767.

HSE Waiting Lists

Ceisteanna (1777)

Fiona O'Loughlin

Ceist:

1777. Deputy Fiona O'Loughlin asked the Minister for Health the length of time children are waiting for a public eye test; and the number of persons waiting three months, six months and over one year, respectively, for assessment in each CHO area in tabular form. [34024/19]

Amharc ar fhreagra

Freagraí scríofa

As this is a service matter it has been referred to the HSE for attention and direct reply to the Deputy.

Speech and Language Therapy Waiting Lists

Ceisteanna (1778)

Fiona O'Loughlin

Ceist:

1778. Deputy Fiona O'Loughlin asked the Minister for Health the length of time children are waiting for speech and language therapy in each CHO area; and the number of persons waiting longer than 12 months in each CHO. [34025/19]

Amharc ar fhreagra

Freagraí scríofa

The 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. This commitment is outlined in the Programme for Partnership Government, which is guided by two principles: equality of opportunity and improving the quality of life for people with disabilities.  

As the Deputy's question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply to the Deputy.

Long-Term Illness Scheme Coverage

Ceisteanna (1779)

Fiona O'Loughlin

Ceist:

1779. Deputy Fiona O'Loughlin asked the Minister for Health his plans to include atypical haemolytic uremic syndrome in the long term illness scheme; and if he will make a statement on the matter. [34026/19]

Amharc ar fhreagra

Freagraí scríofa

The LTI Scheme was established under Section 59(3) of the Health Act 1970 (as amended). The conditions covered by the LTI are: acute leukaemia; mental handicap; cerebral palsy; mental illness (in a person under 16); cystic fibrosis; multiple sclerosis; diabetes insipidus; muscular dystrophies; diabetes mellitus; parkinsonism; epilepsy; phenylketonuria; haemophilia; spina bifida; hydrocephalus; and conditions arising from the use of thalidomide. Under the LTI Scheme, patients receive drugs, medicines, and medical and surgical appliances directly related to the treatment of their illness, free of charge.

There are no plans to extend the list of conditions covered by the Scheme at this time. However, I wish to inform the Deputy that the LTI Scheme will be included as part of a review of the basis for existing hospital and medication charges, to be carried out under commitments given in the Sláintecare Implementation Strategy.

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