David Cullinane (Waterford, Sinn Fein)
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814. To ask the Minister for Health the current status and plans for advancing the Health (Adult Safeguarding) Bill 2017; the legislative timeline; and if he will make a statement on the matter. [36868/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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It is presumed that the Deputy's question is referring to the forthcoming Health (Adult Safeguarding) Bill, which is, as yet, undated. The aim of this anticipated Bill will be to underpin, as required, a new overarching national policy on adult safeguarding in the health and social care sector, which is currently under development by my Department further to a Government Decision in December 2017. 

A timeline for the preparation of this Bill will be finalised following confirmation of Government approval of this important new sectoral policy. It is currently estimated that the draft policy will be ready for submission to the Government for its approval during 2021, following a public consultation process in early 2021.

As the Deputy will appreciate, development of an overarching sectoral policy of this nature is a complex undertaking, not least because the health and social care sectoral policy will apply across the full spectrum of the Irish health and social care sector including all public, voluntary and private health and social care services and settings and will include proposals on cooperation, collaboration, information-sharing and referral arrangements between the health and social care sector and other relevant sectors. Accordingly, my Department's approach to date has been to undertake the required detailed policy work before formulating the legislation which will underpin it, including legal and policy research, public and stakeholder consultation and resource implication analysis. 

Significant preparatory policy development work has been undertaken and the key stakeholder engagement and detailed research phases are essentially complete.  Although, in common with other health and social care sector projects, there has been some degree of disruption arising from the Department’s and the wider health system’s lead role in responding to the COVID-19 pandemic, progress with developing the evidence base and policy has continued throughout 2020.  

I trust this is of assistance to the Deputy.

David Cullinane (Waterford, Sinn Fein)
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815. To ask the Minister for Health the status and plans for advancing the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Bill 2018; the legislative timeline; and if he will make a statement on the matter. [36869/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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Work is progressing on the drafting of the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Bill in collaboration with the Office of Parliamentary Council. 

Pre-Legislative Scrutiny of the General Scheme has been undertaken by the Joint Committee on Health. 

It is envisaged that the drafting process will be complete, and Government approval secured to publish the Bill, in Q1 2021.

David Cullinane (Waterford, Sinn Fein)
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816. To ask the Minister for Health the status and plans for advancing the Mental Health (Amendment) Act 2018 giving effect to the recommendations of an expert group review on mental health legislation; the legislative timeline; and if he will make a statement on the matter. [36870/20]

Mary Butler (Waterford, Fianna Fail)
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The Mental Health (Amendment) Act 2018 makes changes to the Mental Health Act 2001 regarding the definition of voluntary patient and replaces the principle of best interests with principles that support individuals to make their own decisions. The Act also introduces guiding principles for children and refers to capacity within the meaning of the Assisted Decision-Making (Capacity) Act 2015. The provisions of the 2018 amending Act cannot be commenced until further legislative changes are made and the Decision Support Service, established under the Assisted Decision-Making (Capacity) Act is operational.  The changes in these two acts are based on a number of different recommendations of the Expert Group Review of the 2001 Act.

The Department is currently finalising heads of bill to significantly amend and update the mental health legislation, taking into account the 165 recommendations of the Expert Group Review, which was informed in part by a public consultation, a comprehensive submission by the Mental Health Commission (MHC), and Ireland’s domestic and international commitments, such as the Assisted Decision-Making (Capacity) Act 2015 and the UN Convention on the Rights of Persons with Disabilities.  The provisions of the Mental Health (Amendment) Act 2018 are also being incorporated into the draft heads of bill.

There are over one hundred sections in the draft heads. The Department has included detailed information under each head to allow for expert input from the MHC and the HSE to be provided prior to publication, to allow the Department the opportunity to address any concerns earlier in the process. The draft heads of bill propose to extensively amend and update existing mental health legislation, moving from what has been described as a paternalistic approach in existing statute, to a more patient-centric, human rights-based approach. The Department had hoped to submit these heads for legal advice by year-end 2020, however, the Department is currently awaiting further input from the HSE, which is expected in early December and plans to consider the HSE’s submission and finalise the draft heads prior to submission for internal legal advice, and to the office of the Attorney General, as required, in early 2021.

A new Part of the Act related to children is being advanced separately, and the Department has approached the HSE, the Commission, the Ombudsman for Children and the College of Psychiatrists for their expert opinions on draft heads. The Department received the MHC’s input this week and expects to receive the remaining draft heads in early December 2020, and the new Part on children will be finalised at the same time as the rest of the heads.

David Cullinane (Waterford, Sinn Fein)
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817. To ask the Minister for Health the status and plans for advancing the National Research Ethics Committees Bill 2019; the legislative timeline; and if he will make a statement on the matter. [36871/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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The General Scheme of the National Research Ethics Committees Bill was approved by the then government in July 2019.  The purpose of the Bill is to legislatively enable the establishment of a national research ethics committee (REC) framework that will reform and modernise the existing REC framework.  Th effect will be to enhance health research in Ireland and to make Ireland a more attractive location for international health research.

The General Scheme made clear that a twin track legislative approach involving the use of secondary legislation to establish National RECs in areas covered by EU Regulations would allow more immediate action to be taken in the important areas of clinical trials of medicinal products for human use and clinical investigations of medical devices.   

Secondary legislation was possible in those areas because of the EU basis for action.  It is relevant to mention that the EU Regulation on clinical trials of medicinal products for human use and the EU Regulation on the clinical investigations of medical devices are both scheduled to come into effect in 2011 so there was an urgency in taking legislative action in those areas.  

The establishment of national RECs in other areas of health research requires primary legislation which is the focus of the Bill.  Substantive work on the Bill will, as planned, take place when the secondary legislation is completed.  

During the course of the preparation of the General Scheme there was engagement with the health research sector and the rationale for the twin track approach was understood and appreciated as the best way to proceed.  

As per the General Scheme, the principles and policies that are set out in the secondary legislation in the areas of clinical trials and clinical investigations will be replicated in the Bill thereby providing a consistent and unified structure across the spectrum of health research.  

It is also important that the legislation to provide for this type of wide-ranging structural reform needs to be supported by practical operational initiatives if real reform is to be realised on the ground. 

In that regard, I can point to the establishment of the National Office for Research Ethics Committee in March of this year.  In its first few weeks of existence, the Office was directly involved in setting up successfully a National REC to deal with Covid 19 research.  It is now working to ensure that the actions necessary to make the clinical trials and clinical investigations National RECs successful will be in place in early 2021.  Part of that process will see the National Office embark shortly on a public expressions of interest campaign to ensure a broadly based and diverse membership of the National RECs.

In providing for a system of national RECs, I want to also make the point that, as in other countries, there will continue to be an important role for local and institutional RECs that are the backbone of the current structure.  I also want to pay tribute to the members of those RECs who selflessly give up their time and I hope that many of them will be interested in being involved in the new national RECs.

David Cullinane (Waterford, Sinn Fein)
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818. To ask the Minister for Health the status and plans for advancing the Patient Safety (Licensing) Bill 2018; the legislative timeline; and if he will make a statement on the matter. [36872/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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My Department continues to progress work on the Patient Safety (Licensing) Bill which will, for the first time introduce a licensing requirement for all hospitals, public and private, and certain designated high-risk activities in the community. The general scheme of the Bill was approved by Government on 12th December 2017. It underwent Pre-Legislative Scrutiny at the Oireachtas Joint Committee of Health on 13 June 2018 and it is currently with the Attorney General’s Office in order for drafting to be undertaken. 

As a precursor or interim step to the Patient Safety (Licensing) Bill, the Government approved, on the 5 July 2018, the general scheme of the Patient Safety (Notifiable Patient Safety Incidents) Bill 2019 which will provide the legislative framework for the extension of the Health Information Quality Authority regulatory remit to private hospitals. This Bill also includes provisions for the establishment of a legislative framework for mandatory open disclosure and reporting of designated serious patient safety incidents and, the provision of certain legislative protections for the conduct of clinical audit against explicit clinical standards on a national basis. It is part of the current Programme for Government, was introduced into Dáil Éireann on the 12 December 2019, passed Second Stage and is due to go to Dáil Committee Stage.

David Cullinane (Waterford, Sinn Fein)
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819. To ask the Minister for Health the status and plans for advancing the protection of liberty safeguards Bill; the legislative timeline; and if he will make a statement on the matter. [36873/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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Heads of Bill to provide legislative clarity on the issue of deprivation of liberty safeguards are at a relatively advanced stage. A number of complex legal and policy issues which have arisen during the drafting process remain to be resolved.  

Work on the Heads of Bill has been paused due to the diversion of resources, as part of the response to COVID-19.