Diarmuid Wilson (Fianna Fail)
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Amendments Nos. 1 and 2 are related and may be discussed together, by agreement. Is that agreed? Agreed.

Helen McEntee (Meath East, Fine Gael)
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Amendments Nos. 1 to 20, inclusive, seek to insert a new Part 4 into the Civil Liability (Amendment) Bill 2017 to support the open disclosure of patient safety incidents. Senators will recall that in the course of her Second Stage speech the Tánaiste indicated that such amendments would be brought forward. Accordingly, I am very pleased to propose the amendments for consideration by the House. On behalf of the Minister for Health, I thank the Oireachtas Joint Committee on Health for undertaking pre-legislative scrutiny of the provisions which was very helpful in ensuring the legislation would be brought forward today as a positive measure that represents an important part of ongoing patient safety initiatives in the health service. There are 20 amendments in total, including a consequential amendment to the Long Title of the Bill. With the agreement of the House, it is my intention to take the amendments in thematic groups which will follow the narrative of Part 4.

The first group includes amendments Nos. 1 and 2.These introductory amendments seek to amend section 1 to include reference to Part 4 - the new provisions on open disclosure.

The second grouping is amendments Nos. 3 and 4, which address definitional matters relevant to the new Part 4. The third grouping consists of amendments Nos. 5 and 6. Those amendments detail what an open disclosure is, what its legal effect is and the statement to be prepared by the health service provider in regard to open disclosure. The fourth grouping is amendments Nos. 8 to 11, inclusive, 13 and 16, which provide for the steps involved in the open disclosure process, including what happens when a person does not wish to participate in the process or the health service provider cannot get in touch with the patient for the purposes of arranging an open disclosure meeting. The next grouping is amendments Nos. 12, 14 and 15. These amendments cover the requirements for the conduct of the open disclosure meeting and for the provision of further information and clarification of information provided. Amendments Nos. 17 to 19, inclusive, will be taken separately. They deal, respectively, with the records to be kept, the making of ministerial regulations, and saving and transitional arrangements when Part 4 is commenced. Amendment No. 20 involves a change to the Long Title of the Bill and is consequential to the other amendments being carried.

Before I deal with the amendments, I would like to take this opportunity to speak about the purpose of Part 4. The provisions to support open disclosure are part of a broader package of reforms aimed at improving the experience of those who are affected by adverse events within the health service. Last December, the Minister for Health launched a new national patient safety office, located in the Department of Health, to prioritise work in this area. He has directed this office to work on a range of initiatives, including new legislation, the establishment of a national patient advocacy service, the measurement of patient experience, the introduction of a patient safety surveillance system and extending the clinical effectiveness agenda. Within the programme of legislation, it is intended to progress the licensing of our public and private hospitals.

These reforms also include the provisions on periodic payment orders in the Civil Liability (Amendment) Bill. While the open disclosure provisions were originally to be included in the Health Information and Patient Safety Bill, it was thought that they would be a good fit with the Civil Liability (Amendment) Bill, which was more advanced than the Health Information and Patient Safety Bill. Patient safety is fundamental to the delivery of quality health care and to public confidence in the health system, and open disclosure is an integral element of patient safety incident management and learning. Open disclosure is about an open, honest and consistent approach to communicating with patients and families when things go wrong in health care. It includes keeping the patient informed, providing feedback on investigations and the steps taken to prevent a recurrence of the incident, and it may include, depending on the particular circumstances involved, an apology for what happened. For those reasons, open disclosure is important for building patient and public trust in the health system and it is therefore vital that it should be supported.

The report of the Commission on Patient Safety and Quality Assurance, chaired by Professor Deirdre Madden, recommended that legislation be enacted to provide legal protection for open disclosure of patient safety incidents to patients. It is envisaged that such legislation should ensure that open disclosure, which is undertaken in compliance with national standards, cannot be used in litigation against the person making the disclosure.

International experts' experience indicates that open disclosure will happen best by fostering the development of an honest and honest culture. In its consideration of these provisions the Oireachtas Joint Committee on Health recognised that the best chance of creating the conditions necessary for the success of open disclosure lies in taking a voluntary approach backed up by apology laws. In responding to the committee's observations and in order to properly take account of experience into the future, the Minister for Health has indicated that the structured evaluation of the success of voluntary open disclosure will be undertaken in the future once a suitable period of time has elapsed.

The open disclosure legislative provisions in Part 4 are therefore designed to give legal protections for the information disclosed and any apology made during the open disclosure process but only when the information provided and the apology made is in keeping with the requirements set out in the legislation. The section setting out protections is section 10, while the other sections of Part 4 stipulate requirements on the open disclosure process to ensure that it is an open and patient-centred process.

These protections address a situation in the health service at the moment where health practitioners could be reluctant to make a disclosure to a patient regarding a patient safety incident because of concerns they may have in regard to the potential consequences it could have for their career as well as the financial implications that may arise with regard to insurance. I wish to be clear, however, that there is no question that the protections being proposed will provide for protections for incompetent, negligent or other unprofessional patient care. Clinicians will still operate within the existing accountability framework, including through the bodies regulating their particular professions. The objective of the legislation is to create a safe place for open disclosure and to encourage the growth of a culture of openness and transparency within our health service, ensuring that patients are getting relevant information when an open disclosure is made. The protections provided will apply in both the public and private sides of the health service so as to support a uniformed system of open disclosure across the health system.

I will now deal with the specific amendments. Amendments Nos. 1 and 2, which are being taken together, amend section 1 of the Civil Liability (Amendment) Bill to insert references to the new Part 4 concerning open disclosure as that part of the Bill will be the responsibility of the Minister for Health rather than the Minister for Justice and Equality. The intention is that the commencement of Part 4 would be a matter for the Minister for Health. The Tánaiste has also asked me inform the House that she is considering tabling further amendments on Report Stage in regard to a number of issues related to the periodic payments part of the Bill.

Section 51O provides that the Part dealing with periodic payment orders will apply to proceedings which are brought on or after the commencement of the Part or in respect of which no final decision has been made on the date of such commencement. The Tánaiste is examining the issue with the Office of the Attorney General to ensure that the provisions on periodic payment orders can only apply to cases where a court has already made an internal award and, if necessary, the Tánaiste will bring forward an amendment on Report Stage to clarify this matter for Senators.

The Tánaiste also notes that discussions are under way between her Department, the Department Jobs, Enterprise and Innovation and the Office of the Attorney General on the possibility of giving the Personal Injuries Assessment Board the power to make periodic payment orders in catastrophic injury cases. Again, if required, the Tánaiste will bring forward any appropriate amendments and information on Report Stage.

My Department and the State Claims Agency are preparing comprehensive provisions dealing with recovery of costs, specified health and personal social care services in the cases of persons who are in receipt of periodic payment orders. This is to avoid a situation referred to as double recovery where a person in receipt of the periodic payment order for the purpose of his or her long-term health care need also receives health benefits under, for example, a medical card. It would also be necessary to avoid the situation where, for example, a defendant could seek to reduce the amount of damages payable because of a plaintiff's entitlement to a medical card. The intention is to table the required amendments on Report Stage.

Diarmuid Wilson (Fianna Fail)
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Amendments Nos. 3 and 4 are related and they may be discussed together by agreement. Is that agreed? Agreed.

Helen McEntee (Meath East, Fine Gael)
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This is the second group of amendments, amendments Nos. 3 and 4. This grouping is concerned with the definitions surrounding the concept and process of open disclosure in Part 4. Amendment No. 3 inserts section 7, which is the general definitions section for Part 4. Senators will notice that "health service" and "health services providers" have been defined extensively to ensure that the definitions capture the full range of health services providers available in Ireland, both on the public and private sides. Another key definition is "relevant person" which, in relation to a patient, is a person closely connected to the patient who may be present at any open disclosure meeting. The person can be a spouse, civil partner, cohabitant, parent, son or daughter or could be someone the patient has nominated in writing.

Amendment No. 4 inserts section 8, which defines the key concept of "patient safety incident" separately, highlighting its importance to the operation of Part 4. The definition follows the accepted international classification and nomenclature used in the World Health Organization Conceptual Framework for the International Classification of Patient Safety. The definition covers three things: the actual adverse events where harm is caused to the patient; no harm events, which are incidents that could have caused harm but did not do so; and near misses, which are outcomes that did not reach the patients but would have caused harm if they had.

Diarmuid Wilson (Fianna Fail)
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Amendments Nos. 5, 6 and 7 are related and may be discussed together by agreement. Is that agreed? Agreed.

Helen McEntee (Meath East, Fine Gael)
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I will now focus on the third grouping of amendments. This grouping describes what an open disclosure is for the purposes of the Bill, what its legal effect is and the statement that is to be prepared by health services providers regarding open disclosure.

Amendment No. 5 inserts section 9 into the Bill, which provides that a disclosure of a patient safety incident made in accordance with the legislation will be considered an open disclosure.

Amendment No. 6 inserts section 10 into the Bill, which provides for certain protections for open disclosure, which will only be given when all the requirements in the legislation are met. The protections are as follows: information provided, and an apology where it is made, in an open disclosure meeting will not constitute an express or implied admission of fault or liability in a clinical negligence action regarding that patient safety incident; information provided, and an apology where it is made, in an open disclosure meeting are not admissible as evidence of fault or liability in a clinical negligence action regarding that patient safety incident; and information provided, and an apology where it is made, in an open disclosure meeting are not admissible as evidence of fault in professional fitness to practise proceedings. Section 10 also provides that insurance or indemnity is not affected by an apology made as part of an open disclosure.

Amendment No. 7 inserts section 11 into the Bill, which provides that a health services provider will prepare a written statement outlining the procedure for making an open disclosure and the restrictions on the use that the patient may make of any information provided and any apology made. I would stress at this point that the patient's medical record will still be fully accessible for use by patients and nothing in Part 4 affects that.

Diarmuid Wilson (Fianna Fail)
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Amendments Nos. 8 to 11, inclusive, 13 and 16 are related and may be discussed together by agreement. Is that agreed? Agreed.

Helen McEntee (Meath East, Fine Gael)
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This grouping sets out the steps in the open disclosure process, from when the health services provider first becomes aware of a patient safety incident to the organisation of the meeting itself, and includes what happens when a patient decides not to take part in the process or if the health services provider cannot get in touch with the patient.

Amendment No. 8 inserts section 12 into the Bill, which provides that a health services provider may make an open disclosure regarding a patient safety incident to a patient and-or his or her relevant person.

Amendment No. 9 inserts section 13 into the Bill, which provides for who makes the disclosure on behalf of a health services provider. It will generally be the principal health practitioner involved in the patient’s care. If the principal health practitioner is unavailable, another health practitioner who the health services provider considers appropriate will make the disclosure.

Amendment No. 10 inserts section 14 into the Bill, which deals with the timing of an open disclosure meeting, which should take into the account the circumstances of the meeting, including the desirability of the open disclosure being made as soon as practicable. The meeting can go ahead even if not all of the information is available at the time.

Amendment No. 11 inserts section 15 into the Bill, which provides for matters to be addressed by a health services provider before making an open disclosure. Matters to be addressed include: to whom the open disclosure should be made, whether it should be a patient or a relevant person or both; whether it is appropriate for an apology to be made; taking steps to ensure the information is given in as clear a manner as possible; and designating a person to liaise with the patient regarding the open disclosure.

Amendment No. 13 inserts section 17 into the Bill, which provides for what happens when a patient or relevant person declines to participate in a proposed open disclosure meeting. It is important to note that there is no obligation on them to agree to participate.

Amendment No. 16 inserts section 20 into the Bill, which provides for what happens when a health services provider cannot contact a patient to arrange an open disclosure meeting. A health services provider should take all steps reasonably open to them to get in touch with a patient to arrange an open disclosure meeting.

Diarmuid Wilson (Fianna Fail)
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Amendments Nos. 12, 14 and 18 are related and may be discussed together by agreement. Is that agreed? Agreed.

Helen McEntee (Meath East, Fine Gael)
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This group of amendments deals with the open disclosure meeting itself and the subsequent engagement between the health services provider and the patient concerning the patient safety incident that was the subject of the open disclosure in terms of the provision of further information or clarification of information already provided.

Amendment No. 12 inserts section 16 into the Bill, which provides for the open disclosure meeting itself, specifying what information must be provided at the open disclosure meeting as well as the manner in which that information and, where appropriate, an apology is to be made and specifying that a statement in writing containing the information provided must be given to the patient or relevant person.

Amendment No. 14 provides for a situation where further information may become available after the open disclosure meeting. The amendment inserts section 18 into the Bill, which provides for the provision of any new information, given pro-actively by the health services provider to the patient and or relevant person.

Amendment No. 15 takes into account a situation which is likely to arise where a patient may have questions following an open disclosure meeting. The amendment inserts section 19 into the Bill, which provides for how requests for clarification of information already provided by the health services provider are to be addressed.

The protections inserted under amendment No. 6 also apply to clarification of information and further information provided under the sections inserted by amendments Nos. 14 and 15.

Helen McEntee (Meath East, Fine Gael)
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Amendment No. 17 inserts section 21, which requires that a health services provider keeps records of specific matters relating to open disclosure, including written statements given to the patients. The keeping of appropriate and proper records is considered very important.

Helen McEntee (Meath East, Fine Gael)
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This is a standard provision. Amendment No. 18 inserts section 22, which provides that the Minister for Health may by regulations provide for matters relevant to Part 4 that are specified as prescribed or to be prescribed. This regulation-making power will help to ensure consistency in the open disclosure process, particularly as regards standardising forms to be used.

Helen McEntee (Meath East, Fine Gael)
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Amendment No. 19 inserts section 23, which is a saving and transitional provision. It provides that Part 4 will apply to the making of an open disclosure of a patient safety incident by a health services provider on or after the coming into operation of the Part. Where a patient safety occurred or came to the notice of the health services provider before the commencement of the legislation, the provider may still make an open disclosure in accordance with the legislation. For completeness, it also provides how "as soon as practicable" is to be interpreted in such a situation.

Helen McEntee (Meath East, Fine Gael)
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Amendment No. 20 amends the Long Title of the Bill to include the open disclosure provisions. It is a necessary consequential amendment. I hope that Senators will agree that these new provisions are timely and important. As Members of the House will be aware, Ireland's patient safety record has been compromised by a number of high-profile events and reports over the last three years which have affected public confidence in the health service. We have also seen that on occasions, patients and their families have felt unsupported by the system, have not been afforded adequate explanations following adverse events or have found the health service complex to navigate. These provisions mark a major step forward in creating a different mindset within the health service. Through the creation of a culture of open disclosure and emphasising the need to learn from the things that go wrong, we will see a safer health service emerge.The open disclosure provisions form part of a number of initiatives to improve the management of patient safety incidents. HIQA and the Mental Health Commission are at an advanced stage of development of standards on the conduct of reviews of patient safety incidents which expand on the national standards for safer and better healthcare. This set of standards, along with the mandatory reporting of serious reportable events provided for in the Health Information and Patient Safety Bill and the provisions intended for open disclosure will provide a comprehensive patient-centred approach to preventing, managing and learning from incidents. Delivery of health care is inherently risky. While it is inevitable that things will go wrong, there is much that can be done to prevent harm or error, identify and act on when it occurs and to learn from this to improve services.

As I have outlined earlier the provisions for open disclosure form part of the broad and ambitious programme of patient safety reforms being progressed by the Minister for Health. This programme of reform is aimed at a whole systems approach to improving patient safety.

Diarmuid Wilson (Fianna Fail)
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When is it proposed to take Report Stage?

Joe O'Reilly (Fine Gael)
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Next Tuesday.

Diarmuid Wilson (Fianna Fail)
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Is that agreed? Agreed.