Charles Flanagan (Laois, Fine Gael) | Oireachtas source

I want to refer to the extensive debate on this issue on Committee Stage. The House will be aware that Part 4 of the Bill, as initiated, provided for the voluntary open disclosure of patient safety incidents and that an amendment was made to section 12 on Committee Stage in the Dáil on 29 June last to instead provide for mandatory open disclosure.

Amendment No. 31 seeks to return to the original intent of voluntary open disclosure in this Bill. The set of new amendments brought forward by Deputies Daly and Wallace for consideration today clearly recognise the burden that would be placed on the system by making all patient safety incidents, including near-misses, the subject of mandatory open disclosure. The amendments seek to change the definition of a patient safety incident and introduce a significant modification to the approach to open disclosure, creating a two-tier system in respect of patient safety incidents.

Category A incidents which result in the death of a patient, major or moderate harm or prolonged psychological harm to the patient would be subject to mandatory disclosure provisions.

Category B incidents relate to incidents that have caused less serious harm, which is defined as harm which does not meet the criteria for major harm, moderate harm or prolonged psychological harm. Category B incidents also include no-harm incidents and near misses. Category B incidents would be subject to voluntary disclosure provisions.

The amendments are extensive and detailed, and they reflect the attention and commitment that Deputies Daly and Wallace have brought to open disclosure as a critical patient safety issue. More time is needed, however, to consult on the changes to the meaning of "patient safety incident". Creating a two-tiered system of patient safety incidents for open disclosure in the health service without having fully explored the implications of the definitions proposed creates a real challenge for assurance of implementability of the legislation. Moreover, time is needed to consider the legislative implications that may arise in the open disclosure provisions of the Bill as a consequence to the amendments. I say with the greatest respect to the Deputies opposite that the last thing any of us want is legislation that is open to challenge. It appears, with the import of these amendments, that not only would the legislation be open to challenge but it is wide open. This would defeat the joint aim that we all have to promote open disclosure and learning from patient safety incidents when they occur.

The Minister for Health has given serious reflection to the Deputies' proposals and agrees there are merits in progressing legislation regarding mandatory open disclosure for a defined set or list of serious events. The Minister's view is that a reasonable approach at this time is to proceed with voluntary open disclosure in the Civil Liability (Amendment) Bill as initiated. Provision for mandatory reporting of serious events to the appropriate external agency is already included in the general scheme of the health information and patient safety Bill. He is proposing a rescoping of these approved patient safety elements to provide for an addition of mandatory open disclosure to accompany the list of reportable serious patient safety events in the health information and patient safety Bill. At this stage, and subject to Government approval and legal advice, it is envisaged that such a list would be the subject of ministerial regulations and could be tested and amended as necessary.

The Minister would welcome the opportunity to work with Deputies Daly and Wallace, as well as other Deputies and stakeholders in the preparation of these legislative proposals. My colleague, the Minister for Health, also commits to examining all options to expedite the patient safety provisions currently within the health information and patient safety Bill. With this commitment in mind, I am proposing amendment No. 31, which amends section 12 of the Bill, to provide for voluntary open disclosure as was the original intent of the legislation when published and debated.

It is important to provide some further context but we can come back to it. The goal of the Minister for Health from the outset has been to create a safe space where there can and should be full disclosure of the facts surrounding a patient safety incident and the implications, if any, for the patient’s care and treatment. There has been considerable deliberation of the advantages of a mandatory or voluntary open disclosure framework. That took place before the Minister for Health came to the view that a voluntary approach offered the best way forward in this Bill.

There are issues of real significance here within my remit and that of the Minister for Health, who proposes we return to the original wording of section 12. I ask the Deputies to appreciate and understand why we should accept amendment No. 31. I am not in any way questioning the sincerity or the desirability of the proposals from the Deputies opposite. I am very concerned about the import of this legislation should we go down the road of making these amendments as they are proposed.

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