These sections are the key to the Bill and concern the issue of open disclosure. We are dealing here with new definitions of the types of safety incident that cause serious and less serious harm; with mandatory open disclosure regarding serious incidents; with voluntary open disclosure of less serious incidents; and so on. This is a huge group. With the Leas-Cheann Comhairle's permission I would like to deal with one half of it first before dealing with amendments Nos. 38 to 47, inclusive, separately as they deal with a different issue.
The first group-within-the-group is, we believe, the most important. It deals with making the open disclosure of serious safety incidents in the health service mandatory. Open disclosure is absolutely crucial. When something goes wrong the patient has to know what happened and there also has to be an acknowledgment of the fact that something went wrong. When somebody is injured because of a mistake it is imperative that there is openness all around. At Committee Stage our amendment to provide for mandatory open disclosure of all incidents, whether major or minor, was miraculously accepted. That was a very welcome development. Following from that we had meetings with officials from the Department of Health at which we gave a commitment to table further amendments on Report Stage to the effect that near misses and very minor incidents would not be subject to open disclosure. This is because the way in which our amendment was accepted on Committee Stage would probably have resulted in it being too burdensome for health care workers to go through open disclosure for every near miss. We were very happy to meet the departmental officials halfway on this matter and we gave a commitment that we would limit what was agreed at committee. That, then, is what these amendments are about.
What we now propose is, first, that in the cases of near misses and minor incidents open disclosure to the patient is something that the health providers can and should do but is not absolutely obligatory in law. It is of course open to the HSE to make a disclosure of all incidents mandatory as a matter of policy if it so wishes. This would not, however, be defined in law. Second, and crucially, we propose that when it comes to more serious incidents and more serious harm, health care providers must be open with the patient about what happened and what the consequences for the patient might be.
It is important to say that we have had a system of voluntary open disclosure in Irish hospitals since 2013 and all of the evidence and anecdotes so far point the fact that it has not done much good. The United Kingdom, on the other hand, has a mandatory duty of candour. It is not an unknown quantity and it has been shown to work very well. The departmental officials, in fairness, agreed with us when we met them that they do not know which is best. Everybody wants a system in which patients get information but it remains an open question as to which approach is best. We believe that the UK example is the best model to follow because the open disclosure of serious incidents is simply too important for patients, safety, staff, and for our health service in general to be left on a voluntary footing.
As we said before, we know that there is a problem with the culture in our health service. We know this from the hepatitis C scandal; maternal deaths; baby deaths in Portlaoise and Portiuncula; and from cases of catastrophic injuries that have occurred in hospitals. We know that the default position of the HSE in many of these cases is to admit nothing and to circle the wagons. This is an entrenched culture that will not change without a lot of prodding. As far as we are concerned, voluntary open disclosure will not work in this kind of culture. Incidents will not be disclosed and honest health care providers will be penalised for making disclosures if nobody else is doing so. We will end up with an awful prisoner's dilemma situation in the health service where each hospital will end up eyeing the others to see who is going to go first. This will not be good enough. There is no evidence to support the view that a voluntary system of open disclosure is better or more effective than a mandatory system. That evidence is not there. The UK example, however, shows that the mandatory model is a good one.
We also deal here with the new definitions that we propose in the second group of amendments in this section. When an incident takes place that causes major harm, moderate harm or prolonged psychological harm to a patient, we propose that the service owns up to it and tells the patient what happened. What this means, then, is that there is mandatory open disclosure in these cases. This has been limited following the Committee Stage debate. We have put forward the definitions of those kinds of harm and modelled them on the definitions of the types of harm given in the HSE's own safety incident management policy and on the impact table for incidents used to make what we are talking about here smoother to implement. These definitions are also based on the definitions of harm given in the UK's duty of candour regulations. It is worth noting that this duty of candour only mandates the disclosure of incidents above moderate harm, which is exactly what we propose in this legislation.
We define major harm as "a permanent lessening of bodily, sensory, motor, physiological or intellectual functions, including the removal of the wrong limb or organ that is related directly to a safety incident and not related to the natural course of the patient's illness or underlying condition". Moderate harm is defined as "harm that requires an unplanned return to surgery, an unplanned re-admission, a prolonged episode of care, extended time in hospital or as an outpatient, cancelling of treatment or transfer to another treatment area (such as intensive care)". Finally, prolonged psychological harm is "psychological harm which a patient has experienced, or is likely to experience, for a continuous period of at least 28 days".
We consider that our proposals are reasonable and fair, taking into account the committee discussions and our subsequent discussions with the Department of Health. We do not see how it could be argued that the open disclosure of more serious incidents should not be mandatory. That is all that is on the table here. We are talking about cases of serious catastrophic harm up to and including the death of a patient because of a mistake made in a hospital. It would be lunacy to give hospitals permission to clam up about what happened in such cases. We view these amendments, then, as incredibly serious.