My Lords, the Opposition strongly support the thrust of the Francis report in its determination that the NHS be honest with patients who have been harmed. I very much echo the comments made by the noble Baroness, Lady Masham, in describing why we need an open culture. I welcome government Amendment 140. It is very important; we welcome the duty of candour being placed in the Bill. The amendment is less detailed than my own and will rely on regulations, as the noble Earl, Lord Howe, has said. The important thing is to get this in the Bill.
I have a couple of questions for the noble Earl. First, can he confirm that the regulations will be affirmative? Secondly, in considering the regulations, will he look at the issue of the threshold? For instance, the regulations might restrict the statutory duty of candour to cases that could be described as of severe harm or fatal; or it might go wider. In his report, Robert Francis used the word “serious”. Clearly, there is a distinction between severe harm and seriousness, but most patients and their relatives, or anyone involved in anything that could be described as a serious case, would wish the organisation in the health service to be as open as possible about what had happened.
These are not easy issues; but it is noticeable that the being open guidance is clear that cases of moderate harm and above must be disclosed. The NHS constitution does not put any limit on the level of harm that would be disclosed. I do not expect the noble Earl to respond to the detail of those questions tonight, but in drafting the regulations it would be reassuring to know, first, that consultation will take place with patient groups on the contents of those regulations before they are published and, secondly, that the question of the threshold by which the seriousness of the case would come within the regulations will be given very great consideration.
I should—at the end of the day rather than the start—declare my interest. I remind noble Lords of the interest I declared two days ago.