My Lords, I will speak to government Amendments 11 and 47, and those that follow on from them, Amendments 12 and 48 from the noble Baroness, Lady Thornton. The first lot refer to medicines and the second to devices. But first I thank the Minister for his strong emphasis on safety in all the amendments. He certainly has listened to noble Lords. In Committee we stressed the objective of making sure that the Bill is a safety Bill. I believe that safety now permeates throughout the Bill, which is so encouraging, and I thank him and his colleagues for that.
Although I welcome the government amendments, I really do not envy a Secretary of State’s task in weighing up the risks versus the benefits. This will require the wisdom of Solomon. At least once the Bill is enacted we will have the data, which is all-important and has just been referred to. Our review’s report shone the light on our frustration of not knowing what was happening to whom, by whom, when and where. This will, of course, become apparent, which will be very useful once we have these processes in place.
But we are still left with weighing up the benefits versus the risks. Surely this depends on where the threshold is set concerning any medicine or medical device. For instance, if 99 people benefit from one of these products but one dies, what weight do we give to the 99—or, perhaps more importantly, to the one who died? Does the Minister see thresholds as important? If so, does he envisage the application of a threshold
for an individual medicine or device, or would there be a threshold to cover a similar range of products, or indeed a more overriding policy? I am not quite sure how this will be tackled.
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I support the amendments from the noble Baroness, Lady Thornton, because although they would not support the Secretary of State in reaching his decision, they would require talking to patients and a wide range of other people, but also provide some transparency, in that the appropriate authority must publish the criteria and assessment of why the benefits outweigh the risks. This will go some way, I presume, to sorting out this thorny issue of thresholds.
Transparency is, of course, critical to open government and it should be welcomed, but I understand this as being retrospective. Is that right? Is this included in regulations, perhaps, where there will be an important opportunity to debate signal detection to prevent harm, and whether these regulations would be prospective measures? Avoiding harm, rather than actually seeing what has happened in the past, seems much more preferable. Can that be part of this whole exercise of what we will discuss in regulations?