My Lords, I am pleased to follow the noble Lord, Lord Hunt of Kings Heath, who again has raised an important issue. The amendment in this group which more broadly encompass all those elements that go to make the United Kingdom a favourable location for research and the manufacture and supply of medicines gives us an opportunity to make sure that we have got that right.
I support the government amendments in this group and add my thanks to those expressed to the Minister and the Bill team for the immensely constructive way in which they responded to the amendments that we brought forward in Committee and in many related discussions. At Second Reading, the noble and learned Lord, Lord Woolf, and I were worried that the Bill was skeletal. We wanted to put a bit of flesh on its bones and make it more of a framework Bill—I think that is a bit of a theme. In the spirit of the remarks of the noble Baroness, Lady Thornton, it might be helpful if I briefly explained what we were trying to achieve, and how these government amendments appear to have responded well to that.
First, even following the initial changes, the structure of the powers was not objective; they were that the relevant Minister was satisfied that the regulations met certain requirements. What we were looking for from the outset was an objective test. My noble friend Lord O’Shaughnessy asked what that objective test was and why we chose to continue with the structure of safeguarding public health? The short answer is that it is because that is the objective in the European Union regulation; it is not an objective in that context which relates to the internal market provisions. To have moved away from the objective of safeguarding public health would run the risk of it being interpreted as somehow different from the past objective on the basis of which decisions had been made and regulations pursued. That seemed entirely appropriate as an encompassing and overarching objective for all these related requirements. I am happy that the Government’s amendment has taken that forward as an objective measure against which the regulations, the use of these powers, can be tested.
Secondly, we wanted to make sure that safety was built into the structure of regulation-making powers. We had an extremely helpful debate about that, and I think that it was clear that, while we wanted to make safety central to what was being achieved, it would not be appropriate to make it an overriding objective. That would have led to the regulator being required effectively to eliminate risk. That brings me to the point made by my noble friend Lady Cumberlege. We then came to the further question of how, if safety is the issue, we then manage the test of whether benefits outweigh risks, sufficiently so for regulations to be proceeded with. The answer is that the objective is not to eliminate risk; it is to eliminate harm. We must make a distinction between those two things.
Making safety the overriding objective would have meant us having to eliminate risk. At the moment, we balance benefits and risks, not benefits and harms. When my noble friend Lady Cumberlege asked her question, I think she was suggesting that we were having to balance benefits and harms, whereas on pretty much every occasion the regulator is asked to
undertake an authorisation they have to balance benefits and risks, because we can never eliminate risk. The question is: can we quantify it? That is what the trials and the data are meant to enable us to do—to quantify the benefits and risks. In making an authorisation, can we make sure that we have avoided harm but at the same time realised those benefits?
These amendments get us to that balance. They enable us to give an objective test against which the powers can be measured; they enable us to put safety clearly at the heart of the thinking about how the powers are to be used, and they enable the regulator to undertake that appropriate measurement of benefits and risks. I support the amendments and appreciate the way in which we have arrived at this place by constructive discussion.