My Lords, I welcome Amendment 5 and others in this group. I echo the noble Baroness, Lady Thornton, in complimenting both the Minister and the Bill team on their expert handling of this part of the Bill.
I find the sentiment behind Amendment 12 attractive and endorse entirely the words of my noble friend Lady Cumberlege and others who have supported her in wanting to avoid “harm”. The idea of a threshold, as solicited in Amendment 12, seems helpful. I have a question for my noble friend the Minister to which I would be grateful for a response. We are told in the explanatory statement that the amendment would require the Secretary of State
“to publish the criteria that will be used by the appropriate authority”—
obviously not yet set up—
“to determine whether the benefits of regulations that may impact on the safety of human medicines outweigh the risk”
and
“to allow for greater transparency and scrutiny.”
My noble friend said that the Government intended to publish the initial assessments. It would be helpful to know when that would be.
There currently seems to be a gap in the law; for example, as regards the vaccinations—I know that this was debated earlier today. The Government have unilaterally extended the time between the first dose and the second dose of Pfizer and AstraZeneca vaccines from three weeks—21 days—to up to 12 weeks. No other European country that I am aware of has done this. It is true that Denmark is looking to extend it to a maximum of between four and six weeks, which is nearer the initial three-week period. I presume that, if what is proposed by Amendment 12 were law, the Government would be obliged to publish the arguments in the interests of transparency, openness and scrutiny as to how they had reached that decision. If that were the case, I would be minded to support Amendment 12.
Otherwise, I welcome Amendments 4 and 5 and others in the group, which look to establish the overarching objective as being public health. I like the formulation of words that the Government have hit on and hope that they will stick with it. I shall be interested to hear how my noble friend responds, but, as I see it, there is some merit in Amendment 12.