My Lords, I am glad to follow the noble Lord, Lord Sharkey, because he made some important points and it saves me having to make the same points less well.
The purpose of Amendment 35—in my name and that of the noble Lord, Lord Kakkar—is precisely to explore the issues that the noble Lords, Lord Sharkey and Lord Hunt, raised. I am concerned that, as it stands, the provision may mean that we do not align sufficiently with the clinical trials regulations as they exist in the European Union. That is a great pity because we have gone to an enormous amount of trouble to try to improve the clinical trials regulations in the European Union; indeed, we arrived at a point where they were significantly better than the previous regulations. To depart from them now seems a retrograde step.
We cannot be sure that we will stay aligned with those regulations for ever but having the objective of seeking to have our clinical trials regulations correspond to those in the European Union opens the option for us to be in the clinical trials information system. If we start to diverge from the EU clinical trials regulations, I am not sure how we can then be incorporated into that system. That automatically means significant difficulties in trying to manage multi-state clinical trials in Europe with a view to an authorisation process through the European Medicines Agency because the information system will, I think, be an essential pre-condition for marketing authorisation applications to the EMA. The purpose of Amendment 35 is precisely to explore this issue. What do the Government mean by “or similar”? Do they intend to diverge or not? If they intend not to diverge and to retain corresponding regulations, that is excellent. If they intend to do otherwise, that is not so good.
I do not intend to enter into the argument about aligning with the European Medicines Agency for the simple reason that we have been here before. We legislated in the Trade Bill in the last Session to align ourselves with the agency and to participate in its processes. Unfortunately, I do not think that that is going to be available to us, so legislating for it in the United Kingdom will be, I am afraid, without effect. I will focus on the Clinical Trials Information System because there is likely to be a willingness and interest on the part of our European partners to retain the United Kingdom in this process. I hope that is so, that we might be able to attain that, and that that will be the Government’s objective.
5 pm