(6 years, 8 months ago)
Lords ChamberMy Lords, I have had the privilege of being involved in this sort of question for some time. Clinical trials need to be in a system which makes it relatively easy to set them up. The new regulation to which this amendment relates has very much simplified the system. Unfortunately, for fairly technical reasons to do with the portal, it has not come into force yet but the assurance that the Government have given in relation to this seems the best that they could give. It is entirely in accordance with the agreement that we came to yesterday; namely, that the Government will do all they can to bring the regulation into effect. Of course, if it happens during the implementation period then nothing more is required but if, unfortunately, it does not come into force during that period the Government will do everything possible to avoid delay and give certainty to those who plan clinical trials. As your Lordships know, planning clinical trials is not something that happens the day before they start; there has to be a good deal of planning so that such trials may be effective. I think the Government have done all that can be done in this situation to give effect to the intention of the noble Lord, Lord Patel.
My Lords, I thank the Minister for her very full response to the amendment moved by my noble friend Lord Patel. She has given a powerful reassurance that the important elements of the European clinical trials regulation that can be applied independently of the European Union to improve the situation for the conduct of clinical research in our country will be brought into force. That is vital, as the Minister said, for ensuring that those who plan clinical research can do so with absolute certainty over a period of time prior to implementation. I, for one, am most grateful to her for this reassurance.