It was almost inevitable, looking at the amendments that were coming up and knowing the people who would be discussing them in Committee, that this was going to be one of the most interesting debates. It has been fascinating and well informed. The amendments relate to our future relationship with the EMA and other international organisations after Brexit. My Amendment 125 in this group is on future regulatory alignment; I am grateful to my noble friend Lady Sheehan for her contribution.
The Government have not been forthcoming on whether they will pursue regulatory alignment and, more importantly, what the implications of not doing so would be. I would be grateful if the Minister clarified that second point. Our clinical trials are hugely important and widely respected. The clinical trials information system is critically important; the noble Lord, Lord Lansley, made that vital point. What aspect of the role of the EMA are we trying to replace? It has four parts: to facilitate development and access to medicines; to evaluate applications for marketing authorisations; to monitor the safety of medicines across their life cycle; and to provide information to healthcare professionals and patients. We need urgent clarification on how the future information system will work, who will host it, how it will be staffed and how we will share our research.
As the noble Lord, Lord Patel, said, we do not have a large enough population for significant research without partners. Are we clear that we could work with the FDA in the US—or, indeed, with the TGA in Australia? Would that give us a sufficient body of people from which to take on our research? Perhaps. Are there any moves to seek full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use? I am sure that the Minister will have the answers but the regulations must have regard to the desirability of alignment, somehow or other, with the rest of the world. We cannot work as a small unit—perfectly formed, maybe, but we are small compared with the US, Europe and other groupings.
How is this going to be measured and monitored? The noble Lord, Lord Hunt, spoke about the fast-track licensing of medicines and devices. The point he made so clearly is that public safety has to be paramount so we cannot rush this sort of thing. We have to get it right; if people have to wait, so be it. It has been interesting to hear the reflections of the noble Lord, Lord O’Shaughnessy, because he was sitting in the hot seat of the department. I wonder whether he is glad that he is not there now.
The other interesting amendment concerns the definition of attractiveness, which included collaboration with the EMA. The noble Lord, Lord Hunt of Kings Heath, and the noble Baroness, Lady Finlay of Llandaff, attempted a definition. I am sure that if we were all given a piece of paper and asked to write down our definition of attractiveness, there would probably be as many answers as there are people in the debate today. I would like a definition from the Minister: how is this to be measured and by which body?
Without a doubt, under the provisions of Amendment 34, regulations must be made, while under Amendments 35 and 36, they should correspond with the EU clinical trials regulations. Amendment 38 provides that we must continue our collaboration with the EU in whatever form we can manage between us. We also need to look hard at clinical trials portals, not only with the EU but with our other partners in future.