My Lords, I support the two amendments in the name of my noble friend Lady Thornton. I have also put my name to Amendment 22 from the noble Baroness, Lady Finlay—she is currently in the internal markets Bill Second Reading debate—which links this to a definition of attractiveness, and to Amendment 39 in the name of the noble Lord, Lord Patel, which focuses on clinical trials for rare diseases and the importance of alignment with the European Medicines Agency.
At the end of this debate, I hope we will have a better idea of the Government’s approach to the regulation of medicines and medical devices. I do not want to repeat myself, but, as my noble friend said, the big question seems to be that at the moment the EMA covers 25% of global pharmaceutical sales and the UK on its own makes up 3%. We know that the NHS is a very poor customer in terms of adopting new medicines. The UK market is pretty hopeless for pharma. If we are not going to be aligned to the EMA, what will this mean for UK pharma in terms of future investment? My guess is that it will snap off that investment.
This is the big issue, which we do not yet understand. What is the Government’s aim? Is it the idea that a no-deal Brexit is a good thing and UK pharma will survive with a hopeless home market and all the
problems of dealing with Europe? Countries will clearly not come to the UK first when they have the EMA next door, unless we offer fast-track licensing, which brings us back to patient safety, which is why the two link so much together.
I hope that this time the Minister will give us some idea of what the Government are aiming for. The same applies to medical devices, although there are some specific opportunities, because at the moment the MHRA has no involvement in the pre-market phase of medical device development. Is the intention that the UK develops a proactive regulatory role for devices that is more akin to the licensing of medicines? If so, what will be the implications for industry and patient safety? Clearly, there have been many issues about medical devices in the past which have not gone through such a robust regulatory regime. Is it the intention that the UK goes through a more extensive regime in the future under its own steam? What will the general implications be?
Again, we know that Covid-19 is having an impact on clinical trials, a significant number of which have been paused. It is my understanding that only 45% of studies are currently open to recruitment and only 36% of them have successfully recruited patients since 1 June. The ABHI has highlighted the need for a sustainable plan and aims to return clinical research to pre-pandemic levels by spring next year.
This is important because, despite the size and growth of the global market for clinical research, the UK’s share of clinical trial applications and patient recruits has fallen since 2016. The UK is now falling behind the US, Germany and Spain for phase 3 commercial clinical trials. What is to be done about that? What is the Government’s approach? Again, how does this relate to the future regulation of clinical trials?
I hope that the Government’s intention is to stimulate the UK’s clinical research environment, but part of that must be enabling multi-state UK-EU trials to continue. The idea that we can have multi-state trials that do not involve some agreement with the EU seems fanciful in the extreme. Again, at this stage, we are entitled to know from the Government exactly what they intend.