My Lords, it may help if I speak now and then allow other noble Lords to comment: that might help elucidate the situation. This is a very important issue and I am grateful to the noble Lord, Lord Patel, for providing me with the opportunity to make clear the Government’s position on the UK’s future clinical trials framework and to provide clarity on the introduction of the new EU clinical trials regulation.
As the noble Lord knows, the MHRA is working towards the implementation of the new clinical trials regulation. The new regulation, agreed in 2014, is a major step forward. It will enable a streamlined application process, a harmonised assessment procedure, a single portal for all EU clinical trials and simplified reporting procedures, including for multi-member state trials. The UK has been involved in developing the new regulation and this has been widely welcomed by the research sector, including medical research charities and industry.
I pay tribute to the perseverance and interest in this issue of the noble Lords, Lord Patel and Lord Kakkar, the noble and learned Lord, Lord Judge, my noble and learned friend Lord Mackay of Clashfern and the noble Baroness, Lady Thornton. Points raised in Committee were helpful; they were very instructive and assisted the Government. Indeed, a most useful meeting was held yesterday, as the noble Lord, Lord Patel, mentioned, at which the noble Lords, Lord Patel and Lord Kakkar, the noble and learned Lord, Lord Judge, and my noble and learned friend Lord Mackay were most constructive in their approach. I thank them for that, because it greatly assisted in reaching what I think is a resolution of this matter. This means that today I can provide noble Lords with the strongest possible reassurance on the UK’s commitment to implement the CTR. If the CTR comes into force during the implementation period, as it is currently expected to do in March 2020, it will apply to the UK. If this opportunity does not come to pass, the Government will seek to bring into UK law all relevant parts of the EU regulation that are within the UK’s control. I shall expand on that shortly.
The Government have been consistent that a key priority through the negotiations is to ensure that the UK remains one of the best places in the world for science and innovation. Noble Lords will be aware that the life sciences sector in the UK is world-leading. It generates turnover of more than £63.5 billion per annum and the UK ranks top in the major European economies for life sciences foreign direct investment. Importantly, there are more than 5,000 life sciences companies in the UK, with nearly 235,000 employees. The Government are determined to build on this success as we leave the EU. Of course, it is not just UK industry that benefits from a thriving life sciences sector. More importantly, UK patients benefit from having access to the most innovative and cost-effective treatment available. It is in the interest of patients and the life sciences industry across Europe for the UK and the EU to find a way to continue co-operation in the field of clinical trials, and for continued sharing of data and information, even if our precise relationship with the EU will, of necessity, change.
As the Prime Minister outlined in her Mansion House speech, the UK is keen to explore with the EU the terms on which the UK could remain part of EU agencies that are critical for medicines. For example, membership of the European Medicines Agency would mean investment in new innovative medicines continuing in the UK, and it would mean these medicines getting to patients faster, as firms tend to prioritise larger markets when they start the lengthy process of seeking authorisations. It would also be good for the EU, because the UK regulator assesses more new medicines than any other member state.
It is only fair that I deal with the amendment of the noble Lord, Lord Patel. The amendment asks for the EU clinical trials regulation to be deemed operative immediately before exit day, in order that it forms part of retained EU law and is therefore part of the UK statute book after the UK’s withdrawal from the EU. While it is true that the new clinical trials regulation was adopted at EU level in 2014, article 99 of the regulation states that it will only apply six months after the Commission publishes a notice confirming that the relevant EU database is fully functional. This is not expected to happen until after exit day. It is this stated date of application that is relevant to whether the EU law is incorporated by Clause 3 of the withdrawal Bill, and that is why it is not captured by Clause 3. As I have said, today I can offer noble Lords the strongest possible assurance of this Government’s support on the following.
If the clinical trials regulation comes into force during the implementation period, as it is currently expected to do in March 2020, it will apply to the UK. The withdrawal agreement and implementation Bill will give effect to the implementation period in domestic law and will allow regulations to continue to apply in the UK for this time-limited period. If this opportunity does not come to pass, we will give priority to taking the steps necessary to bring into UK law, without delay, all relevant parts of the EU regulation that are within the UK’s control, so that those planning clinical research can do so with certainty. The two key elements of the regulation that are outside the UK’s control, and therefore not covered by this guarantee or pledge, are, first, the use of a shared central IT portal and, secondly, participation in the single assessment model, both of which require a negotiated UK-EU agreement regarding UK involvement post-Brexit. We cannot pre-empt these negotiations and we do not wish to do anything that might disadvantage the negotiating position of the UK by giving any further guarantees at this time.
In short, the Government are committing to being as aligned with the new EU clinical trials regulation as we possibly can be, subject to the negotiatory aspects that I have mentioned. I was anxious to elucidate the position to assist the Chamber and contributors as to the Government’s position and I hope that the noble Lord can accept my reassurances.