My Lords, as the Minister for Innovation, I am very keen on the UK’s continued leadership in this area; I have made it something of a personal cause. I am very proud of the fact that the MHRA approves around 950 medicinal trials a year, over half of which are multinational.
We know that once an early phase trial is established in this country, the industry is more likely to keep its later phase multi-country trials here. I would say to the noble Lord, Lord Hunt, and others who have questioned this point, that I can confirm that the purpose of the measures in this Bill are absolutely to build on our established strengths so that the UK has the opportunity to anchor international drug development in this country and grow that capability. I am committed to international standards, international partnerships and multi-country clinical trials. It is of course important that we work with our international partners both within the EU and globally to the benefit of patients. I assure noble Lords emphatically that we are committed to international co-operation.
However, I do not agree that our future relationships will be furthered by mandating the consideration of alignment with EU regulations and the European Medicines Agency. The UK has a long track record of jointly tackling global challenges with strong international links already in place between research and innovation communities. The UK works closely with many other regulators; those relationships are underpinned by many shared international standards. The EU bases its regulations on exactly those standards, as do we, and we will continue to do this going forward.
As a number of noble Lords have noted, we have the opportunity to create a better regulatory framework. The feedback from the industry is that an agile, proportionate UK system with familiar data submission requirements would increase the UK’s attractiveness as a place to conduct multinational studies, even if we are operating outside the EU’s network. My noble friend Lord O’Shaughnessy’s quote from the ABPI made this point. The powers in the Bill as it stands will allow us to develop exactly that kind of system.
Progress is already happening. The MHRA and the Health Research Authority are already taking steps to streamline the approvals process for UK clinical trials and are currently piloting a new process that has been shown to reduce overall approval times by more than 30%. I say to the noble Lord, Lord Sharkey, that this change does not rule out co-operation. Data generated in a UK clinical trial will continue to be admissible to support regulatory activity in the EU—and, indeed, globally. We can also look at how we can go further in making clinical trials and their results transparent and visible to the public. Co-operation does not require alignment.
Amendment 3 in the name of the noble Baroness, Lady Thornton, also suggests considering alignment with EU licensing processes. In the short term, the MHRA has already taken steps to recognise for two years future EMA decisions for medicine licences approved through the centralised authorisation procedure from January 2021. In the long term, there are opportunities to establish new UK routes to market, such as a new expedited pathway for innovative products, and to establish shorter assessment timeframes.
We have the ability to make corresponding or similar provisions to the EU CTR, but Amendment 38 would oblige us to align. Amendment 35, in the name of my noble friend Lord Lansley, does something similar. My noble friend makes the point that we have the opportunity to do better than the EU CTR, and that is very much our intention. That regulation replaces current separate regulatory authority and ethics approvals with a single national decision for a trial. The UK could adopt a similar methodology and associated data requirements for approvals, but in a much quicker timeframe. We have already introduced the combined ways for a working pilot to streamline approvals by the MHRA and ethics committees, and industry has told us that our scheme is one of the most appealing among the various pilot schemes in the EU, leading to a reported 30% reduction in timelines. The UK may wish to go further and develop our existing national system to further adapt requirements according to
risk so as to reduce unnecessary burdens, such as academic trials involving a marketed product already in common usage.
In his Amendment 49, the noble Lord, Lord Sharkey, suggests that there would be benefits in adopting certain definitions in the EU CTR. These include the EU’s revised definition of a clinical trial and co-sponsorship set out in the EU clinical trials regulations. Under the EU CTR, this new definition of clinical trials is an attempt to avoid current variation in interpretations in different member states. Whether this will have the intended effect remains to be seen. EU legislation already includes a definition of a clinical trial, and the MHRA offers trial sponsors free advice on whether their study meets that definition, to ensure a consistent interpretation. If we wished to amend our definition of a clinical trial corresponding to that in the EU CTR, the Bill as drafted would enable that.
My noble friend Lord Lansley is right that the EU CTR introduces a single submission portal and co-assessment model, but I confirm that member states involved still have to individually authorise the trial, and therefore one or more member states could refuse authorisation. The portal is an IT system, the method of delivery. This does not mean centralised EU approval of a trial. Where a member state has national restrictions that require separate approvals outside the scope of the EU CTR, the sponsor would still have to seek the approval separately of the individual member state, in addition to the processes for seeking authorisation for the trial through the EU portal under the EU CTR. Industry has told us that if the UK has a rapid approval system, the lack of access to the EU portal is not a particular issue.
Amendment 52 introduced by the noble Lord, Lord Patel, suggests provision to develop a clinical trials portal that aligns with the European Medicines Agency for medicines for rare diseases. The EMA’s IT system does not address complex trial designs, such as umbrella, basket and platform trials that involve the use of master protocols. These are the very trial designs that have delivered the UK’s successes in Covid-19 research. On the EU portal, it is also extremely unlikely that the EU would agree to UK involvement, even if one were to request it, given that it is for EU member states and EEA countries. There are many other reasons why the UK is such an attractive place to run global rare disease trials: our world-class research infrastructure and centres for excellence, and so on and so forth.
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Amendment 22, in the name of the noble Lord, Lord Hunt of Kings Heath, specifies a number of components that the term is to cover, including the way in which we work internationally for the future, such as establishing and forging international regulatory standards. Noble Lords touched on a number of points. We intend to have international relations in our own right going forward, as in Amendment 125 in the name of the noble Baroness, Lady Jolly, which requires the Government to seek full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. The MHRA has already submitted its application to the ICH, and we expect to hear the outcome of the
application following the ICH assembly’s meeting in November. The MHRA has a longstanding history of demonstrated commitment to the ICH as part of the EU’s delegation and we remain committed to making a significant contribution in the future as a stand-alone regulator. However, there are other partnerships in the future. From 2021, the MHRA will take part in Project Orbis, an international consortium led by the US FDA, with regulators working together on the review and authorisation of cancer medicines.
The amendment in the name of the noble Lord, Lord Hunt, also touches on the importance of getting medicines when they are developed by referring both to the importance of reimbursement in parallel with the granting of marketing authorisations and facilitating prompt access through new approaches to reinvestment. I reassure the noble Lord that NICE and the MHRA are already working to ensure that marketing authorisation procedures in health technology assessment timings are aligned as much as possible to ensure that new medicines are available to patients earlier. However, the subject of reimbursement is outside the scope of the Bill’s remit.
Excellent clinical trials are run here now, and that will continue in the future. While we make changes where they are seen to be needed or helpful to facilitate clinical trials, we will work with partners, establish relationships, and continue to set international standards as part of the framework for clinical trials.
I hope that the noble Baroness has heard enough to feel able to withdraw Amendment 3 and that other noble Lords with amendments in the group will not press theirs.