I thank the Minister for bringing this legislation to the Floor of the House and for providing us with a summary of it, which helped immensely. We are expecting many more health SIs in the weeks to come, so I must make it clear again, as I will in future, that it is incredibly concerning that we are now only 38 days away from
Moving on to the legislation, clinical trials will probably not be in the forefront of people’s minds, but they are crucial for the safety and efficacy of medicines, as well as for our health and wellbeing. Medicine is not something that we should get wrong, but when we do, as in the case of Primodos, valproate and vaginal mesh as a surgical procedure, we must hold up our hands and take urgent action.
While this may not be the most eye-catching statutory instrument, it is hugely important. It is about patient safety and confidence. It would mean that in a no-deal scenario, the Medicines and Healthcare Products Regulatory Agency would be able to operate as a regulator outside the EU system and would therefore take on roles formerly conducted by the European Medicines Agency and through the wider EU regulatory framework. I must put on record my disappointment that the EMA is relocating from the UK to the Netherlands next month because of Brexit. Our loss is the Netherlands’ gain, but we should not have let it come to this. However, this SI means that in the event of a no-deal Brexit, the MHRA will be able to regulate clinical trials to ensure that they continue to operate effectively.
I want to ask the Minister for clarification on a few points. The new EU clinical trials regulation was introduced in April 2014 and was expected to come into force in October 2018. I understand that owing to technical issues that has now been delayed. The Government’s no-deal guidance says that
“we’ll align where possible with the CTR without delay when it does come into force in the EU”.
Will the Minister please restate that commitment to the House today?
If the UK does leave with a deal, which I hope we do, what will the arrangements be for the CTR and the UK? Could the UK, no longer being a part of the EMA, delay the availability of new medicines in the UK? I am aware of concerns raised that, because the UK will be seen as a smaller market for new drugs than the EU, companies will be more likely to prioritise the authorisation of new drugs in the EU rather than in the UK. Has the Minister made any assessment of this risk?
Will the Minister please tell the House what the implications of a no deal would be for clinical researchers who are EU nationals? Will the UK also be eligible for EU funding for clinical trials under a no-deal scenario? The UK is currently one of the largest recipients of funding for clinical trials, and I am concerned about the implications for future trials and opportunities. The MHRA will have the power to publish its own guidance on clinical trial applications and applications for an ethics committee opinion, as well as declarations of the end of clinical trials and the content of documents forming trial master files. Could the MHRA continue to work with EU states in order to keep regulation in line with the EU? Will the Minister review important details, such as ethics, where concerns are raised?
In July 2017, the then Health Minister, Lord O’Shaughnessy, said that in the event of a no deal the Government would ensure that any system put in place would not impose additional bureaucratic burdens. Can the Minister reaffirm this commitment today? I know that this instrument was subject to consultation and that because of concerns raised amendments were made. Will she please say whether any further amendments are expected and whether there will be further consultation? Finally, will she please confirm that any changes made by the instrument will be communicated effectively to stakeholders in a timely manner?