My Lords, let me say how much I welcome the amendment moved by the noble Baroness, Lady Brinton.
When I had the temerity to raise this issue and all the others raised by the noble Baroness on Monday at Second Reading, I sought information and assurance
on a range of healthcare matters. I think we can say that I got the bum’s rush from the Minister when he answered my questions. In fact, he did not answer them at all. I hope we might fare better this evening.
The medical research sector has been clear that continued close co-operation should be a priority in the negotiations. Indeed, the Government have recognised the international nature of the life sciences sector. They are committed to aligning as closely as possible with the European Union clinical trial regulation when it comes into effect, safeguarding vital UK-EU clinical trials. Indeed, the political declaration also refers to continued co-operation with the European Medicines Agency, which would help ensure that patients in the UK have swift access to the newest medicine. However, the political declaration has no legal standing, so the noble Baroness, Lady Brinton, is quite right to repeat in the Committee the concerns expressed by the European Union Committee. As it stands at the moment, we cannot see that the European Medicines Agency will continue to benefit patients in the UK.
For some treatments, those of rare diseases, a single authorisation at EU level is vital in providing for cost-effective licensing and distribution of medicines for small populations. If the UK is outside the EU market and companies are required to pay again for separate MHRA licensing, as well as an appraisal by NICE and equivalent bodies in the devolved nations, there must be real concern that some treatments for rare diseases may become not financially viable to launch in the UK, therefore risking patient access entirely.
I know that the Minister absolutely understands all this, so it is very important that she reassures the Committee that these issues will not just be taken into account but will be part of the negotiations and will be successful.