My Lords, I know what the noble Baroness, Lady Cumberlege, means when we have the privilege of hearing, as we have in this debate, so much expertise on very challenging
issues. Much of the debate has been about devices, but of course my noble friend Lady Finlay’s first amendment related to medicines. To reiterate, she sought to create a rapid two-year provisional licence without reducing safeguards on new medicines. She thought this would enable us to make best use of innovative new medicines without compromising safety at all.
It is understandable that much of our debate was on devices, because it was informed by the report from the noble Baroness, Lady Cumberlege. She has identified a number of issues around the regulation of devices—it is clearly a less vigilant approach than for medicines, with a lack of data and transparency, the equivalence issue and the challenges she raised. The noble Lords, Lord Kakkar and Lord Patel, went into further detail on some of the challenges around devices, particularly those that have a capacity to cause damage. The argument they put was that provisional licences would allow much more effective safety monitoring and early identification of problems and would protect innovation.
The noble Lord, Lord O’Shaughnessy, raised the interesting idea of extending the innovation fund that we are shortly to debate to devices. That deserves a great deal of consideration, although he will of course know that the innovation fund will essentially be funded by payments from the pharmaceutical industry. Seeing how money from the devices industry would come about is a much more challenging issue.
The Minister essentially said two things. The first was that what my noble friend wants to achieve in relation to medicines can be done already, that it is in the Bill and that, in any case, there is a new process to expedite medicines where it is deemed appropriate. I think my noble friend will want to look very carefully at that.
The Minister is right on devices. I think he spoke of 500,000 devices. It is a massive challenge; there is no question about that. There are reasons why devices regulation is different from medicines regulation, but when it is clear that there are defects in the current system, we must at least take advantage of the fact that we are now in a position, post-Brexit, to develop our own regulations.
The Minister went through the processes that are currently in place, including the role of notified bodies, but he said that the system can be strengthened and that regulations can be reviewed. At this stage, I urge that this be as open as possible so that we have a really good debate about medical device regulation, informed by the report from the noble Baroness, Lady Cumberlege, and by experience elsewhere. We want to do two things: to ensure that our innovative devices sector is given all encouragement, but also to ensure safety in a way that it has not been ensured before. That is a challenge, but it is one worth accepting. In begging leave to withdraw the amendment, I say that this has been a very good debate and I hope it will inform government thinking.