Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023

Baroness Merron Excerpts

Monday 20th March 2023 Grand Committee

With those questions, including the nerdier questions on the designation of agencies, I hope that the Minister will be able to clarify some of those points. In principle, we do not oppose the idea that there needs to be a properly funded approval process—and I hope that it is one that works consistently and to a high quality.

[Baroness Merron (Lab)]

My Lords, I thank the Minister for introducing the SI and the important provisions within it. As my noble friend Lord Jones said, it is an important SI, and we acknowledge the role that the MHRA plays and the need to increase the fees that it charges for regulating medicines and related products.

I appreciate that the Minister said that the MHRA has not increased its fees to this extent since 2016-17, which was in an effort to provide the industry with certainty and stability through the EU exit period and the challenges of the pandemic.

The noble Lord, Lord Allan, asked some questions the responses to which I would also be interested to hear. The consultation process was important, and I am glad that it took place and has guided the SI and its provisions, because the views of relevant stakeholders are key in making sure that we get things in the right place.

There is a clear acknowledgement from noble Lords that the MHRA needs to be financially stable, because it needs to be able to deliver regulatory services that protect and improve patient safety with high-quality, safe, effective and innovative medical products. I certainly welcome the greater clarity that the SI provides on the increased costs of providing quality care in our health services. However, I have a question for the Minister specifically on the SI. Where the increased costs of the fee simply cannot be absorbed by the NHS, which is already facing the worst of crises, could the Minister outline how the Government will ensure that the increase will be accommodated without affecting the stability of NHS finances and without impacting patient care? In other words, how will it be done?

I will make some more general points about the work of the MHRA. Innovative companies in this field often say that a key block to their progress—a key block to getting their work through the MHRA—is the speed, or the lack of speed, with which it can be processed. Can the Minister indicate how he will ensure that the MHRA stays up to speed with the latest advances and is able to process them as quickly as possible?

It would also be helpful to know how the department scrutinises and assesses the work of the MHRA. For example, what is the formal matrix for success and the speed at which it processes new devices? How well does the MHRA communicate with other organisations in the sector? What engagement does the department have with the MHRA, both to hold it to account and to improve its practices?

In drawing my more general points to a close, I note and welcome the recent announcement of the extra £10 million of funding for the MHRA. Can the Minister outline the blocks to quick approval to which this money will be targeted? How will the impact of this additional money be measured, and is it sufficient to deliver the service we need to ensure that UK patients have faster access to the most cutting-edge medical products in the world? As part of the additional money, the Chancellor announced last week that treatments already approved by “trusted” regulators internationally would be nearly automatically approved. Which countries are counted as “trusted”? Has an impact assessment been carried out for this change and, if so, can it be published?

We are always looking forward and looking to make further strides in patient safety, it is certainly my opinion that this statutory instrument takes us further along this route, and we welcome it.

[Lord Markham (Con)]

I thank noble Lords for their contributions today and, as ever, will try to reply and follow up in writing where necessary. I shall try to take them in order, for ease. The noble Lord, Lord Jones, asked who is working on the bloods, for want of a better word. We have qualified professionals who are working to WHO standards, such as phlebotomists. Related to this was the question of who is in receipt of these fees. It is twofold. Obviously, a lot of fees go to fund MHRA itself, but a lot of the cost base is when it is hiring in subject-matter experts. In that case, they get the fees.

The general point raised by all noble Lords was the basis of this. As I said, it is a cost-recovery model. There are swings and roundabouts there, but it has tried to ensure that where there are bigger increases, it is only because that is the legitimate cost, but on average it comes to about 12% to 13%. I think that we would all accept that, for something that has not increased since 2016-17, that is reasonable. It is quite a bit behind inflation. That notwithstanding, I am very alive to the impact on SMEs, having been, as I said, in a similar space myself in the past. There are easements and waivers that can be applied, if that is the case.

To the general point about how we are trying to keep up with the speed of advances in the industry, it is very much the understanding that the industry is providing a service. Of course, safety must always be paramount, but it is a service to bring in innovation and attract new people into the sector. It has a transformation programme to ensure speedy replies—but I was pleased to hear that it is also looking to introduce a consulting service to help companies get into the field. That will be different from the regulatory side—obviously, we need a Chinese wall between the two. But it is recognised, especially for a small company, which does not have a regulatory team in place, that being guided and hand-held through the process, and having someone to tell them that this is what they need to do to get in, is very important. That is something that it is committed to doing.

As for holding the MHRA to account, to be candid, I see that very much as my job. That is obviously for officials as well, but I have the brief for the ALBs, and I set up regular meetings with them. As I said, I am very much alive to the fact that that is needed to make sure that it really is serving the industry properly. Part of holding it to account is about making sure that it is providing a decent service level. That is something that I will look for it to carry on doing. Consultation is useful as a formal process, but it should always talk to its customers and get that sort of feedback.

I have to fess up that I probably cannot answer some of the nerdy questions right now, particularly on the reclassification of the agency. I will have to phone a friend or get my colleagues to reply on that point. Likewise, I think we would all agree that the extra £10 million is welcome in this space. How the MHRA will go about that distribution and how it will measure that effectiveness is something I will follow up in the detailed letter that I will send.

Similarly, on which countries are counted as “trusted”, my understanding is that often the MHRA looks at the processes that are in place—again, I will come back in detail on this. Rather than a country being trusted, per se, it is more about the scrutiny process that it undertook. Obviously a regulator would be accepted as good in a place, but again, I have some personal experience. If you can see that the CDC or the FDA has gone through a very similar process, does it really make sense to do that all again? Clearly, it is felt that I have not quite answered the question—but I mentioned the waivers.

At this point, I hope I have covered most of the questions that I can right now, but I will follow up in detail. I appreciate that noble Lords are generally supportive of what we are trying to do here, and that we all agree that the MHRA has an important part to play and that the cost recovery is a reasonable approach, particularly with some of the price increases in recent years. As I said, I will happily follow up in writing. On that, I commend the regulations to the Committee.