Mesothelioma Lump Sum Payments (Conditions and Amounts) (Amendment) Regulations 2024

Debate between Baroness Finlay of Llandaff and Lord Allan of Hallam

Monday 19th February 2024 Grand Committee

[Baroness Finlay of Llandaff (CB)]

My Lords, I also declare that I am a member of the all-party group on asbestos. Following what has been said about schools, which is incredibly important, it is also worth remembering that many of the people who die of mesothelioma have been healthcare workers, because they were in hospitals where the pipe lagging, often done with asbestos, was poorly maintained and loose. When they ran through the corridors, sometimes the basement corridors, to get to emergencies they would have been inhaling this fine dust without realising it. I was one of the junior doctors working in that type of hospital.

The all-party group is desperate—I use that word advisedly—for these regulations and for this compensation scheme to come through. I undertook in the meeting today to make that representation here. I was interested in the Government’s figures, if I heard right, of 2,860 awards in a year, because new cases are estimated to be around 2,700 a year, which tallies completely with the appalling survival rate of only 2% at 10 years. Mesothelioma is an awful malignancy from which people die very quickly. We have heard repeated stories of people who suddenly became ill and were dead within months, so it is devastating. It is also devastating in the younger age groups, who may leave children bereaved of a parent.

The other thing I want to flag up and keep on record is the fact that we still have many school buildings with asbestos in them. That problem has not been solved and I have particularly brought it to the attention of the Government from Wales, where there has been dispute over how it will be ameliorated. As well as this compensation scheme for the victims, we need to remember that prevention is absolutely crucial and to make sure that all buildings where there is asbestos are adequately managed. It may well be that what has been done in many of those schools and hospitals to date has been inadequate, thinking that it could be covered up, because the walls get nails put into them and if children bounce against them, the walls crack. Water can also get in, and you can easily get a leak of asbestos fibres.

There is no current requirement to monitor the air quality in an ongoing way. Individual sampling is inadequate because these fibres will fall to the ground, so a one-off air sample may not detect them. There needs to be continuous air quality monitoring in schools, and I suggest that it might be a preventive and public health measure.

[Lord Allan of Hallam (LD)]

My Lords, the first two instruments are of course welcome in providing the inflation-based uplift, particularly because the schemes do not require that from their inception, so it is certainly welcome that those payments will be made. I have only one question on that, which is to understand how the process of the change occurs around 1 April, as the Minister said would happen. Given the rate of inflation, the 6.7% is quite material.

I am curious to understand whether it is something that the claimant exercises some control over—in other words, if they decide to put in their claim in March, it will be at the lower rate; if they choose to wait until after 1 April, it will be the higher rate—or is there some other mechanism taking place that determines that it has to be before or after the uplift date? That will be a question for a lot of people now that we have the gap between approving the new rates and when those rates kick in. People will have questions about whether they control that or the department does. What is it that determines whether they get the old rate or this new rate, which is materially increased? I say that not to complain but to welcome it—it is extraordinarily welcome—but if somebody applied and found that by applying a week earlier, they had missed out on a significantly higher payment, it would be frustrating. I hope the Minister can deal with that.

On the final instrument, I again thank the Minister for the very clear and comprehensive explanation of how we got there. It touched on questions that I had when I read the instrument. I will play back to the Minister what I think I heard, and perhaps he can confirm in his closing remarks whether I have understood it correctly.

There are around 300 people a year in the category that we are talking about who were technically excluded from the old payment scheme. These people have been getting their money but, in effect, they have been getting it ultra vires. They should not have been getting it, technically; they have been getting it—that is not a complaint; it is extremely welcome if that is the case—but, in September last year, somebody spotted the fact that they should not have been getting it, and now we have 94 people sitting in the queue until we can fix that. Can the Minister confirm that that is the sort of number of people; that they have been getting the money and no one from the group that we are talking about was being turned away; and that it is just that from a technical, legislative point of view, we have been more generous than we should have been? If that is the case, that is great; I am happy to go with that.

I hope the Minister can just clear that up for us and confirm that, extending into the future, from the point of view of understanding whether someone is eligible, there is not a group of people who will not have applied because, under the prior definition, they thought they were ineligible. If it is the case that there is a group of people who are now eligible who were not previously eligible, I am keen to hear from the Minister how we are making sure that they are all made aware of that and encouraged to apply to the scheme.

On balance, these three instruments seem very welcome. They uplift a much-needed payment for people suffering from serious illness. The one question I have is around the mechanism for when that uplift kicks in between now and 1 April. On the third instrument, again, it is welcome, but I just seek reassurance that people in that category have not been turned away and that future claimants will be made aware of their eligibility effectively.

Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023

Debate between Baroness Finlay of Llandaff and Lord Allan of Hallam

Tuesday 6th February 2024 Grand Committee

[Baroness Finlay of Llandaff (CB)]

My Lords, I should declare that my son is a cardiologist and founder of Rhythm AI and Echopoint Medical—I think those medical devices do not completely fall within the scope of this, but I declare it anyway just in case.

It is notable that the medical devices road map from the MHRA, which set a future regulatory framework for devices and was published on 9 January, talks about four statutory instruments. Does this form part of those four? Are others due to come, and if so, when?

Despite the Government’s warm words about us being an attractive market, the problem is that the UK is becoming an increasingly less attractive market because our application-to-approval time has extended beyond that of other countries such as the US and Australia and, I think, Japan. Clinical trials in general are not being brought to the UK. During the pandemic, we showed that MHRA approval could allow us to be the fastest in the world with vaccine development and, more recently, with treatment of sickle cell disease. However, low numbers of patients are now enrolled in studies. For the life sciences to develop, trial and test new technologies, they need to be able to do so rapidly. How will the MHRA have adequate workforce to deal with an increased workload from Northern Ireland? Has that been factored in?

How will the risk assessment be set? It is important to recognise that some developments will fail and fall by the wayside. A realistic risk assessment recognises that a whole population needs to be studied. That is best done with post-market surveillance, which is key to evaluating the implementation of any new technology in the real world.

There is a view that our regulations have become tighter, making it too hard and burdensome for device development to be brought to the NHS; as the UK market is small, we need to make it particularly attractive for innovation. The eventual market, being small, would allow us to keep our innovations and market them abroad once they had gone through full approval processes. What steps are in place for mutual recognition agreements to be taken forward?

A paper from Birmingham Health Partners, Alternative Routes to Market for Medical Devices, suggests there are three routes. I gather that Switzerland has now undertaken to adopt the Food and Drug Administration approval systems from the US, registering the file—for us, it could be registered with the MHRA—with a post-market surveillance plan in place. Of course, the initial safety standards must be met, but it is in the real world that benefits and risks are revealed.

For our deficits and gaps in the NHS, there are problems that we need to solve by pulling new technology and diagnostics in. But the golden age of innovation will happen only if there is fast approval to evaluate, with good surveillance so that those innovations with problems are rapidly dropped and those with promise and better patient outcomes continue to be developed. This innovation has to happen across primary and community care as well as hospital specialty services. It requires the recognition of intrinsic risk by adjusting the risk threshold, including that not to innovate is also a risk.

The public understands the need to innovate. In the related areas of clinical trials, which I think is an important but salutary comparator, we have dropped from being fourth in the world to being 10th in the world, which is much to the loss of our NHS and our patients, as well as, obviously, innovation business. Our time for the regulatory review is greater, so we are slower than many other countries. How will these regulations strip out unnecessary processes and bureaucracy and speed up processes to make us attractive to innovators? Northern Ireland being in the unique position that it is now in could be a very important market for innovation, with its fast and easy access and attractions for those developing in vitro devices.

[Lord Allan of Hallam (LD)]

My Lords, I was grateful to the Minister for his description of in vitro devices, which is not necessarily obvious from the regulations. I hope that he can confirm that the “in vitro” bit is misleading; we are talking about lots of tests that are done in plastic and no longer glass, so it is a Latin hangover. I think that I am right in thinking that this applies to everything, whether it is a stick test or whatever device it is; it applies to any kind of diagnostic test.

On the regulations, I shall offer a one-sentence Brexit whinge, which is just to say: “Oven-ready, ha ha ha!” Looking at these regulations, we are now in legislative spaghetti territory, where to do something quite small and simple requires pages and pages of legislation to enact it. We are in a very messy regulatory situation, and it is only going to multiply over time. That was the first point that I wanted to raise.

It would be helpful if the Minister could say, for the health area for which he is responsible, the extent to which the Government have assessed how far there will now be divergence between Northern Ireland and Great Britain in the relevant health areas. There are two different scenarios. In one, the UK stands still, but the EU moves on, which is effectively what has happened here: the EU has updated its law, and we are now having to respond, because it will apply in Northern Ireland. So even if we do nothing, there will be change, and we should be reasonably capable of extrapolating that by looking at past behaviour and the EU’s legislative programme. Of course, the other scenario is where we actively diverge from the EU.

I hope that, in both scenarios, the Minister will be able to confirm that there is somebody—or a team somewhere in DHSC—who has all this mapped out. It may not have been possible before Brexit, when we were still living in la-la land—but, since we have had the experience of the retained EU law Bill, where the number of laws that we found tripled from the first exercise to the current iteration, it is important for businesses out there that we understand how much retained EU law there is in the health area, how much of it will be relevant and how much will require this kind of statutory instrument to ensure that we can respect both the Northern Ireland and the Great Britain settlement.

I am also curious: the Minister referred to the fact that the EU’s updated law was implemented as a regulation, which of course applies directly, rather than a directive, which needs transposition. He said that it applied from May 2022, but we are regulating only now. I am genuinely curious as to what happened in the intervening period. Is it the case that if somebody had been selling non-conforming devices, they would get away with it for that period because the law did not catch up? I am curious to hear what the Government’s intention is. Presumably, this scenario is going to be repeated: there will be new bits of EU law and we have to follow on and make sure that they are implemented for Northern Ireland. I am genuinely interested in the Minister’s comments on the Government’s strategy: are they concerned at all that there may be these gaps, or is it something we just have to live with now?