Learning Disabilities Nursing

Lord Kamall Excerpts

Tuesday 17th June 2025 Lords Chamber

[Baroness Merron (Lab)]

We are very focused on that, and NHS England is working with all areas of the country and local services to ensure that that is the case. There is a national plan for learning disability nursing that has been developed with key partners and focuses on four priorities: attracting, retaining, developing and celebrating the workforce. It is very important that we elevate the standing of learning disability nurses, to whom we are all grateful.

[Lord Kamall (Con)]

My Lords, I thank my noble friend Lady Monckton for raising the important issue of a workforce that understands how to deal with those with learning disabilities. Given the importance of this, will the Government consider committing to a targeted health promotion strategy, perhaps in partnership with local community organisations and sections of the private sector, to enable all children with a learning disability to access early promotion, intervention and prevention services to help them develop healthy habits and to improve long-life health outcomes for this vulnerable group?

[Baroness Merron (Lab)]

This is indeed a vulnerable group, as the noble Lord says, and it is probably best that I refer to the upcoming 10-year plan, which will deal with inequalities throughout a number of sectors, including the most vulnerable and including this group.

Adult Social Care

Lord Kamall Excerpts

Monday 16th June 2025 Lords Chamber

[Baroness Merron (Lab)]

Your Lordships’ House will be aware of the financial situation that we inherited and seek to put right. The Government have made available up to £3.7 billion in additional funding for social care authorities in 2025-26, and the noble Baroness is right that just last week the spending review allowed for a further increase of over £4 billion to be made available for adult social care in 2028-29. We are taking a whole range of actions. The Employment Rights Bill, which we will come back to later today, seeks, for the first time ever, to bring in fair pay and professionalisation for those in the adult social care workforce. So it is not that nothing is happening in the meantime. We are making progress and ensuring that the funding will be available so that we have not just a decent adult social care workforce but a way of tackling what no Government have managed to tackle before.

[Lord Kamall (Con)]

My Lords, given the persistent workforce gaps in adult social care over many years, and given the concerns that there are over immigration—even though immigrants often do the work that local people do not want to do—can the Minister outline what plans the Government have, with a clear structure, to make this a more attractive career, particularly to young people in the UK? What are the Government doing in partnership with social care providers, which are stretched at the moment, to look at alternative ways of funding training and skills development and to make sure that this is an attractive career for those in the UK, rather than always having to rely on immigration?

Cardiovascular Illnesses

Lord Kamall Excerpts

Thursday 12th June 2025 Grand Committee

[Lord Kamall (Con)]

My Lords, I begin by thanking my noble friend for securing this important debate and, as other noble Lords have said, for sharing his own experience in a very moving way. It really brought home to us that this is about not just figures or statistics but the human side of this story. I thank all noble Lords who have contributed to this debate. It is not a particularly political debate; across the political spectrum, we can agree that we should work as constructively as we can together to try to address these issues.

As the noble Lord, Lord Weir, reminded us, cardiovascular disease is the cause of one in four premature deaths in England. More than 6.4 million people suffer from it and it has resulted in 1.6 million disability-adjusted life years. According to the British Heart Foundation—many noble Lords will have read the excellent briefings that we have received from many organisations, to which we are grateful for informing us—this disease may be inherited or it may develop later in life. As the noble Baroness, Lady Winterton, said, those in the most deprived 10% of the population are twice as likely to die prematurely from these diseases than those in the least deprived 10% of the population. The highest premature mortality rate is in the north-west region, and men are twice as likely as women to die prematurely from this disease.

As the noble Lord, Lord Rennard, said, the NHS has identified high blood pressure, smoking, high cholesterol, diabetes, kidney disease, inactivity—to which my noble friend Lord Moynihan referred—and obesity as risk factors. We also know that those at increased risk of developing this disease include people of south Asian and black African and Caribbean backgrounds.

The King’s Fund think tank has estimated that there are 220,000 admissions for coronary heart diseases and 100,000 admissions for stroke a year, costing the NHS an estimated £10 billion and the economy £24 billion, so the human and financial cost are alarming. We must think about how we can work on this together, across the spectrum, to improve our use of resources and to reduce the number of deaths.

As noble Lords discussed, in January 2025 the Select Committee on Health and Social Care considered the NAO’s report, alluded to by the noble Baroness, Lady Winterton, on progress in preventing cardiovascular diseases. Following this, a letter of recommendation was sent to the Parliamentary Under-Secretary of State for Public Health and Prevention on improving data collection on cardiovascular disease.

When we were in government, we set out ambitious plans in the NHS long-term plan to detect and treat people with the risk factors of developing these diseases. This is not party political; any Government would have done that, because it is important. It included the NHS health check and face-to-face check-ups for adults aged between 40 and 74 in England. It was commissioned through local authorities and delivered through GP surgeries, to help spot early signs of heart disease. Indeed, many noble Lords spoke about how we identify and diagnose, as well as how we prevent. We also introduced a digital NHS health check to operate alongside the in-person NHS health check, to reduce the pressures faced by GP surgeries, particularly as more people now are aware of digital technology and are happy using it.

These Benches also welcome the current Government’s manifesto commitment to deliver a renewed drive to tackle the biggest killers—cancer, cardiovascular disease and suicide—while ensuring that people live well for longer. I understand completely that the Government are in their early days, but, unfortunately, we are yet to see action in some of those areas. I admit that we were slightly disappointed that the new Government scrapped the major conditions strategy. I also understand, however, that we are waiting for the 10-year plan, and if these issues are integrated into the 10-year plan, as I hope they will be, that might be a better approach. As the noble Lord, Lord Weir, said, we should look at these things not in isolation but as part of an overall integrated plan. We would welcome any announcement from the Government on whether and how they would form part of the, I hope, more integrated 10-year plan. Like many other noble Lords, we eagerly await its publication.

I conclude by asking the Minister some specific questions. How do the Government plan to improve support for vulnerable communities who are at a higher risk of developing cardiovascular diseases, including men, those in more deprived areas and people of south Asian and black African or Caribbean backgrounds?

On 18 June, I will host an event with BRITE Box, a wonderful prevention charity that helps families from deprived areas to budget and to cook healthily on a budget, as a family together, to improve their health. I thank the Minister for agreeing to speak at that event. What specific programmes are the department aware of to improve this sort of prevention, including healthy diets and physical activity? How are the Government working with non-state, local community civil society organisations, such as BRITE Box, to make sure that we tackle these issues?

My noble friend Lord Moynihan spoke about the role that physical activity plays in support and prevention. What other specific steps are the Government taking to close the health inequalities of communities in the most deprived areas, especially those faced by some ethnic groups? What progress have the Government made to ensure that those commissioning and delivering health checks are obliged to collect and report on the demographic data so that we can improve the data on age, gender, ethnicity and socioeconomic status, so that we can target better?

My noble friend Lord Polak spoke about Cardiac Risk in the Young. I was slightly disappointed that when I wrote to one of the Minister’s colleagues in the department, they declined to meet with Hilary Nicholls, whom I had met to hear her daughter’s story and those of other people. I hope that the Minister and her officials will be able to accept the invitation from my noble friend Lord Polak, so that at least one person from the department can speak to Hilary Nicholls and Cardiac Risk in the Young. I hope that the Minister can confirm that this will be part of the overall 10-year plan.

I understand that I have asked lots of questions and gone over time, as usual in my typically Socratic way, like other noble Lords, but I look forward to the Minister’s answers. If she does not have them now, I know that, thanks to the wonders of technology and her wonderful officials, she will write to us.

Primary and Community Care

Lord Kamall Excerpts

Thursday 5th June 2025 Lords Chamber

[Lord Kamall (Con)]

My Lords, we on these Benches welcome the Government’s stated commitment to innovation in primary care and the commitment to continue the rollout of community diagnostic centres, which were started by the previous Government. However, unfortunately, last year the Patients Association highlighted barriers to the rollout of point-of-care diagnostics, particularly in rural areas. Is the Minister aware of those concerns, and what plans does the department have to tackle those barriers?

[Baroness Merron (Lab)]

Our commitment to moving towards a neighbourhood health service obviously allows for attention to be given to different circumstances, including in rural areas. It will mean that more care can be delivered locally and that problems can be spotted earlier, including any problems with rollout. We will shortly provide details of a national neighbourhood health implementation programme. We liaise with various groups, including the Patients Association, and I am grateful for their input and for flagging up any difficulties, which we absolutely seek to resolve.

Creon

Lord Kamall Excerpts

Thursday 5th June 2025 Lords Chamber

[Baroness Merron (Lab)]

I can say to my noble friend that serious shortage protocols are a tool that we have and use to manage and mitigate medicine and medical devices shortages. They enable community pharmacists to supply a specified medicine or device in accordance with a protocol rather than a prescription, with the patient’s consent, without needing to seek authorisation from the prescriber. They are used in cases of serious shortage, and we develop those protocols with input from expert clinicians. In addition, we are currently examining options around pharmacists’ flexibilities, including how any risks could be managed, and further details will be set out on this. I hope this gives some reassurance to my noble friend.

[Lord Kamall (Con)]

My Lords, we know that these unexpected shortages occur from time to time, and that this obviously causes patients to worry. As the Minister said, I understand the advice is that alternative therapies are available but may not be sufficient for all patients. Given this, can the Government reassure patients that they are confident that those who cannot turn to alternative therapies will be able to get the appropriate doses of Creon that they require? Also, do the Government have any idea, or have they been given any indication, of when they expect this particular shortage to end?

[Baroness Merron (Lab)]

The supply situation has improved since last year and there is now sufficient stock of lower-strength Creon to meet normal demand. There are still some supply constraints, as I have said, with the higher-strength product stock, but stock is regularly being delivered to pharmacies. As we have discussed, alternative products and unlicensed imports are also available. I totally accept that patients may have concerns, and that is why we have worked closely to keep in communication with patients to assure them that they will not be going without the medication they need. For example, it may be that lower strength in multiple provision can be made, or there are the alternatives that I have described. If any noble Lords are aware of real-life examples of shortages, I would be grateful to hear about them, because we believe that we have made the arrangements, and I can reassure noble Lords that these very important medicines are being provided to those who need them.

--- Later in debate ---

[Baroness Merron (Lab)]

The noble Baroness puts forward an interesting perspective. There will always be a number of matters that are outside any Government’s control. What is in the Government’s control is what action we can take. In terms of alternatives to Creon, for example, supplies of Nutrizym have more than doubled since last year, and Essential Pharma has also secured additional manufacturing capacity for Pancrex. In May last year, pancreatin preparations—the active ingredient in the medicine we are talking about—were added to the list of medicines that cannot be exported from the UK or hoarded in order to reserve supplies. These actions, along with some of the ones that I have just mentioned and more, all show a very active government position.

[Lord Kamall (Con)]

My Lords, since we have a bit of time, perhaps I may be allowed a supplementary. Given that part of the answer is to import unlicensed medicines, what quality-control procedures are there in place to ensure that people can be reassured that these unlicensed medicines are suitable and fit for patients?

[Baroness Merron (Lab)]

It would not be possible to prescribe them if they were not fit and safe for use. I am grateful to the noble Lord for allowing me to make that reassurance. There is very clear information on ordering and prescribing unlicensed imports on the NHS Specialist Pharmacy Service website, should the noble Lord or any other person wish to be reassured of what that means.

Young Children: Convenience Foods

Lord Kamall Excerpts

Wednesday 4th June 2025 Lords Chamber

[Lord Kamall (Con)]

My Lords, when there are concerns about nutritional content, there are three, perhaps more, possible approaches. First, you could ban the product, although prohibition does not always work. Secondly, you could try nudging consumers towards healthier choices—maybe by taxation or restrictions. Thirdly, you could work with local community organisations. In addition to family hubs and Start for Life, many local community non-state civil society organisations work with local families to help them cook and eat healthily together as a family. Given what has been mentioned already, will the Minister tell us what work the Government are doing with such local community organisations, apart from Start for Life and family hubs, to make sure that civil society is playing its role in educating our children?

[Baroness Merron (Lab)]

On the three ways forward that the noble Lord identified, the approach often has to be a mix of all three. It is the balance that is the point under debate, and it has to be informed by evidence. I certainly share the noble Lord’s view about the importance of civil society and working with community groups. Indeed, my department, but also the Department for Education and other departments, have worked closely with community groups in order to advance the policies and practices we need to improve the health of the youngest in our communities.

Health: Ultra-processed Food

Lord Kamall Excerpts

Tuesday 3rd June 2025 Lords Chamber

[Baroness Merron (Lab)]

First, I do not accept that the advertising restrictions represent any watering down. In May, a Written Ministerial Statement set out, to the noble Baroness’s point, that the Government will provide a brand exemption in legislation. The restrictions will come into force officially on 5 January. I realise that the noble Baroness regards this as not the position that she would choose, but I believe that it will provide certainty for businesses to invest in advertising campaigns with confidence and encourage them to develop more healthy products—that is the situation that we want—as well as protecting UK children from the harms of junk food advertising.

[Lord Kamall (Con)]

I thank the Minister for the answers that she has given so far on the evidence, because it is really important that any policy in this area is evidence led. When I looked at the British Heart Foundation website, I saw that it said that additives in ultra-processed foods

“could be responsible for negative health effects”

and that the

“actual processing of the food could … make a difference”.

It also says:

“Another … theory is that … ultra-processed foods could … affect our gut health”.


But what it says overall is that there is insufficient evidence here. We really need more research to be done. We are not sure whether it is something in the ultra-processed foods or the processing itself that makes them unhealthy. The Minister has touched on this already. We have talked about the timeframe for research, but when people are looking for a source to consider the dangers, or otherwise, of ultra-processed foods, are there any particular websites or sources that the Government could point people to, so that people are more aware of and more educated on the research on ultra-processed foods?

[Baroness Merron (Lab)]

The important point that the noble Lord raises is that our role is to encourage people to ensure that they are choosing a healthy diet and can achieve a healthy diet. As the noble Lord said, the word “could” is a bit of a problem. That is why we continue to invest in research and, as I say, work closely with the Scientific Advisory Committee on Nutrition.

Doncaster Royal Infirmary

Lord Kamall Excerpts

Monday 12th May 2025 Lords Chamber

[Baroness Merron (Lab)]

My noble friend is right about the effects of a poor estate. In addition to productivity, it very much affects safety, staff working conditions and capacity. The benefits are considerable, as she identifies—and indeed as the noble Lord, Lord Darzi, identified. I assure my noble friend that we are working across government—including with the Treasury and, to the right reverend Prelate’s point, with the local ICB and trust—to tackle this. My noble friend is aware that this Government committed nearly £20 million from the critical infrastructure risk fund to the hospital’s NHS foundation to move a section to the ground floor—not the part to which my noble friend referred, but it shows the seriousness with which we are taking this.

[Lord Kamall (Con)]

My Lords, the injection of capital to Doncaster Royal Infirmary is welcome. When the CQC inspected DRI in 2024, it found that the hospital

“did not have enough maternity staff with the right qualifications, skills, training, and experience to keep women safe from avoidable harm”.

While the Government develop their 10-year and workforce plans, what action are they taking in the meantime to address safety concerns from a lack of adequate staffing in maternity services? While we are on the subject, given the recently announced crackdowns on immigration and that many people who work in our health and care system are immigrants, how do the Government intend to encourage more British workers to fill vacancies in health and social care?

[Baroness Merron (Lab)]

On that point, I feel that the Government taking the backlog very seriously, against the background of what we have inherited, will make conditions far better for staff, which will make it a far more attractive place to work. That will be reflected when we report on the workforce plan. To the point about maternity, we are recruiting extra midwives and we are looking extremely closely at how we can better support best practice—as I saw just last week—how we can extend that and how we can bring better patient safety measures into the system. I am afraid that it is another area that we inherited in a difficult position, but noble Lords can be assured that we are working on it. I look forward to updating your Lordships’ House.

Care Quality Commission: Mental Health Care Waiting Times

Lord Kamall Excerpts

Thursday 8th May 2025 Lords Chamber

[Baroness Merron (Lab)]

As the noble Baroness says, it is very important that people use the right support. Otherwise, there is immense danger in going for what is perhaps less suitable. To my knowledge, we have not made a particular assessment, but I will pick up the noble Baroness’s point, because it is very right. On a more positive note, we are—and I am particularly—looking at what support we can develop in a digital and online sense to support people, not just on waiting lists but to prevent ill health and assist in their recovery.

[Lord Kamall (Con)]

My Lords, given that there is a waiting list for mental health care, including community-based services, and given the many competing demands on public finances, what can the Minister tell the House about conversations that her department and local ICBs may well be having with local community non-state civil society organisations, including those that offer music, art, talking drama, dance and other therapies, to help those on the waiting list?

[Baroness Merron (Lab)]

As the noble Lord is aware, I regard the contribution of the community sector—the third sector—as absolutely crucial here. I personally work very closely, like the department more generally, both to improve our practice and to recognise the difference that the creative arts, for example, can add to people’s mental well-being, as the noble Lord says.

Medical Devices (Amendment) (Great Britain) Regulations 2025

Lord Kamall Excerpts

Tuesday 6th May 2025 Grand Committee

Finally, I think that the Minister said that existing EU regulations will remain in force in Northern Ireland, but will that not potentially create trade barriers across the Irish Sea, although—I accept—it will prevent them occurring between Northern Ireland and the EU? Therefore, would not a UK-EU-wide regulation make much more sense in future?

[Lord Kamall (Con)]

My Lords, I thank the Minister for introducing this statutory instrument. I want to be clear that we on these Benches recognise the need for this measure, since, without it, key regulatory provisions would expire at the end of this month, as the Minister explained. That would create uncertainty and risk disruption to the oversight of medical devices in Great Britain.

We understand that this instrument is, in essence, a stopgap, as the Minister said, and that the MHRA’s consultation, particularly with small and medium-sized enterprises and clinicians, demonstrated strong support for continuity. But while the measure preserves the status quo for now, it has provoked some questions about the Government’s long-term strategy. I am grateful to the Minister for reassuring us that this is definitely a temporary stopgap and that they are looking for a longer-term and more pro-innovation solution than when we were in the EU.

As the Minister said, this revokes the sunset clauses in four areas in particular: performance standards for diagnostic devices, electronic instructions for use, the regulation of devices containing animal tissue and the designation and oversight of approved bodies. These are not mere technical footnotes; they are essential to ensuring safety, clarity and public confidence in the medical device sector, so we understand that revoking their expiry is necessary to avoid disruption.

Can the Minister add any more detail at this stage to what she has already said? This first phase, focusing on pre-market regulation, is expected in 2026. What further reforms are expected to follow? I know that she explained some of that in brief—I suspect that she did not elaborate as much as she could have for reasons of time—but can she say a bit more about the future plans for this regulation? If she cannot now, perhaps she will write to me, because that was a very welcome move. I was going to ask lots of questions about whether the short-term fix will remain in place for the long term, but the Minister has reassured us. Nevertheless, perhaps she could set out some more details either today or in writing.

I do not believe in regulatory divergence for divergence’s sake, but let us be clear that neither should we agree with regulatory alignment for the sake of regulatory alignment. I understand the concerns of the noble Lord, Lord Rennard, but I recall that, when I was a Health Minister, many a supplier—regardless of whether they supported the UK leaving or remaining in the EU —asked me, “Now that we’ve left, can we take advantage of our independence and develop a more pro-innovation approach than the EU?” In technology—I spent 14 years in the European Parliament—the EU was known as an area for regulation; if you wanted innovation, that was in the US. We have to get a better balance between the two. Whereas the EU focuses more on the precautionary principle and less on innovation, perhaps we can get a better balance in this country, so that we do not align for alignment’s sake.

The Minister also mentioned Northern Ireland. As we know, as a result of what noble Lords, said there are some concerns in Northern Ireland but, given that the EU is seen as an area generating regulation, should the EU impose additional regulatory burdens on businesses in Northern Ireland? What steps will the Government take to support them to protect their competitiveness? That is one of the concerns I know from the most pro-innovation businesses in Northern Ireland.

Finally, on international trade, not strictly within the remit of these regulations, so I hope the Minister and her officials will forgive me—this does not have to be answered straight away—has the Minister or the department assessed the impact of recent US tariffs on medical device imports? Does the UK import a substantial number of medical devices from the US? I know that we talked about the importance of the US as an export market. Will these tariffs have an impact on medical devices from the US, particularly those that have been made with components imported from outside the US into the US before being re-exported? Does that have a price implication? Have the Government made any assessment of the implications for availability, cost and affordability, particularly for NHS procurement? Clearly, as the noble Lord, Lord Rennard, and others said, there is the impact on medical device suppliers exporting to the USA. Has any assessment been made of that market? Across the House, we all want a thriving life sciences sector in this country, but we should be assessing the impact of the proposed tariffs. I know some of them have been in abeyance.

I recognise that I have asked many questions, and I do not expect the Minister to have all the answers straight away, despite the advances of iPad technology and wireless communication. Maybe one day that will extend to telepathy. Perhaps the Minister can write to me on the questions that she is unable to answer today. In drawing my remarks to a close, I will be clear that noble Lords on these Benches support this measure as a necessary step to prevent regulatory disruption, but the real test follows. I hope the Minister, in answering the questions, is able to share a clear timeline for the programme for reform as we hopefully move towards a more pro-innovation approach.

[Baroness Merron (Lab)]

I am grateful to noble Lords for their valuable contributions and the way in which they have raised issues relating not just to the statutory instrument before us but this whole area of important work. I am also grateful for the support more broadly on the need to get the legislation right in order to protect patients, get the best medical technology within our grasp and support innovation. I am sure we will return to this subject. I will respond to a number of the points, and I will come back to noble Lords on anything significant that I have not responded to.

I reiterate that this SI is essential if we are going to prevent what I would call significant disruption. The words used were “a stopgap”. I think that is a fair legal term in this setting. It will preserve the status quo as we progress to more comprehensive regulation, which I know is what noble Lords are interested in.

The noble Baroness, Lady Finlay, asked for an assurance that we would not jeopardise not just the European market but other markets because we need to export technology. That is a fair point. I can say in response that over recent years we have learned important lessons from the implementation of new medical devices regulations in the EU as well as the global approach to regulation. How has this informed our approach to regulatory reform? It is why the Government are taking a phased approach to the delivery of these regulations to support the sector and adapt to the changes. It is also the reason why we are in continued discussion and are working closely with the sector.

We recognise the benefit of international harmonisation of medical device regulations in order to reduce, as we would all like, unnecessary regulatory burden or duplication of assessment for manufacturers, which is something that has been raised many times with me and I am sympathetic to. This means that, where sensible, we will align with the regulations of other jurisdictions, including those in the EU. Any reform to assimilated law will be to support domestic priorities and the Government’s national health and economic growth missions.

The noble Lord, Lord Rennard, raised a number of points. He raised the issue of products being subject to EU and UK regulations and whether this would make tech companies less likely to innovate. I believe the noble Lord also argued that we should be in line with the EU, and he raised the important issue of Northern Ireland. On these points, we will seek to align with international best practice and EU regulations where they are sensible, support manufacturers and support where we want to get to on patient safety and the contribution of medical technology.

On Northern Ireland, the MHRA is the competent authority for devices placed on the Northern Ireland market. It continues to have oversight of medical devices across the whole of the UK. We will continue to monitor any risks to the supply of devices to the whole of the UK market. I can give the assurance that, at present, the supply is stable and processes are in place to identify alternatives if needed. My final reassurance is that the SI before us today will not have any impact on the supply of devices to Great Britain or Northern Ireland.

The noble Lord, Lord Kamall, also raised a number of key points and requested more detail on what further reforms are expected to follow. He also raised regulatory alignment, making the point that, in his opinion, the EU can be more cautious and asking how we as a country can be more innovative. The noble Lord also asked about Northern Ireland and about the impacts that US tariffs have in respect of medical devices.

On plans for regulatory reform, the MHRA has published plans to introduce several SIs to amend the framework for medical devices. The post-market surveillance SI, which will come into force in June as noble Lords may recall, represented the first significant step in this reform. That legislation will put in place strengthened legal requirements for how manufacturers monitor and report on their devices once they are being used.

In November last year, the MHRA launched a consultation on further aspects of regulatory reform which will inform a subsequent pre-market SI that introduces, among other things, a new international reliance scheme, measures to improve traceability of implantable medical devices, more risk-proportionate changes to the classification of certain devices and the prohibition of misleading claims. We expect that legislation to come into force in 2026. I think that all those will put us in a much better place than we are currently, because they will allow us to keep pace with changes in the market.

The MHRA also continually monitors the UK’s medtech landscape for developments that could affect patient safety and the implementation of regulations. Details of further regulatory proposals will be communicated when available, and I look forward to bringing those before your Lordships’ House.

On US tariffs, there are ongoing discussions, and I will not seek to pre-empt them. The MHRA will monitor any impacts once they become clearer. That is very much under a watching brief.

I hope I have demonstrated the need for these regulations, not just for the public currently but as being key to the forthcoming 10-year plan. I hope that the Committee will agree that we are continuing with this assimilated law to prevent significant disruption to the current framework and to ensure that patients, device users and the economy are all protected.