(1 day, 9 hours ago)
Lords ChamberMy Lords, NHS staff told us through the 10-year health plan engagement that they were crying out for change. This Bill is but one step in delivering that change. It will ensure a more sustainable and resilient medical workforce. It will ensure that we make the best use of the substantial taxpayer investment in medical training, and it will give our homegrown talent a clear path to becoming the next generation of NHS doctors.
The issue of bottlenecks for postgraduate medical training has been growing since the removal of the resident labour market test in 2020. I am most grateful to Parliament for expediting the passage of the Bill to tackle this problem, while giving it the careful scrutiny it deserves. I express my gratitude to noble Lords across the House for their constructive engagement throughout its passage. I wish to thank and credit noble Lords for passing the Bill unamended. My thanks are also due to officials and leaders from the devolved Governments for their support and commitment to ensuring we have a process that works for all of the United Kingdom, and for their determination to ensure that all legislative requirements were met within what was, and is, a challenging timeframe. I thank my officials in the department, as well as our lawyers, for their tireless work over these past few months.
We are clear that this Bill does not and cannot resolve all the workforce issues within our National Health Service. It sits alongside a range of action that the Government are taking to ensure that the NHS has the right people in the right places, with the right skills to care for people when they need it. The changes that the Bill introduces for foundation specialty training are a crucial step forward and will lead to a more sustainable medical workforce that can meet the health needs of our population.
I again thank all noble Lords who contributed their knowledge and insight during the Bill’s consideration. I beg to move.
My Lords, although this was emergency legislation, we have had detailed and constructive debates on prioritisation. We have also had the opportunity to debate some of the deeper issues around the supply of medical specialty training places, and I am grateful to the Minister for her letter. We will continue to hold the Government to account on the delivery of these places over the coming years. As we have said previously, the Bill is not a complete solution to the problem, as the Minister graciously acknowledged. We accept that it is a step forward.
During our debates, we touched on a number of issues, including whether UK citizens who are graduates of UK medical schools should be given first priority. We discussed the issue of international medical graduates who chose to contribute to the UK system of healthcare rather than go to another country, but who may now find themselves at the back of the queue. We discussed graduates of overseas branches of UK medical schools, some of which follow the same curriculum as UK medical schools, and whether some could be granted so-called grandfather rights. We also pressed for secondary legislation to be subject to the affirmative procedure. We understand why the Government have come to their position and why Ministers have not been able to take action on these points in this emergency legislation. However, given more time, I hope Ministers will continue their work to resolve these concerns, which were eloquently set out by a number of noble Lords from all Benches.
There was some debate about whether this was really emergency legislation or whether, in reality, it was simply giving the Secretary of State a bargaining chip in negotiations with the BMA. That may be no bad thing in itself, but the question remains of whether emergency legislation should be used to give Ministers bargaining chips.
Before I sit down, I thank the Minister and her officials for all their engagement throughout the Bill. As His Majesty’s loyal Opposition, we look forward to working closely with the Minister as the Government press ahead with its implementation.
Baroness Gerada (CB)
My Lords, I know it is not normal to speak at this stage, so I will be brief. I thank the Minister and everyone who has worked on this Bill, but I want to raise one or two anxieties which have already been touched on.
I believe that the Bill fundamentally challenges one of the principles that I have always held dear, which is fairness. It is unfair to international medical graduates, who we have entreated to come to this country for the last two decades—we have even paid for them to come —to work in hard jobs, in places where UK graduates did not want to do them. Now that we have more people than places, we are basically pulling the rug from under them. We are jeopardising their careers, their futures, their families and their visas.
It is also unfair to those UK nationals who chose, again in good faith, to study overseas and now have been treated like international medical graduates, when they are not. Finally, it is unfair to the commitment that the Department for Education has made around transnational undergraduate and postgraduate education. This Bill, I am afraid, takes away that commitment and says that we do not really mean what we say.
However, I look forward to working with Ministers and officials to see whether we can address some of what I fear will be the unintended and, I suspect, intended consequences of this Bill.
(2 days, 9 hours ago)
Lords ChamberMy Lords, this group of amendments relates to heated tobacco and its inclusion in the Bill, and in particular the rising age of sale. It is essential that the measures in the Bill apply to all tobacco products without exception. We have learned repeatedly that, where legislation leaves loopholes, the tobacco industry exploits them. We saw this with cigarillos—products defined as cigars but designed to resemble cigarettes, evading plain packaging with the flavour and pack size rules, as we discussed in Committee.
The Bill is a chance for truly comprehensive legislation. I am particularly concerned about Amendment 89, which would remove the phrase
“or consumed in any other way”.
That would leave the door wide open for further innovation from the industry to continue selling tobacco products here in the UK. The regulatory powers in the Bill must be broadly defined, including powers over packaging and presentation. This is not overreach; it is future-proofing based upon our past experience. Without it, we invite industry innovation designed solely to sidestep regulation and undermine public health.
Heated tobacco products should not be conflated with vapes. Vapes can be and are recommended for smoking cessation, following evidence, including a Cochrane review, showing that they are a helpful tool for smokers. Heated tobacco products do not meet that standard and are not recommended by NICE. They are used by fewer than 1% of people in the UK, yet awareness of them is rising, particularly among young people. Alarmingly, nearly one-quarter of 11 to 17 year-olds are now aware of these products, and that may well be the result of their marketing in supermarkets and online.
I therefore welcome government Amendments 217, 218 and 219, which ensure that the comprehensive definition of a tobacco product applies from the moment the Bill comes into force. That will help to address the ongoing and unacceptable advertising of heated tobacco products in supermarkets and elsewhere. If we are indeed serious about creating a smoke-free generation, all tobacco products, including heated tobacco, must be included without ambiguity or exception.
My Lords, my noble friend has tabled a number of amendments on heated tobacco products. Although there may be some concern about what is behind them, they raise important questions that I am afraid the Government have yet to answer with any real precision.
As I noted in Committee, there appears to be some evidence that individuals who switched from conventional cigarettes to heated tobacco products show lower levels of exposure to harmful chemicals than those who continue smoking. I am just comparing them to cigarettes, not to vapes. To be clear, I do not suggest that this settles the question of harm—these are relatively new products, and the long-term evidence base is still developing—but it means that the Government cannot simply treat heated tobacco products as interchangeable with conventional cigarettes without explaining why they refuse to consider their relative harm compared to cigarettes. I am talking about not absolute harm, but relative harm.
There is also the practical question of where these products may be used. The position on indoor and outdoor spaces remains, as far as I can tell, unclear. Heated tobacco does not produce combustion or sidestream smoke in the conventional sense, and yet it is not obvious from the Bill how the Government intend to address that distinction—if they intend to address it at all.
More fundamentally, can the Minister explain what specific evidence underpins the decision to include heated tobacco in the generational ban? I am sure all noble Lords accept that current evidence shows that vapes are relatively safer than smoking. It may be that vapes are relatively safer than heated tobacco, but as yet, we have not seen definitive evidence. Unfortunately, as noble Lords have said, much of the research on heated tobacco is funded by the tobacco industry. I can understand the concern there. I hope the Minister will correct me if I am wrong, but there is no definitive independent research on the relative harms of heated tobacco. If there is definitive research, can the Minister write to noble Lords with links to the relevant academic papers? I think we saw one link to a meta study that was not very good, but there has been no meaningful in-depth research.
This reminds me of a conversation I had with a friend, who told me that when they tried vapes to quit smoking, it unfortunately did not do the job for them. When they went back to their doctor, he said that he was not supposed to do this, but he suggested heated tobacco as a relatively less harmful alternative. While he hoped his patient might have switched from cigarettes to vapes, since this had not happened—we do not live in a perfect world—he preferred his patient to use heated tobacco to going back to cigarettes. Once again, this was a practical approach based on relative harms.
I completely understand the concern that, if we overpromote heated tobacco, we might find that smokers switch to it rather than vapes. Given that the policy rationale rests substantially on reducing harm—we should be looking at absolute harm and relative harm— I would welcome clarity on whether the Government are satisfied that the case for treating heated tobacco like cigarettes is proven. It will be interesting to see that distinction between heated tobacco and cigarettes. Is the science still sufficiently uncertain to warrant a more cautious approach?
My Lords, I appreciate the contributions made in this debate. I will start by addressing government Amendments 217, 218 and 219, tabled in my name; I am grateful to the noble Baroness, Lady Northover, for her support.
The Bill updates the definition of a tobacco product in legislation relating to promotion and advertising, and in Scottish legislation, to
“a product consisting wholly or partly of tobacco and intended to be smoked, sniffed, sucked, chewed or consumed in any other way”.
Those last few words,
“consumed in any other way”,
are the key ones. What does this definition do? It ensures that all forms of tobacco products, regardless of how they are consumed, are captured by this legislation, including—this is important to the points raised by noble Lords—any future novel tobacco products.
These amendments bring forward the commencement of this updated definition to the day of Royal Assent, rather than two months after Royal Assent. That is because the Government’s view is that all tobacco products currently on the market are already captured in the current definition, so it is appropriate for this future-proofing amendment to come into force at Royal Assent because there is no change to the law for which notice would be required.
Amendments tabled by the noble Lord, Lord Udny-Lister, seek to redefine how heated tobacco products are captured within the Bill so that they are no longer treated in the same way as other tobacco products. These amendments also seek to prevent provisions being extended to heated tobacco devices in the future.
On the points raised by the noble Lord, as well as by the noble Baroness, Lady Fox, and the noble Lord, Lord Kamall, the Bill deliberately defines tobacco products expansively and includes heated tobacco. The reason for that is that there is no safe level of tobacco consumption and all forms of tobacco are harmful.
On the points raised about evidence, there is evidence of toxicity from heated tobacco in laboratory studies; the aerosol generated by heated tobacco devices contains carcinogenic compounds. Unlike vapes, there is limited evidence that heated tobacco can support smoking cessation, despite what is claimed by the tobacco industry. On the matters of evidence raised by the noble Lord, Lord Kamall, and the noble Baroness, Lady Fox, as has been set out by all four UK Chief Medical Officers in a technical note to noble Lords, any suggestion that heated tobacco products are safe or should be promoted as quit aids in some way is entirely misleading.
I say to the noble Lord, Lord Kamall, that, through the National Institute for Health and Care Research, we are funding high-quality research into tobacco products. Between 2020 and 2025, £25 million was invested in a NIHR research programme to research tobacco control, and that will help us develop the evidence base. Exempting heated tobacco products from the smoke-free generation policy and other provisions in the Bill would simply allow the tobacco industry to continue to find a way to addict future generations to harmful and addictive products. The Bill is completely geared to go the other way.
The noble Lord, Lord Kamall, asked about heated-tobacco-free places. We will return to the whole issue of tobacco-free places when we come to group 16, so I am sure that that will be debated then. I hope that I have been able to clarify the Government’s position for noble Lords, and that the noble Lord, Lord Udny-Lister, will feel able to withdraw his amendment.
Before the Minister sits down, she talked about research that was done on tobacco products between 2020 and 2025. In that time, was any specific research done on heated tobacco as part of tobacco products?
The specific definition is “tobacco control research”, so it would be strange if it did not include what we know about already, which includes heated tobacco. I will be glad to confirm that to the noble Lord in writing.
My Lords, I am delighted to have the support of the noble Baroness, Lady Fox, on my earlier amendment on the communications strategy, and that she has come around to my point of view on this. It clearly is vital that we have an excellent, proactive communication strategy in relation to this new policy, as I argued on the first group.
These amendments seek to ensure that penalties for offences are fair and proportionate. I am very sympathetic to Amendment 60 from the noble Lord, Lord Udny-Lister, which looks like a very useful attempt to take a stepped approach to fines; it seems a very reasonable way to go about this. I look forward to hearing what the Minister says about that, and why she feels, if she does, that it is not necessary or appropriate.
We believe that Amendment 63 is not necessary, as the ability to give warnings already exists. On Amendment 17 on counterfeit products, I am delighted to return the compliment to the noble Baroness, Lady Fox, who says that she does not like to have unnecessary new offences, by telling her that we understand that this is currently an offence under the Trade Marks Act and that offences under that Act are automatically lifestyle offences, meaning that a proceeds of crime application can be used to remove criminal earnings. Maybe the Minister can comment on these various amendments.
My Lords, my noble friends Lord Moylan and Lord Udny-Lister benefited this debate by coming forward with their amendments in this group based on their extensive experience in local government. I warmly welcome Amendment 17; counterfeiting nicotine products is not a victimless crime. It undercuts legitimate businesses that are already operating under considerable regulatory and financial pressure.
Let us be clear that the cumulative burden placed on small businesses, regulatory or otherwise, is already substantial. These businesses, as other noble Lords have said, are already playing by the rules. They pay their taxes and comply with an ever-increasing, complex regulatory framework. It is simply not fair that they should find themselves undercut by operators selling counterfeit products outside that framework entirely.
Beyond the commercial harm, there is a serious consumer safety dimension. Counterfeit nicotine products are unregulated, untested and potentially dangerous. I ask the Minister to confirm that the Government share the view that the robust criminal penalties for counterfeiting are not only appropriate but essential. I would be grateful to hear what steps are being taken to ensure that enforcement capacity exists to make sure that these penalties are meaningful.
At earlier stages of the Bill, I know there were some concerns about the capacity of trading standards, for example. The sum that the Government have made available for local trading standards is to be welcomed, but some still wonder whether it will be enough or whether it is a drop in the ocean.
My noble friend Lord Udny-Lister’s amendments reflect a sensible approach to fixed penalty notices. A step penalty structure that treats a first offence differently from repeated non-compliance is surely right. While some local authorities may already have discretion to issue a warning instead of a fixed penalty for first-time offenders, as my noble friend has raised, it is important that first-time offenders are not treated unduly harshly given the complexity of some of the regulations that these small retailers will have to face. I hope the Minister, if she feels that she cannot accept the amendments as they stand, can say some positive things about them.
My Lords, this has been a helpful debate on an issue that concerns us all in this Chamber.
On Amendment 17 tabled by the noble Lord, Lord Moylan, I agree with his desire to take robust action against counterfeit products—I am sure we all do—but I cannot accept the amendment simply because I do not believe it is necessary, not because of specific objections. I heard his invitation for me to continue as I started, but, unfortunately, I cannot do so for this amendment. We believe it is not necessary, as referred to by the noble Baroness, Lady Northover, because protections against trademark infringement are already a matter for existing legislation.
On the point about necessary legislation addressing counterfeit products, which I accept, I say to the noble Lord and the noble Baroness, Lady Fox, that the Trade Marks Act 1994, as we have heard, already provides significant penalties for breaching these rules. They include: on summary conviction, imprisonment for a term not exceeding six months or a fine not exceeding the statutory maximum, or both; or, on conviction on indictment, a fine or imprisonment for a term not exceeding 10 years, or both. These are significant penalties.
My Lords, my noble friend Lord Lindsay’s excellent and persuasive arguments in support of the amendments in his name and that of the noble Lord, Lord Mendelsohn, who is not in his place, cannot be bettered, so I shall not try to, except to say that I support them.
Regardless of one’s attitude to smoking, there is a general recognition of the important role that specialist tobacconists play. They are small, highly regulated businesses that serve a discerning adult clientele. They are not engaged in the mass-marketing of cigarettes, nor are they driving youth uptake. Specifically, handmade cigars are not cigarillos. Premium handmade cigars are luxury products, purchased occasionally at a considerable cost by informed adult consumers. I was surprised to learn in Committee that they attract overseas visitors, who spend huge amounts of money here in the UK because these handmade cigars are packaged and marketed in a way that is unique to the United Kingdom. It is difficult to see how such establishments constitute a meaningful threat to the Government’s stated objective of reducing youth smoking and creating a smoke-free generation.
I stress that many of the criticisms made of cigars are made of cigarillos, but it is important that we distinguish between cigarillos and the unique products that are artisan cigars, whatever one thinks of them. I do not smoke; I think smoking is a disgusting habit. I do not drink alcohol; I think drinking alcohol is a terrible thing. But I am a liberal and I do not seek to impose my views on other people. It is important to distinguish between handmade crafted cigars and mass-marketed cigarillos, which may well be attractive to young people. I believe that cigarillos should be seen in the same light as cigarettes.
Since the introduction of the Bill, there has obviously been enormous anxiety among specialist tobacconists around the country about what the Government might choose to do to their day-to-day businesses. These amendments will, I hope, provide the Minister with an opportunity to reassure the sector. There is real concern that if plain packaging regulations were to be imposed on hand-rolled cigars, this would constitute an almost instant death for every specialist tobacco business. We heard about other countries where plain packaging has been imposed, but the UK continues to attract people who want to buy the packaging and all the marketing around it, whatever we may think of it.
For the good reasons already stated, these businesses enjoy special dispensations from the provisions of the law which apply to the generality of tobacco retailing. These dispensations are well founded, well understood and respected across the supply chain. As far as I am aware, they have not been abused. Many of the complaints about the uptake of cigar smoking are in relation not to these types of cigars but to cigarillos. This area of tobacco retailing is so niche that it is irrelevant to the vast majority of smokers. There is no reasonable case for the Government to choose to exercise powers to impede, restrict or otherwise alter the day-to-day lives of those involved in this specialist sector.
To be clear, I am talking about packaging. I am not referring to any of the amendments concerned with cigar lounges. I understand the concerns that have been expressed about workers who may not wish to be exposed to cigars but have no choice but to take that job and be exposed. I am talking about specialist tobacco manufacturers and retailers. Obviously, any attempts to restrict these businesses would involve some consultation with the Department for Business and Trade, so I sincerely hope that the Minister will be able to confirm that the Government have no intentions to restrict the specialist manufacturers in this way and to make their businesses unviable.
My Lords, I am grateful to all noble Lords who have contributed to this debate. On Amendments 127 and 147, tabled by the noble Earl, Lord Lindsay, and Amendment 126, tabled by the noble Baroness, Lady Walmsley, I have listened to the points that have been raised by noble Lords, not just today in the Chamber but in engaging outside the Chamber, which I have been pleased to do, and I have listened to the calls for handmade cigars to be exempt from packaging provisions in this legislation.
I remind the House, as I have had to remind noble Lords in other discussions, that the powers to regulate the packaging of all tobacco products are not new; they already exist. They were first introduced under the coalition Government as part of the Children and Families Act 2014. At the time when the powers were introduced, the Government of the time rightly recognised the need to ensure that these powers applied to all tobacco products, future-proofing the legislation, so introducing an exemption for handmade cigars now would weaken what is in effect long-standing legislation. I remind noble Lords that one of the points about the Bill is to bring together legislation that is in other areas into a Tobacco and Vapes Bill, which is what we are doing.
As I have said on a number of occasions, all tobacco products are harmful. That includes cigars and those marketed as premium or handmade. When burned, all tobacco products release toxic compounds that pose a risk to the user. In fact, research has found that some toxicants, including carbon monoxide and certain carcinogens, are higher in cigar smoke than cigarette smoke, and of course the toxicants that are found in tobacco smoke in cigars increase the user’s risk of developing diseases such as cancer, heart disease or respiratory disease. As the four Chief Medical Officers of the UK set out in their technical note to noble Lords, any suggestion that cigars are substantially safer than other tobacco products is not accurate.
Given the health harms of all cigars, it is appropriate that they are in scope of the legislation and that the Government retain our current ability, introduced in 2014, to regulate the packaging of all tobacco products. Moreover, exempting product categories is likely to lead to exploitation by the tobacco industry, which will always find a loophole to exploit. For example, following the ban on menthol cigarettes in 2020, tobacco companies began marketing cigarette-like menthol-flavoured cigarillos.
I shall provide some assistance on the points being raised today. As I said, I have heard concerns from noble Lords about future packaging restrictions that could impact specialist tobacconists more significantly than other retailers, and concerns about potential unfairness arising from that. I can say, as I have said before, that it is absolutely not this Government’s intention for any future packaging requirements to put any small businesses, including specialist tobacconists, out of business. Our intent is that any future packaging regulations make the health harms of these products clear while minimising the impact on businesses.
The noble Earl, Lord Lindsay, asked about future regulation on packaging. If that is to be the case, further impact assessments will be prepared in advance, including the economic impact of any proposed regulations. The policy proposals for any packaging requirements will be a matter for consultation, and all businesses—including, I am sure, specialist tobacconists —will want to respond and will be welcome to. I want also to be clear that the Government will consider the impact any policy proposal has on small businesses, including specialist tobacconists, via future published impact assessments, as I just said. It is important, however, despite these points, that the Government retain their current powers to regulate the packaging of all tobacco products, as any carve-out would potentially create loopholes for exploitation, as other noble Lords have expressed concern about.
Amendment 192 from the noble Earl, Lord Lindsay, seeks to maintain the existing exemption to allow individuals to sample cigars and pipe tobacco indoors in an enclosed and ventilated area in a specialist tobacconist shop. The Government are, as noble Lords know, committed to protecting people from the harms of second-hand smoke, which is why we launched a consultation on expanding smoke-free places on 13 February.
On the point the noble Baroness, Lady Bennett, made, there are a number of exemptions to the current smoke-free legislation, including an exemption for sampling rooms—not smoking lounges, as the noble Baroness, Lady Northover, referred to—in specialist tobacconists, providing certain criteria are met, as outlined. The Government do not intend to remove this existing exemption for specialist tobacconists. The consultation explicitly states our intention for the exemption to remain.
Finally, Amendments 18 and 19, tabled by the noble Earl, Lord Lindsay, seek to maintain the existing exemption for specialist tobacconists to display tobacco products. There are several exemptions to the current tobacco display legislation, including an exemption for specialist tobacconists. In England, this allows specialist tobacconists to display tobacco products as long as they are not visible from outside the premises. The Government’s intention is not to remove this existing exemption for specialist tobacconists. This will be reflected when we consult on future display regulations later this year.
It is important that the Bill balances the public health aims with any disproportionate impacts on businesses, including specialist tobacconists. However, we will continue to monitor this niche market to ensure that it is not targeting young people or exploiting the existing exemptions. I hope that, on this basis, the noble Earl, Lord Lindsay, will feel able to withdraw his amendment.
From these Benches, the Minister can count on our support.
My Lords, the hour is late and, given that some of my noble friends have left the Chamber—no doubt to enjoy a very expensive handcrafted cigar—it is left to my noble friend Lord Effingham and me to offer the opposition. If I had any temptation to call a Division, I can see that I am outnumbered.
I thank the Minister for tabling these amendments. I know that many of them are technical, but some are very important. I particularly welcome Amendment 165, which provides sensible protection for internet service providers acting merely as conduits, caching services or passive hosts. They are not really active in this space. They do not initiate, select or modify the content transmitted across their networks, and it would not be fair or practical to render them criminally liable for material of which they have no knowledge and over which they exercise no control.
Similarly, Amendments 166 and 178 ensure that legitimate public health campaigns are not inadvertently caught out by the advertising offences in the Bill. Where a person is acting in accordance with arrangements made by a public authority and for the purpose of promoting or protecting public health, it would be wrong for them to face criminal liability.
Finally, we welcome Amendment 183 because it ensures that the new restrictions do not apply retrospectively to programmes that were already in production before the new rules came into force. I suppose this is all a very long way of saying that we welcome the amendments from the Government.
I am delighted to receive the support of both Front Benches, either in a few words or in a few more words. This is to fulfil a mandate to stop the blatant advertising of vapes to children, while continuing to support adult smokers to quit. I therefore commend the amendment to the House.
(2 days, 9 hours ago)
Lords ChamberMy Lords, I have added my name to two amendments in this group. Before coming to those, I will say a word about Amendment 77 from the noble Baroness, Lady Bennett, which I was initially attracted to. Like many other noble Lords, I went to a presentation by ASH, where we listened to health experts explain that filters do not prevent anything noxious reaching the lungs. On the contrary, they have ingredients in them that might be damaging. Far worse, because of the filter, smokers inhale more than they would have done had there not been one, as they think it is safe. It may be that the 25 government amendments achieve in a rather roundabout way what the noble Baroness seeks to do in Amendment 77. We will listen with interest to the Minister when she speaks to her amendments.
Amendment 133 was ably spoken to by the noble Lord, Lord Rennard. As I have said before, when I was a Health Minister in 1979, I tried to get the tobacco industry to adopt putting a warning on cigarettes and it declined on the grounds that ink was carcinogenic. This was not an argument I found very persuasive. Here we are, nearly 50 years later, still discussing something that at the time was world-beating, although I understand that I have now been overtaken by Canada.
Amendment 204, spoken to by the noble Earl, Lord Russell, sits rather uneasily in this group, which is otherwise about filters, in that it is about the tobacco levy. I want to make a number of points. First, previously the Government ruled this out on the grounds that they consulted on a levy model in 2014. Indeed they did, but this is a very different model from that which they consulted on. Crucially, in the one they consulted on, the levy would have been passed on to the consumer, with all the impact on RPI or CPI. This model has been constructed to avoid that; it would control the price that tobacco can be sold for, leading to very different outcomes from the model consulted on by the Treasury, and would not allow tobacco companies to pass the costs on to consumers as they do at the moment. It would raise revenue. One estimate has been £5 billion. Even if it is a fraction of that, it is money well worth having.
The scheme would not be complex to administer. As the noble Earl said, there are only four manufacturers. The department already operates the PPRS, controlling medicine prices, with far more manufacturers than are involved in tobacco. Crucially, the Khan review, already referred to, which was initiated by Sajid Javid when he was Health Secretary, pointed out that the Government were not going to hit their then target of a smoke-free England by 2030. It recommended the levy—this was an independent review commissioned by the last Conservative Government—and reinvesting the money in media campaigns targeted at those elements of the population who were still smoking.
Finally, I know that the Minister will not mind me reminding her of what she said when a similar amendment was debated in 2022 and passed in your Lordships’ House by 213 to 154. She knows what I am going to say; she supported and voted for that amendment, saying that it would
“provide a well-funded and much-needed boost, and a consultation would allow this proposal to be tested, refined and shaped”.—[Official Report, 16/3/22; col. 297.]
Well, that is what we are asking for today. She did not persuade me in Committee when she gave the reasons why she had changed her mind. Perhaps she can have another go this evening and explain why she will now urge the House to reject what she thought was a good idea four years ago.
My Lords, since this is the first time I have spoken on Report, I declare my interest as a professor of politics and international relations at St Mary’s University, Twickenham, where I teach an MBA module on healthcare policy and strategy. I also work with the Vinson Centre for the Public Understanding of Economics and Entrepreneurship at the University of Buckingham, and we sometimes run seminars on evidence behind public health policy.
(3 days, 9 hours ago)
Lords ChamberMy Lords, I should advise the House that if this amendment is agreed to, I cannot call Amendment 15 by reason of pre-emption.
My Lords, I thank the noble Lord, Lord Mohammed of Tinsley, for opening the debate on this group—and the numerous noble Lords who spoke to it.
I redeclare my interests. I am a professor of politics and international relations at St Mary’s University, Twickenham, where I teach a module on healthcare policy and strategy, and I have been helping with its new medical school. I also work with the Vinson Centre for the Public Understanding of Economics and Entrepreneurship at the University of Buckingham, which has a medical school, although I have no direct connection with the medical school there. I hope I have touched on all potential conflicts.
Amendment 14, from the noble Lord, and Amendment 16, in my name, were debated in Committee, so I do not intend to repeat the arguments that were made then. However, I think it would be helpful if we reminded ourselves that we are dealing with emergency legislation. This is key. The Constitution Committee has warned against the Government’s overuse of emergency legislation, not least because when we legislate in this way we risk creating unintended consequences. We should be very careful and selective in using emergency legislation. In that context, it does not seem unreasonable that your Lordships’ House should be given an opportunity to scrutinise secondary legislation in more detail through the affirmative procedure. I hope the Minister will take on board the concerns about using the affirmative procedure rather than other procedure.
Turning to Amendment 16, I have retabled this amendment for debate today because I am afraid that I was not completely satisfied with the Minister’s response in Committee. I am sorry to say that but, at Second Reading, the Minister explained that the Government’s view is that commencement may not happen with Royal Assent because the changes introduced by the Bill are “a major undertaking” and
“there is a material consideration about whether it is even possible to proceed if the strikes are ongoing”.
However, in the same speech she explained that this is “emergency legislation” which is being brought forward
“as quickly as possible, rather than wait … another year to do so”.
On the one hand, this is a major undertaking that, in the words of the Minister,
“cannot be switched on overnight”.—[Official Report, 4/2/26; col. 1681.]
yet at the same time it is emergency legislation that cannot wait.
(2 weeks ago)
Lords ChamberMy Lords, in speaking for the first time in Committee, I refer to my interests as a professor of politics and international relations at St Mary’s University, Twickenham, where I teach an MBA module on healthcare policy and strategy, and where I also co-operate with the school of medicine, which will start accepting students later this year. I also work as an honorary fellow at the Vinson Centre for the Public Understanding of Economics and Entrepreneurship at the University of Buckingham, which also has a medical school but with which I have no direct connection.
I tabled Amendment 22 to facilitate a wider debate on the level of provision of medical training places and its impact on the outcomes for doctors and, by extension, patients, as well as the need for regular review. We all agree that the NHS and other health providers need highly qualified staff if they are to deliver the quality care that people expect of them, but that means that policymakers should seek to establish an education system that encourages young people to see the benefits of medicine as a career path, supports those going through medical training every step of the way and removes barriers to those who want to be doctors. As my noble friend Lord Howe said earlier, currently, too many young doctors reach the point at which they need to secure a medical specialty training place but find themselves disappointed, either because they are unable to access a training place or because the training place they are able to secure does not meet their needs.
A 2023 study by Tomas Ferreira on the career intentions of medical students found that many medical students finishing their foundation programme do not intend to take up medical specialty training places. The report says
“we report an increase in intention to not take up specialty posts immediately after the Foundation Programme, with an increase from 6.75% … of first-year students to 35.98% … of final year students. A contributing factor to this scenario could be a significant increase in competition ratios for specialty training posts, partly due to increasing medical student places and no corresponding increase in the number of training posts available”.
The lack of specialty training places to retain those medical students within the NHS is a challenge that the Government and we all face—something, I concede, we realised perhaps too late when we were in government. If the issue is not tackled, we will continue to see talented young doctors who might otherwise prefer to stay in the UK and work within the NHS, and maybe other health providers, leaving the UK to complete their training elsewhere.
The Government have announced their offer to the BMA to expand specialty training posts by 4,000, with 1,000 of them brought forward this year. That expansion in training places is welcome and necessary. I ask the Minister to confirm whether there will be any delay in their delivery and whether they will be delivered this year.
In May last year, I tabled a series of Written Questions on resident doctor medical training places, and the responses showed that very small numbers of training places are available in some regions. For example, in 2024, just one medical oncology specialist training stage 3 post was offered in the whole of the north-east region. The figure for the Wessex region was two places. For the earlier specialist training stage 1 posts in gynaecology, the Wessex region had just 11 places in 2024, while the whole of the south-west region had just 16 of those places. Can the Minister say whether those numbers are meeting the needs of those regions and whether there is a gap? What are the key factors that restrict the number of training places that can be offered in those regions?
The overall number of training places is probably the most important challenge young doctors face, but there are other considerations that affect talent retention. The geographical distribution of training places is also something that we all know needs attention. Last month, the Government announced that they will introduce new training places targeted at trusts with the biggest workforce gaps, prioritising rural and coastal areas, where patients currently struggle the most. We welcome that. That is good news. But, in designing this policy, I ask the Minister what assessment the Government have made of the number of medical students who actually want to train in these rural areas and whether that is a factor in some UK medical graduates choosing to go abroad or is irrelevant.
In response to concerns from the BMA about the challenge of doctors having to cover the upfront cost of their training, the Government have offered cost-related measures in their offer to the BMA, including reimbursement of exam fees. I ask the Minister for a little transparency and to give the Committee more detail on how reimbursement would work if the BMA were to accept that offer.
I hope that the Minister is able to answer these questions, either today or later in writing. I assure her that we look forward to working constructively with the Government as they face up to these workforce challenges. I beg to move.
My Lords, to help the Committee to assess the need for this further report that the noble Lord, Lord Kamall, just set out, it would be helpful if we could hear from the Minister when the Government will produce their replacement long-term workforce plan for the 2023 edition, which itself was deemed to be long term but ended up having a half-life of less than two years. How imminent is that and will it deal with the sorts of points that the noble Lord, Lord Kamall, rightly brings to our attention? When will we see the follow-on to the excellent Medical Training Review: Phase 1 Diagnostic Report, authored by the Chief Medical Officer and the previous National Medical Director of NHS England, published in October, which sets out these issues extremely well? The clue is in the title: it is the diagnosis. But when do we get the prescription? When does the treatment begin?
In a sense, the problem that we are dealing with through the Bill—again, as the noble Lord, Lord Kamall, just set out for us—owes its antecedents to the disconnect between the provision of NHS services and the ability to make smart, long-term workforce decisions. Unfortunately, for the period 2012 to 2022, those decisions on medical training were outwith the NHS and in effect were being controlled by the Treasury, which was constantly saying no to Health Ministers who were at the time trying to bring forward constructive solutions. Indeed, it was only when a former Secretary of State for Health became Chancellor that the situation was unblocked and we got the medical school expansion. Perhaps that is an inspiring example for the current Health Secretary—I do not know; perhaps he aspires higher. The fact is that we need that whole-government engagement on these kinds of questions to bring coherence and deal with these problems at root. Therefore, in responding to the noble Lord, Lord Kamall, any light that the Minister can shed on when precisely we will have line of sight to these sorts of questions would be, I think, of great benefit to the Committee.
My Lords, I am grateful to all noble Lords who spoke on this amendment. I recognise the answer that the Minister gave about the impact report that the Government have announced. I will reflect carefully on whether what I intended with this amendment aligns with that impact report. If this is just a problem of synchronisation of when data is available with the report then, if the impact report that the Minister mentions does not provide information, perhaps we could find an amendment. We could look at syncing that data to make sure that it is a meaningful report that meets both our needs. Obviously, I will need to do a careful review, but at this stage I beg leave to withdraw the amendment.
My Lords, in the absence of my noble friend Lady Coffey, who is not in her place, I hope it is acceptable if I move Amendment 26 and speak to Amendment 27. Both amendments seek to bring forward the commencement of the Bill rather than leaving its provisions to be implemented by regulations.
The Government say they need the Bill to pass as soon as possible but then refuse to commit to a date for commencement. Given that there is no date for implementation, noble Lords will rightly ask: what is the hurry with this Bill? There is a fundamental constitutional point here. Emergency legislation should be avoided as far as possible and, where it is necessary, it should be delivered urgently. In this case, we have been asked to fast-track the Bill without there being any apparent urgency to implement it.
The Minister sought to partly address this concern at Second Reading. Could she please explain exactly why the training allocation system will be unable to cope with the changed prioritisation arrangements introduced by the Bill if the BMA continues with its strike action during the coming months? What factors would frustrate the rollout? Would it be systems? Would it be the availability of officials? Would it be the ability of trusts and institutions to engage with the Department of Health and Social Care in a timely way? Or are there other reasons that noble Lords should be aware of? I hope this gives the Minister the opportunity to explain some of those reasons.
While we agree with the principle of giving UK graduates priority, and many noble Lords across the Committee have said this, we should take the time to have a proper debate on whether any other students should also be prioritised and in what order. We should have a debate to consider and debate questions such as: while qualifications may be similar, whether graduates from overseas branches of UK universities really do have similar experience to those who studied in the UK and worked in the NHS, or whether the country in which they studied has a patient profile similar to the UK, and whether in fact any of these distinctions are actually important. Another possible question that we should be looking at is whether historical prioritisation is still valid for today’s world, and whether it is worth while or too much effort to revisit some international agreements.
Instead of this much more considered debate, the Government tell us that they need to get the Bill on the statute book as soon as possible, but they are not forthcoming—perhaps not transparent—when it comes to implementation. Given this lack of clarity, I must say that there is a suspicion that the timing of the Bill and the Government’s rush to get it on to the statute book may appear to be not entirely unconnected with negotiations with the BMA resident doctors.
Whatever our politics and whichever Bench we sit on, legislation should be about making the lives of British people better. Although this Bill has the potential to help British citizens who are graduates of UK medical schools, the lack of transparency on implementation gives the impression that this legislation is more about giving the Secretary of State a negotiating chip in discussions with the BMA. I gently suggest that this is not a good enough reason for rushing such legislation, which is why my noble friend and I tabled these amendments. I look forward to hearing the Minister’s response.
My Lords, I will speak to Amendments 26 and 27 on commencement, proposed by the noble Lord, Lord Kamall. I confess that we are conflicted on these. This brings us back to the tension at the heart of the Bill. We have UK graduates urging immediate implementation to resolve their uncertainty; conversely, we have international medical graduates asking for delay or transition because the rules are changing mid-cycle. If the Government eventually accept the amendments in group 2, providing a fair transitional arrangement for those with NHS experience, then immediate commencement becomes less punitive. However, if they persist with the blunt ILR proxy for 2026 then rushing to commencement simply accelerates an injustice.
I urge the Minister to clarify when precisely the regulations for the 2026 cycle will be laid if this Bill passes and whether they will include the transitional protections we have argued for. I am somewhat pessimistic on that. Certainty is needed, but it must not come at the expense of fairness.
In that context, as we are at the end of Committee, I must ask the Minister to confirm that she is going to meet the cross-party group of those of us who have spoken at Second Reading and in Committee before Report takes place. I have kept my diary free for the Monday before Report and I know that the noble Baroness, Lady Gerada, mentioned that earlier. We would all welcome a face-to-face meeting with the Minister. She talked about us being co-operative, and we all realise the Government’s desire for speed, particularly in the context of the industrial dispute, but, quite frankly, it takes two to tango.
I am grateful for the noble Lord’s advice in his last comment.
I thank noble Lords for their contributions. The noble Lord, Lord Kamall, spoke about what I am going to call the tension between emergency legislation and the commencement clause. I will start on that point. I hope he is aware that our intent is, of course, to commence the Bill as soon as we possibly can, subject to its passage through Parliament. That is why I am so grateful to noble Lords and to Parliament more broadly—both Houses—that they have agreed to expedite the progress of this Bill.
I will come back on to this later in a bit more detail but, as I have already stated, there is a genuine question about operational feasibility, if strikes are ongoing, due to the strain that they put on the system. I am sure everybody in your Lordships’ Chamber would understand that. I will now refer to the amendments, and I have some other points to answer some of the questions that were raised.
Amendment 26, tabled by the noble Baroness, Lady Coffey, and spoken to by the noble Lord, Lord Kamall, and Amendment 23, tabled by the noble Lord, Lord Mohammed, and spoken to by the noble Lord, Lord Clement-Jones, relate to the date upon which the Act comes into force. Both would remove the provision that allows the Secretary of State to appoint the commencement date.
We cannot accept these amendments, as they remove an important element—and I emphasise this point—of operational flexibility, should it be needed. The commencement provision within the Bill is not a mechanism for delay. It is, we believe, a necessary safeguard to ensure that systems planning and operational capacity are in place before the Act is brought into force. Noble Lords will also appreciate that it is a material question, as referred to by the noble Lord, Lord Kamall, about how possible it is to proceed if industrial action continues, given the strain that strikes put on the system.
It is our intention to commence the Bill as soon as we are able, but it is essential that the Secretary of State is able to take all the circumstances, including operational readiness, into account when deciding when the Act should come into force. I think that it is honest to say this. Amendment 26 also seeks to require the Act to come into force one month after it is passed. Specialty training offers must be made from March. Delaying commencement by even one month would leave insufficient time to implement prioritisation for this year’s application round. In short, fixing a commencement date one month after Royal Assent, as Amendment 26 suggests, would create a situation where the Bill comes into force too late to tackle the bottleneck problem that we seek to resolve—the one that it is designed to remedy for the 2026 year—while also removing our ability to commence the Act only when systems are ready to deliver it effectively.
On the comments about industrial action made by the noble Lord, Lord Kamall, I reconfirm that the Government have been in intensive and constructive discussions with the BMA resident doctors committee since the start of the new year. The aim is to try to bring an end to the damaging cycle of strikes, and to avoid what is undoubtedly further, unnecessary disruption for patients and NHS staff. We continue to hope that those talks result in an agreement that works for everyone, so that there will be no more strike action by resident doctors in 2026.
With regard to the noble Lord’s request for more detail on operational readiness, I know he understands that introducing reforms to such a large-scale recruitment process is a big undertaking. We do not want the risk of creating errors that could lead to further uncertainty for organisations, for educators and, most importantly, for our trainees. An effective commencement demands clear processes for delivery across the health system. The reality is that industrial action will put this at risk because it is a diversion of resources, as it always is.
The noble Lord, Lord Clement-Jones, asked about further engagement. I have already had engagement with a number of noble Lords, including both Front Benches. If it is possible to do so before Report, I will write again. Time is extremely short, so while I am always glad to do so, if the noble Lord will allow me to look at that in a practical sense, I will be pleased to. With that, I hope that the noble Lord will withdraw the amendment.
I thank the noble Baroness for that considered response to the discussions. I thank all noble Lords who have spoken, not only to this group of amendments, but today. I also thank the staff for being here to look after us while we stay to this hour.
I should perhaps clarify for the noble Lord, Lord Clement-Jones, that when I laid the amendment it was with the amendment from my noble friend Lord Howe in mind. If we can address some of the perceived injustices or unfairness in the system, we should implement as soon as possible. I was not seeking to create a tension there.
I am grateful to the Minister for explaining that there are operational issues. I think that it would help the Government, and help this Bill to go forward, if the Minister were able to explain in a letter to noble Lords some of those operational issues, because sometimes it may be that we think that it is quite easy. I know, having been in government, that there are a number of issues. I can see that the Minister is looking forward to spending her Recess formulating that letter with her officials. The noble Lord, Lord Mohammed, talked earlier about a holiday, but I do not think that Ministers ever get a holiday. I am giving the Minister a challenge during the Recess to explain some of the operational challenges that lead to the Government not being able to accept this amendment to implement the Bill as soon as possible.
With that, I thank the Minister for her response. I thank all noble Lords who have spoken today and I beg leave to withdraw the amendment.
(2 weeks, 2 days ago)
Lords ChamberMy recollection from debating that point previously is that we are looking at the evidence and the best way to tackle the issue that the noble Baroness raises: in other words, what best supports children to have that healthy and best start in life? We are looking at this in the round and I am sure that we will return to it, but I will also be pleased to follow up in writing to the noble Baroness.
My Lords, many noble Lords would support the objectives of the Better Start longitudinal programme, with its focus on improving children’s diet and nutrition, social and emotional development, and speech, language and communication skills. But can the Minister explain how, rather than with a top-down, Whitehall or Westminster-knows-best attitude, it is working with local civil society organisations, such as BRITE Box, which works with families and local communities to help them learn how to cook healthier meals on a budget to improve their nutrition and well-being?
This will not be a top-down approach. We are ensuring that Best Start Family Hubs and Healthy Babies are in every local authority area. That is a major development, because from April it will reach more than 500,000 more children. It will also help us transition to neighbourhood health services. However, all of this will, as ever, be more successful by working together with other groups, including third-sector organisations such as BRITE Box.
(2 weeks, 2 days ago)
Lords ChamberI can certainly confirm that to my noble friend. The new Best Start in Life hubs will take the best from previous programmes, including Sure Start. We are providing information through an online service that has had 4.5 million hits so far, and we are working closely with the Department for Education on that. But yes, we will be taking the best of Sure Start.
My Lords, when a Government restrict the sale of products to some but not all customers for whatever reason, it is essential to pre-empt the effects on businesses that will be at the sharp end of enforcing this ban, especially corner shops and small retailers. What engagement have the Government had with small retailers, especially small corner shops, some of which do not always feel represented by the Association of Convenience Stores, to understand their concerns over violence or abuse when they ask for ID from customers who may appear to be underage?
As we discussed on the Tobacco and Vapes Bill in this Chamber, the whole issue of age verification is crucial. I feel that businesses are used to seeking age verification. What matters is that they feel empowered to ask for it and that staff are trained. That is why we are indeed working with businesses in the way the noble Lord says. Many of them responded to the consultation and we are very pleased to have their voice in that.
(4 weeks ago)
Lords ChamberI certainly agree with the concerns about the impact on individuals. Further to the point raised by the noble Lord, in addition to the noble Baroness, I would recommend that people who are using hearing aids do not ration their hearing. That is not where we want to be, but in fact it is about not giving more supplies than are immediately needed. The real issue is that people are being asked to get their batteries more often. If that is a problem for people, they should raise it with a supplier, who will ensure that, for example, the postal service is used or some other way of getting batteries to individuals.
My Lords, in response to that previous answer from the Minister, I understand that, as a result of these shortages, some patients are being required to return to hospitals as frequently as once a week to obtain replacement batteries, while rationing their use in the meantime. Patients have also reported additional travel costs, and even hospital parking charges, because they are going more frequently to the hospital than they otherwise would. What steps is NHS England taking to mitigate these additional costs, particularly for those on lower incomes: for example, by offering, say, free temporary parking if they are going to the hospital only to pick up their batteries, or other mitigations that would help those people?
Well, it is of course a matter for local ICBs to decide what their best response is, depending on their local community. I should emphasise to your Lordships’ House that the reason for the increased demand is that there was a cyber attack on the alternative supply of batteries. That was an unpredictable issue, but is always one for which we need to have resilience. I do recognise what the noble Lord is saying, but that is why I answered to the noble Baroness that there are alternative ways of getting batteries to individuals.
(4 weeks, 1 day ago)
Grand CommitteeMy Lords, I am glad to introduce these regulations, which will take effect from 1 April. These regulations will amend the fees structure for the relevant medical devices regulations and provide for a new annual medical device fee to replace an existing fee. The fee will enable funding for the MHRA’s strengthened post-market surveillance—or PMS—activities in respect of medical devices. I want to clarify that, for 2026-27, the fee will be part-subsidised by the Department of Health and Social Care, with the intention, subject to further ministerial and parliamentary approval, to move to a fully cost-recovering annual fee from 2027-28.
Why are these regulations needed? Post-market surveillance refers to the work that the MHRA does to collect, review and act on safety and performance issues relating to devices on the market. The Independent Medicines and Medical Devices Safety Review highlighted the need for a high-quality PMS framework. That is necessary because the framework strengthens the medical devices safety and surveillance framework, improving patient safety and supporting the Government’s risk-proportionate, pro-innovation approach to regulation. The framework is estimated to increase the MHRA workload by 60% to 70%, at an annual cost of around £17 million, so it is vital to get the right level of funding. Historically, PMS activities have been funded mainly by subsidy from the DHSC, and partly by the current device registration fee.
I should say that subsidising ongoing regulatory activity through general taxation is not the usual approach of the MHRA to fees and services. The usual approach is based on HM Treasury’s Managing Public Money guidance, which states that fees should be set on a full cost-recovery basis. Therefore, as noble Lords will appreciate, these regulations reduce subsidy by introducing an annual fee, so that those who benefit from access to the market fund the regulatory activity that supports it.
I turn to how the regulations are intended to operate in practice. The new annual fee apportions the overall costs of the MHRA activities by using the Global Medical Device Nomenclature system, or GMDN for short. The fee will be calculated using the number of registered devices with the MHRA. In practice, the MHRA will charge based on the number of chargeable GMDN categories in which a manufacturer has registered devices. If a manufacturer has multiple devices within the same category, it will be charged once a year for that category.
A consultation was done by the MHRA on this fee as part of its last statutory fees uplift, so this is a new fee rather than an additional increase to a fee in the last fees uplift. The consultation ran from the end of August to 24 October 2024, and it was widely promoted, including through an SME webinar. In the consultation, the annual fee was proposed at £210 per GMDN code, using the most granular level of the GMDN structure. Several changes have been made following the consultation feedback, which we appreciated, in response to the concerns that were raised. The MHRA set up a group of industry representatives to assist with this, to discuss the approach and to seek advice on implementation. This has been welcomed and has provided useful feedback and assurance.
To meet the concerns that were raised, the fee is being phased in. It will give the sector time to adapt, as I outlined in my earlier comments. The costs have been fully subsidised in 2025-26, and this instrument introduces a part-subsidised annual fee for 2026-27. The fee was remodelled to be charged at a higher grouping of GMDN category, rather than individual codes, resulting in the costs being more equitably spread. The MHRA estimates that 56% of manufacturers will pay £300 a year and 82% will pay no more than £900 a year. Small and medium-sized enterprises are likely to pay only £300 a year, as they are likely to have a more limited range of products compared to larger companies.
Let me put this in context. The medtech sector generated an estimated £48 billion in turnover in 2023-24, and the total PMS cost of £17 million represents about 0.035% of this. I recognise that businesses would prefer to avoid any additional costs, but I am satisfied that moving to a fair, predictable, cost-recovering approach, along with the changes that have been made, will help address the key concerns and make the measure workable and fair.
On implementation and readiness, the MHRA has been working with the sector. The phased rollout has given the sector time to get ready. The MHRA published guidance explaining the new fee, how it will be calculated, what account holders need to do to ensure that their registration data is accurate, and how and when payment will be made. The MHRA is improving its systems currently, so that businesses will be able to see their GMDN categories, which will help them understand what they will be charged for by 1 April this year.
In closing, these regulations introduce a necessary and fair new annual fee from 1 April to help fund the MHRA’s strengthened PMS work. The approach has been improved in response to consultation feedback—for which we are most grateful, as I said—and is being introduced in a phased way, giving the sector the time it needs to adapt while ensuring that the MHRA has the resource it needs to protect patients and maintain confidence in the market. I beg to move.
My Lords, I am grateful to the Minister for introducing these regulations. Although we support a strong and properly resourced system of post-market surveillance for medical devices, I am afraid we have significant concerns about the Government’s approach to this instrument.
As the Minister said, these regulations introduce a significant shift in how medical device registration is funded. As she outlined, manufacturers will now be required to pay an annual fee of about £300 per device category, replacing the previous one-off registration fee of £261. A further annual maintenance fee of £300 will also apply. This is a substantial change to the cost base for manufacturers. Of course, while large companies may be able to absorb these costs, there is huge concern among the small and medium-sized enterprises that make up a large part of the UK’s health technology sector.
The Government argue that these fees are necessary to fund the MHRA’s post-market surveillance functions. We do not dispute the importance of ensuring that devices used across the NHS are safe, effective and properly monitored. We also do not oppose the notion of charging fees. However, the question before us is not whether surveillance matters but whether the Government have provided the evidence and analysis required to justify the scale, structure and timing of these new changes.
I am afraid that, both here and in the other place, we are concerned that the Government fall short on these. The most striking omission is the absence of the full impact assessment. Instead, the Government relied on de minimis assessment on the grounds that the fee remains partially subsidised for one more year. Of course, we welcome that, because it helps to cut the costs for some of the manufacturers but, at some stage, manufacturers have to be weaned off these subsidies—or what some people term “corporate welfare”. Yet Ministers have already confirmed that the subsidy will be removed in 2027-28, when the full recovery model will be introduced. We think that this is an extraordinarily short-term approach for a regulatory change with such long-term consequences. It is difficult to understand how the Government can justify this new fee regime, when it clearly imposes additional costs on businesses without providing Parliament with a full and transparent assessment of its impact.
The Minister will know that industry bodies, including the Association of British HealthTech Industries and the British In Vitro Diagnostics Association, have repeatedly raised concerns about the uncertainty surrounding long-term fee levels. It is only right, therefore, that we raise their concerns here. The BIVDA has warned that, under the original proposals, some IVD manufacturers could have faced fee increases of up to 5,000% due to the granularity of the GMDN categories. Let us be clear: we are grateful that the Government have since moved to a higher-level categorisation—they should be given credit for that—but the underlying uncertainty remains. The MHRA’s own modelling suggests that the full cost recovery could require charges of more than £800 per device category. This is not a marginal adjustment for some of those small companies. It could be the difference between entering the UK market and walking away from it.
The Minister will be aware that these concerns were echoed in a Delegated Legislation Committee in the other place. Yet, despite these legitimate questions, the Government have still not provided clarity on how the new fee structure will affect different types of manufacturers. Unfortunately, they have also still not provided clarity on how they intend to mitigate the risk of reduced product availability, particularly for low-volume devices, including those used in diagnosis of rare diseases.
This is not an isolated change; it follows recent regulations on post-market surveillance on in vitro diagnostic devices. The cumulative effect is a regulatory environment that is shifting rapidly without the stability or predictability that businesses need in order to plan investment and product development.
We are disappointed by these regulations—not really their content but more the lack of the full impact assessment. The Government have not provided clarity on the long-term fee levels, addressed industry concerns about the risk of product withdrawal or given Parliament the information that it requires to scrutinise the consequences of this new fee regime. A proper impact assessment should have been conducted to avoid problems later.
Noble Lords will know that I take an interest in the phenomenon of unintended consequences. They will be aware of the “dash to diesel” when, in 2001, the then Chancellor of the Exchequer introduced a system of car tax to incentivise motorists to switch to diesel cars in order to meet lower CO2 emissions targets. That was understandable, but it was later found to have also led to an increase in emissions of harmful nitrogen dioxide and particulates. The reason I raise this is that, at the time, it had been claimed that some civil servants raised concerns about this consequence but were ignored.
This is not a party-political issue. The question is whether Governments of any colour have learned the lessons from that incident. How do we make sure that, when potential consequences are raised with the Government, they are seriously taken on board, particularly in terms of a full impact assessment? Given the current concerns that have been raised, rather than introducing these new charges now only to find out that, as a result of the consequences, they will have to be reversed or tweaked, surely it would be better for the Government to pause the process to introduce the new charging regime until a proper and full impact assessment has been conducted.
We understand that the running costs of the MHRA have to be met somehow and we agree with the Government that they have to wean companies off those subsidies in the adjustment. However, in the other place, my honourable friend the shadow Minister for Health, Caroline Johnson, pointed out that previous calculations of the cost base of the MHRA had not taken account of, for example, the impact of the rise in NI contributions on the running costs of the MHRA, so the Government have had to find some extra money to plug that gap. Perhaps that is why this SI has been rushed through without a proper, full impact assessment, although it may well not be.
My honourable friend also asked about a consultation that revealed widespread concern, with only 10% support. The Minister replied that changes had been made following discussions with a “trusted advisory group”. My honourable friend then asked:
“Who is in the trusted advisory group? Whose voices from micro and small businesses were heard in that group?”.—[Official Report, Commons, Third Delegated Legislation Committee, 21/1/26; col. 7.]
Unfortunately, she has not had an answer.
I completely understand if the Minister cannot answer this now, so maybe she could write, but can she explain why the Government have committed to the full impact assessment then, rather than now?
(1 month ago)
Lords ChamberMidwives are absolutely crucial, and I pay tribute to them and to the wider maternity team. As of October 2025, there has been an increase of some 3.6%—that is 878 more midwives—compared to October 2024. Importantly, we are seeing the introduction of a range of initiatives to improve retention in the maternity workforce, including in midwifery. That will include mentoring and giving better advice and support on pensions and flexible retirement options, because we are keen to retain the long years of service that many midwives and other staff have.
My Lords, touching partly on the question from the noble Baroness, Lady Gohir, data from MBRRACE-UK shows that black women are three times more likely to die during pregnancy or childbirth than white women. Do the department and NHS England have any evidence on the reasons for these disparities that the Minister can share with the House? Will she tell noble Lords how NHS England and the department intend to tackle these disparities?
I am glad to say that my noble friend Lady Amos will be very much focusing on this area. I referred earlier to the maternal care bundle, which focuses on the five main causes of maternal death and harm, as well as on setting up best practice. A number of the risk factors are particularly associated with groups who live in areas of greater disadvantage, those who have pre-existing conditions and, as the noble Lord rightly says, sadly, black women, who are three times more likely to die—something that is totally unacceptable in any day and age, but certainly now. We cannot allow this to go on. That is why we have picked up a key recommendation from the Black Maternal Health inquiry for mechanisms for surveillance of severe maternal morbidity. The first data are expected in the summer.