Tobacco and Related Products (Amendment) (Northern Ireland) Regulations 2023

Lord Dodds of Duncairn Excerpts

Monday 24th July 2023 Grand Committee

I will leave those questions with the Minister. I look forward to his response.

[Lord Dodds of Duncairn (DUP)]

My Lords, it is a pleasure to follow the noble Baroness, Lady Ritchie. Like her, I declare that I am neither a smoker nor a user of vapes.

Despite their technical-sounding name, these regulations are important in their own terms for what they do in this area. However, they are also important in the wider political sense because they are a manifestation of the direct application of European Union law to Northern Ireland as opposed to the decision being made by anyone who has been elected in Northern Ireland, either in the Stormont Assembly or in this Parliament. It is therefore a good illustration, whatever your views may be on the subject, of the issue that is at the heart of the problem now facing Northern Ireland politically and that is causing so many problems in getting the institutions back up and running.

I would have thought that an issue such as this would be something that elected representatives of the people of Northern Ireland would wish to consult on, discuss, debate, come to a conclusion on and eventually pass, either at Stormont or at Westminster. However, under the Windsor Framework, which is a version of the original protocol, they are not allowed to do that. This decision, as the papers make clear, is a decision that has been made by the European Union.

I want to explore with the Minister—if he cannot answer these questions today, I would obviously be happy to receive a letter setting out some of the answers in detail—first, what consultation was carried out by the Government, in bringing forward these regulations to implement European Union laws, with anyone in the Department of Health or any other department in the Northern Ireland Executive. This instrument says that it applies changes “to Northern Ireland only”. What is the position in Great Britain and in the rest of the United Kingdom? The committee on which the noble Baroness, Lady Ritchie, serves and to which she referred in this debate references the general restrictions that apply to the market in Great Britain for vaping machines and products but there is nothing there about the actual issue of characterising flavourings, which is the subject of this piece of legislation for Northern Ireland. What consultations have been carried out in Great Britain thus far on whether to go down the same route as the European Union? If it is decided that the rest of Great Britain will not go down that route, what implications does that have for regulatory divergence with the rest of the United Kingdom—namely, Northern Ireland?

For instance, what will happen to somebody who buys or gets a vaping product in England, Scotland or Wales, brings it back to Northern Ireland and uses it, hands it over or sells it to friends? Under the term “supply”, I would have thought that that would be illegal. How will that be enforced—or will it? I have a further question for the Minister. Will there be checks carried out at any point to determine whether people have such products and are bringing them back as an individual for use or for distribution among friends, or even as a small business to sell them? How will that be implemented? If it is to be implemented by surveillance in market, why cannot that happen in relation to a whole lot of other products that are subject to green and red lane checks under the Windsor Framework? Again, I would like the Minister to deal with that question.

We have here before us a statutory instrument that is UK law but applies only to Northern Ireland. However, it has been brought forward at the behest of the requirement under the Windsor Framework to implement EU law. The noble Baroness, Lady Ritchie, serves on the protocol Select Committee with me; we are honoured to do so. We have many examples of legislation from the European Union, applied under the Windsor Framework, which are just applied directly and do not require any UK legislation at all. Again, I would be grateful if the Minister could explain why it is that this case requires UK-implementing legislation whereas, in many cases, it does not. It sometimes seems hard to rationalise what the difference is, although I accept that that is a wider question than the Minister be here at this Committee armed to answer. If that could be explained to your Lordships, I would be very grateful, as I would be if the Minister could explain where we might find the list of the statutory instruments that are being brought forward and the Explanatory Memorandum in the case where they are not being brought forward by the Government but are being brought forward by the EU directly.

The noble Baroness, Lady Ritchie, mentioned the district councils that are required to enforce these regulations. An impact assessment has not been carried out. I would therefore like to know what consultations there have been with the district councils in Northern Ireland, which are under severe pressure at present. What is the estimated cost in terms of enforcement of this and other requirements under the Windsor Framework, given that they have presumably had no consultation from anyone at the Stormont level or, indeed, at the Whitehall level? I would be grateful if the Minister could answer that one.

On the requirement to decide whether a tobacco product has a characterising flavour, the regulation of the European Union sets out the procedures for determining that. It also lays down the procedure for the establishment and operation of an independent advisory panel to assist in this determination. It seems quite convoluted but there you have it: it is in EU law. We are told that, in accordance with the Windsor Framework, both pieces of EU tertiary legislation apply in Northern Ireland. Again, what exactly does that mean in terms? Where is this legislation and will it be brought forward by statutory instrument or directly by the European Union? Will there be a chance to consult on it? If there are to be people appointed to an independent advisory panel, how will we find out how that is done? Questions around that would be deserving of an answer.

Small businesses and retailers in Northern Ireland—small shopkeepers and so on—will have to be aware that, after 23 October this year, they will no longer be able to sell heated tobacco products with a characterising flavour. So where do they get their supplies from? Has anyone talked to the retailers and small shopkeepers? Has anyone sat down with them to say what the impact of this on their businesses will be? Whether or not you agree that this is a good idea—I am not making any pronouncement on that; I have a lot of sympathy with everything that the noble Baroness, Lady Ritchie, said on the issue, particularly around young people—it is an issue of process and proper accountability. Who has actually sat down with wholesalers, retailers and shopkeepers and discussed this matter with them? What guarantee is there that these people will be aware of this change in law?

I am aware that I have asked a number of questions and that they are perhaps not all capable of being answered today. However, when they are answered, either here today or by letter, I hope that they will provide some clarity to people on this issue. As I say, it illustrates the issues that we have with a form of legislation for part of the United Kingdom when the people who make the law are not accountable to anyone in that part of it and nobody elected as a representative of the people in that part of the United Kingdom has any opportunity to have a vote or bring forward legislation in this area.

[Lord Allan of Hallam (LD)]

My Lords, it does rather feel like the old days to be transposing EU directives into UK law—the good old days, from my political perspective—but I certainly recognise some of the political challenge that the noble Lord, Lord Dodds, has outlined around the agreement that the former Prime Minister, Boris Johnson, signed up to, as confirmed by the current Prime Minister. This is one of the anomalous situations that they have created made real for us because we have to transpose certain elements of EU law specifically into regulations that have an impact on Northern Ireland but not on Great Britain.

The substance of the change seems to us to be entirely sensible from a health perspective. My questions relate to similar areas to those raised by the noble Lord, Lord Dodds, around the relationship with Great Britain, but they come from perhaps a slightly different perspective.

My primary question as a health spokesperson is: why not Great Britain? If we are seeking to limit flavoured heated tobacco products today, why are we not limiting them across the entirety of the United Kingdom? Why are we doing it for Northern Ireland only? I have a concern that there may be a “not invented here” syndrome going on. While we have to implement this for Northern Ireland, we have a choice in Great Britain; there is nothing to stop us imposing similar limitations on Great Britain. I would be concerned if the position of His Majesty’s Government is almost that we are aiming to be awkward and are somehow deliberately misaligning with something that has a public health benefit.

Human Medicines (Amendment Relating to Original Pack Dispensing) (England and Wales and Scotland) Regulations 2023

Lord Dodds of Duncairn Excerpts

Monday 24th July 2023 Grand Committee

Before this important debate is opened, I hope I have set out what we have done and the rationale behind amending the HMRs to enable original-pack dispensing and the whole-pack dispensing of valproate. I look forward to what I know will be an informed and constructive debate.

[Lord Dodds of Duncairn (DUP)]

My Lords, I rise very briefly to raise a point. I was intrigued when reading the title of these regulations that they are for England, Wales and Scotland, but they do not include Northern Ireland. While the regulations are designed to increase patient safety and create efficiencies in the pharmacy sector—I agree with all that and think we can all subscribe to it—I would be grateful if the Minister could tell the Committee whether a decision has been made not to apply them to Northern Ireland, whether is it the case that we have no power in this Parliament to apply them to Northern Ireland, whether the Northern Ireland Assembly has any power in this area, or whether, despite what the Minister said in outlining potently and clearly the reasons for these changes, this is something that no elected representative in Northern Ireland, here or in Stormont, has any power over. I would be grateful for clarification.

[Lord Allan of Hallam (LD)]

My Lords, I start with the point made by the noble Lord, Lord Dodds. Reading the Explanatory Memorandum, it was curious that in paragraph 10.2 we are told that the consultation was carried out by all the United Kingdom authorities, including

“the Department of Health in Northern Ireland”

yet the regulations clearly state

“England and Wales and Scotland”.

This does not surprise me. We are dealing with two instruments on the same day, one of them Northern Ireland-only and one England, Wales and Scotland-only.

I was curious about the answer on the Northern Ireland instrument, which is that we would need primary legislation, so it is easier to regulate tobacco products in Northern Ireland than it is in England, Wales and Scotland. I hope the reverse does not apply here, and that Northern Ireland is not included because some kind of legislative barrier means that they would find it harder than we would to regulate something which, on the substance of it, seems eminently sensible. Many people outside here might be surprised that pharmacists did not already have some discretion over how they dispense, given that packs are quite often in odd numbers. Having dealt with the scope point, again, the substance of it seems entirely sensible.

This must be a pre-recess present, as it is rare that people bring before us regulations which are good for patients, pharmacists and GPs. It is not only that everybody wins from the change being promoted; the Government have managed to get a “two for the price of one” by incorporating another change, which I know has come up. The noble Baroness, Lady Cumberlege, and others have campaigned for some time to improve the information given to women who are prescribed sodium valproate. So here we are: we are making two sensible changes in one instrument, and the Government should be congratulated on that.

For once, we have an impact assessment. We have four pages of regulation and 40 pages of impact assessment. My heart always sinks when I see a huge impact assessment but this one was really good. Whoever prepared it should be congratulated. There are lots of really good facts and figures about how prescribing works in the United Kingdom to help support the case, so I thought it was very well worked out. The fact that savings were identified independently for patients, GPs and pharmacists was extremely helpful in trying to assess the impact of the regulations. It highlighted that there is a potential increase in drug costs but that that is far outweighed by the savings that all those other constituencies make.

I would be interested in the Minister’s reaction to one number in it that surprised me. The impact assessment said that the cost of an e-consultation that would be saved—I assume it is for some sort of repeat prescribing —was £1.40. That is a very precise amount, but less than the saving from a patient going to the pharmacist to pick up their drugs. That figure surprised me because it felt low. I would expect a greater saving from reducing the number of e-consultations for people being represcribed drugs. Again, I am curious about where that came from.

I thought the model of trying to price out where the savings are, in a sort of piecework way, was extremely helpful, down to the 45p that will be saved by assistants in pharmacies not spending 90 seconds on splitting packs. That is super precise, but it is the kind of data that we want, and which can be tested to really understand how you are making savings all through the chain.

The other numbers that came out, that were just fascinating, were on the spread of prescriptions of paracetamol. There were two prescriptions for 10,000 paracetamol in there that were checked and found to be correct, which did surprise me. Even more surprising than the two prescriptions for 10,000 were two prescriptions for 1,009 paracetamol each. 1,009 is a very large prime number, so there is no “so many per day”; you cannot divide it by anything to get anything else. I assume that is a mistake, and that they meant to write 1,000 or 100 and stuck a nine on the end, because that is the only way I can think of that any GP would ever prescribe a large prime number of paracetamol.

I welcome more impact assessments like this with fun numbers in them, as they are extraordinarily helpful on a Monday before we head off for our break. More substantively, I genuinely hope that we will see more innovation such as this around prescribing and dispensing, because this is one of the areas that we have talked about a lot with the Minister. If we are to see improvements in primary care, we have to look for the kinds of efficiencies that benefit patients and make everything quicker and easier for the patient, but also make it more cost-efficient, because there are savings to be made that can in turn be ploughed back into the new enhanced services that we want to get from our pharmacists.

Again, as a substantive point, the general sustainability of community pharmacies is a problem. They are not getting the kind of income they need to continue to be present in all our communities. We see that in the closure rates; there are hundreds closing every year. As we look at changes such as this—the Minister talked about things such as the hub and spoke model—we have to bear in mind all the time that if we are making savings and are able to put those savings back into community pharmacies, that will be essential if we are to continue to have the kind of network that we need for the Minister’s ambitious plans.

This is a very welcome development. It is great to get two for the price of one; reducing the risks to pregnant women from sodium valproate is very welcome, but in terms of the scale of the dispensing operation, it is the 10% change that will potentially have a significant impact. As I say, I hope the Minister can commit that savings made through this will go back into that community pharmacy network that we all depend on.

Bread and Flour Regulations 1988

Lord Dodds of Duncairn Excerpts

Tuesday 7th February 2023 Lords Chamber

[Lord Dodds of Duncairn (DUP)]

My Lords, I join the noble Lord, Lord Rooker, in welcoming the Government’s firm announcement on dates. The delay has been as frustrating as it has been inexplicable for many people. Can I seek an assurance that, when this measure is finally adopted legislatively, it will apply across the entire United Kingdom equally and at the same time?

[Lord Markham (Con)]

Yes, that is my understanding. One of the aspects that has taken time is getting the devolved Administrations on board and the complications of the Northern Ireland situation with the EU.

Bread and Flour Regulations: Folic Acid

Lord Dodds of Duncairn Excerpts

Wednesday 6th July 2022 Lords Chamber

[Lord Kamall (Con)]

I have been advised on this issue, and I have asked if this could be done quicker. Let us put it this way: I anticipated the reaction that I might well get in this Chamber to some of these answers. Indeed, I had to go back to the department on some of the answers and ask for clarification. The point is that there has to be a consultation. Think back to where there has been improper consultation, or where certain evidence has been ignored—the dash to diesel, for example. That consultation identified that while diesel might have lower levels of CO₂, it has higher levels of other things that damage air quality. But that advice from the consultation was ignored. They pushed ahead, and the situation end up worse as an unintended consequence. We have to be careful on this one.

[Lord Dodds of Duncairn (DUP)]

My Lords, the Government first announced that they were going out to consultation on this issue in October 2018. That was very welcome after many years of delay. Given the number of countries that have implemented this very sensible policy, what on earth are the scientific arguments for not proceeding? Surely, all these other countries have tested this in real terms, in actual practice. Can the Minister give us a target date for when all the consultations will have finished and the regulations will come into force?

[Lord Kamall (Con)]

Perhaps I have not made it clear enough that we are proceeding with this; there is no stopping the process or review. We are clear that the scientific debate should not hold up progress, so we want to launch the consultation in August/early September. The closing date will be 12 weeks after that, and we should have a government response on the final position in Q1 2023. We would then notify the WTO and European Commission, and once that is all cleared, it should result in legislation being ready to be laid in Q4 2023, and the transition period for the industry would be discussed after that. When I spoke to the noble Lord, Lord Rooker—I hope he would acknowledge this—he believed that I was one of the few Ministers who is very intent on progressing this.

Folic Acid Fortification

Lord Dodds of Duncairn Excerpts

Wednesday 6th April 2022 Lords Chamber

[Lord Kamall (Con)]

In the brief which I received yesterday the recommendation is for a daily supplement of 400 micrograms of folic acid during the first 12 weeks of pregnancy. I am told that this advice will remain. Certain women with a higher risk of an NTD-affected pregnancy are advised to take a higher, 5-milligram supplement. This is why we have to get the right level. Increasing folic acid in flour alone will not solve the issue.

[Lord Dodds of Duncairn (DUP)]

My Lords, I commend the Government for reaching this position and for being the Government who have brought this matter to this stage. On a couple of occasions, the Minister mentioned the Northern Ireland elections. We know that there are some concerns about what might happen after those elections in terms of a Government being formed. This is a UK-wide matter. Can the Minister assure me that it will progress regardless of the state of devolution in Northern Ireland?

[Lord Kamall (Con)]

Call me old-fashioned, but I anticipated that there would be questions about further delays. When I asked the officials about this, I was advised that once the Northern Ireland elections were out of the way, they could get on with the consultation.

NHS: Nursing Workforce

Lord Dodds of Duncairn Excerpts

Wednesday 8th September 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, there are vacancies in nursing, as there always are. The vacancies at present are not hugely higher than they are normally and, in fact, we have more nurses today than we did two years ago. What I can report to the noble Baroness is that UCAS data shows 27,720 acceptances to nursing and midwifery courses in England as of 7 September. That is extremely good news; it shows the commitment of our graduates to the nursing profession and our commitment to making sure that more nurses are trained.

[Lord Dodds of Duncairn (DUP)]

My Lords, there are concerns that in some areas there are dangerously low staffing levels as a result of nurses leaving the profession. In the Belfast trust, in the first six months of this year alone, hundreds have left due to the Covid pandemic and for other reasons. Undoubtedly, that will have an impact on tackling long waiting lists. Can the Minister assure me that the money raised under the new health and social care levy and sent to the devolved Administrations, including Northern Ireland and Scotland, will actually be spent by those Administrations for those purposes, including addressing nursing shortages? As things stand at the moment, that money could be used for other purposes.

[Lord Bethell (Con)]

My Lords, there are 303,900 full- time nurses in the NHS trusts and CCGs, an increase of more than 8,900 from June 2020, so the impression that the noble Lord is giving is not, I am afraid, entirely supported by the numbers. In terms of recruitment, 2021 saw a third consecutive year of growth in the number of applicants to nursing and midwifery courses, which again is very good news. As for commitment on devolved Administrations, of course devolved does mean devolved, so I am not sure that I am in the position to make the commitment that he has sought.

Medical Devices (Northern Ireland Protocol) Regulations 2021

Lord Dodds of Duncairn Excerpts

Monday 12th July 2021 Grand Committee

[Lord Dodds of Duncairn (DUP) [V]]

My Lords, I begin by thanking the Minister for his clear explanation of the purposes of this secondary legislation. The statutory instrument is necessary, of course, only because of the Northern Ireland protocol, as the Minister made clear. That protocol means that EU law is applied to Northern Ireland across a wide range of matters without any elected Member of the Stormont Assembly or this Parliament having any vote on the matter.

On Friday, in evidence to the Northern Ireland Assembly, the noble Lord, Lord Frost, said that

“you need to have broad consensus”

to make the protocol work between now and four years’ time,

“and the fact we don’t have it is what worries us so much.”

He has also said previously, in speaking to the Northern Ireland Affairs Select Committee on 16 June, that

“the protocol depends on consent. It is very difficult to operate it if there is not consent and willingness from one segment of Northern Ireland opinion”.

I am sure the Minister will confirm his agreement with his ministerial colleague on this vital issue.

So we have before us this afternoon a situation where the EU regulation on medical devices entered into force in Northern Ireland directly on 26 May, and Northern Ireland is now subject to the EU regulatory system for medical devices and not the UK one. This statutory instrument is necessary to try to meet the challenges and practical applications of the EU directive applying directly to Northern Ireland. Whatever the mitigations, it would be better in every sense if Northern Ireland were simply in the same regime as the rest of the United Kingdom. Most medical devices, and £600 million-worth of medicines, are brought into Northern Ireland every year, 98% of which are from Great Britain. As has been mentioned, there are 300 operators of medical devices in Northern Ireland affected by this SI.

Following up on what the noble Lord, Lord Lansley, referred to, can the Minister confirm that the CE marking will be required indefinitely for devices placed on the Northern Ireland market by manufacturers, unlike in the rest of the United Kingdom? Can he confirm that the somewhat bizarre UK(NI) marking will be needed if a UK-notified body undertakes third-party conformity assessment? Can he also confirm that, to place a device on the Northern Ireland market, Great Britain manufacturers will need to appoint an EU or Northern Ireland-based authorised representative? The complexity and extra bureaucracy of all of this, and the cost to the taxpayer, need to be called out and quantified.

The applicability of the EU regime in this area adds not one jot to the safety or security of the people of Northern Ireland. Having Northern Ireland under the UK regime for medical devices would not harm or endanger the EU single market in any way. The whole basis of this SI is unnecessary and undemocratic.

Finally, the noble Lord, Lord Frost, has indicated that the EU is yet to respond to 12 papers tabled by the UK Government. Can the Minister indicate in his response whether any of them relate to medicines or medical devices?

Folic Acid

Lord Dodds of Duncairn Excerpts

Wednesday 23rd June 2021 Lords Chamber

Asked by

[Lord Dodds of Duncairn]

To ask Her Majesty’s Government what progress they have made with the response to their consultation about the fortification of flour with folic acid.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

My Lords, the administration of folic acid to the bread of the nation to avoid around 500 neural tube defects a year is exactly the sort of preventative health intervention that we are putting at the heart of our health strategy. I am pleased to say that progress is being made, and I thank the devolved Administrations for their engagement in this measure to ensure that we have alignment between the four nations. I reassure noble Lords that this remains a priority for the Government.

[Lord Dodds of Duncairn (DUP)]

My Lords, surely the Government have run out of time and must now announce that they will follow the science and finally act to help to prevent the entirely avoidable numbers of babies born with neural tube defects? Recommendations were to be announced as soon as the recent elections were over, and if we are serious about preventative medicine and health, surely on this issue, where UK research has led the way to many other countries taking action long before now, there really can be no further delay or excuses.

[Lord Bethell (Con)]

My Lords, I entirely agree with the noble Lord that we are committed to following the science and are totally persuaded by it. However, I cannot avoid the fact that there were elections in devolved nations, which have meant that politicians and Secretaries of State in some of those countries were not available to engage with. I am pleased to report to the House that we have made a lot of progress in engaging with the devolved nations. We could not possibly do this policy without their support, buy-in and alignment. Progress is continuing at great pace, and I look forward to returning to the House and updating it at a future date.

Covid-19 Update

Lord Dodds of Duncairn Excerpts

Tuesday 15th June 2021 Lords Chamber

[Lord Bethell (Con)]

No, I am afraid the noble Lord completely overstates the case; I do not accept the characterisation he has made at all. The challenge is enormous, and he is right to feel that this is one of the most important tasks for humanity in the round—I cannot emphasise that enough. But the practicalities are that, in Britain, we make hardly any vaccine at all. It is not for us as a nation to manufacture the vaccine. Where we have contributed is, first, through the science—particularly the AstraZeneca vaccine—and, secondly, through global leadership. The Prime Minister, through the G7, has sought to use that post as much as he can, in order to promote the vaccine. I do not accept that China and Russia have in any way contributed anything like the West has done; the numbers simply do not support that. We are working extremely closely with the regions of the world—with Africa, South America and beyond—in order to set up the kind of manufacturing that those countries need to provide their people with the safety from the virus that they deserve.

[Lord Dodds of Duncairn (DUP)]

My Lords, urgent decisions on Covid restrictions are needed elsewhere in the United Kingdom as well. Does the Government accept, however, that decisions that are for a devolved Government to make must be that devolved Government’s responsibility, and their responsibility alone? For Westminster to impose its will on the Assembly on devolved matters would be totally unacceptable and would lead inevitably and inexorably to a collapse of confidence in devolved institutions.

[Lord Bethell (Con)]

I am enormously grateful to all the devolved authorities for the work that they have done with the vaccine and in healthcare. Generally, it has been a very close collaboration, and one that I hope continues.

Carers: Support

Lord Dodds of Duncairn Excerpts

Thursday 10th June 2021 Lords Chamber

[The Lord Speaker (Lord McFall of Alcluith)]

I call the noble Lord, Lord Pendry. No? In that case, I call the noble Lord, Lord Dodds of Duncairn.

[Lord Dodds of Duncairn (DUP)]

My Lords, I too pay tribute to the millions of unpaid carers across the country; they contribute and sacrifice so much on a daily basis. We recognise the great demands and burdens that have resulted because of the pandemic. I urge the Minister to think what more can be done to provide these people with breaks. They need them to counter social isolation and loneliness and for their mental and physical well-being. I thank the Government for what they are already doing. What more can be done?