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

Debate between Lord Allan of Hallam and Lord Dodds of Duncairn

Monday 24th July 2023 Grand Committee

[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

Debate between Lord Allan of Hallam and Lord Dodds of Duncairn

Monday 24th July 2023 Grand Committee

[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.