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Grand Committee

Volume 832: debated on Monday 24 July 2023

Grand Committee

Monday 24 July 2023

Immigration and Nationality (Fees) (Amendment) Order 2023

Considered in Grand Committee

Moved by

That the Grand Committee do consider the Immigration and Nationality (Fees) (Amendment) Order 2023.

Relevant document: 44th Report from the Secondary Legislation Scrutiny Committee. Special attention drawn to the instrument.

My Lords, this fees order sets out the immigration and nationality functions for which a fee is to be charged, and the maximum amount that can be charged in relation to each of those functions. In the order we are debating, we are proposing a number of changes that will facilitate major government policy, play an important role in the simplification of the Home Office’s fee structure, and allow vital decisions to be made to ensure that the migration and borders system is properly funded.

Before I set out in detail the changes proposed in the order, I reiterate that the Government’s aim is to reduce the burden of operating the migration and borders system on the UK taxpayer. The fees set within the parameters of this order are a vital part of the Home Office’s funding settlement. Without the flexibility afforded by the order to adjust fees for all immigration and nationality routes through separate legislation, it is not possible for the Home Office to take a balanced approach to setting fees.

It is therefore vital that the maximum amounts set out in the order allow appropriate choices to be made on individual routes to support a balanced overall approach, avoiding the potential for increases to fall disproportionately on routes where there is flexibility to adjust fee levels. Noble Lords will be aware of proposals to increase fees across a number of immigration and nationality routes. Those fees can be set only through separate legislation, which will be laid later this year, and not the instrument we are debating today. That separate legislation will be accompanied by the production of a full economic impact assessment.

Turning to the changes we are proposing to the fee maximas, the majority of these have not changed since the previous order was laid in 2016. The changes we propose, which are accompanied by an economic impact assessment, will provide the necessary flexibility to make changes to fee levels where they are required to ensure that the sustainability of the migration and borders system is maintained and that we are able to set fees at a level that recovers the cost of processing an application.

As the Committee will know, the United Kingdom is launching an electronic travel authorisation scheme that will strengthen the security of our border and support our wider ambition for digitising the UK border. This is a familiar concept to the majority of international travellers, with many of our international partners having had similar schemes in place for a number of years. My Written Ministerial Statement on 6 June this year outlined the intention to set a fee of £10 for each application on the initial rollout of the scheme. The order before us provides a power to charge a fee for the scheme and sets the maximum fee that can be set by the Home Office for each application. Although we have announced our intended fee level of £10, that fee cannot be set through this order. We will set the fee formally through the immigration and nationality fees regulations, which, as I said, will be subject to approval by Parliament later this year.

We are continuing to simplify our fee structure by removing fees that have become increasingly redundant as part of the wider transition to digital evidence of immigration status or that are no longer required to support wider policy objectives. We will remove the chargeable function for biometric enrolment for all remaining instances of the £19.20 fee in the regulations, reducing the number of fees that customers are required to pay in relation to an application in respect of biometric enrolment. We are removing the £161 fee charged in country for a transfer of conditions for those with limited leave to remain because this fee is now largely obsolete, with all new customers applying in country now issued with a biometric residence permit or digital status.

We are also removing the fee to amend details on physical documents—such as name, sex marker, nationality and photograph—for those with limited leave to remain. This will bring these customers in line with those issued digital status and those with indefinite leave to remain, who are not charged a fee to make this sort of amendment. Finally, the order provides that we will no longer charge a fee for a like-for-like replacement of a biometric residence permit where that document has expired. This will primarily benefit those with indefinite leave to remain, whose cards have a maximum 10-year validity, with most due to expire in 2024.

The final changes that we are proposing in the order will ensure that it and subsequent fees regulations are aligned with the wider policy changes being made in the migration and borders landscape. Under new arrangements being rolled out as part of broader reforms to the innovator route, contact point meetings—a term defined in the order—will be required between an endorsing body and the individual applicant to assess progress against their business plan. The fee maximum for these meetings is set at £500. The fee for each assessment will be £500 and will be set in the Immigration and Nationality (Fees) Regulations in the next year, ahead of these meetings being chargeable in April 2024.

The current sponsorship system is being reformed, with the existing system of certificates of sponsorship being phased out and replaced with the “sponsor a worker” service. This will happen in stages with a limited beta test in 2024, during which both the certificates of sponsorship and the “sponsor a worker” scheme will operate side by side. The amendment that we are making in this order will facilitate this charge, providing a fee maximum to be set at the same level as the certificate of sponsorship, which is £300.

In closing, the changes that we are proposing through this order are vital to providing enough flexibility to amend fee levels, with the approval of Parliament, to ensure that the system is sustainable. I beg to move.

May I ask my noble friend the Minister about something to do with the policy background? In discussing the changes for which the order provides, both in function and fee levels under the regulations, my noble friend referred to one of the policy objectives: the overall security of our borders. In discussing security here and elsewhere, the Government have referred to pre-entry checks that will facilitate entry at our borders. My related question is: is there any proposal or plan to have ongoing checks, including checks when a successful applicant leaves the country, given that the proposed electronic travel authorisations will last for up to two years for short visits? If so, what does the Home Office intend to do to operate these?

My Lords, I want to raise two main issues with the Minister. He will undoubtedly not be surprised to hear that the first is a process issue; the second will deal with the operation and impact of this SI.

As the Minister knows, he is the Minister responsible for all SIs in the Home Office. I am sure that he will have seen and noted the criticisms and comments expressed in the 44th report of the Secondary Legislation Scrutiny Committee of this House, which draws this SI to the special attention of this House, and its findings on the Home Office’s approach to SIs more generally.

I also note the Minister’s remarks to the Secondary Legislation Scrutiny Committee in giving evidence on 11 May. There is much information in that evidence, so I will restrict myself to looking at Explanatory Memorandums and the Minister’s role in all Home Office SIs. The committee’s report states:

“The Home Office’s Explanatory Memorandum (EM) omitted key information about the wider context of the policy changes, something that has been a theme of our comments on recent EMs from the department”.

As this is where the examination of these matters is concerned, would the Minister like to respond to this point?

Secondly on the Minister’s role, I note the judicial analogy he gave in evidence to the committee. The question was being asked by the noble and learned Lord, Lord Thomas of Cwmgiedd, who is of course a former Supreme Court judge. He asked the Minister,

“do you look at the Explanatory Memorandum before it is sent out, or are you a bit like some Silks who never read the skeleton argument that they will subsequently have to defend?”

The Minister replied:

“I cannot confess that I read every SI that the Home Office lays before Parliament and every Explanatory Memorandum. If there was a really controversial or difficult SI, the expectation is that it would be raised with me as the SI Minister and I would review it”.

The noble and learned Lord, Lord Thomas of Cwmgiedd, then went on to ask:

“Do you then, in that process, go through it, read it and say, ‘Look, this hasn’t got the right disclosure. You ought to be making this point and that point’, a bit like you would as a Silk dealing with your junior?”

To this the Minister replied—and I am sure he remembers this:

“I shall certainly take that away and adopt that as best practice”.

Could the Minister tell us how that best practice is going, having adopted it? There are clearly criticisms in this report and the Committee would like to hear how the Home Office Minister is responding on behalf of the whole Home Office.

I turn to the content of the SI, on which I have three issues to raise. The first is the impact on tourism from the ETA, the second is the impact on universities—I shall cite Cranfield University in particular—and the third is the operations of the common travel area. This SI touches on all three and there are certainly matters that could do with further explanation.

First, on tourism, the Secondary Legislation Scrutiny Committee report, in paragraphs 7 to 10, outlines the range of potential negative economic impacts. Given that the figure the Minister referred to is based on the cost of ETAs and processing them, rather than the impact on the tourism industry, and given the flexing from the difficulty in understanding how many people this will deter from entering the United Kingdom, why has visitor expenditure not been quantified in the documentation that accompanies this SI? I am sure that there are data that outline visitor spend per head in country. Any tourist who comes into this country will be spending money here on hotels, food, visitor attractions and so on. Does the Minister agree that it is possible to quantify the level of expenditure per head? If the reduction is 1% or whatever figure is inherent in the documentation, you could quantify that as a loss to the tourism industry.

If the Minister does agree with that, the question arises: how can you offset that? Of course, you can offset it by further expenditure on tourism promotion outside the United Kingdom to get people to come here. The money raised could also be used in some way to help the tourism industry, to compensate for any reduction in numbers that might occur.

Secondly, the 22% increase in student visa fees will provide another trigger to reduce the overseas student population. Once again, it makes us less attractive, and I wonder what the Government’s current position is on the number of overseas students studying in the United Kingdom’s universities. If that is a positive thing, we need to be doing positive things to state that. There are universities, such as Cranfield, as I explained, which work with a particular focus on postgraduate students, and they need some reassurance about the messages coming out from the Government—particularly this fee regime—that are not providing the most welcoming approach that our universities both seek and desire financially in a global marketplace for those who will become students in this country and will have some affiliation with this country in their future careers.

The third issue relates to the CTA. I am genuinely seeking explanations and advice from the Minister. I was trying to think of an easy way of putting this. Let me describe a character whom I have invented, called Jo O’Malley—which means they could be a man or a woman. I am not talking about the Jo O’Malley who comes from County Cork, I am talking about the Jo O’Malley who comes from Boston, Massachusetts, who takes the easy route into Ireland because of an Irish background and name, through the special facilities for Americans at Dublin Airport. He or she may not know what the regime is for the ETAs in Northern Ireland. They come in with an appropriate one for the European Union, to enter Ireland, and then they wander across and look at things in Northern Ireland. Perhaps they decide, “Let’s get on a ferry and go across and see what northern England has to offer”. As the Minister explained, there will be no checks or inspections of documents either at the border between Northern Ireland and the Republic or between Northern Ireland and the rest of the United Kingdom—Great Britain. If there is no one checking, how do we know whether people have an ETA or not? We just do not have that information unless there will be some checks— because Jo O’Malley would walk through, not having to show any documentation, into Northern Ireland and then off the ferry into England as well. That is a possibility and it is laid out—the Minister said that there would be no checks in either case.

How will it work? I do not understand how that understanding of who will do the checks and what will be checked will work.

I have a point of clarification. What I do not understand, behind the noble Lord’s probing, is that if it is a requirement under law to have an ETA for all visitors coming, for instance, from the Republic of Ireland, if they travel on a ferry, as the noble Lord suggests, over to somewhere else, or indeed if they come to this country—it will not be required for the Republic but it will for Northern Ireland—is it not the law that they must have it? For instance, it is very important for insurance purposes if they are taking a car on the ferry. They must be covered under law and they must have an authorised travel document, as I understand it. So why would this be an issue, given the way that our law works? If you are obliged to do something, it is expected that you will do it.

I thank the noble Baroness; she has asked the question to which I particularly wanted to know the answer: how do you enforce it? There is no way of knowing whether anyone has any documentation at all. Whether people avoid it deliberately or because they do not know and they are just moving around, at some stage we have to know—and we do not know. It is easy if you are coming in from Europe, because if you are doing so in any other capacity there is definitely a documentation check, but there is no documentation check coming into the United Kingdom and Great Britain. That is the bit I am trying to find out and that is why I have asked the question. I know this is very tricky and that discussion is going on about it, but I just do not understand how enforcement of any sort will—or could—take place.

My Lords, following the passage of the Nationality and Borders Act 2022 and related changes to the Immigration Rules in March this year, this order is the next stage of a lengthy process to implement the Government’s planned ETA system. Ministers have set themselves a target to begin issuing ETAs to people from Qatar and other Gulf states this autumn and for the scheme to be fully operational by the end of next year.

With respect to the new ETA system, the scope of the order is limited to fees to be charged and requirements for applicants to submit biometric information. A number of the most important issues, about how the scheme will work and what impact it will have, are left for another day. The new ETA system is a major undertaking, and its effects will be wide-ranging.

Significant numbers of UK-bound travellers who do not need a visa will be required to obtain formal clearance to enter the UK for the first time. Whether or not the system will function as it should will depend to a substantial degree on the effectiveness of new technologies that are still in development. In this case, the ETA system will require applications to be made and, eventually, biometric information to be submitted, online or via a new app which is yet to see the light of day. The Government say that even the decision-making process may be automated. That will take highly sophisticated technologies, and robust testing will be essential before the new system comes online. Will the Minister therefore provide an update on what progress has been made in the development of those technologies to date, and tell us whether he believes that the Home Office is currently on track to meet the deadlines it has set for the rollout of those changes?

There is a series of questions about the potential impacts of the order, especially on the tourism sector and the wider economy, including how travel across the border with Ireland might be affected. I have yet to be convinced that Ministers are taking adequate steps to address the concerns raised by stakeholders and to mitigate the unintended consequences. With regard to tourism, the impact assessment published alongside the order recognised that it is reasonable to expect a fall in tourist numbers once the ETA has been implemented, and that revenues can be expected to decrease as a result.

Concerns about the implications for cross-border travel between Northern Ireland and the Republic are especially acute in this sector. However, the impact assessment fails to capture the different effects that the ETA may have across the UK’s different nations and regions. That is a significant oversight. Members of the Northern Ireland tourist board have expressed extreme concern about this issue. They feel that their marketing strategy is very much based on an all-Ireland approach and that the ETA might risk this. Will the Minister therefore set out what steps the Home Office plans to take to mitigate any adverse effects on the tourist trade that these changes may have across the UK, including but not limited to the effects on Northern Ireland?

Given that we are dealing with an order that addresses fees, can the Minister tell us what consideration the Government have given to the potential merits of ring-fencing some of the income generated from applicants’ fees as a means of providing financial support to any business that may find itself struggling with the transition?

Alongside the measures pertaining to ETAs, this order makes changes to the maximum fee level applicable to a range of UK visa routes. For the most part, the proposed increases are relatively modest. The notable exception is for student visas. At present, applicants cannot be charged more than £490, but the order would increase the maximum fee to £600, which equates to a more than 20% increase on the current level, with significant potential implications for international student numbers. As the Secondary Legislation Scrutiny Committee has noted, the scale of the increase is particularly striking when measured against the actual cost to the Home Office of processing those visas, which is less than half of what applicants have to pay. The Government’s impact assessment for the student visa fee increase acknowledges that this potential change is likely to have significant knock-on effects on the number of visas granted to international students and, as a result, on revenue from tuition fees, on which so many of our leading universities remain reliant.

Can the Government go some way to quantifying this? The noble Lord, Lord German, talked about quantifying these impacts and was disappointed by this lack of quantification, but, of course, this funding can be monitored as the system continues to roll out as there will be a number of stages in future. I seek reassurance from the Minister that the impact of the system as it is rolled out will be monitored in a quantitative way as far as possible.

My Lords, I am very grateful for this constructive short debate. Turning to the various points that have been raised, first, I confirm to my noble friend Lady Lawlor that the Home Office will continually monitor the suitability of a person to hold an ETA and will cancel an ETA once granted if that becomes appropriate. An ETA can be cancelled on a range of grounds, including criminality, exclusion or deportation and on non-conducive grounds. Clearly the whole point of having an ETA of limited duration—two years—is that when a further application is made, further checks are run on the applicant. The electronic travel authorisation scheme is designed in such a way that the security of our borders is paramount.

On the process point made by the noble Lord, Lord German, as the SI Minister for the Home Office, I am very familiar with the work of the Secondary Legislation Scrutiny Committee and the content of its report. I reassure him that, as I said in my Written Ministerial Statement on 6 June, our intention is to charge a fee of £10, and this order allows for £15 as a potential maximum. As this order establishes only the chargeable function and the maximum chargeable fee, not the actual intended fee, the Explanatory Memorandum for this SI focused on the chargeable function and maximum rather than the intended fee, which will, as I said in my earlier remarks, be set out later this year in the immigration and nationality fees regulations.

The Secondary Legislation Scrutiny Committee raised concerns with the Home Office that the Explanatory Memorandum did not, as the noble Lord said, provide enough information about the bigger picture of the ETA policy and should have included the intended level of fees and the rationale for them. I have explained the logic behind the way we have set out the Explanatory Memorandum for this instrument, but of course I will bear in mind what the Secondary Legislation Scrutiny Committee said when I prepare and review the Explanatory Memorandum for the fees regulations that will be introduced later this year, and of course I will reflect more generally on the point in relation to fees legislation in future. I thank the noble Lord for raising the point.

I turn to the three substantive points on the content: first, the impact on tourism. As I understand it, the average spend per visit for non-visa nationals in 2022-23 is estimated by the Home Office at £722 per head. It is on that basis that we have proceeded. Clearly, the noble Lord’s question in relation to the impact on tourism was really in the context of the suggestion that somebody would be put off from visiting the United Kingdom because of the need to pay for an ETA. In the context of a world where virtually all the likely competitor destinations are also charging for a similar electronic travel authorisation, I suggest to the noble Lord that the fee of £10 is very reasonable.

The ETIAS—the electronic travel authorisation proposed by the European Union—is to be set at €7, when that comes in. However, for example, the one used by the United States, the ESTA, is set at $21—£16.36 at today’s rates. The Australian version is 20 Australian dollars, or £10.51, and the New Zealand version is 23 New Zealand dollars if completed online and 17 New Zealand dollars if completed on a mobile app. The Canadian version is 7 Canadian dollars and, as I say, the EU’s version is €7. So I suggest to the noble Lord that the £10 level is an appropriate one, and will not have any adverse impact on tourism in the context of the global position.

Perhaps I could probe a little deeper there, because we get most of our tourists, in bulk numbers, from within the European Union. That is the number we are looking at, and where people can choose which other country they want to go to. They have a choice of 25 countries, including the Republic of Ireland. The difficulty here is that it is suggested that there will be a 1% drop in the number of tourists to this country, and it is that bit I am trying to find out. If they are predominantly from the European Union, then it is not the cost issue there, because for people who are in the European Union, there is no cost to moving from one country to another. So I would just like to probe a little bit more on that.

As I say, it is the Home Office’s view that the cost will have a negligible impact on the choice of destination. Interestingly, just picking up on a point that the noble Lord raised, the Republic of Ireland is not proposed to be part of the ETIAS, and has chosen to opt out, as it is not in the Schengen area. So the Republic of Ireland is something of an outlier now in this field, which of course ties back to the point that I will come to in relation to the noble Lord’s third point on the common travel area.

I turn to the noble Lord’s second point: the impact on universities. Fees for immigration and nationality applications are kept under review, as the noble Lord knows. Increases to student visas were announced as part of a wider announcement on fees on 13 July by the Chief Secretary to the Treasury. Those changes will be made in the same regulations that I have already discussed that will come later this year. Those fees will be within the maximum that we are setting in today’s order. While the student fee maximum was increased by a small amount in 2022, the Home Office has determined that further flexibility is necessary to ensure that we are able to take a balanced consideration of fee levels across all routes. The amendment we are proposing to this order will allow this to happen over the longer term.

The Government are of the view that it is right that those who benefit most from the immigration system should contribute towards the cost of operating it. We also note that there is limited evidence that past fee increases have affected demand on study routes.

I turn to the noble Lord’s final point, in respect of the common travel area. As now, there will be no routine immigration controls on journeys within the common travel area and no immigration controls whatever on the Ireland/Northern Ireland land border, as the noble Lord would expect. However, as is currently the case, individuals arriving in the United Kingdom, including those crossing the land border, will need to continue to enter in line with our immigration framework, which obviously will include the requirement to obtain an ETA when they are introduced. I should add that an ETA will not be necessary for an Irish national, of course, because they have special status.

The general principle that one enters the common travel area while adhering to the immigration framework is a long-standing and well-established one. Those crossing from Northern Ireland into Ireland have long been expected to comply with immigration requirements. Once granted, an ETA will be valid for multiple journeys over an extended period, as I discussed in relation to the point made by my noble friend Lady Lawlor. Third-country nationals who are already legally resident in Ireland will be exempt from the requirement to obtain an ETA when travelling to the UK on a journey within the common travel area. In order to benefit from this exemption, if required to do so by a UK immigration official, non-residents of Ireland will need to present physical evidence demonstrating that they are legally resident in Ireland. I hope that this answers the point raised by the noble Lord, Lord German. Guidance as to the forms of identification that will be required has been provided as of Thursday last week; I can provide a copy to the noble Lord after this debate.

I turn to the points made by the noble Lord, Lord Ponsonby, in relation to the process; in particular, how we have tested the tech for electronic travel authorisations. I assure him that I have personally tried the tech. It is very impressive and is swift and easy to use. It simply uses a mobile phone handset, the chip in the applicant’s passport and their credit card details, while their biometric details are taken by the camera on the phone. I assure the noble Lord that this technology has been subjected to robust testing and the Home Office remains on track to launch the scheme in Qatar in October this year.

We have made a deliberate decision to have a phased rollout, starting with Qatar, before rolling it out worldwide in 2024, to ensure that our systems and processes can accommodate the expected number of applications; we expect the figure to be in the region of 30 million a year. We have invested in brand new technology to ensure that customers receive the best user experience when applying for an ETA. As I say, the Home Office has done extensive testing on the mobile application. We are using the same technology that we used for the highly successful EU settlement scheme, so we are confident that the tech should be fully successful when the scheme is launched; as I say, we remain on track to launch in October 2023.

I have already partly responded to the question asked by the noble Lord, Lord German, about Northern Ireland tourism. I can assure him the Home Office has been working closely with tourist bodies across Ireland to ensure that the ETA requirement has as little impact as possible on Irish tourism, both from Northern Ireland into the Republic of Ireland and the other way around. We are committed to working with stakeholders to ensure that the requirement is effectively targeted through a variety of channels and to mitigate any risk of it being seen as a barrier to pan-Ireland tourism, if I can call it that.

Finally, on the noble Lord’s point about the general increases proposed, these increases clearly reflect that the majority of fees have not been subject to a significant increase since 2018, despite a context of high inflation and record high migration into the UK. As I have already said, it is the Government’s policy that those who use and benefit most from the immigration system should contribute towards the cost of operating the system, reducing the burden on the UK taxpayer. The increases announced by the Government will mean that a greater share of that cost will be met by those users of the system. This in turn will allow more funding to be prioritised elsewhere in the Home Office, including to pay for vital services and support public sector pay rises. These increases, which are within the existing fee maxima, will, as I have said, be made through separate legislation after the Summer Recess.

I reassure noble Lords that the immigration fees will be kept under review over the lifespan of this order and will be updated within the parameters that we are setting today. In the event that fee levels are changed, they will need to be approved by this House and accompanied by a full economic impact assessment. I commend this order to the Committee.

Motion agreed.

Police Act 1997 (Criminal Record Certificates: Relevant Matter) (Amendment) (England and Wales) Order 2023

Considered in Grand Committee

Moved by

That the Grand Committee do consider the Police Act 1997 (Criminal Record Certificates: Relevant Matter) (Amendment) (England and Wales) Order 2023.

My Lords, this order amends the Police Act 1997 to require all unspent convictions and cautions to be disclosed on standard or enhanced criminal record certificates issued by the Disclosure and Barring Service—DBS.

The DBS issues three types of criminal record certificate: a basic certificate, which is available for any role; and two higher levels—standard and enhanced—which are available for roles that require a high level of public trust and/or working closely with children or vulnerable adults. More criminal history information is disclosed on the standard and enhanced checks than on the basic, in proportion to the sensitivity of the roles to which they relate.

The legislation which governs disclosure on basic certificates is different from that which determines what is disclosed on standard and enhanced. Disclosure on a basic certificate is governed by the Rehabilitation of Offenders Act 1974. This sets out the periods of time after which convictions and cautions become spent. Once spent, they are not disclosed on a basic DBS certificate. Disclosure on a standard or enhanced certificate is governed by the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 and Section 113A of the Police Act 1997. Together, these allow an employer recruiting for more sensitive roles to see a person’s fuller criminal history.

The filtering rules that govern this disclosure on standard and enhanced certificates define particular criminal records as a relevant matter which must be disclosed. The definition of “relevant matter” includes the seriousness of the offence, whether there was a custodial sentence and the length of time since the date of conviction or caution. The intention is that the convictions covered by the definition of “relevant matter” should include the unspent convictions disclosed on a basic check, in addition to more serious spent convictions, which are relevant to more sensitive roles.

However, the filtering rules do not currently include explicit reference to whether a conviction or caution is spent. This has created an anomaly where, in certain limited circumstances, an unspent conviction that would be disclosed on a basic certificate would not be disclosed on a standard or enhanced certificate.

An example may assist, the most straightforward of which involves youth conditional cautions which remain unspent for three months or until the condition is met if earlier. So if somebody applies for a basic DBS check during that three-month window, the youth conditional caution will be disclosed. However, there is no provision for youth conditional cautions to be disclosed automatically on a standard or enhanced check, even during the three-month window in which they remain unspent.

This might play out as follows. Let us say that a 17 year-old receives a youth conditional caution for common assault. Two months later, they apply to volunteer in a nursery and are required to undertake an enhanced DBS check. There is no provision for their youth conditional caution to be automatically disclosed on the enhanced check so it comes back clean. However, to earn some money alongside their volunteering, the 17 year-old also applies for a job in a supermarket, for which they are asked for a basic DBS check. The basic check discloses the youth conditional caution because it is not yet spent. The supermarket therefore ends up with access to more information than the nursery.

In this situation, the anomaly in disclosure is temporary as the youth conditional caution will be unspent only for a maximum of three months. Once that time is up, the youth conditional caution would not automatically be disclosed on any DBS check. However, this draft order will remove the anomaly altogether and will ensure, in cases such as this 17 year-old’s, that the youth conditional caution would automatically be disclosed on any type of DBS check for the three months that it remains unspent. The order amends the filtering rules so that unspent convictions and cautions are included in the definition of “relevant matter” and are therefore always disclosed on standard and enhanced certificates.

In conclusion, the disclosure and barring regime is based on the principle that those making employment decisions for the most risky jobs have access to more criminal record information than is available for less risky ones. This order will ensure that this principle is always delivered. For that reason, I commend this draft order to the Committee.

My Lords, I start by saying that the rationale for this SI seems sensible. Standard and enhanced DBS certificates should never have a lesser capture of information than that provided by basic checks. However, as is always the case with complex organisational things of this nature, the devil lies in the detail; in other words, does all this match up together appropriately? I want to ask a few questions about the connection between the new disclosure provision for standard and enhanced DBS certificates and the provision for filtering—that is, where things are filtered or not filtered accordingly.

As I understand it, police national computer records relating to protected cautions and convictions will not automatically appear on a certificate. If that is the case, is it the case across all three if they are protected? Are there any unspent offences or cautions that will now become declarable and where filtration will or will not apply, as it could be one way or the other? Will the unspent caution change apply equally to both simple and conditional cautions, which are two different styles of caution?

I want to ask the Minister a question about the two-tier caution system, which is obliquely associated with this SI. This regime was investigated in a pilot, which resulted in 2018 with three police forces undertaking the activity. I wonder whether, now that they have got to the end of that and we have passed through Covid, any further consideration has been given to a different regime here, such as the one described in the 2018 report.

Finally, on the consultation on this SI, there are bodies and agencies such as Unlock, which supports prospective employees who have convictions. Can the Minister say that their awareness of what is happening and why has met with their consent or approval? Has it been met with any concerns from bodies such as them about the way in which this order is before us today? I have only those questions.

My Lords, this appears to be a sensible SI. No concerns were raised by the SLSC, nor was the instrument reported by the JCSI. It will align the separate rules which determine what criminal record information is automatically disclosed on a basic DBS check, on the one hand, and what is disclosed on the higher-level standard and enhanced DBS checks, on the other, so that higher-level checks will never disclose less criminal information than is disclosed on a basic DBS check. The Explanatory Memorandum states:

“The Home Office is working with DBS to ensure that this change and the timing for this to come into effect, is widely understood by those it may affect”.

The example that the Minister gave of the 17 year-old working in a supermarket and then also applying to work with children was a very good one, and one which I have actually seen myself in youth courts. I had not realised that there was this anomaly, and I am glad that this SI is rectifying it.

This morning, I sent the Minister a particular conundrum I had, which is actually outside the strict remit of this statutory instrument. I will just run through that scenario, and I hope the Minister will be able to answer the question it raised with me. I was recently sitting as a magistrate to hear domestic violence protection order applications. Of course, these are civil orders. The applicant was a young mother, who was represented by a lawyer who happened also to be a part-time judge. The respondent, the former boyfriend, was unrepresented. The applicant’s lawyer suggested that the best way to deal with this matter was to not find any facts and just put an order in place for a relatively short time, and everyone could continue living their lives separately and the matter could be disposed of in that way quite quickly. I explained to the respondent that, if he were to breach that order, it would be a criminal offence and he needed to be aware of that. The respondent said to me that he was employed as a primary school teacher, and he was in a much more serious situation than seemed to be realised by the court. He would have to tell his headteacher if the DVPO had been put in place. So I put it off for a contested hearing and advised the young man to get a lawyer.

Subsequently, I talked about this case with a legal adviser, and she said that, as a solicitor, she would not have to disclose whether she had any equivalent civil order put in place. She would not have to tell the Solicitors Regulation Authority, so she doubted whether this primary school teacher would have to do so in his case. I did not know the answer to that question. I suspect there may well be more stringent regulations for teachers, particularly primary school teachers, and there is of course the wider question of all these—really quite a lot of—civil orders which magistrates now put in place, for the reasons we have often debated, and whether there are any guidelines for the various professional organisations about what the requirements for disclosure are and whether that is a ramification which may be taken into account within the whole DBS system.

Also this morning, I went on to the website of the charity Unlock, which deals with people who have left prison and who have had community sentences and that sort of thing. It has a number of worked examples about when things are declarable and when they are not, and at what stage of the job application process matters are declarable. It is an extremely complex picture. It is something which people often fall foul of, and the rules are not clear at all. Can the Minister say anything in a wider sense about how these checking procedures are being reviewed and simplified, from the point of view both of employers and of those people who do have criminal records, so that a system which is better understood can be operational, which would be to the benefit of both sides?

I thank both noble Lords for their contributions to this debate. I am glad that they both agree that this instrument is necessary to align the two sets of rules that determine disclosure of criminal records on basic certificates, on the one hand, and the standard and enhanced certificates on the other. This will ensure that on all occasions the levels of disclosure on criminal record certificates align with the levels of risk and vulnerability inherent in particular roles.

Perhaps if I go into a bit more detail, it will answer all or most of the noble Lord’s questions. I shall come back to the noble Lord, Lord Ponsonby, on his specific example towards the end. It is worth pointing out that the circumstances in which this might occur are very limited, which suggests that the practical impact is likely to be fairly low. The nature of the offences involved also reduces the impact of this anomaly. The DBS has had regular contact with employers regarding criminal record checks across a range of sectors, and we are not aware of any evidence that this lack of alignment between the two sets of rules has had any significant real-world impact. It is worth stating that. Although we believe this impact to be low in practice, it makes sense to rectify the situation.

To go into more of the sort of detail that the noble Lord, Lord German, asked for about the types of convictions or cautions that are currently not disclosed on standard and enhanced certificates, we believe that the practical impact of this lack of alignment is low. However, as mentioned earlier, with youth conditional cautions, which are only unspent and disclosed on a basic DBS check from three months of issue, it will apply only to those youth conditional cautions because they are not immediately spent—so youth cautions will not be automatically disclosed. I hope that that answers that point.

Some of the other things that would be disclosed include earlier convictions in a string of repeat convictions. In that circumstance, there is likely to be a clear standard or enhanced DBS certificate. Then there are relevant orders, which include restraining orders and care orders—that sort of thing—if they relate to convictions that are old or less serious and if they have unlimited, indefinite or “until further order” end dates. As I said, we believe that the impact of this will be relatively low, but I hope that that gives an example of the sort of thing that we are dealing with here.

The noble Lord, Lord German, asked what cautions are not disclosed on standard and enhanced certificates for the relevant matter, and asked whether this was not a safeguarding risk. We believe, as I have said a number of times, that the impact is likely to be low, given the limited circumstances in which it can occur, and the nature of the offences involved. I have gone through them to some extent: I have talked about the youth conditional cautions, the early convictions and relative orders, so I think that that generally answers the relevant question that the noble Lord asked me.

To go back to the specific question from the noble Lord, Lord Ponsonby, on the case that came before him as a magistrate, this is not a complete answer—we will have to do some consultations with the Department for Education as well—so I hope that he will be content to leave that with me, and I shall return when I have concluded those discussions. From the perspective of the disclosure and barring regime, the domestic violence prevention order, if not handed down as part of a conviction, does not need to be disclosed by an individual to an employer, nor will it be automatically disclosed on any kind of DBS check. It is possible that a civil order such as this might be included as additional information on an enhanced check, but only if the police consider it to be relevant and proportionate to disclose. Teachers are subject to regular DBS enhanced checks, with children’s barred list checks. If there is a conviction, either due to a breach of the order or its attachment to a conviction, it would be disclosed on an enhanced DBS check. If asked by his employer, the teacher would be obliged to tell them of the conviction and the order.

I take the point made by the noble Lord, Lord Ponsonby, that this is somewhat complicated—he makes a very good point about that. The Disclosure and Barring Service ensures that applicants and employers have guidance to explain the changes and the impact that they may have in any particular circumstances. It goes to both noble Lords’ questions as well as to the external bodies that have been consulted. We have certainly engaged with Unlock; whether it approves of this measure, I really could not say, but I would imagine so because it brings clarity to this situation. But we have certainly engaged with it and other interested stakeholders on a regular basis.

I should also say that existing guidance makes it clear that, where an employer is aware of a conviction, it should not be an automatic bar to employment. We urge employers to exercise a balanced judgment and take into account factors such as the person’s age at the time of the offence, how long ago the offence took place, the nature of the offence and its relevance to the individual’s role. All of those deserve to be restated. I will take the suggestions of the noble Lord, Lord Ponsonby, about simplifying the guidance, or the regime that delivers the guidance, and making it a little easier for people to understand.

With that, I think I have answered the questions. I thank both noble Lords for their contributions and once again commend this draft instrument to the Committee.

Motion agreed.

Agriculture and Horticulture Development Board (Amendment) Order 2023

Considered in Grand Committee

Moved by

That the Grand Committee do consider the Agriculture and Horticulture Development Board (Amendment) Order 2023.

My Lords, I declare my farming and land management interests, as set out in the register. This order was laid before the House on 6 June 2023. It delivers a package of financial and operational improvements to the Agriculture and Horticulture Development Board—AHDB.

I start by highlighting the AHDB’s important role in supporting and developing our agricultural sectors, investing around £42 million each year in a range of levy-funded services for farmers and others in the agri-food chain. These important services include: applied research and knowledge exchange, such as developing genetic improvements for livestock and tackling pests and disease in crops; market intelligence and analysis, such as providing data and information on input costs, prices, shifting consumer trends and future outlooks for supply and demand of commodities; marketing and consumer education, such as delivering the campaign, We Eat Balanced, to encourage consumers to eat British red meat and dairy as part of a balanced diet; and working with industry and government to establish new export markets.

This instrument modernises the Agriculture and Horticulture Development Board Order so that it can continue to deliver these important services efficiently and effectively. It will also enable more agricultural sectors to access AHDB services if they wish to. Currently, the narrow scope of the order limits the AHDB to working with only the sectors that are listed. By expanding the scope of the order to include other agricultural sectors and related industries, we are providing flexibility for the AHDB to work with a range of other sectors that may wish to access the AHDB’s expertise and services. Any activities that the AHDB undertakes through this expanded scope will be funded directly by those industries and will not involve a statutory levy.

The AHDB will apply clear governance principles to its expanded scope, including that there will be no cross-subsidising of new activities with existing levy-funded services. Another key principle will be that activities in other sectors will add value to the core work the AHDB delivers for levy payers and will not detract from or undermine levy-funded services.

The instrument also delivers changes to help the AHDB reduce administration costs and operate more efficiently. It will put in place more efficient processes for ministerial approval of levy rates so that, in future, approval must be sought when changes are being proposed, instead of the bureaucratic annual approval by default. It will also enable the AHDB to deliver a temporary zero-rated levy to provide financial relief to a sector in exceptional circumstances such as a disease outbreak or market crash.

This instrument will also deliver important modernising changes to the outdated levy deduction provisions. These provisions will enable third-party levy collectors to deduct a percentage of the levy that they collect to cover any administrative costs they may incur. Modern automated financial systems have significantly reduced the administration costs of collecting the levy. Therefore, going forward, rather than having a deduction rate set in statute that cannot easily be updated, the provision will enable any deduction rate to be reviewed and agreed between third-party levy collectors and the AHDB. This will deliver better value for money to levy payers, as reviewing and amending levy deduction rates on a cost-recovery basis will reduce any unnecessary administration costs and enable more levy income to be returned to the AHDB to invest in delivering services.

A further important update we are making to the order concerns the maximum levy rate allowed for the sheep sector. The levy rate for the sheep sector has been at the maximum allowable rate for more than 10 years. We are raising the maximum rate ceiling by 25% to provide headroom for the AHDB to consult further with the industry on an appropriate rate to maintain the services that it receives in future. The new ceiling will be 75 pence per head for sheep producers and 25 pence per head for slaughterers and exporters. The government consultation on this reform shows that key industry organisations, such as the National Sheep Association and the National Farmers’ Union, are supportive of raising the sheep levy ceiling. The AHDB will undertake detailed consultation and engagement with the industry on future options for changing levy rates.

Finally, this instrument delivers some smaller changes to modernise the AHDB order so it is up to date with current practices on invoicing, reflects consolidation in the pig sector and is in line with Cabinet Office guidance on public appointments of board members.

I take this opportunity to thank the chief executive and the chair of the AHDB, Tim Rycroft and Nicholas Saphir, for their service and contribution. Together, they have delivered a significant programme of change putting levy payers at the heart of what they do and supporting our agricultural sectors to adapt and thrive in a changing world.

In conclusion, these modernising updates to the AHDB regulations will ensure that the board can continue to deliver important services to farmers efficiently and effectively. I beg to move.

My Lords, I thank the noble Lord, Lord Harlech, for his thorough introduction to this statutory instrument which, although straightforward, is confusing in some elements. Throughout the Explanatory Memorandum, there are references to what is being changed and what it will do now, but they do not always appear coherent. The AHDB was set up in 2008 under the provisions of the NERC Act 2006 and provides advice to a number of industries involved in animals and horticulture. The original 2008 statutory instrument, No 576, allows the AHDB to introduce and set levies to cover the cost of its operations to all the sectors set out in paragraph 7.2 of the Explanatory Memorandum to this order. The original 2008 statutory instrument is quite clear in Article 11.7 that the appropriate authority for each sector is not bound by the decision of the levy set as a result of a ballot of its sector. I understand why this would be an unwelcome obstacle to overcome and that, as the Explanatory Memorandum to this order states in paragraph 7.6, the levy rates

“have already been approved by the appropriate authority is unnecessary and inefficient. It also limits the ability of the AHDB to put forward proposals for changes to levy rates”.

However, paragraph 7.7 of this Explanatory Memorandum states:

“Final decisions on approving a proposed change to the levy rate will remain with the appropriate authority”.

This gives a strong impression that the appropriate authority can refuse to approve a new levy rate. Can the Minister provide some clarification on this issue?

Paragraph 7.8 states that Article 6 of the 2008 order will allow for

“a zero rated levy to be imposed on an industry … for a temporary period”.

Can the Minister say how long “temporary” is likely to be? It is clear from paragraph 7.2 that the pig industry is included in the provisions of this instrument, but there appears to be some dispute about what constitutes a pig keeper in terms of influencing the outcome of a vote on the levy. Why do some pig producers not pay the levy? Do the producers have undue influence on the outcome of the vote on the levy? If so, has this been the case since 2008? If so, surely this should have been sorted out before now?

I turn now to the issue of the sheep levy. As is generally accepted, sheep is not the sector that produces untold wealth for their farmers. Having looked at the actual rates proposed in the schedule attached to the original SI No. 576, I found that the levies set then per beast were a total of £8.75 for cattle, £1.50 for calves, £1.625 for pigs, and a pound for sheep. It would seem that this levy has remained the same for 10 years, although I think the Minister may have given some different information, which I am pleased about. The current SI proposes that the sheep levy will rise by 25% and the industry will be consulted. This would allow the AHDB to increase, reduce or keep the levy at the same rate. Can the Minister confirm that the 25% increase will be on the figures quoted on the original SI of 2008, or whether it will be on some other figures, which I think he has said will be 75p for the buyer for sheep and, if I heard correctly, 25p for the slaughterers? Could he confirm this in relation to sheep?

There is also a question mark over when invoices will be raised by the AHDB. Payment will be due 30 days from the date of the invoice for the levy issued. I realise that it is extremely important for budgeting purposes for invoices to be issued and payment received as soon as possible. Is the Minister able to say whether all invoices will be issued at the same time, maybe at the beginning of the financial year, or whether there will be a gradual issuing of invoices throughout the year?

Lastly, I turn to the issues raised in paragraph 7.18 of this EM, which states that buyers, slaughterers and exporters have lost levy income of between £600,000 and £700,000 per year due to admin costs. Those costs are all part of running a business, and would be expected to be accounted for in business plans. The original instrument No. 576, in the paragraph on levies, in sub-paragraph 6(3)b states that the AHDB can impose a levy to meet its administrative costs, so this would appear to have already been considered. It is important that, when these changes to the levies are implemented, all concerned accurately calculate their admin expenses in relation to the current economic climate, so that levies are not increased at a later date to retrospectively put this right.

When the consultation between December 2022 and February 2023 was conducted, there was some disagreement on establishing a statutory register of levy payers. Consequently, this proposal was dropped in favour of a voluntary approach. Given the very varying nature of the areas covered by the AHDB, I can envisage that there will not be voluntary unanimity on this subject across the various sectors. It may be that there will have to be a statutory duty to keep a register to ensure parity across those differing sectors. I am nevertheless happy to support this SI and can see that it is long overdue.

My Lords, it is a pleasure to respond on behalf of His Majesty’s Opposition to this final Defra SI before the Recess. I thank the Minister for his overview.

As we made clear in the other place, the Labour Party will support the provisions outlined in the statutory legislation. This is an important step forward for the wider agricultural and horticultural sectors. As my colleague Daniel Zeichner said in the other place:

“working across a host of agricultural sectors, the AHDB undertakes important research, development and farm-level knowledge transfer, along with working to improve supply chain transparency and stimulating demand to help develop export markets”.—[Official Report, Commons, Delegated Legislation Committee, 18/5/23; col. 4.]

While some of the larger agricultural organisations have the resources and capacity to engage in those activities themselves, the vast majority of farmers do not. Therefore, pooling financial resources from farm businesses large and small to invest in improving the sector for everyone is important. In fact, I would argue that the AHDB is more significant than ever given the range of challenges facing the food sector. But, as ever, this SI raises some concerns with regards to implementation and potential impact. In light of that, I hope the Minister can assist with a few questions.

Many of the changes proposed in the SI are entirely sensible but, given the pressures that different types of farmers have been facing for a number of years, it is not clear why the Government are acting only now to reform the Agriculture and Horticulture Development Board. Can the Minister explain why they did not act more quickly?

While it makes sense for the AHDB’s remit to be widened to include other parts of the agricultural sector, is the Minister confident that these additional tasks will not lead to any reduction in focus on the organisation’s core functions? Does he accept that, if the AHDB is not able to devote the same time and energy to these core functions, it could undermine its relationship with levy payers?

Following that point, the Agriculture and Horticulture Development Board currently works with more than 100,000 farming and supply chain businesses. Given the proposed expansion in remit, how many more entities do we believe the AHDB will work with going forward and what provisions are being made to ensure that it has capacity?

When debating this instrument in the Commons, there was some discussion of the ability of larger farming organisations to buy services directly from the AHDB. How does the department propose to ensure that smaller producers, which often face significant financial pressures, are not priced out of the organisation’s activities or otherwise disadvantaged in comparison to larger businesses?

I look forward to the Minister’s response but, in the meantime, I wish all members of the Committee a relaxing and happy Recess.

My Lords, I am grateful to noble Lords for their views and questions on this instrument. We all recognise the importance of the services that the AHDB delivers to our agricultural sectors and that this instrument will help it to continue to do that that as efficiently and effectively as possible. I will now address some of the points that have been raised in the debate, and I undertake to follow up in writing any questions that I cannot answer today. I will place copies of those letters in the Library.

It may be helpful to expand on the financial impact of the AHDB in detail and how funds are allocated. In total, the AHDB collects and invests around £42.1 million a year in statutory levies. The investment that the AHDB makes in each sector, and the gross amounts that are collected and invested annually, are broken down as follows: cereals and oilseeds, which is UK-wide, £11.2 million; dairy, which is GB-wide, circa £7.3 million; beef and lamb, which is England only, circa £14.7 million; and pork, which again is England only, circa £8.9 million.

Both noble Baronesses talked about the impact of the AHDB and what it delivers for farmers. The noble Baroness, Lady Anderson, talked about scale and how smaller producers are perhaps affected. This is exactly why the board is so important: most individual farmers do not have the financial resources to invest in large research and development programmes that will help their businesses thrive in the future. By pooling resources through the statutory levy, the AHDB delivers those services for the whole sector so, even if someone is not invested—so to speak—the research and development going into the sector, the knowledge that is created from it, the expertise in new farming techniques and so on will have an overall benefit for everybody. These services include applied research and knowledge exchange, market intelligence and analysis, domestic marketing and consumer education and, crucially, export market development opening up new markets abroad.

With a view to talking about the scope of the board and how we will ensure that an expanded scope does not distract from the AHDB’s core purpose, the AHDB is clear that levy payers are at the heart of its activities. With this in mind, the AHDB intends to deliver services and activities to sectors where they will add value to its core work with levy-paying sectors. The AHDB will ensure that any new activities do not undermine or detract from its core activities.

The noble Baroness, Lady Bakewell, talked about a statutory register of levy payers. Such a register was consulted on but was not supported by industry, so we feel that a voluntary approach is the best way forward. However, we will keep this under review.

We are keen to ensure that the AHDB does not intend to operate where there is already a trade body or consultancy delivering a viable solution. The AHDB intends to use this expanded scope only where there is a unique need from industry that is not being met somewhere else and where that activity adds value to the levy-funded activity.

The noble Baroness, Lady Bakewell, talked about the zero-rated levy and asked how long it will continue to be allowed. I am not sure how much I can say because the exact length of a zero-rated temporary levy holiday would need to be determined on a case-by-case basis according to industry needs. However, we would expect this to be a short-term measure of no more than a few months to help the sector through a difficult time. For example, the pig levy holiday introduced last winter to help pig producers through a difficult time lasted one month. I hope that this provides some clarification on the sort of timescales that we envisage it being used for.

The noble Baroness also talked about the evidence needed to support a change in levy rates and asked what kind of evidence Ministers would want to see before a change in the rate would be approved. Ministers would expect to see evidence from the AHDB setting out why a change in the levy was necessary, what the benefits and impacts would be for levy payers and, crucially, the views of levy payers and representative trade bodies on those proposed changes before anything was approved.

I shall focus in a bit more detail on pigs because they were raised in the debate. Most pig contractors who raise pigs on behalf of larger pig owners do not pay the pig producer levy and so will no longer have voting rights on how the levy is spent. It is right that only those who pay the pig levy should be able to vote on levy spend priorities. This will result in a smaller number of pig producers voting on levy matters in future, which is consistent with recent consolidation in the sector. Currently, the wide definition of “keepers of pigs” means that anyone who keeps a few pigs but does not pay the producer levy could have undue influence on the outcome of a vote on how the levy is spent. It is therefore right that the vote is limited to only those who pay the levy in future.

I hope that I have addressed the issues raised by noble Lords. Once again, I commit to reading back through Hansard to check whether there are any specific questions that I have missed; I will write to all members of the Grand Committee if I have. I hope that noble Lords will approve this instrument, thus ensuring that the AHDB can continue to deliver value for money and support farmers for years to come.

Motion agreed.

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

Considered in Grand Committee

Moved by

That the Grand Committee do consider the Tobacco and Related Products (Amendment) (Northern Ireland) Regulations 2023.

Relevant document: 45th Report from the Secondary Legislation Scrutiny Committee

My Lords, the purpose of this instrument is to implement the EU Commission delegated directive (EU) 2022/2100 of 29 June 2022, which amends directive 2014/40/EU—the tobacco products directive—to withdraw certain exemptions in respect of heated tobacco products placed on the Northern Ireland market.

The instrument amends the Tobacco and Related Products Regulations 2016—the TRPR—in relation to Northern Ireland. The regulations will apply to producers, suppliers, retailers and wholesalers that produce or supply heated tobacco products for consumption in Northern Ireland. Subject to the regulations being approved by Parliament, they are due to come into force on 23 October 2023.

The regulations apply to Northern Ireland only and are made for the purposes of dealing with matters arising from the Windsor Framework. The SI implements a change so that, from 23 October 2023, heated tobacco products can no longer have a characterising flavour, such as menthol, vanilla and fruit flavours. This is not a ban on heated tobacco, but it will limit the flavours available. A characterising flavour ban is already in place for cigarettes and hand-rolling tobacco in the TRPR.

We do not need to make changes in light of the Commission delegated directive’s requirement for heated tobacco products to contain health warnings and information messages if they combust. If heated tobacco products that involve a combustion process were placed on the UK market, they would be regulated as tobacco products for smoking and subject to existing regulations in the TRPR that require these products to contain a combined health warning and information message. There are currently no heated tobacco products on the GB or Northern Ireland markets that involve a combustion process and, as such, they are subject to the labelling requirements applicable to smokeless tobacco products.

A full impact assessment has not been prepared for this instrument because the costs involved for business fall below the threshold for producing one.

Heated tobacco products on the UK market are produced and manufactured outside the UK by the tobacco industry. The characterising flavour ban will limit the products it can produce and supply to the Northern Ireland market and may impact on profits, in what is a relatively small market for the industry in Northern Ireland.

The DHSC has communicated with the tobacco industry, Northern Ireland retail representatives and enforcement agencies regarding the proposed changes. There is no significant impact on the public sector. Each district council in Northern Ireland will enforce the new requirements. They are not expected to be a significant burden on district councils, given the low use of heated tobacco products in Northern Ireland.

I am content to bring forward this legislation today. These regulations allow us to honour our current commitments under the Windsor Framework and will have limited impact on Northern Ireland business. I commend these regulations to the Committee.

My Lords, I thank the Minister for his presentation of the statutory instrument. I have to declare an interest: I am a member of the Secondary Legislation Scrutiny Committee, and we discussed this SI. There was no dissent from it and there was general support, but we drew it to the attention of your Lordships’ House.

I am a supporter of the Windsor Framework, and any shilly-shallying around it can lead to uncertainty in Northern Ireland. It is important that we and the people of Northern Ireland, particularly businesses, can avail themselves of the economic opportunities in relation to access to the UK internal market and the EU single market.

Notwithstanding that, I have certain questions. First, I note that an

“impact assessment has not been produced for this instrument as no, or no significant, impact on the private, voluntary or public sector is foreseen”.

I am a non-smoker and I do not use vapes. However, I see a heck of a lot of young people vaping. They use fruit flavours in particular. As a consequence of this legislation, from 23 October, they will no longer be able to use fruit-flavoured vapes. In that respect, although consultation will have taken place with district councils, what consultation took place in advance between district councils, the Department of Health and the Department of Health in Northern Ireland, along with schools, youth groups and youth societies because this will affect young people?

I believe that, although it may be better to use these particular vapes than tobacco products, there is a health risk with them none the less. Has the Minister considered the Committee on Toxicity’s report, which stated that the evidence is limited that it is plausible that these devices are less harmful than conventional cigarettes but that they are not risk-free? It would benefit smokers to quit smoking completely rather than to switch to heated tobacco products, because such products will still be available in Northern Ireland.

I am not seeking to be the Gestapo in relation to these matters but there is one final, serious point that I want to make. During our troubled history in Northern Ireland, paramilitary organisations used the black market to import and export cigarettes whenever Northern Ireland was a manufacturer of such. My fear is that, if certain products are prevented, certain paramilitary organisations will try to use that method to import flavoured varieties of vapes. What mitigation measures have been put in place with HMRC, the Treasury and Customs, working with district councils to address this issue and ensure that this level of crime is both detected and, I hope, eradicated? Will the Organised Crime Task Force be involved in this matter? I am not trying to create a sense of fear in relation to this; I am just presenting a political reality in Northern Ireland. After what has happened in the past, how can this be addressed because prevention often leads to underground activity?

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

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.

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.

The note that we were given carefully explained how the European Commission has done some work and released a report on 15 June 2022 giving its rationale for why it needed to make this change. I would be interested to hear from the Minister what assessment his department has made of that report because one version is that the European Commission has done the hard work for us. If it has spent time looking at the potential harms done by allowing the continued sale of flavoured heated tobacco products, presumably that evidence is also useful for us and could allow us to shortcut our way to a similar policy conclusion. It is important that we understand, both for this and for other directives, what position the Department of Health and Social Care is taking in the United Kingdom in looking at what the European Commission is doing and learning from it.

Similar to the question from the noble Lord, Lord Dodds, it would be helpful to understand from the Minister what consideration the department gave to whether this should be for Northern Ireland only or an amendment should be made for the United Kingdom. As I understand it, there is nothing to stop the Government doing so. It certainly seems to me that it might have been a similar amount of work to bring forward a change to all the tobacco product regulations at the same time as it would have been to bring it forward for just Northern Ireland. If we are to reach the same conclusion, we will back in this Room in a few months having the same debate about a similar change to the regulations for Great Britain. Why not do that all together and make a positive health change in one fell swoop rather than in two different stages?

I have a final couple of points. One is on the issue of vapes, which the noble Baroness, Lady Ritchie, raised. I understand that these particular regulations do not deal with vapes but with those little cartridge-based products, as opposed to liquid-based products, which do not count as heated tobacco. However, there are similar, perhaps even stronger, arguments as to why we should limit the availability of flavoured vaping products. This is another opportunity to ask the Minister what the Government are doing on that because the evidence that we all see as we go around is that people are deliberately marketing vaping products to children and young people and they are being taken up in huge numbers.

Here we are, spending time debating a change to the rules to deal with this very minor segment of the market when it seems to me that we are being very slow to find the time—or perhaps the will—to deal with this much larger segment of the market, which presents a clear and present danger to teenagers in particular. People are out on Oxford Street today pushing raspberry-flavoured and bubblegum-flavoured vaping products. What is that all about and why are we not finding the time to deal with it? That is a legitimate question on the back of this debate on flavoured heated tobacco products.

Another area that I wish to look at is enforcement for both heated tobacco and vaping products, which, again, is critical and was raised by the noble Baroness, Lady Ritchie. Even within the legal nicotine delivery market—if I can describe it that way—there are people pushing products that I understand are already outside the law today. The weak point seems to be trading standards being able to enforce and shut down people who are pushing illegal products. I would be very interested to hear from the Minister what work his department is doing with health bodies and trading standards bodies in Northern Ireland, Scotland, Wales and England to make sure that nicotine delivery products really are within the regulations and that, when people stray outside them, they have some fear that they may be caught; if they think that there are no consequences, they will continue to sell products, including the products that we are debating today. If there are no consequences of being caught, why would unscrupulous vendors feel that they need to come into line?

My final point is on the question raised by the noble Lord, Lord Dodds, about whether we are going to see a landscape in which there is divergence across the piece. We are dealing with a small segment of the market today but I can easily imagine that the European Union might get its act together and regulate vaping much more aggressively and quickly than we do. It is potentially a much bigger deal if we have one regime for vaping in Northern Ireland and a different regime for vaping in Great Britain. It seems to me that that would be much more unsustainable and create all kinds of issues around cross-border smuggling and people moving products around so, again, it will be interesting to hear from the Minister where the Government’s thinking is in terms of convergence, which seems entirely sensible around the whole range of nicotine delivery products, versus divergence, where we end up with different rules on vaping, combusted tobacco products and these heated tobacco products. If we end up with divergence across all these fields, we are potentially walking ourselves into trouble.

I start by thanking the Minister for introducing these regulations, which we welcome, and expressing my appreciation for the way he set out their application, the summary of which is that, from October, it will be illegal in Northern Ireland to produce or sell heated tobacco products that have what is called a “characterising flavour”. As the Minister explained, this change is happening because of the requirements of the Windsor Framework and in response to a policy change implemented by the EU—more of that later.

With regard to heated tobacco products, unsurprisingly, some in the tobacco industry have claimed that they are less harmful than conventional smoking. Has the Minister had time to review the analysis by the University of Bath, which has shown that most of the studies referred to in order to back up said claim were either affiliated with or funded by the tobacco industry? Surely that raises a considerable flag. Conversely, the European Respiratory Society has pointed to independent research showing that heated tobacco products emit substantial levels of toxicity as well as other irritant substances. Although the use of these harmful products is said to be very low in Northern Ireland, they are increasingly being marketed, without evidence, as a healthier alternative to smoking.

On that point, I would like to pursue the questions that have been asked by noble Lords in the course of this debate about whether there are plans to adopt similar legislation here so that there is parity between England and Northern Ireland; and whether there have been discussions with the other devolved Administrations in order to ensure that there is parity in legislation and, therefore, not the problems across borders that have been described. The noble Lord, Lord Dodds, explored this matter extremely well. I was particularly taken with the obvious practical example that somebody can purchase a product here and take it to Northern Ireland. What is the implication of that? That is going to happen all the time; it is just a fact. I am sure that all noble Lords will be interested to hear the Minister’s response on that.

Have the Government made any assessment of the prevalence of heated tobacco product use across the rest of the United Kingdom, principally in England, along with the wider health implications of such use? Perhaps the Minister could also outline what action his department is taking to combat the increased marketing of such products—marketing that is often underpinned by spurious tobacco industry-backed research, as I referred to earlier.

As was spoken to by the noble Baroness, Lady Ritchie, and the noble Lord, Lord Allan, can the Minister set out how the Government will assist Northern Ireland in the implementation of the ban, particularly given the possibility of illegal importation from England? It certainly seems strange—this point has come out in the debate—that, following the implementation of the draft regulations, there will be more stringent legislation in place to clamp down on heated tobacco products in Northern Ireland than in the rest of the United Kingdom. Can the Minister assist us in trying to understand how that will help? Are the Government considering implementing a ban on these products in their tobacco control plan, which was promised by the end of 2021? That leads me to the question of when—indeed, whether—we will ever see it published?

I want briefly to highlight concerns in relation to children and young people in particular. I note that the Secondary Legislation Scrutiny Committee referred to the fact that it was in the light of increased sales volumes among under-25s that the EU amended its legislation on heated tobacco products. In this regard, the Health and Social Care Committee in the other place recently took evidence from not only health experts but the industry. It made for interesting reading. The committee heard evidence that the topic of conversation for young people in the playground was often the different flavours that they were trying, such as

“Gummy Bear, Slushy and … Unicorn Milk and Unicorn Frappé”.

This was also referred to by the noble Lord, Lord Allan. These are different flavourings that are clearly not aimed at an adult audience. While we are talking about vanilla and other flavours in heated tobacco products, does the Minister agree that it will not be long before we see them being extended to products that are deliberately constructed to be attractive to children to get them to take up smoking? What is the strategy to deal with this?

It is absolutely crucial, in dealing with tobacco control and ensuring that we reduce harm to the health of people of all ages, that we look ahead. I hope that these regulations and the debate around them, including noble Lords’ contributions, will again alert the Minister to the need to anticipate future developments in tobacco products, not just in Northern Ireland but across the whole of the United Kingdom.

I thank noble Lords for their contributions. As ever, they showed that there are interesting intricacies in every part of health; it is one of my key learnings over the past nine or 10 months that I have been in this role.

I want to clear up one thing. I admit that there was a bit of confusion on my part, as well. As the noble Lord, Lord Allan, said, we are not talking about vapes here—we are talking about heated tobacco. There is a heated tobacco stick, which basically heats to temperatures lower than that of a cigarette and releases an aerosol. I am sorry if noble Lords knew that already, but I thought that was worth clarifying. Because of that, this product is used by a very small number of people. It is estimated that less than 0.5% of smokers use this product; if you apply that to the population, it is 0.065%. I hope that this gives some sort of clarification behind our decision, when we talk about whether we did an impact assessment, because we are talking about very small numbers being involved here.

Of course, there are wider read-across questions about vapes, but that is a larger subject. There is a consultation on that going on as we speak. Clearly, we need to see the results of that and decide where we go from there but, in GB, we would need primary legislation if we wanted to do something in this space. It is only the fact that this is part of the Windsor agreement under the EU, which was a primary legislative process, that enables us to do it through a secondary instrument in Northern Ireland, which we are not afforded to in GB. That is not to say that we should not consider those things and, as I said, we absolutely are considering them in the consultation that we are doing at the moment, but that is why this is not just a simple case of piggybacking off what the EU has done. It is obviously a larger subject for debate.

I think that we in the Committee would all agree that cigarettes are the worst form of smoking and not smoking at all is best. Both vapes and heated tobacco lie somewhere in the middle, where we would rather people use heated tobacco or vapes than cigarettes; but really, of course, we would rather they do not do any of those things at all. However, right now, our strategy is that we believe that vapes are a legitimate and important way of getting people off smoking, albeit I think we all accept the unintended consequences that we are starting to see from the marketing of vapes to children and hence the consultation that we need to do because that is clearly an area of concern.

The noble Lord, Lord Dodds, asked about some of the wider issues, including the consultation carried out with the Northern Ireland Executive, and whether it will lead to divergence, the movement of goods taken backwards and forwards, and so on. As he suggested, I will give him a detailed response, because it requires that but, inevitably, this clearly will be an example of divergence by its nature, unless and until we decide to enact primary legislation to make similar regulations if that comes out as a result of the consultation. On the questions relating to the movement of goods bought here and then taken over there, the honest answer is that, because we are talking about such a small part of the market—0.5% of smokers and 0.065% of the whole population—we would probably be better focusing our attention on other areas in terms of the movement of illicit goods.

I am not aware of the Bath University study, but I will make sure that I find out about it. I hope that, in this conversation I have managed—

I thank the Minister for giving way. In relation to what he said about the transport of these substances, I indicated the issue of regulation, as did the noble Lord, Lord Allan. In the past, during our troubled history, cigarettes were used as a form of smuggling, and also used as contraband by paramilitary organisations. The Minister says there is only minor use of these cartridges, for want of a better description—but I have seen them sold along with cigarettes in locked-up containers in shops, and young people purchasing them, particularly the fruit-flavoured ones. If they do not have access to that, how will they be able to get them? What mitigation and control measures will be put in place to prevent them becoming like contraband and being abused by erstwhile paramilitary organisations?

I thank the noble Baroness for that remark. I think that I probably need to give that a detailed response as well. The point I was trying to make was that these heated tobacco products are a very small part of the market to begin with and the flavoured versions are even smaller again. While the noble Baroness is correct that that potential is there, the amount is very small indeed, but I will give her a detailed response on that.

I have tried to answer the specific points raised; as I say, I will follow up in more detail in writing. We have to honour the regulations set out by our commitments under the Windsor Framework agreement. With that, I commend these regulations to the Committee.

Motion agreed.

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

Considered in Grand Committee

Moved by

That the Grand Committee do consider the Human Medicines (Amendment Relating to Original Pack Dispensing) (England and Wales and Scotland) Regulations 2023.

I am grateful to be here today, as is right, to debate such an important issue. The Human Medicines Regulations 2012—the HMRs—set out when medicines need to be prescription only and requirements for pharmacists selling or supplying prescription-only medicines. This SI will make two amendments to the HMRs to enable original-pack dispensing of medicine—OPD—and to require whole-pack dispensing of medicines containing valproate.

The first amendment, on OPD, is to enable pharmacists and pharmacy staff under their supervision the flexibility to dispense up to 10% more or less of the medicine compared to the quantity prescribed if it means that the medicine can be dispensed in the manufacturer’s original packaging. The second amendment requires medicines containing valproate always to be dispensed in the manufacturer’s original packaging, supplying a quantity as close to the quantity prescribed as possible, with exceptions in specific circumstances when the prescribed quantity must be dispensed.

The aims of enabling OPD and requiring whole-pack dispensing of medicines containing valproate are to increase patient safety by ensuring that patients receive the necessary information that is included on, as well as inside, the manufacturer’s original packaging about the safe and effective use of a product. A further aim of OPD is to support efficiencies in community pharmacies.

The Human Medicines Regulations require that a pharmacy may not sell or supply prescription-only medicine except in accordance with a prescription given by an appropriate practitioner. Currently, we interpret dispensing

“in accordance with a prescription”

to mean that pharmacists must supply the exact quantity of medicine prescribed, with a few exceptions where it is practically impossible or very difficult to split the original pack. This means that, where the quantity prescribed on a prescription is not equal to or multiples of a pack size, pharmacy staff need to split the manufacturer’s original pack. In order to dispense the prescribed quantity, the medicine may be supplied in a plain dispensing box or bottle or in the manufacturer’s original packaging but with some taken out. In the case of tablets and capsules, this usually means snipping the strip of medicines.

When supplying in plain dispensing packaging, pharmacies look to provide patient information leaflets but this may not always happen. Patients certainly will not receive or have the opportunity to read the safety information printed on the manufacturer’s original packaging. Further, they may get a collection of snipped strips in a plain dispensing box, which makes it difficult to know whether they have taken their tablet that day or how many tablets they have left and therefore when they need to reorder their medicines. Where patients get the manufacturer’s original pack but with some tablets taken out, and where any tamper-evident seal is broken, they may be concerned that their medicines have been interfered with.

In the case of medicines containing valproate, these amendments will mean that they must always be dispensed in whole packs in the manufacturer’s original packaging, regardless of the conditions that we set around other products for original package dispensing. The requirement is that the nearest number of whole packs to the quantity prescribed—either rounding up or down—will be supplied so that the patient receives only the manufacturer’s complete original packs. These must not subsequently be repackaged into plain dispensing packaging.

Further to the consultation responses, an exception is being included: pharmacists will be able to make an exception to whole-pack dispensing of medicines containing valproate on an individual patient basis where a risk assessment is in place that refers to the need for different packaging, such as a monitored dosage system, and where processes are in place to ensure the supply of patient information leaflets. The risk assessment might identify that the patient needs different packaging to support them taking their medication. Otherwise, while dispensing in original packs may support increased access to patient information, there is a danger that it may undermine measures being taken to support individual patients to take their medicine appropriately.

Amendments to the HMRs for OPD will enable pharmacists, or pharmacy staff under their supervision, to dispense 10% more or less of the medicine compared to the quantity prescribed if it means that they can dispense the medicine in the manufacturer’s original packaging. However, judgment by the responsible pharmacist will remain a critical part of the process; for instance, there are some prescriptions, such as a course of steroids or antibiotics, where a decision may need to be made to supply the exact quantity prescribed.

It is important to note that OPD will not apply to controlled drugs, which are medicines that have further legal controls on top of those that apply to all prescription-only medicines. This is because they may cause serious problems, such as dependence and harm, if they are not taken as intended by the prescriber or are diverted for other uses. Furthermore, OPD does not apply where a medicine is in a form that is not practicable to dispense in the exact quantity ordered, where there is an integral means of application, where splitting the packaging could adversely affect the medicine, such as inhalers, or where the packaging is keeping the medicine sterile.

Although the flexibility of 10% will not enable all medicines to be dispensed in manufacturers’ original packs, it will deal with the issue of whether a month’s supply is 28 days or 30 days and multiples. For example, if a prescription is for 28 days but the pack has 30 tablets, the 10% flexibly enables the full pack to be supplied and vice versa.

The amendments for OPD will apply across Great Britain and are enabling, so pharmacists can decide whether they utilise OPD 10% flexibilities. A transitional provision has been included so the flexibility to dispense up to 10% more or less does not automatically apply in NHS pharmaceutical services in England and Wales. This will allow these administrations to decide how they want to apply this in their respective NHS services. In Scotland, the OPD 10% flexibility will apply immediately.

The amendments will directly contribute to the overarching objective of safeguarding public health by improving patient safety. Ensuring that patients receive the necessary information included in and on the manufacturer’s original packaging will support them taking their medicine safely and effectively. More patients will receive their medication with any tamper-evident seal intact, which reduces concerns that someone has somehow interfered with the medicine. This amendment will lead to a reduction in the use of plain dispensing packaging so that patients will stop getting lots of small “snips” from a blister strip, which we know will make it easier for them to manage their supply and supports compliance as it makes it easier for patients to identify whether they have taken their tablet that day.

OPD is a commitment in the community pharmacy contractual framework 2019-2024 to support efficiencies for pharmacies. This will help pharmacists and their staff become more efficient as the number of times that they have to snip blisters, repackage medicines and source extra patient information leaflets are reduced, freeing up their time for other tasks such as providing clinical services to patients.

Both OPD and expanding hub-and-spoke dispensing arrangements are recognised in the primary care recovery plan, published in May 2023. The NHS long-term workforce plan, published in June 2023, highlights hub-and-spoke arrangements alongside the greater use of automation, which would be facilitated by OPD. These plans recognise OPD and hub-and-spoke arrangements as important foundations in the transformation of community pharmacy that, together, aim to facilitate the greater use of automation in order to increase efficiency and free up pharmacists and their staff to be able to provide more clinical interventions.

The benefits of OPD will be synergistic with the benefits of expanding hub-and-spoke arrangements, which we are also progressing and which will need separate further legislative amendments. Hub-and-spoke arrangements are where parts of the dispensing process are undertaken in separate pharmacy premises. Typically, there are many spoke pharmacies to one hub pharmacy. The concept is that the simple, routine aspects of assembling prescriptions can take place on a large scale in a hub that usually makes use of automated processes.

Splitting packs typically cannot be done by machines that automate the dispensing process. By giving flexibility for supply to be 10% more or less than the prescribed quantity, the number of medicines dispensed in the manufacturer’s original packaging will increase, which in turn increases the number of prescriptions that can be dispensed through the highly automated processes that hubs are likely to employ. The greater use of automation brought about by OPD and hub-and-spoke arrangements, as well as increased efficiency, has the objective of contributing to an improvement in patient safety. By splitting the routine aspects of dispensing for community pharmacists and their staff, hub-and-spoke arrangements can deliver an environment that supports pharmacists and their staff, at both hub and spoke, to focus on the specific tasks they are doing, which in turn protects patient safety. The use of hub-and-spoke dispensing arrangements has been consulted on and the consultation response will be published in due course.

As I have already mentioned, there is a specific amendment for medicines that contain all forms of valproate. Valproate is an effective medicine prescribed for the treatment of epilepsy and bipolar disorders but it is associated with birth defects and neurological disabilities in unborn babies. For children whose mothers took valproate during pregnancy, the risk of having neurodevelopmental disorders is estimated at 30% to 40%, in addition to an 11% risk of congenital abnormalities.

Valproate is an umbrella term for medicines including sodium valproate, valproic acid and valproate semisodium. Products may also be referred to using various brand names. These regulations require that the nearest number of whole packs to the quantity prescribed, so rounding either up or down, will be supplied so that the patient receives only the manufacturer’s complete original packs, with limited exceptions in specific circumstances. Those exceptions, in specific circumstances, to the whole-pack dispensing of medicines containing valproate is when a risk assessment is in place identifying that the patient needs to be supplied with the medicine in different packaging than its original packaging—for example in a monitored dosage system, which helps patients to comply with their medicine—and processes are in place to ensure that the patient continues to get the manufacturer’s patient information leaflet.

This provision is mandatory across Great Britain. There is no transition for the amendments on the whole-pack dispensing of medicines containing valproate, as it will apply in legislation as soon as the amendments come into force.

Sodium valproate and its associated valproate medicines were considered as part of the independent medicines and medical devices review undertaken by the noble Baroness, Lady Cumberlege, to whom we offer our thanks. For some women, valproate may be the only effective treatment for their epilepsy. The regulatory measures are robust and clear that sodium valproate must not be prescribed to any girl or woman of child-bearing potential, unless she has a pregnancy prevention programme in place and is fully informed of the risks.

The requirement for a pregnancy prevention programme was introduced in April 2018. While wider regulatory measures such as the pregnancy prevention plan have already reduced the number of pregnancies exposed to valproate, the latest data indicates than an estimated three pregnancies a month in England are being exposed to medicines containing it. This new legislative amendment, requiring the supply of the manufacturer’s original packaging, is a further measure to ensure that those taking valproate have access to information setting out the risks and need for a woman or girl of child-bearing potential to have a pregnancy prevention programme in place before taking valproate.

The manufacturer’s original packs include specific warnings and pictograms on the labelling, including a patient card, along with the statutory patient information leaflet and an additional patient booklet, which highlight the risks of taking the medicine while pregnant. The aim of the whole-pack dispensing of medicines containing valproate is to decrease further the number of babies who are born with serious complications, thereby improving their lifespan and quality of life.

The exemption to whole-pack dispensing still requires processes to be in place to ensure that the patient receives the patient information leaflet while not cutting across any mitigation put in place to support them taking their medicine appropriately. This exception to whole-pack dispensing has been put in place in response to feedback that we received as part of the consultation. There was concern that, while dispensing in the manufacturer’s original packaging may support increased access to patient information and reduce risk to unborn babies, there is a danger that it may undermine measures such as different packaging, such as monitored dosage systems, which support individual patients to take their medicine appropriately.

No patient should stop taking their medicine without medical supervision. If patients are concerned about the reproductive risks of medicines containing valproate, they should talk to their healthcare provider. Valproate is subject to a range of safety measures. All girls and women taking it should meet the requirements of the pregnancy prevention plan.

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.

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.

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.

My Lords, as the Minister said in his introduction, this is an important issue. I too express my enthusiasm for this SI. We do not have a lot of SIs for which we have a lot of enthusiasm, so I hope the Minister and his team will be very happy with that. The reason for that is that this is common-sense and practical, and provides savings that can be diverted to benefit elsewhere, but also increases patient safety and is a better service to patients. It also allows pharmacists and their teams to do the job they are there for. That, in itself, is somewhat liberating for members of the healthcare team, so it is very welcome.

I also felt that the Minister had given an extremely detailed and welcome introduction, so I will just focus on a few questions in that regard. The first is about pharmacists. Given the changes and the impetus on pharmacists’ professional judgments, will there be any extra training, checks, reviews or similar put in place? I talk about the review not just to ensure that it is doing the job; are there other innovations that we can welcome in SIs in the future? That would be a very positive outcome.

Turning to the matter of valproate, I, too, acknowledge the contribution of the noble Baroness, Lady Cumberlege, who undertook the independent medicines and medical devices review and identified this as a special case. Again, it is good to hear that be responded to. My question for the Minister here is about the exception, which, as he outlined, talks about where there is a risk assessment in place. To that point, where that exception exists, even if it is based on risk assessments and balances with the need to ensure that individuals take their medicine appropriately, it still potentially leaves some unquantifiable risk. With this in mind, what will be done to ensure that pharmacists receive the correct guidance and support to carry out risk assessments accurately? Again, how will this use of the exception be monitored and reviewed?

I turn to the impact assessment. There must be few Ministers who get an accolade for an impact assessment. I very much share the views expressed by the noble Lord, Lord Allan. I say to the Minister, in a serious way, that I hope this will be an example of good practice that we see across all SIs from all departments because it is clearly doable and the right thing to do. Indeed, it creates around the regulations a real statement of importance as well as application to making lives, costs and arrangements better. I really feel that the impact assessment supports what we are talking about; it is good to be able to say that rather than arguing about where the impact assessment is, asking why it is not thorough enough and saying that it is of no use to us. We are not saying that at all today. I hope that this will be an impetus for the Government to ensure that this is the standard.

I want to make a couple of points on impact. It would be helpful if the Minister could clarify what he feels the overall impact of this change will be on GPs. In this regard, I am thinking in particular about GPs’ capacity to handle these changes amid wider pressures. I ask the same question about pharmacists and pharmacy teams. Does the Minister expect any changes in how repeat prescriptions are managed as a result of this regulation, particularly with respect to in-patient appointments compared with online requests and the like? Will there be any requirement for additional in-person appointments to ensure that the implementation of this change is well monitored by GPs?

With that, as this is the last SI—certainly the last health and social care SI—for us to discuss before the summer, I wish the Minister, his officials, the Whip and all noble Lords a very enjoyable and happy Recess.

As ever, I thank noble Lords for their constructive comments and general welcoming of the proposals.

On the points made by the noble Lord, Lord Dodds, unfortunately, we do not have the power. It is one of those bizarre situations whereby the Windsor agreement enabled us to follow what is happening in the EU but, for other matters such as these, it requires the involvement of the Northern Ireland Executive and Northern Ireland Assembly where we instigate moves from this side. It is a concern; I am concerned. We have all welcomed the benefits here today as an example, but they are benefits that Northern Ireland obviously will not receive.

One of the things that I am responsible for in the department are the rule changes that are happening. It is a general concern in Northern Ireland. We will talk about this in the new year but there are some very exciting medicine developments, for instance point-of-care medicines. We see as one of the benefits that we can get on and move quickly in those areas. It is a concern that we may, again, have to do them as GB-only if there is no functioning Northern Ireland Executive and Assembly. I have met Northern Ireland Office Ministers to express this concern; they are aware of it. From their point of view, they are doing everything they can to try to get the Northern Ireland Executive and Assembly up and running, but I appreciate that these are complex issues. I know that that is not an ideal response but that is the position that we find ourselves in at the moment.

On the other points, I appreciate the welcome given to these regulations and, in particular, the impact assessment. I will directly, for the benefit of Hansard, thank the team for it. It is appreciated. As has been said, there is incredible attention to detail in it. I am impressed by the attention to detail shown by the noble Lord, Lord Allan; I wonder how he is going to occupy himself over the Recess without impact assessments. Seriously, these are a set of well-thought-out, sensible arrangements and, as has been said, are an exemplar of how we should be doing these things.

On the question about savings, my understanding is that they will be seen by pharmacists themselves and people in their stores. They will be getting paid and they will be keeping it in the system, so to speak. This will help their viability, which the noble Lord, Lord Allan, mentioned.

The point on extra training and checks is well made. I know that that is being kept under review. It is a good point that we need to make sure that it is diarised formally so that we can assess it, particularly in terms of risk assessment. How it was explained to me is that we are talking more about where a person has many medications so it is better for them to have a blister pack-type format and they may not be of child-bearing age so making sure that they can take the correct medicine each day outweighs the risk of side effects for an unborn baby. That is one of the examples that have been described to me of where a logical case can be seen.

Noble Lords might be aware that there is also concern about potential fathers taking valproate pre-conception and how that can have an impact. This is primarily a concern for women of child-bearing age but potentially for males as well, hence the suggestion about the packaging.

As ever, I will respond in writing, but I am not aware that this will specifically impact GPs because they will continue to prescribe in the same way. It will be for pharmacists to use their judgment to make sure that they round up or down for the packaging or dispensing, in the case of valproate in its original form. I repeat that I will write in detail but, off the top of my head, I do not think it will have an impact on GPs.

The wider point is that this should help pharmacists in a lot of their processes. The need to sometimes make judgment calls means that they will obviously need to apply a bit more intelligence but, on balance, we believe that those cases will be isolated enough to be outweighed by the benefits of whole packaging. In response to the points made earlier, that is exactly the sort of thing we should consider when we review it all. As the noble Baroness, Lady Merron, mentioned, the whole point is to free up some pharmacy time so that pharmacists can spend it where they want to on patient care.

I will happily follow up in detailed writing on all the questions. I thank noble Lords for their input; as ever, it was a very interesting debate. I echo the wishes for a happy recess; personally, I cannot wait. Although I will be doing a lot of hospital visits, as I mentioned, it will indeed be lovely. On that note, I commend the regulations to the Committee.

Motion agreed.

Committee adjourned at 6.26 pm.