Grand Committee
Monday 5 June 2023
Arrangement of Business
Announcement
Good afternoon, my Lords, and welcome to the Grand Committee. We are not expecting Divisions this afternoon, but if there is a Division in the Chamber while we are sitting, the Committee will adjourn as soon as the Division Bells are rung and resume after 10 minutes.
Packaging Waste (Data Reporting) (England) (Amendment) Regulations 2023
Considered in Grand Committee
Moved by
That the Grand Committee do consider the Packaging Waste (Data Reporting) (England) (Amendment) Regulations 2023.
Relevant document: 38th Report from the Secondary Legislation Scrutiny Committee
My Lords, these regulations were laid before this House on 20 April. The date of laying is the same as in the Commons.
These regulations amend the Packaging Waste (Data Reporting) (England) Regulations 2023. Since those regulations came into force, further engagement with stakeholders has brought to our attention two key issues, which these amendments seek to resolve. Along with these, we have taken the opportunity to pursue additional amendments that improve the clarity of provisions.
Let me turn now to the details of this instrument. These regulations introduce two key changes, but I can assure noble Lords that the changes being introduced are not a change of policy. First, this SI adds to the obligations of importers of packaged products or unfilled packaging. Erroneously omitted from the original statutory instrument, importers will need to report packaging which they import and subsequently dispose of without supplying onwards. It was always our intention to include this packaging in the regulations and, indeed, it is data which importers already collect and report under the current packaging producer responsibility scheme. We estimate that the amount of packaging this relates to is approximately 1 million tonnes, or about 8% of the total amount of packaging placed on the market each year in the United Kingdom. If this packaging were to go unreported, it would seriously hamper the proper functioning of the packaging recovery note system and would also lead to a distortion of the producer fees that will be payable under packaging extended producer responsibility.
Secondly, this amending statutory instrument makes changes that remove uncertainty around the definition of a brand owner. These amendments address two main scenarios, the first being where there is more than one brand name printed on the packaging—for example, a limited-edition chocolate Easter egg made by one brand that contains a toy made by a different brand. The amendments make it clear that it is the brand that first sells the packaged product that is responsible, which in this instance is the brand owner of the Easter egg, not the brand owner of the toy. The second brand scenario is where a single sales unit groups together multiple items from different brands. An example of this would be the Sunday Times wine box. The amendments make it clear that the brand which brings a number of other products together into a single product should be responsible only for the packaging it adds. In this example, the Sunday Times would be obligated for the carboard box, and the wine producers would be obligated for their wine bottles.
In addition to the two key areas I have discussed, the regulations also make several other changes, and I will now briefly discuss them. The amendments provide further clarification on the data reporting requirements for reusable and refillable packaging and simplify the reporting. As drafted, the regulations require producers to report if their reusable packaging was refilled at home or in-store. The amendments remove the need to describe the type of reusable system, which will reduce the data-gathering and therefore burdens on those producers.
However, key data will continue to be reported to inform policy development ahead of introducing new measures to increase the uptake of reuse and refill systems in 2025. This data is the amount of reusable packaging a producer has supplied and whether it is primary packaging. Primary packaging is the packaging which surrounds a product and forms a sales unit to the consumer—for example, a reusable plastic detergent bottle—whereas secondary and tertiary packaging are the items of packaging which businesses interact with and are typically removed before a product is sold to a consumer: for example, carboard boxes used for display purposes or pallets used in the distribution of products.
The changes will also allow producers that have instituted reuse systems to obtain a discount on their extended producer responsibility disposal cost fees where they have collected this waste packaging and sent it for recycling. The amendments also include minor corrections to the drafting of the data SI and fix some incorrect cross-references.
These amending regulations will apply to England only, but similar regulations are being progressed and amended, where needed, in Wales, Scotland and Northern Ireland. My officials have worked closely with the relevant departments in the devolved Administrations in the development of this legislation.
In conclusion, I emphasise that the measures in these amending regulations are crucial for enabling the effective implementation of extended producer responsibility for packaging and realising its associated environmental benefits. I commend these draft regulations to the Committee.
My Lords, I am grateful to my noble friend for giving us the opportunity to debate these regulations. I generally support them, but I have a couple of queries. One relates to the 38th report from the Secondary Legislation Scrutiny Committee, which refers to a submission from Green Alliance that questions how the offsetting set out in the regulations will work and how Defra will ensure that
“the ability to offset obligations will not create incentives for producers to recycle potentially reusable packaging before it reaches the end of its useful life, to avoid paying producer fees”.
It is important to point out that this is a very complex area of policy that the Government are trying to roll out.
I received a briefing from the Food and Drink Federation earlier this year on its concerns about extended producer responsibility, which forms the crux of these regulations and is explained in the impact assessment and the Explanatory Memorandum. The problem we face—as my noble friend is extremely well aware, having served, as I have, as an MP in the other place—is that every single local authority seems to have a different rule relating to how waste packaging is to be disposed of. There is then the problem of potential contamination, particularly if foodstuffs form part of the waste disposed of.
From the consumer point of view, it is a bit depressing to learn that, although hundreds of local councils collect household waste, each has different rules as to how it can be recycled, which bin to put it in and what consumers should do with their waste. Then they find that much of it is not recycled at all; it is incinerated. Years ago, when my noble friend and I served as shadow Ministers in the other place, I went on a visit to SELCHP—South East London Combined Heat and Power—which now is combined heat and power but at the time was not. It burned everything, but it did not do anything with the energy it could have recovered from the process. It was interesting to see that all the waste from Westminster at that time was not recycled; it was just burned.
The Food and Drink Federation has raised some very real questions, which I ask my noble friend to comment on in the context of extended producer responsibility. First, should we not have basic principles agreed at the outset by all concerned? That would include the producers of the packaging, the manufacturers of a product, the Government and the local authorities which are looking to recycle. Secondly, it asks: how should an extended producer responsibility be framed as it relates to local government, including the financing
“of potential stranded assets and management of existing local government contracts”?
How could those be managed as part of an agreed transition without hampering the development of what everyone wants to see: a long-term, world-class solution to enable the UK to reduce the cost and disruption of packaging?
Thirdly, the federation calls for “Partnership with industry” to bring about a producer-led extended producer responsibility that harnesses the considerable expertise arising from setting up these schemes all over the world. This would
“drive innovation and business growth while constraining costs”
that would otherwise
“lead to higher consumer prices”.
The example it gives is that of a biscuit wrapper, in which the flexible plastic used
“is specially designed to guarantee the freshness and quality of the biscuits in it. The companies that use this type of valuable, flexible plastic for biscuits and other food types need it back. But flexible plastics are neither collected nor recycled in the kerbside system today”.
Does my noble friend not agree that in a good end-to-end extended producer responsibility system,
“each biscuit wrapper thrown away should be collected and given a second life as part of a circular system, creating jobs and driving green growth along the way”?
That is my main concern, but the other concern the Food and Drink Federation has raised is the way in which the Government have created their producer-led scheme administrator. It seems to be different in this country from other models that have been used elsewhere. Why have the Government chosen the model that we have for extended producer responsibility?
While I support the regulations before us, there are obviously practical problems with the way they have been drafted. I think my noble friend said that these are amendments to previous regulations, which presumably came before the House as well. I realise that this is a complex area but it would be better, in one sense, to slow the process down and have regulations which are fit for purpose: for the consumer, so we know what we are doing when we dispose of the packaging; for the producer, so they know what they are doing when they create the packaging in the first place, and are held responsible for that packaging; and for the local authorities which collect and dispose of this packaging. I support the amendments but I would welcome my noble friend’s comments in this regard.
My Lords, I thank the Minister for his introductory remarks and welcome this SI, which is intended to reduce the amount of plastic packaging in circulation. This is long overdue and I look forward to seeing a lot less packaging from McDonalds, Kentucky Fried Chicken and other fast-food outlets littering our town centres and rural countryside.
The SI makes provision for the collection of data about plastic packaging ahead of the full implementation of the regulations in 2024. I will read out in full Paragraph 7.1 of the EM, because I will be referring to it later:
“Extended Producer Responsibility … for packaging will require producers to take responsibility for the environmental impact of the packaging they supply by obligating them to pay for the collection and disposal costs of this packaging when it becomes waste. This will provide a financial incentive for producers to reduce the amount of packaging they supply and to improve the recyclability of their packaging”.
Hooray—and not before time.
The regulations, and the need to collect and report the data on the plastic packaging used, apply to those businesses with an annual turnover of £2 million and above. But the de minimis threshold turnover is £1 million, at which level the data has to be collected but not reported. Can the Minister say why this is? What is the purpose of collecting the data if it does not have to be reported?
Defra conducted a consultation with industry on the implementation of these regulations twice: first, from February to May 2019, when there were 679 responses; and secondly, from March to June 2021, when there were 1,241 responses—nearly double that of the earlier consultation. The first consultation was a general one while the second was more detailed and outlined the proposals to require producers to report twice yearly in April and October, covering a six-month period; it could be that that detail is what generated the greater level of response.
The EM states that these regulations
“are expected to be in place for one year, after which they will be revoked and replaced by the Producer Responsibility Obligations (Packaging and Packaging Waste) Regulations 2023”.
This gives the impression—I could be wrong—that the SI we are debating is a pilot project to see how collecting the data goes before local authorities start to charge businesses for the collection of their plastic packaging waste. If so, can the Minister tell us whether we will debate the PRO regulations again next year? The EM also tells us that this change in the regulations will bring a further 1,823 businesses into scope. Can the Minister say how many businesses currently report their plastic waste packaging, or is this SI the first time this will happen?
I have said that I fully support this SI. However, like the noble Baroness, Lady McIntosh of Pickering, I have some issues with it. A major company that provides meals in trays to housebound people—apetito/Wiltshire Farm Foods—has contacted me. Many of its customers are over 85 years of age. Wiltshire Farm Foods operates a closed loop system for these food trays. It delivers meals to people in their homes and then collects the empty used trays, which are returned to the factory and recycled, to be refilled with relevant food and then used again. This waste is therefore not going into the kerbside collections. Wiltshire Farm Foods currently achieves a 50% recycling rate of trays, compared with a kerbside collection recycling rate of 38%; the noble Baroness, Lady McIntosh of Pickering, referred to the amount of kerbside collection that goes to incineration.
In answer to a letter from the chair and CEO of apetito, addressed to the Secretary of State, Minister Pow said:
“EPR will not allow for offsetting of packaging where it is collected by more than 75% of local authorities, as it risks reducing ‘system efficiency’”;
the Minister here has referred to system efficiency today. Minister Pow went on:
“If we incentivise producers to collect their own packaging, which we are also requiring local authorities to collect, that will reduce the efficiency of kerbside collections overall and therefore increase costs for producers. It will undermine that system, which will be a cornerstone of the whole triage”.
Surely that cannot be the rationale for this scheme. It directly contradicts paragraph 7.1 of the EM, to which I referred earlier, which states that the aim is to provide an incentive for producers to reduce the amount of packaging they supply and to improve the recyclability of their packaging. Under this scheme, the producers who are doing that are being penalised; I do not think that brand packaging, as the Minister called it, affects this. I fully support this SI but I cannot understand the logic of expecting a company that collects and recycles its plastic trays to pay the EPR fee, as though this was going into the local authority waste stream. This could result in vulnerable and low-income pensioners having to pay an extra £60 per year for their meals.
I am unclear whether the Minister’s earlier comments cover this issue. I requested a meeting with him about it but was told that Minister Pow is the responsible Minister, which I accept; that she has agreed to meet Wiltshire Farm Foods along with the policy director in Defra; and that this meeting is likely to be scheduled shortly. I am reassured by that response and look forward to hearing both that the meeting has taken place and that progress has been made. I am therefore happy to support the general principle of this particularly important SI.
My Lords, I thank the Minister for outlining the amendments to the data reporting regulations, which your Lordships’ House passed in February this year. As it is a sunny Monday afternoon and we are all rather relaxed after the recess, I will not be churlish but will congratulate the Minister and his department for listening to industry and bringing amendments this quickly. His Majesty’s Opposition support this and all measures that actively seek to promote better use of our natural resources and active recycling programmes. The establishment of correct base data is fundamental to the success of the associated schemes. However, I have a few questions for the Minister, which I hope he can assist us with.
While I appreciate that the SI is limited in scope to data collection to ensure that we have accurate facts and figures at hand for the imminent implementation of the extended producer responsibility scheme, there are substantive issues associated with the EPR itself. Can the Minister assist us with an update following news coverage last week that the food industry is seeking delays to the implementation of the extended producer responsibility scheme? Can he assure the Committee that the current timescale for implementation remains in place? Would the Minister also be kind enough to inform your Lordships of his department’s most recent engagement with both the British Retail Consortium and the Food and Drink Federation regarding the details of the scheme, given their public concerns?
Much debate in the other place focused on the potential impact of this new scheme on small businesses, many of which are facing other challenges at present. We appreciate that Defra has carefully considered the turnover and tonnage thresholds, and that the department has been running engagement sessions for producers, but does the Minister have anything new to say on information sharing and implementation dates?
These regulations also add the obligations of importers, which were
“Erroneously omitted from the original statutory instruments”.—[Official Report, Commons, Second Delegated Legislation Committee, 23/5/23; col. 1.]
Given that imported packaging makes up around 8% of that placed on the UK market each year, and that, by the Commons Minister’s own admission, not including this data would “distort the system”, how is it possible that Ministers missed this before now?
Among other things, this SI deals with reusable forms of packaging, such as bottles or containers that may be used to purchase household items at zero-waste shops. The Minister knows that questions have been raised, via the Secondary Legislation Scrutiny Committee, about the potential for offsets to incentivise the early recycling of reusable packaging, so that firms avoid paying producer fees. The department’s response has been published online, but could the Minister read a summary into the record?
These seemingly minor changes to the regulatory framework could have a further inflationary effect on our food prices when the EPR is implemented. Food inflation is running at 19.1%; if food manufacturers opt to pass the full costs of these regulations on to the consumer—a sum the BRC currently speculates to be in the region of £1.7 billion per annum—it will have further inflationary effects. In the middle of a cost of living crisis, it is therefore vital that we get this right.
I thank noble Lords for their valuable contributions to the debate. I turn first to that from my noble friend Lady McIntosh regarding her concerns about offsetting for widely recyclable, single-use materials that a producer collects for recycling. The packaging extended producer responsibility scheme will not allow for this material to be used to offset disposal costs, because it could risk duplicating existing collection systems, which would reduce overall system efficiency. In doing so, this would shift costs on to other producers.
On my noble friend’s wider concerns about the packaging EPR, we have listened to feedback from the industry very carefully and have amended our proposals following consultation. This has reduced the cost to businesses from an estimated £2.7 billion to £1.4 billion per annum. That addresses some of the wider concerns expressed about the impact this could have, and the last point made by the noble Baroness, Lady Anderson, about any inflationary effect, which I will address later.
We are committed to continuing to work closely with industry on the final design of the scheme and our delivery plans. Defra has set up a business readiness forum and a local authority forum in order to keep businesses, producers and local authorities up to date about changes. These groups have been meeting regularly since January this year.
The noble Baroness, Lady Bakewell, raised the issue of a de minimis. The collection and reporting of data by smaller producers is done to inform a review of whether the de minimis should be reduced in future years. She is absolutely right that this will need to be revisited by another statutory instrument next year as we see these systems bed in.
On the question raised by my noble friend Lady McIntosh about whether this is the right time and whether there should be a delay, I note that as part of the transition between the old and the new regulations, producers and compliance schemes may need to continue to comply with their 2023 obligations in respect of packaging placed on the UK market in 2022, which are determined by the 2007 regulations. It is planned that the data reporting regulations and the 2007 regulations will be revoked by the new Producer Responsibility Obligations (Packaging and Packaging Waste) Regulations 2023, which are expected to come into force towards the end of this year. The regulators will keep producers informed about compliance requirements as part of the transition from the 2007 to the 2023 regulations.
I really do recognise the concerns about the timing of this, but it is vital that we do not delay the scheme. We are working on implementing the packaging extended producer responsibility from 2024. In doing so, we are continuing to engage with stakeholders to ensure that the burdens of transitioning to this new scheme are minimised.
Local authorities will be able to collect dry recyclable waste streams together in circumstances where it is not technically or economically practicable to collect the waste streams separately, or there is no significant environmental benefit to doing so. Shortly, we will publish the government response to our consultation of last year, which will also confirm any exemptions to separate collection whereby local authorities can co-mingle recyclable waste streams in all circumstances. It is important to set this scheme in relation to other factors.
On whether this impact will feed through to household bills, we have to recognise that there is a huge cost to the taxpayer in the environmental impact of not recycling. The only way we can encourage more recycling is to know precisely what companies are doing, how they are using it and therefore how we can incentivise them to change behaviour. Huge benefits have been achieved by companies that have addressed this in what they do and made a virtue of it. We want to support them in this.
An important point was raised by the noble Baroness, Lady Bakewell, regarding Wiltshire Farm Foods and apetito. As she says, they do wonderful work in providing food for sometimes vulnerable people, and they recycle their trays in a closed-loop system. Producers will not be permitted to off-set their fees where the packaging in question is collected for recycling by more than 75% of local authorities. The key reason for this is that we do not want to incentivise producers to start collecting their own household packaging for recycling where that packaging is widely collected by local authorities. We want significantly to increase kerbside recycling through consistency and extended producer responsibility, and to do so in the most efficient and effective way. Potentially competing arrangements are unlikely to achieve this.
We also want to encourage producers to move to reusable packaging and reduce single-use packaging where possible. That is why we have included an exemption to this rule for any packaging that is being used as part of a reuse system—for example, reusable glass milk bottles.
I will speak to my honourable friend Rebecca Pow to make sure that she follows up on her agreement to have a meeting with Wiltshire Farm Foods or apetito, or both. I am sure that that is in the process of happening and I will make sure that it does.
With those few words, I hope that I have addressed the concerns raised today. I am grateful that noble Lords have indicated their willingness to accept this instrument. It will make crucial changes to the Packaging Waste (Data Reporting) (England) Regulations 2023. These changes will ensure the proper functioning of the packaging recycling evidence scheme and that fair producer fees are set that reflect the true amount of packaging that arises as waste in the UK. These amendments will also clarify the definition of a brand owner, ensuring that producers have confidence in where their obligations lie.
Finally, further amendments will be made through these regulations which will provide clarification on producer reporting as well as correcting minor inaccuracies in the drafting. I take the noble Baroness’s point, but we have listened to the points raised and reacted accordingly. I thank noble Lords for their support today and I commend these draft regulations to the Committee.
Before my noble friend sits down, may I just follow up? I am trying to understand what he said in response to the noble Baroness, Lady Bakewell of Hardington Mandeville. If it is a closed-loop system and the waste is not entering the general household collection system, surely, producers should be exempt and be allowed to have their own system. My noble friend seemed to answer the question by saying that if it is general household waste collection, they could not save more than 75%, but, if this is a closed-loop system, should they not be exempt?
My noble friend referred to the EPR regulations which will come into force later this year. Will we be given a similar chance to discuss them, in a similar forum?
On the latter point, I can certainly assure my noble friend that there will be plenty of opportunity to discuss them.
Producers will not be permitted to off-set their fees where the packaging in question is collected for recycling by more than 75% of local authorities. That assesses the type of packaging we are talking about and how it impacts local authorities. Where there is a closed-loop system, we think that is the right measure to take. The key reason for this is that we do not want to incentivise producers to start collecting their own household packaging for recycling where that packaging is largely collected by local authorities. We want significantly to increase the amount of consistent kerbside collections we are conducting and thereby create economies for these products where possible. It is really important that the case raised by the noble Baroness, Lady Bakewell, be brought to the attention of my ministerial colleague and officials so that we can talk through its impacts.
Motion agreed.
Animal By-Products, Pet Passport and Animal Health (Fees) (England) (Amendment) Regulations 2023
Considered in Grand Committee
Moved by
That the Grand Committee do consider the Animal By-Products, Pet Passport and Animal Health (Fees) (England) (Amendment) Regulations 2023.
My Lords, these regulations were laid before the House on 18 April. This instrument seeks to make amendments to the Animal Health (Miscellaneous Fees) (England) Regulations 2018 and the Animal By-Products and Pet Passport Fees (England) Regulations 2018 to ensure that there is no under-recovery or over-recovery of costs. These amendments do not contain any changes to policy or processes, only to the fees that the Animal and Plant Health Agency can collect on behalf of the Secretary of State in relation to statutory animal health services carried out by the agency.
The fees are designed to fund APHA’s front-line statutory animal health services for safeguarding animal health and supporting our domestic and international trade. These are: inspection of consignments and licensing of facilities involved in the trade of livestock semen, eggs and embryos; inspection and licensing of facilities involved in the handling, storage or incineration of animal by-products not destined for human consumption; inspection of live animals arriving from third countries at our border control posts; surveillance of commercial poultry flocks for salmonella; licensing and proficiency testing of private laboratories carrying out salmonella tests under our national salmonella control programme; and registration and approval of premises intending to export breeding poultry, day-old chicks and hatching eggs from Great Britain.
The proposed amendments also include the removal of the fees regime for pet passports, as APHA is no longer involved in the issuance of passports for the movement of pets to and from the UK and other countries. Following public consultation, new fees for these services were last introduced in 2018, with a commitment to businesses that fees would be reviewed biennially to ensure the charges and exemptions were appropriate.
Due to the agency’s focus of effort and resources on EU exit work, Covid and avian influenza, these reviews were put on hold and the fees for these schemes have consequently not been refreshed. As a result, businesses are being charged in a way which does not reflect full cost recovery for APHA. The schemes are failing to achieve recovery of their full costs, with a deficit of between £0.4 million and £0.5 million per year. This shortfall is currently being funded by the public purse.
Following the cost recovery principles of the Managing Public Money guidelines, APHA and Defra finance teams have developed a new fee schedule to deliver full cost recovery. No additional margins or profits have been included, and my counterparts in His Majesty’s Treasury have approved the approach taken.
The average increase to overall scheme fee income to achieve full cost recovery would be 51%. Given the substantive cost increases for some elements within the fee schedules, in designing this instrument we have balanced a proportional approach for businesses with the need to cover costs. We are proposing to follow the approach agreed in the 2018 consultation and apply a phased increase in fees over two years, with 50% of the fee uplift delivered in July 2023 and full cost recovery for the services delivered from July 2024. Border control post services are the exception to this phasing option. Here, we are proposing to increase fees and achieve full cost recovery from July this year. This will help us avoid any operational conflicts with changes that may follow the review of the new borders and boundaries fees process.
Delaying this uplift further would only increase the gulf between cost and recovery, and the impact of the changes would be even greater because of the impact of compounding factors such as inflation. APHA has continued to engage with business users and business associations on service performance and service fee schedules following the 2018 consultation, and these businesses are aware of the proposed new fee schedules and have engaged solely on service performance, rather than the fee increases themselves.
This statutory instrument applies to England only. The Scottish and Welsh Governments are following a similar approach, as APHA provides the same services to both Administrations. The Scottish and Welsh Governments have laid their own corresponding legislation. I commend the draft regulations to the House.
My Lords, I am grateful to my noble friend for presenting the regulations before us. First, can he explain when the last consultation was? He said that there had been a consultation in 2018. Paragraph 10.1 on page 4 of the Explanatory Memorandum refers to a consultation but seems to indicate that the last one was held in 2018, which is five years ago.
Secondly, these are huge increases. They are not 5% or 10%; we are looking at a 41% increase for the cost of animal by-products regulations, a 53% increase in the current fees of the animal health regulations, 65% for the animal health regulations relating to artificial breeding controls, and a more modest 21% increase for animal health regulations relating to the poultry health scheme. In the context of the general situation and the increases we have seen in public sector salaries, everyone balked at a 14% increase and 5% or 10% increases. I quite accept that, as my noble friend said, there has not been an increase since 2018, but these are huge increases. Can he put my mind at rest and say that there has been a more recent consultation with the industry, which is feeling fairly beleaguered?
Earlier, the noble Baroness, Lady Anderson of Stoke-on-Trent, referred to the cost of living crisis. What is becoming clear is that, while supermarket prices are going up, those increased costs are not being passed on to, for example, producers of meat and poultry. I am concerned. I realise that they are spread over two years but these are really big increases. If there has been a more recent consultation, I would be interested to know what the feedback from the industry has been in this regard.
My Lords, I thank the Minister for his introduction to this important SI, which wraps two previous SIs up into one and deals mostly with the levying of fees.
The Explanatory Memorandum indicates that the fees will use the actual
“cost to the agency and are not uplifted using inflationary rates”,
and that “no profit element” is involved. The noble Baroness, Lady McIntosh of Pickering, has already said very eloquently what a large increase there has been in these fees. The fees also cover seven different service areas provided by the Animal and Plant Health Agency, APHA, which is an executive agency of Defra. The fees have not been updated for some time, as the Minister said, with Brexit and Covid somewhat dominating the agenda.
Paragraph 7.3 of the EM gives details of how the costs will be calculated and the fees collected by APHA, stressing again that inflation will not be considered. I wonder whether this is wise. If there is no allowance for inflation, how will the true costs be calculated and passed on to those involved? An annual review—if not uplift—in fees is generally accepted in all other areas of life, so why not here? The Treasury requires, quite reasonably, that true costs be recovered. If there is no annual review of these fees and inflation is not to be considered, it is not going to be very long before a full-scale review is needed again. I would be interested to hear the Minister’s comments.
Paragraph 7.9 of the EM, relating to border control posts, indicates that documentary and identification checks will be conducted by authorised vets
“to prevent the introduction of diseases harmful to animal and public health”.
This is especially important. However, we have had debates over the years, especially since the advent of Brexit, about the availability of adequately qualified vets to conduct this inspection work. This type of work is not high on British vets’ “must do” lists. It is nevertheless extremely important that these border checks be conducted and carried out thoroughly. Is the Minister confident that sufficient trained vets are available to implement the necessary checks?
I note that, in the instrument itself, there is a category on page 7 headed “Animals not covered by any other category”. Can the Minister say whether this includes Camelids—that is, llamas and alpacas? If not, where are they covered in the instrument?
Lastly, the uplift in fees will be implemented over a two-year period, as the Minister said, with some this year and the rest in 2024. The cost will fall on businesses, charities and voluntary bodies that have not had an uplift since 2019. It is to be hoped that they will be expecting this uplift. Whether they have looked at the fees listed in the APHA section of the Government’s website is another matter; I did not find my search of that website a terribly rewarding exercise. None the less, I am happy to support this SI.
My Lords, I thank the Minister for his time today and for outlining the need for the changes laid out before us. This is a wide-ranging SI, increasing the fees charged by the Animal and Plant Health Agency for a range of services, from bovine semen controls to salmonella control programmes. While His Majesty’s Opposition of course support the enforcement of our agreed regulatory framework, I worry about steep and speedy increases in associated costs, as the noble Baronesses, Lady McIntosh and Lady Bakewell, have already referred to.
This SI provides for an average median uplift in fees of 41% for services related to animal by-products, 53% for services related to salmonella controls, 21% for services related to poultry health and 65% for services related to breeding controls. The Explanatory Memorandum notes that, due to a lack of uprating in recent years and the need to ensure cost recovery, these increases to fees are higher than inflationary rises. While we accept that the increases will be phased over two years, can the Minister understand that these are not the only additional costs that will be faced by many businesses? Given that the current rate of inflation is running at 8.7% and that some key agricultural inputs have increased by over 100% in the last 18 months, is the Minister convinced that this is the right time to see such stark increases in costs?
The Explanatory Memorandum also notes that regular reviews of the 2018 fees were put on hold due to “reviewed agency prioritisation” in light of Brexit preparations and the Covid pandemic, hence the need for a significant jump now. The document states that the responsible body
“had already engaged with key stakeholders for the businesses affected and are planning to re-engage”,
but no further information is offered. What form did the previous engagement take? What was the general response? When will the next round of engagement commence and what will that look like? Can the Minister also inform your Lordships when the next fees review will be undertaken, and can he give an assurance that we will not see a repeat of the issues that seem to have been encountered this time around?
Our agribusinesses are struggling, and additional and unexpected costs will not help. I worry that capacity issues at Defra, unquestionably due to challenges post Brexit and the pandemic, are hitting our sector at just the wrong time. I think your Lordships would therefore appreciate an update from the Minister informing us of how many more SIs on issues pertaining to the sector are delayed and when we should expect them. I look forward to his response.
I thank noble Lords who have contributed to this debate. As I described earlier, this instrument will maintain alignment of animal health inspection fees with the UK Government’s policy to recover the full costs of official checks essential to managing the risks arising from commercial activity.
My noble friend Lady McIntosh and a number of other noble Lords asked about consultation. A full public consultation was held between October and December 2015 to support the introduction of these fees, which came into force in 2018. As part of that process, a road map of two-yearly reviews of the fees was discussed with stakeholders. We have now established a process for charging fees based on this consultation, which follows option 2—to introduce fees with phased fee increases to achieve full cost recovery. This option had the widest support.
On advice from the better regulation team, and as we are still proposing the same methodology and approach as before, neither an impact assessment nor a consultation is required. We are uplifting existing fees only; there is no introduction of new fees. APHA has engaged with key stakeholders—for example, in the liaison group meetings with stakeholders and associations—and shared a detailed package of proposed changes. In August 2022 and again in March this year, letters and emails were sent to targeted stakeholders and articles were published on GOV.UK. An article published on GOV.UK in June last year informed stakeholders that:
“Any scheme uplift will be phased in over 2 years except BCP. As FCR wouldn’t be achieved until October 2023 the fees will not be reviewed for another uplift until 2 years after that. Therefore, with the exception of BCP, APHA wouldn’t be considering an uplift again until 2025 depending on the outcome of the review.”
The fees have not been uplifted for five years, so the gap between costs and income has been a burden on the taxpayer. The longer the fees are left unchanged, the more the gap will increase. APHA is spreading the increases over two years, except for BCPs. This is to give customers time to uplift their charges and make their own customers aware of the impending increase. APHA is required to fully recover costs for these services.
APHA can have statutory services only when the service is provided only by APHA and there is no alternative supplier for the customer. If there is an alternative supplier, the service should be charged as a commercial service. It is government policy that businesses benefiting from a service should pay the full cost of delivering the service rather than looking to the taxpayer to subsidise it.
I was asked why we are charging for some activities and not others. We can charge only for services that have primary legislation and allow fees to be collected. Several statutory services undertaken by APHA have a commercial benefit to their users. Decisions on which primary legislation powers to use and which services to start to charge for are based on several criteria, including the cost-effectiveness of fee recovery, availability of data and the impact on the end-user.
The fees are calculated on a whole range of different categories, including the proportion of payroll costs, non-project costs, notional charges and depreciation. Payroll costs include salary, overtime, national insurance contributions, pensions, bonuses and allowances. Non-project costs include the costs required to support the staff in performing the chargeable work: staff support, consultancy, operating consumables, training, information and communications technology, outsourced vet expenditure—a point raised by the noble Baroness, Lady Bakewell, which I will come to—and other overheads. The charge-out rates used for calculating the fees are service delivery only. Therefore, the specific costs relating to the science division work are excluded from the costs apportioned across the staff’s production hours. Our approach is in line with the duty to manage public money by demonstrating a clear timeline to the introduction of full fees. That is an accepted method across government.
The noble Baroness, Lady Bakewell, asked about vets. There is a shortage of vets in APHA. Attempts to solve this matter fill my mind, and I am working with the royal colleges and the new veterinary schools, as well as with the Home Office to make sure that the English language requirements for vets from overseas are being fulfilled. We are doing this through the “one health” agenda, making sure that we are not denying people in other countries the veterinary coverage they need but working with them to try to make it a fair system.
The noble Baroness asked about camelids. The requirement to collect fees for bovine and porcine semen approval is a statutory requirement set out in domestic legislation for those species. The APHA fees and charges team is looking at extending those fees in the workstream 2 new fees phase. The animals being reviewed as part of that workstream include deer, goats and sheep. The animals being reviewed are farmed livestock bred for furs or skins, for entering the food chain or for working the land. Horses and camelids will not be reviewed as part of workstream 2. I hope that answers the key point that the noble Baroness raised.
The noble Baroness, Lady Anderson, asked about the level of engagement. I hope I covered that in my comments on the ongoing work that APHA and Defra are doing with the key groups, making sure that it is not just them and that they are discussing it with their customers, because this undoubtedly will have an impact on them.
As I have outlined, the regulations ensure that UK government policy for full cost recovery for our animal health services is maintained and that the costs of providing these services are met solely by businesses using them. With that, I hope I have covered all the points raised and I commend the draft regulations to the Grand Committee.
Motion agreed.
Strategic Highways Company (Name Change and Consequential Amendments) Regulations 2023
Considered in Grand Committee
Moved by
That the Grand Committee do consider the Strategic Highways Company (Name Change and Consequential Amendments) Regulations 2023
Relevant document: 38th Report from the Secondary Legislation Scrutiny Committee
My Lords, these draft regulations were laid before Parliament on 24 April. They make consequential changes to five pieces of legislation to reflect the change in name for the strategic highways company from Highways England to National Highways.
The change in name was announced in August 2021. National Highways has completed a range of administrative, legal and digital changes to implement its name. The name National Highways better reflects the company’s focus on delivering the Government’s roads investment programme while continuing to set highways standards for the whole of the UK. It also makes clear the distinction between local roads, which are the responsibility of local authorities, and the strategic road network, for which National Highways is responsible.
The legislation to be amended was identified by a legal analysis of the almost 100 references in legislation to the previous name, Highways England. A large number of references do not require amendment. These are development consent orders or other local orders that are similar in nature, such as traffic orders. These orders often do not have an express expiry date but are of limited application and cease to have any practical effect once an action or development is complete. Most of these entries reference National Highways’ company number, which also further reduces any risk.
As a result, just five pieces of legislation were identified for amendment via this SI. They are where there is the most risk of ambiguity or confusion arising over time, should the old name remain. The legislation is as follows: first, the Appointment of a Strategic Highways Company Order 2015; secondly, the Infrastructure Act 2015 (Strategic Highways Companies) (Consequential, Transitional and Savings Provisions) Regulations 2015; thirdly, the Equality Act 2010; fourthly, the Equality Act 2010 (Specific Duties and Public Authorities) Regulations 2017; and, finally, the Local Transport Act 2008.
Where possible, the amendments will future-proof the legislation against any future name changes that may occur. This is being done for three of the five pieces of legislation being amended by inserting a reference to:
“A strategic highways company appointed under section 1 of the Infrastructure Act 2015”,
instead of a potentially time-limited reference to National Highways.
To conclude, these draft regulations will make consequential changes to a small number of references to Highways England, identified by a legal analysis as those most at risk of ambiguity or confusion over time. Where possible, the amended wording has been future-proofed. I beg to move.
My Lords, I am grateful to the Minister for introducing these very interesting draft regulations. I have a few questions to ask her, which I am sure she will not be surprised about.
The main question is: how much is this change going to cost? It obviously has costs in regulation time, but I imagine that there are signs all around the network saying how clever the Highways Agency is. It will have to have new signs there and on much other documentation, so it would be nice to know how much all this is going to cost.
My other main question relates to the purpose of changing the name of the Highways England Company to National Highways. Which nation are we talking about? Is it the United Kingdom of Great Britain and Northern Ireland? Is it Great Britain—in other words, England, Scotland and Wales? Is it England and Wales, or what? There seem to be one or two differences in the references in the Schedule referred to in these regulations.
There is a proposed change to the Local Transport Act 2008. It says,
“for ‘Highways England Company Limited’ substitute ‘a strategic highways company appointed under section 1’”.
It says “a” highways company, so will there be other highways companies? Will the Welsh Government have their own highways company and regulations? Apparently, under Section 133 of the Local Transport Act, it applies to England and Wales. I would have thought that some people in Wales might be rather unhappy if we had an English national highways authority or something applying to them. Under Section 217 of the Equality Act, which is also referred to in these regulations, it applies to England, Wales and Scotland. I do not know what the Scots will be thinking about it, but my concern is why, in some of these changes, we are talking about “a” strategic highways company, indicating that there might be more than one.
Finally, the Infrastructure Act 2015 (Strategic Highways Companies) (Consequential, Transitional and Savings Provisions) Regulations 2015 say that
“‘the company’ means Highways England Company Limited, a company limited by shares and incorporated in England and Wales under company number 9346363”.
Will that change with a new company? Will it have the same number? I am sure the Minister has answers to all these things, as well as the cost, so I look forward to hearing from her. If she does not, I am sure she would like to write to me.
My Lords, on the face of it, this secondary legislation is simple, reflecting a name change that took place in 2021, when Highways England Company Ltd became National Highways Ltd. It is a simple change, but one that raises a number of questions, some of which the noble Lord, Lord Berkeley, has raised. I hope that the Minister will be able to answer my questions as well.
I thank the Minister for providing an updated Explanatory Memorandum in response to the issues raised in the 38th report from the Secondary Legislation Scrutiny Committee. The updated EM attempts to explain the rationale behind the name change and gives details of the costs incurred, both of which are welcome, although the rationale for the name change is rather weak.
The Secondary Legislation Scrutiny Committee encourages us to take the opportunity to ask the Minister to explain the choice of the new name, which it finds unclear
“as the ‘National Highways’ remit does not extend to Scotland, Wales or Northern Ireland”.
It is all very confusing, as the other great piece of national infrastructure, National Rail, does refer to England, Scotland and Wales. It leaves me and my tiny mind feeling rather confused.
I am concerned about the second sentence in paragraph 7.2 of the Explanatory Memorandum, which says:
“The strategic road network plays a key role by connecting England’s regions and providing the most heavily used cross-border routes between England, Scotland and Wales. The name signalled a new era for the company and recognises the role it plays in ensuring national connectivity”.
I am looking for assurances from the Minister that National Highways will not claim responsibility for cross-border routes within Wales and that the responsibilities and powers of the Welsh Government will not be challenged.
I have two final short questions. First, given that the new name came into being in 2021, why has it taken so long for this SI to come before Parliament? Secondly, I recognise that we are dealing with a fait accompli and that there is nothing we can do about the SI, but what would have been wrong with calling the new organisation National Highways England? At least that would have made it clear that the body had responsibility for the nation of England, not the nation of the UK. I look forward to the Minister’s response.
My Lords, I am grateful to the noble Baroness and noble Lord who have contributed to the debate, and to the Minister for her clear explanation, at least of the purpose of the regulations. On the face of it, as the noble Baroness, Lady Humphreys, said, this is a fairly straightforward process of updating a number of pieces of legislation with the current name of National Highways, and we would not want to object to the statutory instrument from that point of view.
However, I pick up on some of the questions that have been asked previously but on which I could not trace any detailed answer from Ministers in the other place or your Lordships’ House. First, my noble friend Lord Berkeley referred to the change from Highways England and set out some of the confusion that might arise because different descriptions are used in different pieces of legislation. In different countries of the UK, different names apply. That is very confusing. The noble Baroness, Lady Humphreys, also referred to that. It seems blindingly obvious to me that National Highways England would have been a better name. She also referred to the rationale for the change being rather weak. I agreed with that when I read the explanation.
The Secondary Legislation Scrutiny Committee suggested that the Minister may wish to explain the name, given that “national” is confusing for an organisation focused on only one nation of the UK. I hope the Minister will give us a full explanation so that we can all understand how it applies to different pieces of highways legislation that reflect different parts of the UK.
Secondly, it was my experience in local government that the new name of the agency is not commonly known, resulting in the term Highways England still being in very common usage. Do the Government intend to do anything further to communicate the change of name once the situation between the four nations has been clarified?
The regulations have the stated aim of future-proofing the legislation against any future name changes. Does the Minister have any plans to update other legislation to future-proof against potential name changes of other bodies? We have heard a couple of suggestions: we might have National Highways Wales or National Highways Scotland. Your Lordships will appreciate that I ask this question because we all know that name changes and subsequent rebranding come at considerable cost. The Minister referred to digital, legal, administrative and communication costs, and so on, and my noble friend Lord Berkeley also referred to them.
Lastly, I note that the Minister said that road traffic orders will not be changed. Presumably, this means that local authorities need have no concerns about any legal challenges that might arise as a result of the fact that the name of the agency has now changed. Those are my questions; I thank the Minister.
My Lords, I am enormously grateful for noble Lords’ contributions in this brief debate on this statutory instrument. I will do my best to answer their questions and perhaps address some of the ideas that have come forward in this Grand Committee about other names that might have been used; I am afraid that I do not agree with noble Lords there.
I turn first to cost, which was mentioned by the noble Lord, Lord Berkeley. National Highways met the cost of the name change from within its budget and kept costs to a minimum. There has been no “big bang” rebranding, as there was never intended to be and there does not need to be. Existing items and assets such as uniforms and fleet vehicles will continue to use the old branding until they reach their end of life. We estimate the total cost of the change to be around £312,000.
The noble Baroness, Lady Taylor, asked whether it matters that this change is not commonly known. From my experience in my several years as Roads Minister, it is becoming known and will feed out into the system. It is not the end of the world if somebody calls National Highways “Highways England”. Indeed, this leads back to the rationale for this statutory instrument. It does not bring about the name change; the name change happened at Companies House.
The noble Baroness, Lady Humphreys, talked about a new organisation. There is no new organisation. Exactly the same organisation exists, with exactly the same company number as exists in many long-term contracts and other such things that are held by the organisation. I assure the noble Baroness, Lady Taylor, that things like TROs—traffic regulation orders—DCOs and other local orders will continue to be valid.
Basically, the legal assessment is that it is clear from Companies House that the name change has been made. Let us project ourselves 15 or 20 years down the road to when some of your Lordships—including me—are perhaps no longer in our roles. People might say, “Hang on a minute, what’s this Highways England?” That is why we are doing this; it is for many years hence rather than for now. We do not believe that there is any significant risk of there being legal challenges because the name change sits in Companies House and will say “formerly known as Highways England” there. So that exists, but one never knows what will happen in the future.
I turn back to the rationale for doing this, which brings in many of the questions asked by the noble Lord, Lord Berkeley—indeed, by all speakers. Noble Lords asked, “Why did you do it? Surely Highways England does England”. That is not right, which is the point that we were trying to get across in the Explanatory Memorandum and that I tried to get across in my opening remarks. National Highways does a large number of things and is hugely respected. It has a different remit in different pieces of legislation. However, it does an awful lot of non-statutory work as well.
For example, I am perfectly comfortable calling National Highways “national” because it develops highway standards that are used across the UK. It is leading the way on the delivery of greener roads; that information is used by all parts of the UK. It is also developing road infrastructure standards for the connected and autonomous era, which refers to self-driving vehicles. Again, that sort of work will be used throughout the UK. I am not suggesting at all that, any minute now, National Highways will take over the strategic road network—or anything else—in Wales or Scotland. I am saying that what it does and has done for a long time is work closely with the devolved Administrations to ensure that we do not have completely different standards in different parts of the United Kingdom because, clearly, that would not be particularly positive.
Again, this is all about collaboration when it comes to strategic roads, which do not end at a specific border. It is the case that the A1 switches over to Transport Scotland as it crosses the border but that does not mean that we have to dismiss the work that National Highways does in many other really important statutory and non-statutory areas and suddenly get a bit funny about the name. That is why “National Highways England” does not work. It is not about just England; that is the whole point.
As I have explained, there is no change to National Highways’ remit or Welsh devolution and no new organisation. The only thing that is new is the name. We are bringing this measure in purely so that, many years down the track and in the mists of time, people do not get confused when they look at something that says “Highways England” and wonder. We just want to make sure that that is not the case.
There are two pieces of legislation that we have been unable to future-proof. Should National Highways change its name again—I very much hope that it does not—those two pieces of legislation would need to be amended. However, as I say, I suspect that the chances of that happening are relatively limited.
Before the Minister sits down, can I ask about the questions that we raised on Scotland and Wales? Will National Highways have a different remit in those nations of the UK? I understand the point about it doing certain things across the UK—the Minister mentioned highway standards, greener roads and infrastructure standards—but it will presumably have different roles for the management of roads in Wales and Scotland than it has in England. That is where confusion is likely to occur. Will we end up having more secondary legislation that clearly sets that out?
It has absolutely no role in the management of roads in Scotland and Wales. It never has had and never will have. I commend this instrument to the Committee.
Motion agreed.
Medical Devices (Amendment) (Great Britain) Regulations 2023
Considered in Grand Committee
Moved by
That the Grand Committee do consider the Medical Devices (Amendment) (Great Britain) Regulations 2023.
Relevant document: 38th Report from the Secondary Legislation Scrutiny Committee (special attention drawn to the instrument)
My Lords, I am grateful to be here to debate these important regulations. Plasters for a scraped knee, blood tests that detect cancer, pacemakers, pregnancy tests and software that calculates insulin doses for people with diabetes—medical devices are used by millions every day.
The MHRA regulates medical devices in the UK, helping to ensure that these products are safe and perform as intended. Today, almost 2 million different medical products are registered with the MHRA for use in the UK, of which an estimated 500,000 different product types are regularly used in the NHS. The past few years have been a time of great change for medical devices. The Covid-19 pandemic saw big advances in the life sciences and diagnostics sectors.
This instrument is intended to give the medtech sector additional time to transition to our post-EU exit regime for medical devices. It extends the time during which manufacturers and importers can place CE-marked medical devices on the Great British market.
Since January 2021, manufacturers wishing to place a medical device on the GB market have been able to follow either the post-Brexit UK route and use a UKCA mark or the EU legislation and use a CE mark. Without this SI, this flexibility would cease on 30 June this year, with only the UKCA route available. This will impact an estimated 11,000 businesses that have registered medical devices with the MHRA with a CE mark only. These regulations will allow industry the flexibility to use either mark on medical devices for longer.
Continuity of supply is key and we recognise that the industry needs more time to prepare to transition. Without it, manufacturers of medical devices without a UKCA mark would have to stop supplying their products in GB from this July. This could mean some patients losing access to the devices that they need. I make it clear that this instrument has no impact on medical devices already on the market with a UKCA mark.
I will now take a moment to summarise the key changes. First, the instrument provides that medical devices compliant with the EU medical devices directive or EU active implantable medical devices directive with a valid declaration of conformity and CE mark can be placed on the GB market up until the expiry of the device certificate or 30 June 2028, whichever is sooner. Secondly, in vitro diagnostic medical devices, or IVDs, that are compliant with the EU IVD directive can be placed on the GB market up until the expiry of the device certificate or 30 June 2030, whichever is sooner. Thirdly, medical devices and IVDs, including custom-made devices, that are compliant with the EU medical devices regulation or the EU IVD regulation can be placed on the GB market up until 30 June 2030. This is in keeping with the Government’s response to the consultation on the future regulation of medical devices, which ran from September to November 2021.
I thank the SLSC for its thorough review of this instrument. The committee raised with the MHRA the important practical concern of whether firms will be incentivised to seek UKCA certification at an additional cost if CE certification is still accepted. Since January 2021, it has been possible to use a UKCA mark on medical devices. In the year ending March 2023, an estimated 9% of new medical products—around 71,000—were registered with the MHRA with UKCA marking, despite CE marking being an option.
Manufacturers will be prompted to consider shifting to using the UKCA mark through the transition period, including as their CE certificates expire. To transition to the UKCA mark, many manufacturers will need to use a conformity assessment body approved by the MHRA. The capacity of these approved bodies is currently limited. The MHRA is working proactively to build approved body capacity to allow a smooth transition to the UKCA mark. The agency engages regularly with the medtech sector and will continue to do so as it develops a future regime.
By supporting these regulations, we can help ensure that patients and the wider public benefit from continued access to quality, safe medical devices; that the UK remains an attractive market for manufacturers of medical devices; and that the wider medtech industry has adequate time to prepare for the transition to the future regulatory framework for medical devices. I commend these regulations to the Committee.
My Lords, I thank the Minister for his explanation of the statutory instrument. I do not oppose it at all, although the fact that the Government are doing it seems to reflect the serious lack of preparation and planning for the post-Brexit world in which we now exist.
I have two points to put to the Minister. The first is in relation to the 30 June 2030 cut-off date for the sole use of UK conformity assessments for medical devices placed on the market in Great Britain. My understanding is that the transition timelines to 2030 are causing significant confusion for companies, especially SMEs in the health tech and medical devices sector. I refer noble Lords to paragraphs 7.6 and 7.7 of the Explanatory Memorandum in particular, which begin to explore some of the complexities. I say this to the Minister: a clear timeline would be very helpful in giving clarity and certainty to companies.
My second point picks up the point that the Minister made right at the end of his opening speech about the MHRA’s capacity and its plans to reform the current regulatory system. I pay tribute to the MHRA’s work and am sure that it will rise to the challenge but the plan includes proposals
“to reclassify products, to increase information gathered at the point of devices’ registration, to strengthen post-market surveillance requirements to ensure better incident monitoring reporting and vigilance, and to introduce alternative routes to market”.
I can see the reasons for this, of course, but additional regulatory burdens for industry to supply the UK may mean that manufacturers will not bother and will focus on the EU and other larger, certainly more valuable, markets. The number of products made just for the NHS is very small indeed.
The Minister will be aware that the Chancellor talked in the Budget about the rapid, almost automatic approval of devices approved in markets such as the US. Is the MHRA signed up to this? It seems essential to build on current product recognition routes from the EU and rapidly explore building a UK product regulation equivalence route for the approval of medical devices to include other trusted jurisdictions, such as the US, for a greater proportion of products. I would be grateful if the Minister could comment on this.
I now come to the very serious capacity and capability constraints. Clearly, the MHRA has suffered from the reduction in its funding, especially on the devices front. I hope that the Minister will be able to say what is being done to improve it. Also, what philosophy will the MHRA adopt in future? Will it continue to oversee the regulatory process in relation to devices or will it take a more expansive, more centralised and certainly more expensive FDA-style approach, with the attendant recruitment challenges that that brings? It has been announced that one of the MHRA’s senior executives, Dr Laura Squire, will focus on devices and that there is a recognition of skill shortages but I cannot begin to overestimate the problem for UK companies if, in meeting the target that the SI now sets, they find that one of the major problems is a lack of capacity in the MHRA to provide the necessary speedy regulatory assurance that is required.
This comment can generally be made about the post-Brexit arrangements as a whole. If, by “taking back control”, the Government mean that they are serious about developing a new regulatory regime that serves the public interest and is effective in attracting industry to this country, they really must ensure that the regulatory system is both fast and effective. This is the major issue that must lie behind this SI.
My Lords, I will speak about the medical devices issues in these regulations. I thank my noble friend the Minister for introducing them. To some extent, I share some of the concerns expressed by the noble Lord, Lord Hunt of Kings Heath. He and I will recall our debates on what is now the Medicines and Medical Devices Act 2021, which provides the power under which these regulations are being made. When the new medical device regulations are laid, we will look very carefully at the extent to which they reflect the considerations put into Section 15 of the 2021 Act, which are about not just the quality, safety and availability of medicines but the ability to support both clinical research and the supply and manufacture of medical devices in this country.
That latter point bears directly on this statutory instrument, which is helpful in that respect because it extends the transitional period. This will create an opportunity for manufacturers based in or exporting to the United Kingdom to supply medical devices here. They will be able to adapt to the changes in the regulations that are yet to come—we do not know when. My noble friend might like to tell us a bit more about that timing since, in a sense, extending the transitional period is all very well but you have to kick the transition off. We need our regulations to be in place in order to see how significant the differences between the existing regulations and the future ones are and how different our regulations are from those that apply in the European Union.
I will make a general point, on which I know my noble friend can say little at this stage. When we debated medical devices regulation and initially agreed that we would accept the UK CE marking for a period of time, there was always a question as to whether it made much sense to disapply the UK CE marking and when to do so.
We have to think about this very carefully. We are now extending the transition to 2028 or 2030. Between now and then, I hope we can get our regulations in place and enter into a review of the trade and co-operation agreement. One of the objectives of the TCA really ought to be for the United Kingdom and the EU to agree more by way of mutual recognition of conformity assessments. Back in December, at the Trade and Technology Council with the United States, the European Union initiated work to look at further mutual recognition in areas such as pharmaceuticals and medical devices. We are increasingly moving to a point where the greatest benefit to patients and public health would be progressive harmonisation of regulation and mutual recognition of conformity assessments, whereby approved bodies from around the globe are able to do them to similar high standards.
This brings me to the point that the noble Lord, Lord Hunt, made very well. There is an important capacity in the Medicines and Healthcare products Regulatory Agency. I remember that, at the end of the pre-Brexit period, the MHRA was undertaking 40% of assessments for high-risk medical devices for the European Union as a whole. Notwithstanding the quotation from the Chancellor of the Exchequer, we do not want to arrive at a point where we are receiving or are the beneficiaries of other people’s assessments; we want to maintain the capacity to do them here. As things stand, that will not happen in a market that is relatively small, with a UKCA marking system that is correspondingly modest in scope.
If, through mutual recognition, we can arrive at a position in which UK-approved bodies can be notified bodies for EU purposes, it will make an enormous difference. At the moment, we have a one-way street: until 2028 or 2030, we will be giving UK CE marking recognition here but the EU will not do the same for us. An important objective of our renegotiation must be that we secure recognition of our marking.
That will solve everybody’s problems. The EU has had repeated delays in the implementation of its medical devices regulations, the principal reason for which is the lack of capacity in its notified bodies. We do not have the capacity that we require either. I am not entirely sure how many we have at the moment; I am told that there are four approved bodies in this country. However, until our draft regulations are published, we do not know to what extent those approved bodies feel themselves ready to provide UKCA markings for these new regulations.
Either way, both we and the European Union would benefit from the ability of providers in both the United Kingdom and elsewhere in Europe to operate both UK CE and UKCA, and for things like technical assessments to be interchangeable between the two. We are using EU technical assessments to some extent, and we want to maintain the capacity of this country to do the high-quality technical assessments we have done for many years, and for them to be incorporated into UK CE marking as well UKCA marking.
I hope that my noble friend will at least say that we have not abandoned the objective to arrive at mutual recognition of conformity assessments and that the transition will literally buy us time, and that we register the great advantage it would be if we used that time to arrive at mutual recognition in the future.
My Lords, these Benches also welcome the Minister’s introduction to this statutory instrument. I am starting to get used to being presented with a statutory instrument and told, “You can either support this or the sky could fall in on the heads of some part of British industry tomorrow”. It is a fairly straightforward choice: of course we support the statutory instrument going ahead to allow the medtech sector a little more breathing space.
A number of questions have already been touched on about where we are going. The first is a specific one. The MHRA has said that the start date for the new UK regime is 1 July 2025, after which, as I understand it, no new devices with CE marks will be recognised. The existing ones will roll over, as we are discussing today, but post 1 July 2025, any new devices coming onto the market will need the UKCA mark. I have had representations from people in the industry who think that that is what the collective information they have received means, but it would be helpful if the Minister could clarify that: that after 1 July 2025, the new UK regime is in place and new CE marks will not be recognised after that date.
The second question is one correctly raised by the noble Lord, Lord Hunt: where the capacity to carry out the assessment will come from. Of course, the will is there, but what if the staff are not? The Minister is used to discussing in this House staffing across all different aspects of the health sector. This is another aspect where specialist staff will be needed. I am particularly mindful of the Minister’s introduction, when he talked about the important role of software now in medical devices, many of which are software controlled. That is a specialist and high-value area, and it is important that we get some assurances that there will be the capacity, or the Government have a path to developing the capacity, to have people who can do the approvals, particularly of sophisticated software-controlled devices and—dare I say it—flavour of the month, artificial intelligence-controlled devices, which will be embedded in future. Again, that is a very high value, specialist function. MHRA will need to have the capacity to certify devices that use artificial intelligence and other sophisticated forms of software.
The third question is a very specific one about class 1 low-risk devices, which, as I understand it, are things such as wheelchairs and stethoscopes. Again, it would be helpful if the Minister clarified what is intended here and how they fit into the transitional scheme that is being extended today.
The fourth question is about labelling. It would be really helpful for people in our medtech industry who are seeking to export to understand how labelling will work, and specifically in the context of the Great Britain/Northern Ireland question. The Minister referred to medical devices for the Great British market. There is an issue of intonation here: is it the “great British” market or the “Great British” market? I think in this case it is the latter: the market of Great Britain, not Northern Ireland, because of the arrangements we have there. It is really important that people who are making devices understand how labelling will work, particularly if they are selling devices across the island of Ireland, where they are in the Northern Irish and Republic of Ireland markets, but also exporters more generally.
The final issue I think is interesting is information-sharing and government distributing information to the sector. Paragraph 12.4 of the Explanatory Memorandum says that there will be
“some costs for the industry associated with familiarisation with the regulations”.
I think it is much bigger than that, and the noble Lord, Lord Lansley, was quite right: the industry needs to understand the direction of travel, particularly around convergence/divergence. The sector, which, as the Minister rightly said, is an important one in the United Kingdom as a whole—not just in Great Britain, in this case—is in a very different place and needs the information now that will enable it to plan. For example, if a UK-based entity will in future be trying to conform to two very divergent regimes in the EU and Great Britain, it may well want to structure accordingly. It might want to have separate legal entities in the EU and the United Kingdom. The situation would be quite different if the message the Government are giving is that there will be the kind of convergence the noble Lord, Lord Lansley, talked about, whereby approvals might be transferable.
The sector needs to make those kinds of decisions quite quickly. We are talking about an extension of the CE mark to 2030 but, as I said in my opening question, we are talking about the new British regime kicking in in 2025. That is not far away in business terms, so it is extremely important that we get some clarity from the Government—to the extent that they can give it—about the future direction of travel and whether they hope for or aspire to a regime of mutual recognition or instead anticipate that it would be quite divergent.
We need information not just about the technical details of what these regulations mean today but about the direction of travel and how approval processes may be changing over time, which is important. As I said, we will not oppose a statutory instrument that needs to be in force by 1 July to stop the sky falling on people’s heads, but I hope the Minister will take this opportunity to answer some of the questions that people building businesses in the United Kingdom and elsewhere need answers to in order to get essential devices. That kind of information would help them to plan and be most effective in supporting patients.
My Lords, I thank the Minister for introducing the SI and other noble Lords who have spoken today. Those of us involved in the somewhat tortuous passage of the Medicines and Medical Devices Act 2021, and subsequent SIs designed to bring about the transition from the previous, easily understood CE assessment under EU legislation to the UK conformity assessment marking system for medical devices, knew and predicted that the new and complex system needed much more time to develop the new arrangements and work out how they would work, and that the deadline set by the Government for transition would inevitably have to be extended. This last-minute SI fully recognises this, although many questions and issues remain unclear, as we have heard.
Given the complexity of the assessment marking system and what is proposed in this SI, I thank our Secondary Legislation Scrutiny Committee for setting out concise reasons, which were clearer than the SI’s Explanatory Memorandum, about the key points of what the SI seeks to do and why the seven-year extension for some medical devices is needed. On the reasons, the committee says:
“The extension is partly in response to a Europe-wide shortage of assessment capacity for these and other goods and also due to the Medicines and Healthcare products Regulatory Agency’s intention to strengthen the future regulatory framework for medical devices … in a way that both improves safety while also enabling innovation”.
I would be grateful if the Minister could comment on the Europe-wide shortage and the impact that it is currently having.
We have seen today that nobody is at all clear about what is going to happen, when the work and the timelines for MHRA’s new framework will be ready and when the extensive reform that will apply from 2025 will be published. I look forward to the Minister’s explanation of what paragraph 7.3 of the SI Explanatory Memorandum anticipates are the steps the MHRA will take
“to build approved body capacity to meet the demand for UKCA … marking”—
to which a number of noble Lords referred—in order to achieve the capacity when the transition periods after 2025 expire for the relevant medical devices. The capacity covers in particular the ability to assess higher-risk medical devices which we are not yet in a position to assess.
Paragraph 6.9 of the memorandum refers to the MHRA’s intention to lay “further instruments” under the MMD Act and “significant amendments” to regulations. Can the Minister update the Committee on the proposed timetable for this? Is the consultation exercise undertaken last year still under consideration by the MHRA as part of its developing policy? Will a further consultation on the MHRA’s new framework proposals be undertaken and, if so, what is the timescale for this?
The SLSC points out that the MHRA’s plans for reform are extensive. My noble friend Lord Hunt referred to them: reclassifying products, gathering information at the point of registration, strengthening surveillance, better incident reporting and so on. The committee stressed that these are excellent aims, but how and when the MHRA will achieve them—or try to—remains unclear.
The SLSC also refers to the MHRA’s current slow progress: it still does not have estimates of the total number of registered medical devices that are UKCA rather than CE marked. Of the 789,581 new medical products that were registered with the MHRA between April 2021 and March 2022 only just over 9% were UKCA marked. Is the Minister confident that this rate of progress will enable the MHRA to have a proposed new scheme in place in 2025 for transition to 2030?
Since the MMD Act, noble Lords have expressed serious concerns that, despite being a deeply respected body, the agency is just not properly resourced for the hugely expanded role and remit placed on it; the noble Lord, Lord Lansley, queried this, as did my noble friend Lord Hunt. What is the planned MHRA annual budget for 2023-30? What additional resources will it be provided with in order to enable it to meet the timescales and deadlines set out in the SI? Is the Minister satisfied that there will be sufficient capacity and capability within both MHRA and the UK conformity assessment bodies? That is crucial if we are to avoid medical products being withdrawn from the market because of delays or unregulated devices in the market.
I fully agree with noble Lords that the importance of having a clear indication of the long-term plan and route to be taken for the full operation of the UKCA mark cannot be emphasised enough if patients’ safety and their continued access to the extensive range of medical devices covered by the MMD Act and related SIs are to be achieved. The excellent briefing from the industry body, the British Healthcare Trades Association, summed it up when it said:
“Without the regulations or a clear timeline, businesses face a tangled landscape of inter-related laws and regulations against which corporate decisions must be made with unclear costs, deadlines and risks”.
Paragraph 13.3 of the Explanatory Memorandum indicates that the Government do not expect
“a significant cost impact on small and/or micro businesses”
because the draft regulations are a continuation of the “status quo”. Can the Minister explain how this can be when it earlier describes the extended period as a “transition”? Small businesses operate on tight margins and need certainty and clarity. What further information is to be given to them to assist them in transitioning from CE marking to UKCA marking? How will the MHRA share information about the new rules with businesses, the public and patients?
Finally, I just want to underline the huge range of devices that noble Lords have been talking about, which includes invasive, non-invasive, surgically invasive and active devices. Can the Minister confirm, as the noble Lord, Lord Allan, asked, that class 1 medical devices—these are low-risk devices, such as wheelchairs and stethoscopes—are exempt from the new transitional arrangements of the SI, as the MHRA guidance seems to indicate?
I was going to ask about the labelling requirements but the noble Lord, Lord Allan, covered them. There is particular importance here in terms of their impact in Northern Ireland. My noble friend Lady Ritchie is here but did not speak; she will be concerned about that issue.
I look forward to the Minister’s response to the key questions asked by noble Lords, especially on the expected timing of the new MMD regulations. I also look forward to his response on mutual recognition, which the noble Lord, Lord Lansley, spoke about.
I thank noble Lords for their valuable interventions; I will try to answer a lot of their points as far as is possible.
First, I completely agree that clarity is vital in this market. As ever, as well as trying as best as I can to reply now, I will follow up in writing so that there is absolute clarity there. A lot of this depends on the timing. I say this up front in answer to the question from the noble Lord, Lord Allan, on whether things will change for new products from 2025: no. In effect, we are saying that the deadline is the deadline and, as long as a product is approved during that period, it will run to 2028 or 2030. In fact, new products will now be largely under the new EU regulations so will generally run to 2030. Effectively, that 2025 deadline will apply to any new products even if they are approved and get their CE registration after 2025—say, in 2026. Generally, they will run up to the 2030 deadline.
I hope that what I have said clears up that point but, again, I will set all this out in writing; I am sure that I will be thumped by the team behind me if I misspoke. I think I proved the point very well in my explanation just now: this is non-trivial. As a businessperson by background, I know that, if you want people to invest in this market, they absolutely need to understand the rules.
Two major themes came through in all the points and questions. First, we want to maximise the supply of products. That has to be a good thing for us in making sure that we benefit as much as possible, and it goes to us recognising other quality—for want of a better word—regulators. You could say that approving the ceiling now up to 2028 and 2030 is a step along that way.
Similarly, we want to maximise capacity for our regulators. If you start to approve other quality regulators’ approvals, you are in effect pooling capacity and using their regulatory capacity as well. We know that that is an issue. In the last Budget, the MHRA was given a £10 million funding increase to make sure that it can recruit, but we recognise that it having that capacity is vital to all this.
On the point about mutual recognition, we can of course do it in only one way but, as in most free trade arguments, there is an understanding that it is generally to our benefit to recognise other quality regimes. That is to our benefit in terms of having a high supply of quality items here. Clearly, you want them to do the same in reverse. As ever in these things, there is a bit of trade-off in the negotiation: “Do I want to hold back so that I can maximise my leverage and get them to agree with it all?” Generally, as mentioned by the Chancellor, we are at the moment on the page of it being in our interests to recognise quality regulations from other countries because that can maximise our supply. We hope that they will recognise ours in a similar way, obviously, but that is in their power rather than ours.
I will try to answer some specific questions. There was a question from the noble Lord, Lord Allan, about class 1, low-risk products. Generally, the answer is yes, but this again goes to some of the confusion so I will definitely set this out in writing as well. It is not a blanket “yes”, which I appreciate does not help. Class 1, low-risk devices will benefit from the transitional periods in this instrument only where they are within the EU’s own transitional arrangements. I hope that that make sense.
My noble friend was talking about capacity. One aspect of it is the capacity of the regulators here and in the EU but, in some ways, I am equally concerned about the capacity in the approved bodies, or notified bodies as the EU has them. That is what has been delaying the EU’s regulations and its ability to implement them. It could equally be a problem here. We would both have less of a problem if the approved bodies in the European Union and the United Kingdom were all able to work on both sets of certificates.
Yes; that is what I mean by pooling capacity, for want of a better phrase. My noble friend is saying that we can effectively use the EU’s capacity if we are willing to accept that it is doing proper scrutiny and measurement of products. By and large, we would all agree that that is a sensible approach, just as, similarly, there are situations in a lot of clinical research where, even if the regulators want a final sign-off, accepting each other’s data has to be sensible in terms of pooling capacity.
As ever with these things, it takes two to tango. We need to prove willingness on our side. I hope that the recent Windsor Framework agreement is a way to put things on a co-operative basis. Building trust on both sides takes a series of steps but we are trying to put our best foot forward and we hope that that is met in response.
This goes to the point about the EU-wide shortage of approved body capacity, which impacts us all. If, as we all agree, we want the best supply of products here, it must clearly be a concern if they cannot get through that way. If a company is finding that, through a lack of capacity, they cannot get through the EU route because there is no capacity there, it now has the opportunity to take the UKCA route if our capacity is in place, with the increases to the MHRA to which I referred.
When the Minister writes—I understand that this is very complex; I would certainly appreciate having it in writing—could he refer to three things? The first is small businesses; the SI says that it will not have an impact on them but it is clear that it will. When? The second is the timetable for the new MHRA framework being in place, whether there will be consultation around it and whether that process is separate or uses the consultation that took place last year. The final issue is that of the timetable for the new MMD regulations—that is, the timescale by which we will see them coming along. It will help us make sense of the totality of this if we know when all this work is coming forward.
It is probably best if I write on those points. In terms of timing, the MHRA is planning a further consultation on its future regime from October, but I will come back on those other points.
On the labelling question, I wonder if I could helpfully suggest to the Minister something like an infographic, which shows what labels are needed in Great Britain and Northern Ireland and which labels would be helpful on which dates. Somebody who is making devices could just look at that and go, “I’ll need that kind of labelling at this stage of the transition process”. That would help.
I absolutely agree. To clarify—I may have used the terms interchangeably—I am talking here about the Great Britain market. It is a great British market as well but we are talking particularly about Great Britain because we know that, under the Windsor Framework, Northern Ireland has separate CE arrangements.
I think I have answered as much as I can at this point. I will clarify further in writing. I thank noble Lords because this debate has been incredibly valuable in making sure that we are getting this right; it is non-trivial, to say the least. With that, I commend this instrument to the Committee.
Motion agreed.
Justice and Security (Northern Ireland) Act 2007 (Extension of Duration of Non-jury Trial Provisions) Order 2023
Considered in Grand Committee
Moved by
That the Grand Committee do consider the Justice and Security (Northern Ireland) Act 2007 (Extension of Duration of Non-jury Trial Provisions) Order 2023
Relevant document: 38th Report from the Secondary Legislation Scrutiny Committee
My Lords, under this draft order, which was laid before this House on 24 April, trials without a jury can take place in Northern Ireland where the statutory conditions are met for a further two years, until 31 July 2025. The current provisions will expire on 31 July this year. Following a public consultation, and after consideration of the wider security situation in Northern Ireland, my right honourable friend the Secretary of State considers it necessary to seek an extension to these provisions to ensure the continued safe administration of justice in specific cases.
I am keenly aware that this is the eighth extension of these powers since they came into operation in 2007. I hope that noble Lords will be assured of the continued necessity of these provisions for a further two years. This decision was made carefully and informed by a detailed public consultation process, as well as by the work of the non-jury trial working group. This group was established following recommendations by the former Independent Reviewer of the Justice and Security Act, Mr David Seymour CB, and is composed of representatives from the Public Prosecution Service for Northern Ireland, the Police Service of Northern Ireland, the Court Service, the Bar, the Law Society and other independent organisations.
The group has worked to produce detailed reports for the independent reviewer and to develop a set of indicators to assist the Secretary of State in determining whether these non-jury trial provisions remain necessary. The indicators include assessments of the current levels of paramilitary activity and intimidation in Northern Ireland. In conjunction with the consultation responses, the Secretary of State considered these and reached the determination that they further demonstrate that it would not be appropriate to remove the non-jury trial provisions at this time.
I am of course keenly aware of the disappointment that many noble Lords across the House will feel that the security situation today necessitates a further extension of these provisions. We should not, however, lose sight of the real progress that has been made since the dark days of the so-called Troubles. Today, there is a strong presumption of jury trial in Northern Ireland, and in 2021 only 0.6% of all Crown Court cases were conducted without a jury; that is, eight out of 1,358. By contrast, at the peak of the Diplock court system in the mid-1980s, there were more than 300 such cases per year.
Under the provisions of the 2007 Act, non-jury trials are reserved for use only in exceptional cases where the Director of Public Prosecutions for Northern Ireland deems it to be necessary. As correctly stated on 23 May in the other place by the spokesperson for the Official Opposition:
“The provision for non-jury trials is a little-used but vital tool in ensuring the administration of justice”.—[Official Report, Commons, Delegated Legislation Committee, 23/5/23; col. 6.]
I agree with that statement.
As I know noble Lords will appreciate, these proportionate measures remain necessary to safeguard against risks such as juror intimidation and juror bias in an extremely small number of cases. A non-jury trial may be permitted if the defendant is associated with a proscribed organisation or if the offence being tried is in connection with religious or political hostility. Such cases are high profile and continue to provoke strong public opinion on both sides of the community.
Like their predecessors, this Government remain committed to bringing an end to these provisions when it is safe and compatible with the interests of justice to do so. We firmly believe, however, that now is not the time to take this step.
As demonstrated by the recent increase in the threat level to “severe” and the abhorrent attack on DCI John Caldwell in February, a small number of people in Northern Ireland continue to try to destabilise the political situation through acts of terrorist violence. Their activity causes harm to individuals and communities across Northern Ireland.
Despite courageous work by the Police Service of Northern Ireland and others across the community in Northern Ireland, terrorist and paramilitary groups continue to exert influence and control in communities where they operate. In the year 2021-22 there were 163 recorded offences of intimidation or threats to harm witnesses, and 170 households were accepted as homeless due to intimidation in 2022. These are facts that we cannot ignore.
It would be counterintuitive to believe that the same issues faced by witnesses would not be replicated should they be asked to sit as a juror in these cases. Furthermore, the most recent results from the Northern Ireland Life and Times survey in 2022 found that 17% of respondents believed that paramilitary groups create fear and intimidation in their area.
I trust noble Lords will agree that the safety of the people in Northern Ireland and the administration of justice are paramount. The Government remain committed to working strategically with security partners to tackle the threat from Northern Ireland-related terrorism and to support the Northern Ireland Executive’s programme to tackle paramilitary activity. However, we are not prepared to put the safety of individuals or the administration of justice at risk and believe that there has not been sufficient change in the security situation over the last two years to demonstrate that the non-jury trial provisions are no longer required.
In conclusion, I am sure that I can count on the support of noble Lords across the Committee for the Government’s work to safeguard the administration of justice and to normalise all security arrangements as soon as it is safe to do so. On that basis, I beg to move.
My Lords, I thank the Minister for his presentation of the SI. I declare an interest as a member of your Lordships’ Secondary Legislation Scrutiny Committee.
Some 29 years after the ceasefires and 25 years since the Good Friday agreement, it is worrying that there is still a need for an extension of such a power. Although I am not personally opposed to this legislation, I feel that non-jury trials should be an exception rather than the rule. I think the Minister characterised it in that light in his presentation, but I want to know how many such trials took place last year. We have the figure for 2021 in the Explanatory Memorandum but not for 2022.
The Minister gave us the indicators. We probably could have guesstimated those anyway.
We know that the threat level was increased on 28 March this year to “severe”, due to the increased level of dissident republican activity. As the Minister referred to, we had the threatened murder of DCI Caldwell. I am glad to see that he is making a recovery, having been released from hospital and having had some time at home. In fact, he was able to attend the garden party last week at Hillsborough, which showed an improvement in his physical health. I hope he makes enormous strides in that respect.
Only a few days ago, we witnessed on our TV screens and social media an alleged taxi driver taking a gun to a client. He was sacked from his job, although I understand he was not necessarily acting for that firm at the time. Notwithstanding that, he was apparently acting as a drug enforcer for one of the paramilitary organisations in Northern Ireland.
Some 29 years since the ceasefires, the public in Northern Ireland want an end to such paramilitary and criminal activity; they have had enough of it. They do not want to be brought to heel by such paramilitary organisations and criminal gangs; they want to see an end to it. If this debate does anything, it will tell those people, “Get off the backs of the people of Northern Ireland”. We are sick, sore and tired of it, and we want to live in peace and harmony. We want to see the restoration of our political institutions, which, I hope, will be able to help foster economic opportunity for us all.
Related to this is the legacy Bill, which the Minister is also involved in. I know that on the Bill’s last day in Committee he referred to game-changing government amendments. When will they be published? I hope that he is not as surprised as the expression on his face suggests. I want to know when they will be available and what they will cover. Will they enable access to inquests and inquiries? Will they be compatible with the ECHR?
In conclusion, although I do not have a strong aversion to this SI and I generally support it, I hope that it will be the exception to the rule. There could very well be a further extension, depending on terrorist and paramilitary activity in 2025, but I hope that we are looking to bright, fresher new days where terrorism will definitely be a thing of the past and we will not need this type of legislation.
My Lords, I support these non-jury provisions. I am sure that we all want a jury-based justice system. The diversity of a jury is one of its strengths and it has been proved that juries are fair, effective and efficient. However, as we have heard, unfortunately there exists a severe threat from terrorism in Northern Ireland. It is to be regretted that there is still present in Northern Ireland society a small number of people who are actively involved in terrorism. They do not hesitate to intimidate jury members, witnesses and families involved in their cases. Therefore, the extension of the duration of non-jury trial provision is needed.
Of course, as we have heard, it is hoped that the suspension of jury trials will be a temporary measure and that the time will come when non-jury trials will not be necessary, but this can be achieved only when it is safe to do so. As we have heard, it is important to note that the vast majority of Crown Court cases in Northern Ireland are held with a jury. During 2021, only eight non-jury trials took place, which means that 0.6% of all Crown Court cases in Northern Ireland were conducted without a jury.
There are many safeguards in this before we can have a non-jury system. For example, the Director of Public Prosecutions for Northern Ireland can only consider issuing a certificate for a non-jury trial. The judge also must give reasonable reasons for convictions. Indeed, from the defendant’s point of view, any person convicted before a non-jury court has a right of appeal against sentence or conviction without leave. There are built-in safeguards before these trials can take place.
Finally, I am sure that the Minister is aware of the recent criminal justice report which expresses concern regarding the length of time required to bring a prosecution in Northern Ireland Crown Courts. The report is very critical of the Public Prosecution Service and the Police Service of Northern Ireland. It revealed that 50% of evidence presented is not complete, leading to delay. It also revealed that the quality of criminal case files was extremely poor: 54% of Crown Court files did not meet, or only partially met, file standards, and police files took far too long to prepare. Does the Minister agree that it is important that both the police service and the Public Prosecution Service need to be vastly improved? Is it not time that the Police Service of Northern Ireland is adequately funded so that it can speed up these cases?
My Lords, I thank the Minister for the manner in which he introduced the legislation. Not one of us from Northern Ireland would desire to have this legislation on the statute book at all; we would love to see its end. But then we have to ask ourselves: is it needed? The statistics have been produced in the Explanatory Memorandum, and the notes provided under the heading “policy background” at paragraph 7.5 remind us that on 28 March 2023, the level of threat in Northern Ireland related to terrorism increased from “substantial” to “severe”. We wish it were not true, but it is the reality of the situation on the ground.
We have a continual severe threat, especially against members of the security forces. We saw that with DCI Caldwell, but we thank God in His mercy that his life was spared. I join the noble Baroness, Lady Ritchie, in expressing absolute delight that he was able to be present with His Majesty the King at the garden party. That certainly shows an improvement. We hope that that continues and that he will be restored to a very good measure of health and strength. We know that that was not the intention of those who had planned his murder. Sad to say, the reality of the situation is that they in their hearts would have plans to continue. There is no reason to believe that the terrorist organisations—the dissident republicans—wish to step aside from their acts of terror. We have to face that reality, and the order before us does that.
There is genuine concern about jury threat, intimidation, tampering, or even bias, but we want to ensure that the administration of justice in Northern Ireland, which is the heartbeat of any democratic society, continues. I know that we would long to see the Minister say that this is the last occasion on which that he would ever bring these provisions before your Lordships. However, we have seen just how long they have continued until now. It is not in the hands of noble Lords in this Committee to bring that about, but we hope and pray that we will soon ensure that it is unnecessary and get back to jury trials, which would be more acceptable within society.
I have a simple question for the Minister. I notice from the notes we were given that only a small number of responses were made to the extension of the order; only a very small number of representations were made. Does he have any reason why the number was so small? Does he believe that the community in general is willing to accept that this is a reality that has to be carried on in Northern Ireland at this specific time?
My Lords, I too thank the Minister for his detailed explanation of this order. Without repeating the various points made by other noble Lords in this short debate, I add my voice to those saying that this eighth extension of these provisions is deeply to be regretted, but clearly, while the threat from terrorism remains severe and given the current levels of paramilitary activity and intimidation, the Government, supported by the continued work of the multidisciplinary working group, are right to continue with the provisions. I note that, following the consultations, nine respondents agreed with the need to extend the provisions and two were against.
There can never be any excuse for terrorism or murder in Northern Ireland. Any such acts have to be utterly and roundly condemned. The shooting of John Caldwell was horrendous and devastating for him and his family. As the noble Baroness, Lady Ritchie, said, there has been an escalation in other incidents—perhaps lower in profile but none the less deeply worrying. I add my voice to the relief—congratulations is perhaps too strong a word—that John Caldwell is now making a full recovery. I wish him and his family well in that continued recovery.
As others have said, on these Benches we profoundly believe in the right to trial by jury. We must work to find practical solutions to manage the risk of juror intimidation and robust juror protection measures.
In conclusion, like others, I very much hope that this is the last time we need to see an extension of these provisions. Let us hope that by the time of the next revision, the Executive and the Assembly are once again fully functioning and that the security situation in Northern Ireland is very much improved.
My Lords, I agree with everything that has been said, but it is still a grave and terrible thing to take away the right of a citizen of the United Kingdom to have a trial by jury, which goes back many centuries. Of course, I understand why this occurred. Anyone who, like me, has been watching that wonderful series about the recent Troubles, “Once Upon a Time in Northern Ireland” on BBC Northern Ireland, will understand why you could not avoid jurors being intimated by paramilitaries from both sides if they took part in their legal duty.
But times have changed. Over the last 25 years, roughly 160 people have been killed because of terrorist activity, compared with 3,500 before 1998. That is an enormous change. Many people forget that the Good Friday agreement also dealt with the criminal justice system in Northern Ireland and changed it to such an extent that it became acceptable to all communities in Northern Ireland. That is why, in 2007 there was a major change to ensure that only the smallest number of cases are to be dealt with simply by judges and not by juries. No one wants that to continue in our democratic society—of course we do not.
The only thing that needs to be reflected on—it comes out in the consultation document that the Government produced—is that there are still difficulties. When I looked at the figures it struck me that hundreds of families are still made homeless because of sectarianism in Northern Ireland. Hundreds of people are still attacked and injured because of paramilitary activity in Northern Ireland. Tragically, there are still people killed because of that. While those circumstances continue, it is necessary for this legislation to be continued for a further two years.
I hope the Minister will go back and reflect on what the Committee has said about reviewing the situation with non-jury trials over the next two years. I know there is a working party. I hope it actually operates and that the next time, if we are spared, we come to renew this legislation, we might not have to do so, but at the moment, we do.
I conclude on one other factor. Political instability is the cousin of political violence—a distant cousin, but it is there. The more the Government concentrate their effort on trying to ensure that we get political stability in Northern Ireland by constantly talking to the political parties there and to others concerned, the better, so that when we return after the recess, perhaps—who knows?—the institutions will be restored.
My Lords, I am very grateful to noble Lords who participated in this short debate this afternoon, and I thank them for the support— reluctant, in some cases—that they have given to the order before the Committee. I share the frustration of noble Lords in having to bring this order back for an eighth time since 2007, when the Justice and Security (Northern Ireland) Act was passed by the Government of which the noble Lord, Lord Murphy of Torfaen, was a distinguished member. We all share the aspiration that this will be the last time that we have to do it, but the reality of the situation in Northern Ireland as we find it today is that there remains a significant risk of intimidation of jurors and witnesses, and therefore I am afraid there is no alternative at present.
The noble Baroness, Lady Ritchie of Downpatrick, referred to the grip of paramilitaries in communities across Northern Ireland, and I share her anger that, nearly 29 years after the first ceasefires in 1994, paramilitaries continue to operate within the community in this way. There was never any justification for them in the first place, and there is no justification for them today. As she knows, I was involved in the fresh start agreement in 2015, when we looked at this issue very closely and, out of that, there is the Tackling Paramilitarism task force within the Northern Ireland Executive, to which we as a Government are currently contributing £8 million a year in match funding, so we take these matters extremely seriously.
The noble Baroness asked me about the figures for 2022 for the number of cases that were tried in non-jury courts. The latest figures I have are those I read out in my opening speech, for 2021. Of course, as soon as the latest figures are available, I undertake to draw them to her attention.
Slightly at a tangent from the order, the noble Baroness asked me about the legacy Bill and when the amendments to that Bill on Report will be available. I can say only that I hope to be in a position to publish them very shortly, and in advance of the usual timeframe for tabling government amendments on Report. If she can contain her excitement for now, I am sure she will not have very long to wait. We go to Report on the Bill on 21 and 26 June.
A number of noble Lords referred to the security situation, and particularly the case of DCI John Caldwell. I join them in thanking God that he survived that vicious, murderous attack and was able to attend the garden party at Hillsborough a week last Wednesday, when he was presented to His Majesty the King. We all pray for his continued recovery and good health.
The noble Lord, Lord Browne of Belmont, made some interesting comments about the criminal justice system in Northern Ireland. I hardly need to remind him that the operation of the criminal justice system and any potential reform of it is a matter for the Department of Justice in Northern Ireland and the devolved Executive, if one were currently in existence. On the issue of funding, in the recent Budget, difficult as it has been, we allocated £1.2 billion to the Department of Justice, and it is for the department to allocate its resources accordingly.
The noble Lord, Lord McCrea of Magherafelt and Cookstown, asked about the low level of responses. He might be surprised to hear that the response rate of 15 was an improvement on 2021 by the huge number of two, so we may be going in the right direction. In addition to those responses, the Northern Ireland Office also wrote to 38 other relevant organisations. The relatively small number of responses is probably a reflection of the fact that for most people in Northern Ireland, sadly and regrettably, these non-jury trial provisions are non-contentious and the need for them is widely accepted across the community.
I am grateful to the noble Baroness, Lady Suttie, speaking for the Liberal Democrats, and to the noble Lord, Lord Murphy, from the Official Opposition, for their support on this. Of course I will reflect on the operation of the non-jury trial provisions. Like them, I hope that in two years’ time it will no longer be necessary to bring forward the provisions, but, alas, I think we are all far too well aware of the current security situation, much improved though it is—we are a long way from the old Diplock system. Noble Lords will remember that, under Diplock, the presumption was that all cases would be tried by a non-jury. Under the 2007 Act, welcome though it was, the presumption is in favour of jury trials. In my opening speech, I gave the figures for the reduction in the number of non-jury trials since the mid-1980s. It is a considerable change, but we still have a distance to go. We all hope that that distance can be travelled—and relatively quickly—but unfortunately, we are not there yet, which is why these provisions are very necessary in Northern Ireland, as noble Lords across the Committee have accepted today.
Motion agreed.
International Criminal Police Organisation (Immunities and Privileges) Order 2023
Considered in Grand Committee
Moved by
That the Grand Committee do consider the International Criminal Police Organisation (Immunities and Privileges) Order 2023.
My Lords, this instrument was laid before Parliament on 20 April in accordance with Section 10(1) of the International Organisations Act 1968. It is subject to the affirmative procedure and will be made once it is approved by both Houses. The issue was brought to the House of Commons Committee on Wednesday 17 May and was passed unanimously.
The primary purpose of the order is to provide the International Criminal Police Organization, more commonly known as Interpol, with the status of an international organisation in the UK, under the International Organisations Act. This is a prerequisite for the UK to host the annual Interpol general assembly in 2024. Importantly, it will also enable Interpol to function effectively in the UK in the longer term, including by providing it with legal personality in this country.
The Government therefore consider these privileges and immunities both necessary and appropriate to deliver on the short and longer-term interests and commitments that the UK has towards Interpol. The privileges and immunities conferred enable Interpol staff and its representatives from member countries to operate effectively in the UK. They will be afforded to officials attending statutory Interpol meetings and senior officials such as the Interpol secretary-general and executive committee members. They are within the scope of the International Organisations Act and in line with UK precedents.
All categories of individual are subject only to official Act immunities. The one exception to that is the secretary-general, who will be treated in accordance with the UK’s treatment of heads of diplomatic missions, namely receiving personal as well as official Act immunity. The provisions of the order cover: entry into the UK; customs provisions; immunity from legal process within the scope of official activities; inviolability of official documents and correspondence; taxation; inviolability of Interpol premises; statutory meetings; foreign currency exchange; functional immunity for officials; and an immunity waiver. As is standard for agreements of this kind, UK nationals and permanent residents are carved out of provisions regarding taxation and importation exemptions.
Interpol is a global law enforcement organisation whose objective is to facilitate transnational police co-operation in the fight against international crime. That mission is more important than ever when we consider how international crime has evolved since the UK became a member in 1928. Global travel, new technology and the ability of serious and organised crime gangs to exploit world events mean that we need to work across borders to keep our people safe. Interpol is key to that work and the UK remains committed to the organisation as it marks its centenary year. Our commitment is reflected in our plan to host the general assembly, alongside our day-to-day investment in Interpol through our people and expertise.
The general assembly represents a unique opportunity to demonstrate UK policing leadership on a global stage. During the event, police chiefs from around the world, alongside senior government officials, will gather to discuss emerging threats to global security, to set the direction for Interpol’s activities in the following year and to elect a new secretary-general, along with nine of the 13 new executive committee members.
The privileges and immunities granted by the order will enable Interpol’s membership to come together at its 2024 general assembly in the UK. It will also create a basis for closer working between Interpol and the UK Government and law enforcement agencies in future. I commend the order to the Committee.
My Lords, I thank the Minister for introducing this statutory instrument. As he says, it has been considered in the other place. In fact, my honourable friend Catherine West made it absolutely clear that the Opposition support its introduction. She certainly echoed the Minister’s comments on the importance of Interpol’s role and activities, so I will not repeat those, but I have a number of specific questions that I want to put to the Minister.
The immunities and privileges contained in the instrument differ from those in similar regulations that I have considered in Grand Committee. One of those was the 2021 order on the Bank for International Settlements. Can the Minister explain the process to determine which immunities and privileges are given? Do they differ constantly for different organisations?
Also, during the debate on the instrument that gave similar immunities for COP 26, which I know the Minister is familiar with, I asked for assurances that there was no risk of hostile states’ representatives abusing privileges while in the UK. Can he confirm whether there has been any risk assessment of this possibility for the Interpol general assembly, which is going to take place in the United Kingdom?
The Explanatory Memorandum states:
“There was previously no law granting privileges and immunities to INTERPOL in the UK”.
Given that Interpol’s national central bureau is based in Manchester, is there a time lag? Why are we granting these immunities now? Surely there were people who would have benefited from such immunities in Manchester. Did the Government receive representations on this issue? The office in Manchester is responsible for working with and protecting the 14 overseas territories from a range of threats. Are the Government involving them in the arrangements for the general assembly?
Those are the few questions I have on this instrument. I reiterate the Opposition’s support for its introduction.
I am grateful to the noble Lord for his contribution. I will do my best to answer his questions.
The privileges and immunities are a requirement, as the noble Lord knows, of the UK as a host of the general assembly in 2024. In agreeing the privileges and immunities treaty, Ministers considered this aspect and the associated risks, which he has just highlighted. All 195 members of Interpol will receive an invitation to the general assembly; that is the case for every Interpol general assembly and it is a requirement. The UK is required, as per the terms and conditions for hosting the general assembly, to honour those invitations. That is just a fact of hosting this conference or summit. Based on attendance at recent meetings of the Interpol general assembly, we are planning for the attendance of about 1,000 delegates, including the Interpol leadership. That said, and as outlined in the draft, not all of them will have full privileges and immunities.
On the issue that the noble Lord raised in relation to hostile states, the privileges and immunities granted are only those that are strictly necessary. They were negotiated according to functional needs, so delegates of member countries will be granted only the official acts immunity, which applies while they are carrying out their official activities in the UK. We are seeking to limit the size of national delegations permitted to the general assembly sessions to a model of five delegates and five alternates. They must also go through an accreditation process. We work continually to assess potential threats to the UK and will always take proportional action to mitigate risks where we identify them, as we are doing in this case. The immunities granted are official acts immunities only; they cover official Interpol activities and attendance at Interpol statutory meetings.
The noble Lord made a point about the Manchester HQ. My understanding is that it is the National Crime Agency, which is obviously a UK organisation, that is based in Manchester and not Interpol, so there is a crucial difference there.
What was the noble Lord’s first question?
The differences between certain agencies and their immunities.
I am afraid I will have to write to the noble Lord with a detailed answer on that, because I do not have that information to hand.
On Interpol itself as an organisation, the Government strongly support its efforts to ensure that systems are in place that protect individuals’ human rights, in line with Article 3 of Interpol’s constitution, which strictly forbids
“any intervention or activities of a political, military, religious or racial character”.
The Home Office continues to work with Interpol and the National Crime Agency, which acts as the UK’s national central bureau, to monitor the effectiveness of existing safeguards. We encourage Interpol to uphold international human rights obligations and would never hesitate to recommend further reforms to Interpol, if necessary.
I think I have answered the noble Lord’s questions, with the exception of one, on which I will have to get back to him in writing. I thank him again for his contribution today. I know the committee took a keen interest in the UK’s relationship with Interpol. In granting these privileges and immunities, we will be able to host the general assembly in 2024. We will be better placed to influence the organisation as a result, and better positioned to combat international criminality. I therefore trust that the Committee will support the order.
Motion agreed.
Committee adjourned at 6.30 pm.