The Health Protection (Coronavirus) (Requirements) (Scotland) Amendment Regulations 2022 and The Health Protection (Coronavirus) (Requirements) (Scotland) Amendment (No. 2) Regulations 2022: business and regulatory impact assessment

Options Considered

Option 1: Retain mandatory Covid Status Certification in higher risk settings, with proof of vaccination or record of a negative test (LFD or PCR result) accepted (current policy).

Option 2: Retain mandatory Covid Status Certification in higher risk settings and amend the definition of fully vaccinated to include the requirement for a booster vaccination if a person's primary course of MHRA vaccine was more than 120 days ago and amend the definition of late night venue, with proof of vaccination or record of a negative test (LFD or PCR result) accepted.

Option 1: Retain mandatory Covid Status Certification in higher risk settings, with proof of vaccination or record of a negative test (LFD or PCR result) accepted (current policy).

Option 1 would feature:

• Covid Status Certification for access to specified settings required for entry either certificate of vaccine or record of a negative test (LFD or PCR within specified time frame of 24 hours)
• Mandated in regulations
• Public use of paper Vaccine Certification or digital NHS Scotland Covid App or demonstration of a negative LFD or PCR result as reported to the public reporting system
• Event/venue use of Verifier App – NHS Scotland Covid Check app to verify QR code for vaccine certification
• Implementation and compliance supported through Scottish Government Guidance

Option 2: Retain mandatory Covid Status Certification in higher risk settings and amend the definition of fully vaccinated to include the requirement for a booster vaccination if a person's primary course of MHRA vaccine was more than 120 days ago and amend the definition of late night venue, with proof of vaccination or record of a negative test (LFD or PCR result) accepted.

Option 2 would feature:

• Covid Status Certification for access to specified settings required for entry, either certificate of completion of primary vaccine course, or booster vaccination if a person's primary course of MHRA vaccine was more than 120 days ago or record of a negative test (LFD or PCR within specified time frame of 24 hours)
• Amended definition of late night venue covered by certification
• Mandated in regulations
• Public use of paper Vaccine Certification or digital NHS Scotland Covid App or demonstration of a negative LFD or PCR result as reported to the public reporting system
• Event/venue use of Verifier App – NHS Scotland Covid Check app to verify QR code for vaccine certification
• Implementation and compliance supported through Scottish Government Guidance

Sectors and Groups Affected

The change to definition of full vaccination will affect:

• Late night venues with music alcohol and dancing;
• Certain indoor cultural performance venues associated with live events, particularly larger venues that stage unseated performances;
• Certain outdoor venues associated with large cultural or sporting gatherings, such as larger sports stadia and race courses;
• Conference centres, in instances where staging large scale seated or unseated live events, trade fairs open to the public, markets or exhibitions;
• Businesses involved in the organization and staging of live events, such as performers, event promoters, staging and production businesses, associated supply chain businesses;
• Business events that entail a 'peripheral' reception or function outside of the core hours of the event, which would not be excepted should they meet the criteria for certification. Business event professionals note that the majority of high value business events in Scotland encompass receptions that would be in scope (500+);
• Ancillary businesses dependent on live events (e.g. food and drink sales, merchandising);
• Prospective attendees at settings in scope;
• Local Authorities, as they would be required to undertake monitoring and enforcement activities arising from regulations;
• Royal Mail postal services in connection to the distribution of postal test kits
• Pharmacy services in connection to the distribution of test kits

The amendment to the definition of late night venues will affect late night venues with music alcohol and dancing. However this is a technical change that is intended to clarify the regulations and is not intended to bring new settings in scope.

Scottish Ministers will also continue to assess whether any less intrusive alternative measures could be introduced to achieve the same combination of policy objectives in respect of the higher risk sectors concerned. The current default position would be that Covid Status Certification provisions, along with the rest of the Principal Regulations would be due to expire on 28 February 2022.

Assessment of Options

This BRIA has set out the relative costs and benefits of options with the intended effect of suppressing the virus whilst acknowledging and minimising the economic harms faced by businesses.

Option 1: Retain mandatory Covid Status Certification in higher risk settings, with proof of vaccination or record of a negative test (LFD or PCR result) accepted (current policy).

Costs

Under this option, it is not anticipated that there would be additional costs on businesses within scope directly associated with continued implementation, outside of existing potential costs arising from: direct costs incurred by affected businesses to ensure compliance with the Regulations; reductions in footfall and attendance at venues and events covered by the Regulations; cancellation of events and refunds to customers and associated cash-flow impacts. These existing costs were presented in previous BRIA and the Scottish Government's certification evidence papers, and are reprised in the sections below where relevant for ease of reference.

There is clear guidance around how and when to take a LFD test, however, some businesses within scope have indicated that where customers do not have either proof of vaccination or record of a negative test result the business may decide to provide a test kit so that the customer can leave and take the test safely. Any costs of this would fall to that business and if businesses choose to do so, there would potentially be an ongoing cost arising from businesses purchasing additional stock on an ongoing basis.

However, this practice is strongly discouraged by the Scottish Government in updated Guidance which clearly states that businesses should not distribute test kits to prospective customers. The distribution of test kits needs to be carefully managed to meet regulatory requirements to be able to recall test kits from users in the event of a performance or safety issue with the tests. Additionally, lateral flow tests are designed to be used at room temperature, on a flat, clean, dry surface with the ability of the user to wash their hands thoroughly before use to avoid contaminating the test. Individuals should be encouraged to test before they leave home to reduce the transmission risk.

Implementation Costs

The previous BRIA's and the Scottish Government's Evidence Papers^[69] described a range of potential cost impacts on businesses associated with implementation and delivery of certification.

Examples of these costs included:

• Additional resource for recruiting or training staff to check certification.
• Dedicated hardware to scan or read Covid Status Certification (mobiles/tablets) and/or install technology to check QR codes at automatic entry barriers.
• Cancellation of tickets and refunds
• Additional policing costs arising if there are scenes of disorder at sports stadia due to long queues caused by Covid Status Certification checks.
• For business events, additional complexity of exempting one element of the programme (e.g. standing receptions), with associated cost and reputational risk of denying delegates who are attending this and all other elements in a work capacity. Business event professionals have shared that the majority of high value business events in Scotland encompass receptions that would be in scope (500+).
• Costs to Local Authorities of monitoring and enforcing Covid Status Certification

While some of these items of cost, particularly related to technology, could be described as one-off implementation costs that businesses would face and may have already incurred, those associated with recruitment, training and payment of staff, and LA enforcement costs, would potentially be ongoing direct costs associated with implementation and compliance.

The NHS Scotland Covid App will continue to be provided for free, the accompanying Guidance on how to implement within businesses now being live on the Scottish Government website.

The extent of ongoing costs borne by businesses affected by Covid Status Certification will likely vary across businesses, depending on the scope to integrate them into existing staff functions, use existing IT infrastructure, or physical infrastructure. These costs may be higher for businesses that have not delivered a similar function historically, such as venues that do not charge for entry and have previously not had a need for door staff but may now require some to check vaccination status at the point of entry.

Staff costs represent a large component of the overall running costs of businesses in some of these sectors. For example, in the Accommodation and Food Services sector overall, labour costs are estimated to account for 44% of total costs at a sectoral level, compared to 26% across all sectors, while in Arts, Culture and Entertainment sector labour costs are estimated account for around 27% of total costs.^[70]

Impacts on staff costs would likely vary across businesses depending on several factors, particularly whether the Regulations' requirements are accommodated within existing staff responsibilities or require additional staff. If additional staff is required, costs would be influenced by factors such as numbers of staff required, and number of hours required each week. Hourly and weekly gross wage costs for occupational groups that would be affected by the regulations are set out in Table 2 below. It should be noted that these statistics do not include non-wage labour costs, such as Employers' NIC and pension contributions:

Table 2. Gross Mean Hourly and Weekly Pay, Selected Occupations, 2021. Source: ONS, Annual Survey of Hours and Earnings 2021, Tables 15.1a, 15.5a

Security Guards & Related Occupations (SOC 9241)

Mean Gross Hourly Pay, £
All - £12.60*
Part-Time - £11.73**
Full-Time - £12.71*

Mean Gross Weekly Pay, £
All - £496.80*
Part-Time - £326.80**
Full-Time - £526.80*

Bar Staff (SOC 9274)

Mean Gross Hourly Pay, £
All - £9.81**
Part-Time - £8.64*
Full-Time - X

Mean Gross Weekly Pay, £
All - £178.60**
Part-Time - £121.20*
Full-Time - X

Estimates marked * are considered reasonably precise, estimates marked ** are considered acceptable, x denotes an estimate which is considered unreliable for practical purposes

It is noted that there is a widely reported difficulty in securing sufficient numbers of stewarding and hospitality staff at present, due to labour shortages. For instance, in the period 15-28 November 2021, 49.4% of businesses in the Accommodation and Food Services Sector reported that vacancies were more difficult to fill compared to normal expectations for the time of year, and 42.3% reported having a worker shortage^[71]. Hospitality stakeholder organisations have consistently highlighted challenges in the availability of SIA-accredited door staff. There is also evidence of continued strong growth in vacancies in areas like hospitality^[72]. These could create challenges for affected businesses across affected sectors in recruitment of numbers of staff required as a result of regulations.

Feedback from Event Sector member organisations to Scottish Government officials has indicated that those affected may have experienced additional costs associated with implementation. Feedback from one theatre group has indicated that additional staffing costs associated with implementing Covid Status Certification have been of the order of £6,600 per week at a specific larger venue^[73]. Sports sector stakeholders have reported that additional stewarding has been necessary to implement Covid Status Certification as currently designed^[74].

The magnitude of these costs in coming months will be closely linked to the level of enforcement expected from businesses, the type and footprint of venues, and flow of customers at venues and events. Current Covid Status Certification arrangements have varied across settings with guidance taking account of the differences between a venue where there are a smaller number of people queuing to enter the premises compared to a large event such as a sporting event with multiple entrances and larger crowd control required: for instance, late night venues have been required to operate a 100% check on entry, given the option for a visual check. For large events, spot check arrangements have been in place.

This option may have further financial impacts on events which run over a prolonged period of time such as trade fairs and exhibitions which often run over a number of days. The combination of extended event times and changeover in attendees may require additional staffing capacity to allow for Covid Status Certification checks, in addition to standard ticket checks.

For business events there is additional complexity of exempting one element of the programme (e.g. standing evening receptions), with associated cost and reputational risk of denying delegates who are attending this and all other elements in a work capacity. Business event professionals have shared that the majority of high value business events in Scotland encompass receptions that would be in scope (500+).

There have also been reported incidences reported of individual premises changing their offerings and business models (such as through reducing opening hours or converting their premises) to avoid falling within the requirements of certification^[75]. These may have resulted in costs to individual businesses arising from decisions around implementation of certification.

Anti-Social Behaviour

Stakeholder representative groups have also consistently highlighted the risk of increased anti-social behaviour, should customers be refused entry on grounds of not having appropriate certification. Hospitality and Event industry stakeholder groups have provided anecdotal feedback of increased aggression towards security staff and stewards in some contexts. This could impact on recruitment and retention of staff, and importantly, on staff wellbeing.

Local Authority Enforcement Costs

As outlined in the original BRIA, there are costs associated with Option 1 in relation to enforcement. TheLocal Authority Covid-19 Expert Officer Group originally estimated the costs to Local Authority Regulatory service at £225,000, based on the assumption that there are 2,000 businesses and 500 events in scope in the initial 6 months from Oct 1. Scottish Government have committed to monitoring and evaluating the impact of the scheme on local authority resources and have allocated funding of £2.9 million to local authorities to year end to support with Covid compliance activity. The premises in scope have not been expanded therefore there is no additional types of premises where LAs would have a role in enforcement.

It is acknowledged that the previous definition of late night venues covered by Covid Status Certification may have created ambiguity and limited the ability of Local Authorities to engage with premises where the dancing on the designated dancefloor continued. The new definition incorporating 'any space where dancing by customers takes place' provides greater clarity and scope for Local Authorities to engage in a proportionate way following the 4Es and better ensures that the spirit of the scheme is reflected in practice.

Loss of revenue through reductions in footfall and attendance

Businesses subject to Covid Status Certification may experience a reduction in customer footfall and attendance, as those without proof of vaccination would be refused entry – although this could be mitigated by the inclusion of testing. Customers may view Covid Status Certification as a barrier, especially if groups socializing together are divided into certified and non-certified. This could lead to a reluctance to visit venues and attend events where Covid Status Certification is needed, opting to visit venues and events which do not require it. Those affected may also choose to stay at home or go out earlier in the evenings to avoid certification. The anticipation of delays in entry and experience of the customers entering venues and events where Covid Status Certification is required may influence choice, opting for less onerous options. Taken together, these may result in loss of direct footfall for some businesses. Loss of trade and revenue for participating venues could heighten pressures on individual businesses' viability.

The previous BRIA and the Scottish Government's Evidence Papers described the potential for impacts on footfall and revenues for businesses affected by certification. It is challenging to directly identify the impact of Covid Status Certification on losses of footfall and turnover experienced by individual businesses, owing to the relatively short space of time that Covid Status Certification has been in place, and potential impacts from other contributory factors. However, emerging reports from stakeholder organisations in the hospitality sector have consistently suggested that nightclubs and late night settings affected by Covid Status Certification have experienced substantial reductions in footfall and revenues since introduction of certification. Trade bodies have consistently provided reports of members experiencing reduced footfall and takings. Hospitality stakeholders advised of members experiencing footfall reductions of 20%-40%; falls in revenue of around 40% in affected venues^[76], while a joint hospitality industry survey suggested that 87% of respondents that had been affected by Covid Status Certification saw trade levels fall by over 20%^[77].

Events sector stakeholders have also provided anecdotal evidence of business impacts. Individual events organisers have advised of larger drop-offs in actual attendance compared with ticket sales than would typically be expected^[78].

Footfall in the settings that currently fall within Covid Status Certification requirements is potentially substantial. YouGov polling for 2-4 November^[79] suggests 5% of those polled had been in a nightclub or late night venue in the previous week, while 10% had been to any sort of venue/event eligible for Covid Status Certification (a nightclub or late night venue or large event). Generally levels for each of these are higher among 18-29 year olds than other. Updated figures for December have been published. Pre-pandemic, there was also evidence to suggest that larger portions of 16 to 24 year olds, 25 to 34 year olds, and 35 to 44 year olds had attended live music events in the previous year than the share of the population overall^[80].

Footfall could be impacted in the following ways:

• Those without Covid Status Certification or record of a negative test would be refused entry (which in turn depends on numbers vaccinated)
• Others may be reluctant to attend if non-certificated friends were unable to attend
• Entry delays could deter customers if onerous.

The extent of economic harm would arise from the numbers of unvaccinated people within the population overall, and those who are not fully vaccinated in the previous fortnight at the point at which c Covid Status Certification requirements would come into effect. If people within this group were unable to enter settings, this would represent a loss to the potential customer base to affected businesses and sectors, and therefore a source of economic harm. The depth and duration of economic harm would depend on the speed with which people became vaccinated and eligible for certification, and the availability of alternatives to vaccine certification, such as a record of a negative test result.

Under the current requirement for a minimum of 2 weeks between individuals receiving their second dose of vaccine and being eligible for certification, vaccine uptake data^[81] suggests that:

Around 89.1% of the overall population aged 18+ had received two doses of vaccine by 3^rd January, and would therefore be eligible to access Covid Status Certification by 17^th January.

Among younger age groups, this proportion fell to 71.6% of those aged 18-29, 79.4% of those aged 30-39, and 88.7% of those aged 40-49

Should those currently unable to access Covid Status Certification be unable to access premises that require it, this could generate reductions in footfall and turnover for affected premises.

In addition, industry stakeholders have highlighted that there may be negative impacts arising from groups of customers choosing to avoid venues where Covid Status Certification is required in response to some of their members not having appropriate vaccination certification. There may also be impacts on footfall at individual venues should the process of checking Covid Status Certification add to the time taken to enter venues.

Under this option, as the percentage of the population who are vaccinated increases and plateaus, the inclusion of testing could potentially be perceived by some customers as creating morerisky environments as vaccination is not incentivized. This could lead to loss in revenue through a small reduction in footfall and attendance.

Loss of revenue through cancellation of events and customer requested refunds

Live events businesses, including concerts and trade fairs open to the public, may also experience additional impacts under this option if unvaccinated customers who had bought tickets for events before the commencement of this option are subsequently unable to attend. This may generate demand for refunds or transferability of tickets leading to additional cash-flow pressures for event organisers who may not be protected in Terms and Conditions, as it was not a stated condition of entry. To date there has been no funding from Scottish Government to support any events to cover the cost of cancellations as a result of Covid Status Certification being introduced.

Customer cancellation costs may partly come from overseas visitors who have difficulties proving their vaccination status. The Verifier app for business has been developed to be able to read QR codes from the other UK nations and Crown dependencies, as well as from any individual using the EU Digital Covid Certificate scheme, which Scotland is now part of Visitors from other nations, such as USA, can provide the same proof of vaccination status that is accepted for entry into the UK. There is significant variation across the globe on what vaccine certifications/proof of vaccination look like and how they work – and not all will be acceptable if they are not to a certain standard. For domestic Covid Status Certification purposes, only MHRA-authorised vaccine are acceptable and this does not include the WHO list vaccines (including the Chinese vaccines Sinopharm and Sinovac and the Indian vaccine Covaxin). However, there is still a risk of lost business at larger events that have a significant international audience beyond the EU. For example, Edinburgh's Hogmanay in 2019 had visitors from 58 different countries. This risk may be reduced by the ability to accept a record of a negative test.

If live events businesses are unable to ensure that their show is financially secure in advance - through guaranteed ticket sales - they may cancel events. Equally, if ticket sales are at risk, there could be a subsequent impact on the ability of event organisers to secure exhibitors, performers and sponsors – a major source of revenue – and similarly may cancel events due to a lack of viability. Cancellation of events may also arise if the direct costs of ensuring compliance, such as additional stewarding, threaten the viability of the event. Cancellation of events would impact on a number of sectors, including the tourism industry.

Events sector stakeholders have also provided anecdotal evidence of business impacts^[82]. Individual events organisers have advised of larger drop-offs in actual attendance compared with ticket sales than would typically be expected. Individual events have also provided anecdotal evidence of small numbers of individuals being refused entry to specific events as a result of certification, and of refunds being requested, but with these potentially having varied by event type. There have also been examples where Covid Status Certification has been mentioned as a factor in organisation of specific events, Covid Status Certification requirements, specifically the additional queueing time, were cited as one of the reasons for Glasgow cancelling the George Square Lights 'switch on' and Christmas market^[83] .

Under this option, as the percentage of the population who are vaccinated increases and plateaus, the inclusion of testing could potentially be perceived by some customers as creating more risky environments as vaccination is not incentivized. This could lead to loss in revenue through a small increase in cancellation.

Wider Impacts

The Royal Mail postal services could be impacted upon. The UK Government have a contract in place with Royal Mail for the distribution of postal test kits (PCR and LFD) with agreed volumes to cover any demand that arises (up to agreed thresholds) and those contracts cover all parts of Scotland including rural areas and islands. The addition of testing for domestic Covid Status Certification purposes has had a minimal impact on the volumes handled through that contract in addition to the 2-3 million tests that we are already distributing each month by post in Scotland a) because the scope of settings covered remains relatively small; (b) the numbers of people likely to need a test because they are not vaccinated is not likely to be significant and is reducing as more people become fully vaccinated; and c. a significant number of people have already accessed tests due to the encouragement to test before they socialise and therefore will not need additional tests sent to them.

In addition, pharmacies have a similar dedicated contract in place for the distribution of LFD tests, with agreed volumes to cover any demand that arises (up to agreed thresholds) and those contracts cover all parts of Scotland including rural areas and islands. The addition of testing for domestic Covid Status Certification purposes has had a minimal impact on the volumes handled through that contract in addition to the 1 million+ tests that we are already distributing each month through pharmacies.

Benefits

The previous BRIAs and the Scottish Government's Evidence Papers^[84] described a range of potential cost impacts on businesses associated with implementation and delivery of certification. These are repeated below, where relevant, for ease of reference.

Vaccine Covid Status Certification is a protection measure providing some public health benefit and would reduce the risk of infection and transmission within the current scope of settings of the virus and subsequent hospitalisations and pressure on the NHS. SAGE said that one approach to reducing the risk of non-isolated cases entering high risk settings is a COVID certification scheme - based on negative testing, vaccination, or record of a prior infection. SAGE considered with a medium confidence that a certification scheme could have medium effectiveness.^[85]

It would also continue to increase customers' options to socialise, providing wider social benefit while offering increased protection through vaccination and testing.

Reducing transmission benefits business as it would reduce the likelihood of implementing more onerous restrictions or closing sectors completely.

There may also be additional benefits to affected venues and businesses should this option result in a competitive advantage for settings in scope, as they would be perceived as 'less risky' environments. This may provide reassurance to previously reluctant or risk-averse customers and encourage greater attendance, with positive revenue impacts.

This is supported by evidence on public attitudes: research carried out by YouGov for the Scottish Government highlighted attitudes towards the benefits and concerns of the Covid Status Certification. The public demonstrate a high awareness of existing Covid Status Certification and are generally supportive recognising the benefits it can bring. The overall support is 60%, with around a fifth (20%) opposing it. Opposition to the scheme is down from polling carried out in September, October and November. (YouGov, fieldwork: 14-15 Dec). Among those likely to visit such a venue, 28% are more likely to visit a venue that requires a vaccine certificate, whereas 22% are less likely to do so (14-15 Dec). 65% agree the scheme is a good thing if it helps prevent the return of other strict measures, 15% disagree (14-15 Dec). 52% agree the scheme should be rolled out to other types of events / venues, with 27% disagreeing (14-15 Dec).

By widening the scheme to include testing, many of the concerns raised by the night-time sector around equalities and potential inequalities faced by those – such as international students with non-MHRA vaccines – who were previously unable to access settings subject to Covid Status Certification have been mitigated against. The potential legal challenge from customers who are refused entry is also mitigated against, given the ease of access to free LFD tests across Scotland. Equalities Impact Assessment explored these issues in fullness.

Under this option, those without vaccine status including those who have been vaccinated with a non-MHRA vaccine, continue to able to gain entry to late night venues with music, alcohol and dancing, or specified indoor and outdoor live events, expanding the potential customer base and revenue opportunity.

Under the current requirement for a minimum of 2 weeks between individuals receiving their second dose of vaccine and being eligible for certification, vaccine uptake data^[86] suggests that:

Around 89.1% of the overall population aged 18+ had received two doses of vaccine by 3^rd January, and would therefore be eligible to access Covid Status Certification by 17^th January

Among younger age groups, this proportion fell to 71.6% of those aged 18-29, 79.4% of those aged 30-39, and 88.7% of those aged 40-49

This suggests a substantial portion of younger demographics may have been unable to access certification, and would not be able to do so for several weeks. Business organisations representing nightclubs and late night hospitality settings have also provided consistent feedback of reduced footfall and revenues as a result of vaccine certification. Under this option, those unable to access Covid Status Certification would continue to be able to access hospitality and events settings with a record of a negative test result, which would increase the potential eligible customer base for these businesses and reduce scope for cancellations. It also potentially reduces the scope for larger groups to be discouraged from attending hospitality settings or events if individual members of their group were not able to access certification.

Increasing the potential customer base is important for the sectors covered by certification, as they have been significantly affected by the impact of the pandemic as a result of restrictions that have required long periods of closures and limits on their operating capacity^[87]. Some of the hospitality businesses affected by Covid Status Certification generate a substantial portion of annual turnover being generated in December^[88], meaning that continued introduction of proof of a negative test result within Covid Status Certification arrangements may be of particular importance to reducing footfall and revenue losses in the coming weeks.

These measures may also provide a degree of additional reassurance to customers that others in affected venues will be fully vaccinated, or will have demonstrated that they have recently had a negative Covid test result. There may also benefits to affected venues and businesses should this option result in a competitive advantage for settings in scope, as they would be perceived as 'less risky' environments, owing to an absence of unvaccinated people. These may provide reassurance to previously reluctant or risk-averse customers and encourage greater attendance, with positive revenue impacts.

However, it may not fully offset the negative impacts on footfall in these settings that could stem from Covid Status Certification being in place. For instance, it may not address footfall lost from spontaneous decision-making if individuals have not taken a Covid test within the required timeframe. There may also be lost footfall from individuals or groups who have chosen not to take up vaccination and who choose not to take tests or share results. Individuals or groups may also continue to choose to socialize in settings where testing or Covid Status Certification is not required.

Individual businesses may also look to offer lateral flow devices to customers at point of entry, should they be unable to offer evidence of vaccination or a negative test result. This could potentially reduce losses in footfall, and reduce risks of anti-social behavior in settings. However, this practice is strongly discouraged by the Scottish Government in updated Guidance, which clearly states that businesses should not distribute test kits to prospective customers. The distribution of test kits must be carefully managed to meet regulatory requirements to be able to recall test kits from users in the event of a performance or safety issue with the tests. Lateral flow tests are designed to be used at room temperature, on a flat, clean, dry surface with the ability of the user to wash their hands thoroughly before use to avoid contaminating the test. Individuals should be encouraged to test before they leave home to reduce the transmission risk.

However, where individuals have received two doses, vaccine efficacy has been shown to decline over time – particularly in relation to Omicron - in terms of preventing infection and severe illness. Two doses of vaccine have also been shown to be less beneficial for individuals in terms of reducing risk of harm from the Omicron variant of Covid than having two doses and an additional booster dose. This suggests that, under this option, the public health benefit of current Covid Status Certification arrangements could potentially decrease over time.

Option 2: Retain mandatory Covid Status Certification in higher risk settings and amend the definition of fully vaccinated to include the requirement for a booster vaccination if a person's primary course of MHRA vaccine was more than 120 days ago and amend the definition of late night venue, with proof of vaccination or record of a negative test (LFD or PCR result) accepted.

Costs

Implementation and Operating Costs

It is anticipated that there would be limited additional costs on most businesses within scope directly associated with implementing this option, over and above those associated with continued implementation of certification more generally.

This option represents an amendment to the definition of fully vaccinated, with the technical functionality to demonstrate expiration and the addition of boosters in the app, PDF and paper certificates. The amendments also seek to clarify the definition of a late night venue, to reduce scope for uncertainty among Local Authorities and businesses affected by certification, and to reduce risks of avoidance behaviour. As a result this change is not intended to bring additional settings in scope. Any individual who is cannot provide proof of full vaccination can provide a record of negative test (LDF or PCR result).

There may be some, albert modest, compliance costs for individuals making use of paper or PDF copies of vaccine certificates, as these would need to be updated to reflect evidence of an individual's last 2 doses of vaccination (+2 weeks) and booster status (+10 days), if issued in advance of 13 December 2021. PDF's can be downloaded immediately so present a minimal risk of delayed compliance, paper certificates will need to be requested and delivered, meaning an individual could be without Covid Status Certification and temporarily unable to access premises and events within scope of the scheme. It is not anticipated that users of the NHS Scotland Covid Status app will be affected by the amendment; boosters were added to the Covid Status App for international use on 9th December and from the 13th January booster information is now also contained within the domestic QR code. Booster information will appear within around 24 hours in the international section and will become part of the domestic QR code 10 days after receiving the booster, in line with the regulatory definition of 'fully vaccinated' for domestic Covid Status Certification purposes. The alternative of a record of a negative test would minimise the risk.

There is clear guidance around how and when to take a LFD test. However, some businesses within scope have indicated that where customers do not have either proof of vaccination or record of a negative test result the business may decide to provide a test kit so that the customer can leave and take the test safely. Any costs of this would fall to that business and if businesses choose to do so, there would potentially be an ongoing cost arising from businesses purchasing additional stock on an ongoing basis.

However, this practice is still strongly discouraged by the Scottish Government in updated Guidance which clearly states that businesses should not distribute test kits to prospective customers. The distribution of test kits needs to be carefully managed to meet regulatory requirements to be able to recall test kits from users in the event of a performance or safety issue with the tests. Additionally, lateral flow tests are designed to be used at room temperature, on a flat, clean, dry surface with the ability of the user to wash their hands thoroughly before use to avoid contaminating the test. Individuals should be encouraged to test before they leave home to reduce the transmission risk.

Wider Impacts

It is recognised that some people will not have had the opportunity to complete their primary course or booster for various reasons e.g. a period of recent infection, they have become newly eligible etc. and that those who have completed their primary course less than 2 weeks ago and those that had their booster less than 10 days ago will therefore not be considered fully vaccinated for the purposes of certification. The offer of COVID-19 vaccination - for all doses - will remain open to those newly eligible, or those who have not yet taken up the offer of vaccination or booster. As the scheme provides for the ability to alternatively provide a record of a negative test (LFD or PCR) we anticipate that the overall impact would therefore be minimal.

Under this option, there may be a risk of economic harm through losses of footfall, or individuals being unaware of the change in vaccination status. The extent of economic harm would arise from the numbers of unvaccinated or insufficiently vaccinated people within the population overall to access Covid Status Certification in the period between vaccination (2 weeks) or booster (10 days) and full efficacy, to the amendment in certifications definition of fully vaccinated. If people within this group were unable to enter settings, this would represent a loss to the potential customer base to affected businesses and sectors, and therefore a source of economic harm. There is a greater risk to loss of spontaneous footfall. However, the provision of a record of a negative test remains and would mitigate against such impacts.

Under the current requirement for a minimum of 2 weeks between individuals completing their primary course of MHRA vaccine and 10 days in between receiving their booster and being eligible for certification, vaccine uptake data^[89] suggests that:

• Around 89.1% of the overall population aged 18+ had received two doses of vaccine by 3^rd January, and would therefore be eligible to access Covid Status Certification by 17^th January
• Among younger age groups, this proportion fell to 71.6% of those aged 18-29, 79.4% of those aged 30-39, and 88.7% of those aged 40-49
• Around 69.2% of the overall population aged 18+ had received a third or booster dose of vaccine by 7^th January, and would therefore be eligible to access Covid Status Certification by 17^th January
• Among younger age groups, this proportion fell to 34.7% of those aged 18-29, 47.3% of those aged 30-39, and 66.1% of those aged 40-49^[90]

Should those currently unable to access Covid Status Certification be unable to access premises that require it, this could generate reductions in footfall and turnover for affected premises. The depth and duration of economic harm would depend on the speed with which people became vaccinated/boosted and eligible for certification, and the availability and use made of alternatives to vaccine certification, such as a record of a negative test result obtained via lateral flow devices or PCR tests. This may present risks for settings where footfall depends on consumer spontaneity, or larger groups of consumers where some members may lack sufficient vaccination.

Under this option, as the percentage of the population who are vaccinated increases and plateaus, implementing Covid Status Certification to include testing could potentially be perceived by some customers as creating more risky environments as vaccination is not incentivized. This could lead to loss in revenue through a small reduction in footfall, attendance and an increase in cancellations.

As per Costs within Option 1 the Royal Mail postal services and pharmacies distributing test kits have experienced a minimal impact upon inclusion of record of a negative test in December. There is no anticipated further impact.

The amendment to the definition of late night venues covered by Covid Status Certification is intended to clarify the definition and is not intended to bring new settings in scope. However it may create additional compliance or revenue costs for individual businesses that are obliged to implement Covid Status Certification or amend business models as a result. It is acknowledged that industry organisations have raised concerns that the change in definition risks bringing premises into scope that have previously taken steps to legitimately remove themselves from Covid Status Certification requirements^[91].

However, it is not intended or envisaged by Scottish Government that the change of definition will expand the range of premises that potentially fall within the scope of Covid Status Certification beyond those that were within the original intent of certification. It is designed to address instances where businesses whose activities fell within the spirit of Covid Status Certification regulations, but who made use of lack of clarity in the existing definition to avoid requirements of Covid Status Certification without making alterations to their business model. It is not currently possible from official data to evidence the number of businesses, if any, that will be affected by the change in definition. However, initial engagement with Local Authority regulators indicates a very small number of additionalpremises overall.

This change may also have impacts on footfall for individual businesses that fall within scope of the amended definition, though these would be mitigated to some extent by the continued inclusion of the option of provision of a negative test result. It is currently unclear how many businesses may fall within this.

Benefits

This option could provide public health benefit as it would contribute to reducing the risk of infection and transmission of the virus and subsequent hospitalisations and pressure on the NHS over and above that provided by Option 1. This option would retain customers' options to socialise, providing wider social benefit while offering increased protection through vaccination, boosters and testing. SAGE said that one approach to reducing the risk of non-isolated cases entering high risk settings is a COVID certification scheme - based on negative testing, vaccination, or record of a prior infection. This option will maintain or increase the public health benefit relative to Option 1, by reflecting the increased protection offered by completion of a primary course of MHRA vaccine and booster if more than 120 days since primary course, particularly against Omicron.

SAGE said that one approach to reducing the risk of non-isolated cases entering high risk settings is a COVID certification scheme - based on negative testing, vaccination, or record of a prior infection. SAGE considered with a medium confidence that a certification scheme could have medium effectiveness.^[92]

The amendment to the definition of fully vaccinated and boosters may also provide a degree of additional reassurance to customers that others in affected venues will be fully vaccinated, or will have demonstrated that they have recently had a negative Covid test result. There may also be benefits to affected venues and businesses should this option result in a competitive advantage for settings in scope, as they would be perceived as 'less risky' environments, owing to an absence of unvaccinated or untested people. Both amendments may provide reassurance to previously reluctant or risk-averse customers and encourage greater attendance, softening impacts of restrictions.