Coronavirus (COVID-19) domestic vaccine certification: business and regulatory impact assessment

Introduction

This BRIA considers the impacts for businesses and consumers of laying the Regulations under the Coronavirus Act 2020 to mandate the domestic use of Covid Vaccine Certification (referred to as 'Certification' hereafter) in higher risk settings.

Policy proposal

Certification will require certain venues and settings to ensure that 'there is in operation a reasonable system' for establishing that all people in the premises can demonstrate that they are fully vaccinated (possess Certification) (unless they fall into one of the exempt categories), and to refuse access to or remove anyone who is neither fully vaccinated or exempt. Fully vaccinated means that a person has completed a full course of an authorised vaccine, with the final dose having been received 14 days before the date on which they seek to enter the late night premises or relevant event.

Initially, the scheme will not include a negative test result as an alternative to proof of vaccination, but this will be kept under review. At this stage, we do not consider that including testing results would be appropriate and, indeed, it could undermine one of the policy aims of the scheme: to increase vaccine uptake. Also, it is important at this stage to prioritise PCR lab capacity for Test and Protect purposes. While promoting regular lateral flow tests (LFD) tests is an extremely important aspect of our overall approach, further work would be required on an optimal approach to incorporating testing into Certification, including consideration of the appropriateness of self-testing in this context.

The scheme will apply in the following higher risk settings.

• late night premises with music, which serve alcohol after midnight and have a designated place for customers to dance
• indoor events (unseated) planned for 500 or more people at any one time
• outdoor events (unseated) planned for 4,000 or more people at any one time
• any event planned for more than 10,000 people at any one time

The following will not qualify as events for the purposes of the scheme:

• a funeral, marriage ceremony, civil partnership registration, or a reception or gathering which relates to a funeral, marriage ceremony or civil partnership registration
• a mass participation event such as a marathon, triathlon or charity walk
• an event designated by the Scottish Ministers as a flagship event according to criteria, and in a list, published by the Scottish Ministers
• showing in a cinema
• a drive-in event
• an organised picket
• a public or street market
• an illuminated trail
• a work or business conference (except any peripheral reception or function outside the core hours of the conference, whether or not alcohol is served)
• a business or trade event which is not open to the public for leisure purposes
• communal religious worship
• an un-ticketed event held at an outdoor public place with no fixed entry points

Trade events attended by members of the public for leisure purposes, for example wedding fairs and craft fairs will not be excepted. The people working at the event will be excepted (such as exhibitors and venue staff).

Ministers have been clear that Certification will not be a requirement for public services or other settings that many people have no option but to attend such as retail, public transport, health services and education.

The following people will be exempt:

• Under-18s
• People who cannot be vaccinated for medical reasons
• People taking part (or who have taken part) in vaccine trials
• The person responsible for the premises
• Workers and volunteers at the venue or event
• Emergency services responders and regulators carrying out their work

The regulations will require the persons responsible for a late night premises or premises where a relevant event takes place to ensure there is a reasonable system in operation for checking that people seeking to enter the premises are fully vaccinated or are exempt, and to have in place a compliance plan for this system. As outlined below enforcement of the regulations commences on 18 October and failure to comply with this will be criminal offence.

The scheme will come into force on 1 October 2021 (from 5AM). The requirement on persons responsible for a late night premises or premises where a relevant event is taking place to ensure there is a reasonable system in operation for checking Certification and to have a compliance plan will not be enforceable until 18 October. Ministers must review all restrictions under the Health Protection (Coronavirus) (Requirements) (Scotland) Regulations 2021 (which include Certification) at least every 3 weeks to assess whether any requirement in the regulations is still necessary to prevent, protect against or provide a public health response to the incidence or spread of infection in Scotland. We will continue to assess whether any less intrusive measures could be introduced to achieve the same combination of policy objectives in respect of the higher risk sectors concerned; if so, the policy will be immediately reviewed.

For more information on Certification, see the Scottish Government website.

Sectoral Guidance is published on the Scottish Government website.

Public Guidance will be published on the Scottish Government website.

NHS Scotland Covid App and Paper Certificate

On 30 September we will launch the NHS Scotland Covid Status App, which contains 2 unique QR codes, with the first detailing a person's name, date of birth and first vaccination, and the second just holding data on their 2^nd vaccination. Further information, such as testing results or recovery status, will be added in a future release of the app. This product has been designed for use for international travel and so it is necessary to include these details to meet EU standards. This App can be used to demonstrate vaccine status in the settings in scope. The Privacy Notice is already online and can be found on NHS Inform: Personal information we process, How we use your data, Your Rights. The Easy Read Version can be found online.

A domestic section of the App is expected to launch in mid-October. This will simply show the person's name and whether they have vaccination status, demonstrated as either a green tick or red cross through the use of the NHS Scotland Covid Check App.

For those who do not have digital access or would prefer a paper copy, a record of vaccination can be requested by phoning the Covid-19 Status Helpline on 0808 196 8565. The paper record of vaccination will then be posted to the address that is held on the National Vaccination Service System (NVSS).

When registering an account on the App the user needs to verify their identity. This is for privacy protection, to ensure that the user's identity has been verified before they are given access to medical records.

The App will use biometric identification software at the set up stage. This means users will be asked to scan a photo of their ID – for example a passport or driving license – and then take a live photo or video of themselves. The software will then use their live photo to compare likeness with the photo in their ID and confirm their identity. There will be manual verification for the small number of cases which fail the automatic process. For the limited number of cases where a person's identity cannot be verified in the App or through manual intervention, the individual can call the Covid-19 Status Helpline, or use NHS Inform to request a paper Certificate, which will be posted to them.

Individuals who are medically exempt can apply for a paper Certificate through the NHS Inform website. This will be a paper Certificate and will have enhanced security features. Medical exemptions cannot be displayed on the international App due to EU specification but may be included in a future release on the domestic version of the App.

All clinical trial participants have received a letter from their Principal Investigator, and a secure certificate indicating their trial status, both of which can be used to access a regulated setting.

Vaccinated children, as outlined above, are exempt from certification by virtue of their age. Therefore, they are not required to prove their vaccination status.

While children are exempt, 12-17 year olds who have been vaccinated may choose to access their record of vaccination by downloading a PDF via NHS Inform or requesting a paper certificate by calling the Covid-19 Status Helpline.

To support accessibility, we will translate the certificate into different languages and developan Easy Read, braille and large print version. It will also be available in audio format and British Sign Language.

Policy Objectives

In line with our strategic intent to 'suppress the virus to a level consistent with alleviating its harms while we recover and rebuild for a better future', the policy objectives of Certification are to:

• Reduce the risk of transmission of Coronavirus
• Reduce the risk of serious illness and death thereby alleviating current and future pressure on the National Health Service
• Allow higher risk settings to continue to operate as an alternative to closure or more restrictive measures
• Increase vaccine uptake

An evidence paper summarising the range of evidence available on Certification has been published alongside the impact assessments. Consistent with our approach throughout the pandemic, the paper adopts a four harms approach covering the direct health harms of Covid-19, the indirect health harms, the social and the economic harms. Evidence is drawn from clinical and scientific literature, public opinion and international experience.

Public Health Rationale for Government intervention

Although daily Covid case numbers are dropping in Scotland, case numbers remain too high, and we still have a large susceptible population which could lead to cases rising again. In addition, the number of people in hospital and ICU continues to increase. The winter period ahead will pose significant challenges of increased transmission and related pressure on the National Health Service (this impact assessment should be considered alongside the latest State of the Epidemic report). We remain of the view that action is therefore needed across all sectors to ensure adherence to baseline measures. Drawing on the evidence so far available, we consider that Certification has a vital role to play as one such measure.

While no vaccine is 100% effective at preventing infection, disease and transmission, and they do not completely break the link between a high volume of positive cases and serious pressure on healthcare services, they are our best route out of the pandemic. Vaccines help prevent transmission of the virus, as vaccinated people are less likely to become infected and ill than unvaccinated people (and only infected people can transmit the virus). The UK Vaccine Effectiveness Expert Panel (VEEP) is a group of scientific and analytical specialists from academia and government in the UK who provide a consensus view on vaccine effectiveness, split by variant, vaccine and dose. They have published estimates for vaccine effectiveness based on an assessment of the evidence at the time of writing and as new evidence or data emerges, SAGE will update its advice. A summary published on 27 August can be found online. More analysis can be found in a number of large studies including EAVE-II (Early Pandemic Evaluation and Enhanced Surveillance of COVID-19) in Scotland^[1], Real-time Assessment of Community Transmission (REACT-1) in England^[2] and the Office for National Statistics (ONS) COVID-19 Infection Survey ONS study.^[3]

In August 2021, COVID-19 cases increased and surpassed the peak that was seen in early July 2021 but are now declining. The rate of increase in cases in August 2021 was less among fully vaccinated individuals compared to partially or unvaccinated individuals. As of 29 September, 70.0% of the population were fully vaccinated,^[4] and in the week 18-24 September 46.9% of positive cases were in unvaccinated individuals.^[5] However, effectiveness decreases over time for both Pfizer-BioNTech and Oxford-AstraZeneca vaccines due to waning immunity.^[6] Higher risk settings tend to have the following characteristics: close proximity with people from other households; settings where individuals stay for prolonged periods of time; high frequency of contacts; confined shared environments, and poor ventilation.^[78] Therefore, by restricting access in these settings to customers who are fully vaccinated, these are less likely to be settings of infection, and it is less likely that infections within them will lead to illness. Consequently, we can reduce the risk of transmission of the virus and help reduce pressure on health services while also allowing settings to operate as an alternative to closure or more restrictive measures. As such, we consider Certification, as part of a package of measures such as improved ventilation, to be a necessary and proportionate public health measure.