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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

This business and regulatory impact assessment (BRIA) considers the impacts for businesses and consumers of amending 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 amending the definition of late night venue.

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Summary and recommendations

The Scottish Government's Strategic Framework includes a package of measures which, taken together, are designed to suppress transmission of the virus. 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.

This BRIA has set out the relative costs and benefits of an amended Covid Status Certification option, compared against the Covid Status Certification currently in place; both of which have the intended effect of reducing the risk of transmission, reducing the risk of serious illness and death thereby alleviating current and future pressure on the NHS, reducing the risk of settings specified in the scheme being required to operate under more restrictive protections, or to close; and increase the protection enjoyed by those using settings covered by the scheme and their contacts. Our assessment of the options has been informed as much as possible by engagement with the sectors in scope.

A summary of costs and benefits associated with the options is presented below:

Measure: 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).

Benefits: Sectors in scope continue to be characterised by many of the high risk factors associated with transmission of the virus. Covid Status Certification is an additional means through which we can continue to reduce the risk of transmission. As such, it will mitigate the risk of closure and more restrictive measures, and consequent negative economic impact.

This option would result in some public health benefit and would reduce the risk of infection and transmission of the virus and subsequent hospitalisations and pressure on the NHS.

Costs: These include both direct costs of compliance with the regulations (staffing and infrastructure); local government monitoring and enforcement costs; potential losses of footfall and revenue arising from reduction of customer base for affected venues, particularly among younger demographics; cashflow impacts of requirements to provide refunds for ticketed events; business impact from cancellation or reduced scale of events.

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.

Measure: 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.

Benefits: 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. It would reduce the risk of infection and transmission of the virus and subsequent hospitalisations and pressure on the NHS, maintain customers options to socialise, providing wider social benefit while offering them increased protection through vaccination and testing.

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 Covid Status Certification more generally.

This option represents an amendment in 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.

There is a risk with this option that those customers who have not completed their primary course of MHRA vaccination or had the required booster - if over 120 days - and those that are not yet eligible for certification, due to having their primary completion dose of vaccine or booster within 2 weeks and 10 days respectively, could lead to loss in footfall for businesses.

Similarly, those customers opting to use paper or PDF versions of certificates may need to request a new paper version or download a new PDF if dated in advance of 13th December 2021, this again could lead to loss of footfall.

Additionally there is a risk that confusion amongst customers could lead to a loss of footfall as updated proof of vaccination and boosters may not have been acquired.

Summary

We conclude that Option 2 – the retention of mandatory Covid Status Certification in higher risk settings (current policy) and amendment of 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 amendment to the definition of late night venue is a necessary and proportionate response which, alongside an effective baseline of public health protections, will best meet our policy objectives. Continued monitoring and evaluation will inform implementation as well as regular review (at least once every 21 days) of the Regulations to determine 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.

Contact

Email: covid19-certificationhub@gov.scot

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