CRWIA title: The Health Protection (Coronavirus) (Requirements) (Scotland) Amendment (No. 2) Regulations 2021: the introduction of the domestic Covid Vaccine Certification.
Publication date: 30/09/2021
Summary of policy aims and desired outcomes
This Children's Rights and Wellbeing Impact Assessment (CRWIA) analyses the potential impact, both positive and negative, of the domestic use of Covid Vaccine Certification on the promotion of children's rights and wellbeing. The UN Convention on the Rights of the Child (UNCRC) defines a child as anyone under the age of 18. The child wellbeing indicators under the Children and Young People (Scotland) Act 2014 reflect the principles within the UNCRC and also apply to all children up to the age of 18 and so all children are within the scope of this CRWIA.
While it is the view of the Scottish Government that any remaining impacts of Covid Vaccine Certification are currently justified and a proportionate means of helping to achieve the goals set out in the Policy Objectives section. We also recognise that these measures are only required to respond to the current set of circumstances, and only necessary as long as the potential public health benefits can justify any negative impacts caused.
International evidence suggests that crises responses often inadvertently discriminate. The Equality and Human Rights Commission, the Scottish Human Rights Commission and the Children's Commissioner for Scotland stated in April 2020 they had already found increasing evidence that some groups are experiencing disproportionately negative impacts from the virus and some of the responses to it.
The Scottish Government are committed to ensuring that human rights, children's rights and equality are embedded in everything we do and are central to our response to the pandemic. The Framework for Decision Making recognises that harms caused by the pandemic do not impact everyone equally and that we must work to advance equality and protect human rights.
The Health Protection (Coronavirus) (Requirements) (Scotland) Amendment (No. 2) Regulations 2021 (the 'Regulations') are made under powers to make provision for the purpose of preventing, protecting against, controlling or providing a public health response to the incidence or spread of infection, conferred on the Scottish Ministers by schedule 19 of the Coronavirus Act 2020. The Regulations amend the Health Protection (Coronavirus) (Requirements) (Scotland) Regulations 2021 (the 'Principal Regulations').
Covid Vaccine Certification will require certain venues and settings to ensure that 'there is in operation a reasonable system' for establishing that all people in the venue can demonstrate that they are fully vaccinated (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 premise 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 dancing for customers
- 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 (not including 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 premise or relevant event 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.
The scheme will come into force on 1 October 2021 (from 5AM). The requirement on persons responsible for a late night venue or relevant event to ensure there is a reasonable system in operation for checking Certification will not be enforceable under Part 4 of Principal Regulations until 18 October 2021.
Ministers must review the Regulations 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.
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 Covid Vaccine 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 Vaccine Certification schemes 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, from public opinion and from international experience.
Public Health rationale
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 Covid Vaccine 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 was published on 27th August. 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, Real-time Assessment of Community Transmission (REACT-1) in England and the Office for National Statistics (ONS) COVID-19 Infection Survey ONS study.
Therefore, we have strong evidence that vaccines are effective at preventing disease, hospitalisations and deaths: in the four weeks from 21 August 2021 to 17 September 2021, Covid-19 cases increased and surpassed the peak that was seen in early July. Although case rates are now declining, the rate of increase in cases then was less among fully vaccinated individuals. As of 29 September, 70.0% of the population were fully vaccinated, and in the week 18-24 September 46.9% of positive cases were in unvaccinated individuals. However, effectiveness decreases over time for both Pfizer-BioNTech and Oxford-AstraZeneca vaccines due to waning immunity.
High-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. 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 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.
For more information on the Covid Vaccine Certification scheme see the Scottish Government website.