HOUSE OF LORDS Secondary Legislation Scrutiny Committee 8th Report of Session 2021-22 - UK Parliament
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HOUSE OF LORDS
Secondary Legislation Scrutiny Committee
8th Report of Session 2021–22
Drawn to the special attention of the House:
Draft Medical Devices (Coronavirus Test Device
Approvals) (Amendment) Regulations 2021
Draft Health and Social Care Act 2008 (Regulated
Activities) (Amendment) (Coronavirus)
Regulations 2021
Draft Motor Fuel (Composition and Content)
and the Biofuel (Labelling) (Amendment) (No. 2)
Regulations 2021
Town and Country Planning (Development
Management Procedure and Section 62A
Applications) (England) 2021
Includes information paragraphs on:
6 instruments relating to COVID-19 Draft Revision of the Highway Code Rules to
improve safety for drivers using Motorway and
Draft Railway (Licensing of Railway
high-speed roads
Undertakings) (Amendment) Regulations
2021
Ordered to be printed 6 July 2021 and published 8 July 2021
Published by the Authority of the House of Lords
HL Paper 40Secondary Legislation Scrutiny Committee The Committee’s terms of reference, as amended on 13 May 2021, are set out on the website but are, broadly: To report on draft instruments published under paragraph 14 of Schedule 8 to the European Union (Withdrawal) Act 2018; to report on draft instruments and memoranda laid before Parliament under sections 8 and 23(1) of the European Union (Withdrawal) Act 2018 and section 31 of the European Union (Future Relationship) Act 2020. And, to scrutinise – (a) every instrument (whether or not a statutory instrument), or draft of an instrument, which is laid before each House of Parliament and upon which proceedings may be, or might have been, taken in either House of Parliament under an Act of Parliament; (b) every proposal which is in the form of a draft of such an instrument and is laid before each House of Parliament under an Act of Parliament, with a view to determining whether or not the special attention of the House should be drawn to it on any of the grounds specified in the terms of reference. The Committee may also consider such other general matters relating to the effective scrutiny of secondary legislation as the Committee considers appropriate, except matters within the orders of reference of the Joint Committee on Statutory Instruments. Members Baroness Bakewell of Hardington Mandeville Viscount Hanworth Lord Lisvane Rt Hon. Lord Chartres Lord Hodgson of Astley Abbotts Lord Sherbourne of Didsbury Rt Hon. Lord Cunningham of Felling (Chair) Baroness Watkins of Tavistock Lord German The Earl of Lindsay Registered interests Information about interests of Committee Members can be found in the last Appendix to this report. Publications The Committee’s Reports are published on the internet at https://committees.parliament.uk/ committee/255/secondary-legislation-scrutiny-committee/publications/ Committee Staff The staff of the Committee are Christine Salmon Percival (Clerk), Philipp Mende (Adviser), Jane White (Adviser) and Louise Andrews (Committee Operations Officer). Further Information Further information about the Committee is available at https://committees.parliament.uk/ committee/255/secondary-legislation-scrutiny-committee/ The progress of statutory instruments can be followed at https://statutoryinstruments. parliament.uk/ The National Archives publish statutory instruments with a plain English explanatory memorandum on the internet at http://www.legislation.gov.uk/uksi Contacts Any query about the Committee or its work, or opinions on any new item of secondary legislation, should be directed to the Clerk to the Secondary Legislation Scrutiny Committee, Legislation Office, House of Lords, London SW1A 0PW. The telephone number is 020 7219 8821 and the email address is hlseclegscrutiny@parliament.uk.
Eighth Report
INSTRUMENTS DRAWN TO THE SPECIAL ATTENTION OF
THE HOUSE
Draft Medical Devices (Coronavirus Test Device Approvals)
(Amendment) Regulations 2021
Date laid: 18 June 2021
Parliamentary procedure: affirmative
These draft Regulations propose a requirement for all COVID-19 tests sold in the
UK to undergo a mandatory approval process. This is to ensure that tests for sale
in the UK meet minimum standards in their sensitivity and specificity, similar to
the quality standards that are already in place for tests used by the NHS. Separate
quality requirements have also already been introduced for tests used by international
travellers. The Department of Health and Social Care says that while the current
market is “overwhelmingly dominated” by free NHS tests, “rapid intervention”
is required to address quality issues with regard to the tests that are currently sold
and to “create a strong regulatory framework so that consumers can buy tests with
confidence and without confusion” once the market share of such tests grows, as part
of the long-term management of COVID-19.
The draft Regulations are drawn to the special attention of the House
on the ground that they are politically or legally important and give
rise to issues of public policy likely to be of interest to the House.
1. These draft Regulations have been laid by the Department of Health and
Social Care (DHSC) with an Explanatory Memorandum (EM). The
instrument proposes a requirement for all COVID-19 tests sold in the UK to
undergo a mandatory approval process, so that they are validated as meeting
high quality standards, similar to the process already in place for tests used
and distributed for free by the NHS. This is to ensure that tests for sale in
the UK, both molecular or antigen tests,1 meet minimum standards in their
sensitivity and specificity.2 According to DHSC, the market is currently
overwhelmingly dominated by free tests provided by the NHS; the aim of
these draft Regulations is to address the poor quality of many tests for sale in
the UK at present, and to ensure that a new approval process for such tests
is in place as their market share grows.
Background
2. DHSC says that the Government want to ensure that COVID-19 test kits
sold in the UK, including those sold in pharmacies, are of the same high
quality as those used by the NHS, as poorly performing tests giving false
results could undermine national health efforts in containing the pandemic.
1 Molecular tests include polymerase chain reaction (PCR) tests which are mainly used for people with
symptoms and which check for the genetic material (RNA) of the virus in the sample. The sample is
sent for processing at a laboratory. Antigen tests include rapid Lateral Flow Device (LFD) tests which
are only used for people who do not have symptoms. They detect proteins called ‘antigens’ produced
by the virus and give results after 30 minutes.
2 While sensitivity is the proportion of patients with COVID-19 who have a positive test, or the true
positive rate, specificity is the proportion of patients without COVID-19 who have a negative test, or
the true negative rate.2 SECONDARY LEGISLATION SCRUTINY COMMITTEE
The Department explains that during the procurement of Lateral Flow
Device (LFD) tests for the NHS, only 25% passed through all stages of
validation including assessments of performance and quality standards,
and that under the current regulatory regime, the 75% of LFD tests which
were assessed as not meeting the performance and quality standards of the
NHS still qualify “as fit for market”. DHSC says that “rapid intervention”
is therefore required to address this quality issue urgently and to “create a
strong regulatory framework so that consumers can buy tests with confidence
and without confusion”.
3. The Department adds that, as part of managing COVID-19 in the long
term, the Government want to support a “thriving private sector market for
COVID-19 detection tests, to supplement and support testing led by NHS
Test and Trace” and “to encourage the private sector to bring a broad range
of testing products and services to market to meet the differing needs of
businesses and individuals and provide consumer choice”, while ensuring that
all tests that are available meet minimum performance standards. According
to DHSC, the new quality requirements introduced by this instrument “will
make the UK private testing market more competitive, as manufacturers will
need to improve the accuracy and speed of their tests in order to outcompete
competitors”.
4. We question whether intervention more than a year into the pandemic can
still be considered “rapid”, but note that the changes are timed to ensure that
a validation process will be in place for a time when privately bought tests
play a more significant role in the long-term management of COVID-19.
How the new validation process will work
5. The new validation process will be managed by DHSC. The Department
says that it considered a third-party conformity assessment but discounted
such an approach due to the time it would take to implement it, but that this
will be reconsidered as part of the planned review process and “once the
immediate market failure has been remedied”.
6. Under the new process, anyone seeking to place a test on the market in the
UK will need to register via an online portal and submit data for a desk-
based assessment of the specificity, sensitivity and limits of detection of the
tests. DHSC says that to avoid any duplication, tests supplied by government
will be exempt, as the new market validation process is based on the effective
validation process that the Department used during public procurement.
DHSC adds that to avoid any potential supply issues in NHS hospitals
where a contract already exists for the supply of tests, those tests will be
grandfathered and exempt for the duration of the contract. Where such a
contract exists, it can continue to be honoured by the manufacturer, even if
the same test subsequently fails the new market validation process.
7. We asked whether the potential use of such poor-quality tests in NHS
settings meant a risk of false results and therefore of further spread of the
virus. DHSC told us that:
“The risk that the NHS would ever be in a situation where it would
need to use poor quality tests is judged to be extremely low, as the NHS
feel that even a less accurate test may be better than no test at all and
may have some diagnostic value in the hands of clinicians if certain
mitigations are put in place. By contrast, it is not possible to say thatSECONDARY LEGISLATION SCRUTINY COMMITTEE 3
such mitigations would be put in place when used by other providers of
testing outside the NHS.”
8. We note the Department’s explanation which appears to suggest that less
accurate tests can still be of diagnostic value for the NHS if such tests are
used by clinicians who are able to consider other factors and information and
therefore put any test results into a wider clinical context.
9. There will also be a transition period for tests that are already available
on the UK market, to ensure that they can continue to be sold while they
proceed through the new validation process. To remain on the market,
manufacturers will be required to have submitted their application by 1
September, the validation process must be complete, and the COVID-19
test must have passed the minimum performance threshold by 31 October in
order to remain on the market from 1 November 2021 onwards.
10. DHSC says that the new validation process will improve quality standards in
specific areas of test performance, and that it will complement but not replace
the CE marking standard which currently applies to all tests sold in the UK.
The Department explains that under the new validation process, the results
of all tests that pass validation will be published online, so that consumers
will have a single register of all tests that are on the market, enabling them
to make informed decisions when buying a test. Tests that fail to meet the
minimum levels of sensitivity and specificity will not pass validation and will
not be allowed for sale in the UK. The online register of validated tests will
be available to read in hard copy on request.
11. DHSC emphasises that this new process will be an improvement on the
current situation in which the data collection and analysis used by each
manufacturer of COVID-19 tests to achieve its CE marking is unique and
designed by each manufacturer, making it difficult for consumers to compare
the data and acting as a barrier to effective competition. Furthermore, the
Department will carry out the validation itself, in contrast to the CE marking
process which in relation to most COVID-19 tests essentially involves a self-
certification process in which manufacturers affirm that their products meet
the relevant standards.
12. Asked for further information about the new validation process and how it
differs from the CE marking process, DHSC told us that:
“The CE marking process is far less rigorous than the CDTA desktop
review. CE marking requirements do not specify sample size, sample
type (clinical v contrived) or present the raw data from which an accurate
assessment of the performance can be made. Many of the CE marked
products that have been reviewed previously have insufficient and poor
data sets that do not accurately reflect how a test product performs.
This data and evidence does not facilitate accurate assessment of the
product by the end-user and can be misleading. A common example is
“front-loading” of data, whereby the CE marked instructions for use
will provide performance data based on a selection of samples with
a very high viral load thus the test appears to be highly sensitive but
in fact may have a poor sensitivity. Other products have used clinical
symptoms as the comparator method rather than a gold-standard PCR
comparison. [ … ]4 SECONDARY LEGISLATION SCRUTINY COMMITTEE
The desk top review is undertaken by an independent expert and
ensures the validity and quality of the data used by the manufacturer
for their CE mark self-certified claims. The pandemic has highlighted
the inconsistency in the data behind such claims; for example using sets
of samples that will make the performance of their test look better than
if it was used on all samples, or not providing information on how their
test works for all Variants of Concern. The data is then compared to
defined performance thresholds for different testing technology types,
as set within the legislation.”
13. Asked about the independent experts carrying out the assessments, DHSC
told us that:
“We are currently recruiting individuals with appropriate scientific
backgrounds and to add to the current scientists we have seconded in
from the NHS and universities to put our validator team on a more
stable long term footing.”
Fees
14. There will be a standard fee of £14,000 which is intended to cover the
full costs of each validation, with a discounted rate for Small and Medium
Enterprises of £6,200. According to DHSC, these fees are in line with those
applied to other similar processes.
Enforcement
15. The Department says that the new system will be underpinned by the standard
enforcement regime for medical devices.3 This will use the Medicines and
Healthcare products Regulatory Agency’s intelligence-led approach to ensure
manufacturers and retailers comply with their obligations. Local authority
trading standards will ensure that unapproved tests are removed from sale,
and penalties4 will be applied to retailers and manufacturers which breach
their obligations.
Impact
16. The EM estimates that the maximum additional costs for manufacturers
will be £70 million in a £3.7 billion market, leading to potential prices rises
for consumers of around 2%. DHSC says that a full Impact Assessment (IA)
is being developed and will be published ahead of the parliamentary debate
on these draft Regulations. The Department told us that it had received a
first round of comments from the Regulatory Policy Committee (RPC) and
was working “at pace” to address these. While we welcome the financial
information provided in the EM, we reiterate that, as set out in our
guidance,5 failure to have the IA validated by the RPC in time is an
internal planning matter for the Department but not an acceptable
excuse for failing to present all the necessary documentation at the
time the instrument is laid before Parliament.
3 As specified in Chapter 3 of Part 4 of the Medicines and Medical Devices Act 2021.
4 As set out in the Consumer Protection Act 1987: a prison term of up to six months or a fine not
exceeding level 5 on the standard scale or both.
5 See paras 29 and 30 of the SLSC’s guidance for departments: https://www.parliament.uk/globalassets/
documents/lords-committees/secondary-legislation-scrutiny-committee/guidance-documents/
guidance_departments_slsc-_may-2021.pdf.SECONDARY LEGISLATION SCRUTINY COMMITTEE 5
Timing
17. Given the importance of reliable, high-quality testing devices for the effective
management of COVID-19 in the long term, we asked the Department why
the new validation process had not been introduced earlier. DHSC responded
that:
“The market is currently overwhelmingly dominated by free tests
provided by NHS Test and Trace. The exception to that being
international travellers where separate regulation has already set in
place standards for those tests.6 However as it became clear many of the
COVID-19 tests being offered to UK government weren’t fit for purpose
we began expedited work to develop regulations and lay them, this is
why elements like the Impact Assessment have been done in parallel in
order to get regulations in place as soon as possible. As the private sector
currently has a low market share this regulation will be ready and in
place as that share grows.”
18. We note that separate requirements have already been introduced for tests
used by international travellers, and the intention of the Department that
tests which are sold should play a bigger role in the long-term management
of COVID-19. It is essential that free NHS tests remain available at
this stage of the pandemic.
Conclusion
19. The introduction of a quality approval process for all COVID-19 tests sold
in the UK is welcome. It will be important, however, that this new process is
rigorous to ensure that all tests for sale in the UK meet the relevant quality
standards, especially if such tests are to play a greater role in the long-term
management of COVID-19. In the meantime, it is essential that free NHS
tests continue to be available. These draft Regulations are drawn to the
special attention of the House on the ground that they are politically
or legally important and give rise to issues of public policy likely to be
of interest to the House.
6 Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment)
Regulations 2021 (SI 2021/682), see: SLSC, 5th Report, Session 2021–22 (HL Paper 21), 17 June
2021.6 SECONDARY LEGISLATION SCRUTINY COMMITTEE
Draft Health and Social Care Act 2008 (Regulated Activities)
(Amendment) (Coronavirus) Regulations 2021
Date laid: 22 June 2021
Parliamentary procedure: affirmative
This instrument would make it mandatory for anyone working in a care home
to be fully vaccinated against coronavirus unless subject to medical exemption.
The Explanatory Memorandum lacks all practical detail about what evidence is
acceptable, and how a “registered person” “may process” that information. The
Department of Health and Social Care (DHSC) promises more detail in operational
guidance but that will not be available until the end of July. Care home residents,
their family and friends, and emergency services are exempt, but the Regulations
cover a wide range of people including staff, tradespeople and service providers who
might routinely need to enter a care home. Although a 16 week grace period is
provided to allow for existing staff and others to complete their vaccinations, no
analysis is given of the number of current staff and others who may not comply or
the potential impact on care homes if they become ineligible for work. We would
normally expect that information to be included in the Impact Assessment but that
has not been made available either.
This information and the operational guidance are crucial to
the House’s understanding of how the policy underlying these
Regulations will work–for both individuals and on a sector wide
basis. Without this, effective Parliamentary scrutiny is impossible.
We therefore recommend that the debate on the instrument should
be deferred until both are made available.
In the meantime, because much remains unclear, despite the additional material
published at Appendix 1 to this report, we have invited a DHSC Minister to give
oral evidence on these Regulations at our next meeting. In particular, we will ask:
- Why none of the practical information about how the legislation is to operate is
included in the legislation but left to guidance that has not yet been published;
- Why there is no analysis of why DHSC’s vaccination programme has not already
achieved the required levels despite care home staff being prioritised, or why there is
regional variation;
- Why there is no discussion of the potential impact of the policy on the care home
workforce, of any risk to the viability of care homes as a result, or of any other
options considered for achieving this objective;
-Why there has been no exposition about the degree and nature of opposition
expressed during the consultation;
- Why the EM does not state that this legislation is not just intended as a pandemic
measure but is permanent, and that DHSC intends to consult on extending the
requirement to other settings, including the NHS, and other vaccinations.
These Regulations are drawn to the special attention of the House on
the grounds that the explanatory material laid in support provides
insufficient information to gain a clear understanding about the
instrument’s policy objective and intended implementation.SECONDARY LEGISLATION SCRUTINY COMMITTEE 7
20. This instrument would make it mandatory for anyone working in a care
home to be fully vaccinated against coronavirus unless subject to medical
exemption. The requirement is however broader than just staff of the care
home: regulation 5 requires a “registered person” (A)
“to secure that a person (“B”) does not enter the premises used by A
unless B has provided A with evidence that satisfies A that either
(i) B has been vaccinated with the complete course of doses of an
authorised vaccine; or
(ii) that for clinical reasons B should not be vaccinated with any
authorised vaccine;”
21. There are exceptions for residents of care homes, their family and friends,
emergency services and anyone providing “urgent maintenance assistance”,
but a wide range of professionals, tradespeople, people making deliveries and
service providers are included in the definition.
22. In the Explanatory Memorandum (EM), the policy is sketched out at
high level with no information about the practicalities: for example, what
constitutes evidence? will the registered person have to photocopy the
plumber’s NHS record to prove that they have made the required check?
what are the sanctions for failure to check? what is the scope of “registered
person”—is it the home manager or any care worker or nurse who happens to
be on duty at the time person B tries to enter? We have asked the Department
of Health and Social Care (DHSC) an extensive list of questions (which is
included at Appendix 1).
23. We believe that much of the information that we—and the House—need to
understand the intention of, and how, the policy will operate would probably
be included in the operational guidance, but—we have been told—the
Government do not plan to publish that until the end of July.
Vaccination levels required and achieved
24. The EM bases the policy on the premise that the Scientific Advisory Group
for Emergencies (SAGE) has advised that at least 80% of staff and 90% of
residents in a care home should have had a first vaccination dose to provide
a minimum level of protection against outbreaks of COVID-19.
25. The EM states that: “Only 65% of care homes in England are currently
meeting this dual threshold, and the proportion is only 44% of care homes
in London.”
26. The link given in the footnote in the EM takes the reader to statistics that
only relate to care homes for those aged over 65,7 and within that, one source
shows that 70.2% of all staff have received both doses, whereas a table based
on self-reporting states that only 48.1% of care homes have met the SAGE
standard.
27. The picture is further confused by the original policy having been formed
only in relation to care homes for the over 65 age group but having been
7 NHS England, COVID-19 Vaccinations of Residents and Staff in Older Adult Care Homes by
NHS Region [Excel spreadsheet]: https://www.england.nhs.uk/statistics/wp-content/uploads/
sites/2/2021/06/Older-Adult-Care-Homes-Vaccinating-80-of-staff-and-90-of-residents-June-2021.
xlsx [accessed 7 July 2021].8 SECONDARY LEGISLATION SCRUTINY COMMITTEE
extended later, after the consultation exercise, to include all care homes.
There are around 15,000 care homes of which around 10,500 (70%) cater
(but not exclusively) for older adults.
28. DHSC has provided further explanation (see Q1 in Appendix 1) which now
cites that take-up of the first dose in the care home workforce stands at
85.6%, but also states that there is significant variation at regional, local
and individual care home level,8 so that only 65% of care homes for the
over 65 age group are meeting the standard being set by SAGE. Although
these Regulations apply to all care homes, DHSC’s statistics randomly veer
between all care homes and those for the over 65 age group (see for example
Q7 in Appendix 1)
“As of Sunday 27 June, 402,231 staff in care homes serving any older
people have been vaccinated with the first dose (85% of total staff).
347,236 staff are reported to have received a 2nd dose (74% of staff)
based on responses from 98% of providers.”
29. It should be noted that, although the SAGE advice relates to first doses,
it does also state that higher coverage and both doses would increase the
level of protection. At no point, however, does the DHSC articulate its
justification for requiring staff to have received both doses or, as an
alternative, to be banned from entering their workplace.
30. The EM lists a number of DHSC initiatives targeted at improving uptake in
the sector but does not address why they have not achieved the required level
of vaccination compliance. No explanation is provided about why, despite
being prioritised, a large proportion of care home staff have so far not received
both doses to meet the standard being set by these Regulations. Nor does
the EM explain why, although first dose vaccination among staff is now over
85%, only 65% of care homes (44% in London) meet the SAGE standard.
The House may wish to ask the Minister for a clearer explanation
of the criteria in the Regulations and a better analysis of these local
failures.
Impact
31. The EM describes the impact as follows: “providers are likely to experience
a short-term cost of dealing with staff absences, if workers chose not to get
vaccinated as a result of the policy”. That seems to assume that all workers
will eventually comply.
32. A 16-week grace period from the instrument becoming law is allowed for
those who have not taken the opportunity to be vaccinated to do so. There is
no estimate given, however, of the percentage who, for whatever reason, may
chose not to comply. Nor is there any analysis of the potential consequences if
a significant proportion of care home staff become ineligible for employment
because they have chosen not to have the vaccine.
33. Paragraph 12.3 of the EM says that, for local authorities, “contingency plans
should already be in place to deal with workforce shortages and provider
failures as set out in the Care Act”. But no reassurance is given that these will
remain feasible if there is a diminished pool of qualified staff to recruit from.
8 NHS England, COVID-19 Vaccinations [Excel spreadsheet]: https://www.england.nhs.uk/statistics/
wp-content/uploads/sites/2/2021/07/COVID-19-weekly-announced-vaccinations-01-July-2021.xlsx)
[accessed 7 July 2021].SECONDARY LEGISLATION SCRUTINY COMMITTEE 9
Such scenarios are usually dealt with in the Impact Assessment (IA) but,
although we are told one has been prepared, it has not been made available.
Consultation Analysis
34. We also note that the consultation analysis presented in the EM focuses only
on the positives and does not explain the reasons given in the high number
of objections (57%). Further information is provided in the supplementary
information (see Q2 in Appendix 1). This indicates that a significant number
of people take the view that the policy is contrary to the European Convention
on Human Rights on the ground, they say, that it infringes their bodily
autonomy or is contrary to their beliefs. We have, for example, received a
submission from the Christian Science Committee on Publication9 which
says that vaccination is an individual choice and the imposition of it threatens
the operation of the registered care homes that they run according to their
beliefs. Although the EM contains the standard Ministerial statement
that this legislation is compatible with the Convention, we would
have expected DHSC to have provided stronger supporting evidence
and, in particular, its response to the human rights issues raised in
response to the consultation.
Future extension?
35. This policy is not being put forward purely as a short-term measure to deal
with the pandemic. The instrument includes a statutory review clause,
requiring the Health Secretary to review the Regulations and lay a report
before Parliament annually. It does not include any sunset provision.
36. What started as a measure for staff in care homes for the elderly has
already expanded to include (1) other visitors such as other professionals
and tradespeople, and (2) all care homes. The Government response to the
consultation exercise also indicates that DHSC is considering whether to
expand the scope of the mandatory requirement:
“We are therefore considering whether this should be an ongoing
requirement which could be applied across health and social care. There
is also the question of whether the policy should be extended to other
vaccines, such as the flu vaccine.”10
37. The Committee is unclear why similar NHS settings are not included, but
DHSC would also need to explain current levels of vaccination and potential
impact on NHS staff.
Conclusion
38. No one can be unaware of the increased risks to those living in residential
care homes from COVID-19 and that requiring staff to be fully vaccinated
may be the way forward, but the approach of these Regulations, in requiring
both doses, is much stronger than the advice offered by SAGE: The DHSC
needs to justify this policy choice.
9 Published in full on our webpage. Secondary Legislation Scrutiny Committee, scrutiny evidence
page: https://committees.parliament.uk/committee/255/secondary-legislation-scrutiny-committee/
publications/8/scrutiny-evidence/.
10 DHSC, Making vaccination a condition of deployment in care homes: government response (16 June 2021),
Section 4.2 Policy Scope.10 SECONDARY LEGISLATION SCRUTINY COMMITTEE
39. For many years we have made clear to departments that it is not acceptable
to present legislation for scrutiny without all the explanatory material. We
anticipate that the IA will contain a more precise analysis of the care home
workforce, the regional variation in vaccination levels, and a discussion of
whether the standard is likely to be met within the timetable set and how
care homes will be able to continue in operation if it is not.
40. Equally, we have consistently made clear our view that all key definitions and
criteria on which decisions that might affect a person’s welfare or livelihood
will be made, should be included in legislation and not put in guidance that
is not subject to Parliamentary scrutiny or approval.
41. DHSC has laid this instrument with neither. This information and the
operational guidance are crucial to the House’s understanding of how
the policy underlying these Regulations will work–for both individuals
and on a sector wide basis. Without them, effective Parliamentary
scrutiny is impossible. We therefore recommend that the debate on
the instrument should be deferred until they are made available.
42. In the meantime, because much remains unclear, despite the additional
material published in the Appendix to this report, we have invited a DHSC
Minister to give oral evidence on these Regulations at our next meeting.SECONDARY LEGISLATION SCRUTINY COMMITTEE 11
Draft Motor Fuel (Composition and Content) and the Biofuel
(Labelling) (Amendment) (No. 2) Regulations 2021
Date laid: 21 June 2021
Parliamentary procedure: affirmative
To reduce greenhouse gas emissions, “premium” petrol in the UK is currently
blended with up to 5% ethanol, known as E5 grade. These Regulations will
require the ethanol content to be increased to up to 10% (E10) with effect from
1 September 2021 to meet future emissions targets. This is a complex policy area
but issues are raised in the Impact Assessment (IA) that are glossed over in the
Explanatory Memorandum (EM), for example, the role of E10 in propping up
the UK’s struggling ethanol production sector, the comparative CO2 savings from
ethanol and other biofuels, and the long term costs to motorists as E10 delivers lower
miles per gallon. Although the goal of reducing emissions is broadly supported, this
does not exempt the Department for Transport from fully justifying its policy choices
when deciding how to achieve those reductions. Because the EM provides the
House with an incomplete explanation, we recommend the House
reads the IA before the debate and seeks further clarification of the
policy’s effects from the Minister before reaching its decision.
These draft Regulations are drawn to the special attention of the
House on the grounds that they are politically or legally important or
give rise to issues of public policy likely to be of interest to the House.
Background
43. To reduce greenhouse gas emissions, “premium” petrol in the UK is currently
blended with up to 5% ethanol, known as E5 grade. These Regulations
will require the ethanol content to be increased to up to 10% (E10) with
effect from 1 September 2021 to meet future emissions targets. E10 petrol is
suitable for the majority of petrol vehicles, but this instrument also ensures
that E5 grade petrol can still be supplied for older vehicles and some petrol-
powered equipment that still needs it.
44. The Department for Transport (DfT) says that these changes are necessary
to meet future legally binding carbon budgets because voluntary measures
have failed. However, biofuel blending levels are generally driven by a
separate government scheme known as the Renewable Transport Fuel
Obligation (RTFO), and the next RTFO increases are planned for 1 January
2022. According to paragraph 12.2 of the Explanatory Memorandum (EM),
in the interval between these Regulations taking effect and the RTFO
amendments, the policy will cost the motorist around £87 million per year
and decrease CO2 savings.
New Procedure
45. These Regulations follow the published draft procedure required under
Schedule 8 of the European Union (Withdrawal) Act 2018, allowing 28 days
for comment before the instrument is formally laid before the House. This
Committee commented on the published draft in its 3rd Report11 saying:
“DfT does not offer any reason why these two sets of regulations cannot
be more effectively synchronised and until they are, it appears that
the proposed Regulations will operate against the policy intention of
11 3rd Report, Session 2021–21 (HL Paper 10).12 SECONDARY LEGISLATION SCRUTINY COMMITTEE
reducing emissions. We therefore recommend that, in the absence of
convincing reasons to the contrary, the start of these Regulations should
be reviewed with a view to aligning it with the complementary increase
in the RTFO targets from 1 January 2022.”
46. Having completed the required 28-day period for comments, DfT has now
laid the instrument formally as a draft affirmative instrument. To address
our comments, the Department has provided further information about the
additional costs and difficulties for the industry if E10 petrol is introduced at
a different date. (See new paragraphs 7.7 and 12.3 in the EM.)
47. However, DfT did not explain in its response why the date of the RTFO
target increase could not be changed. In additional material the Department
told us:
“The RTFO scheme is a certificate trading scheme with annual
obligations set out in secondary legislation (rising targets are currently
set out to 2032). As suppliers plan to meet their obligations based on
their annual projections for both fuel blending, and their ability to trade
renewable fuel certificates, changing the obligation mid-year would be
akin to changing the goal posts for those obligated suppliers and would
have the same impact as a retrospective change. Suppliers who could
have blended more earlier in the year, at a lower cost, if they had been
aware of the change, would be forced to blend more later in the year. Due
to the nature of the certificate scheme, and the market this has created,
the value of certificates could be affected in ways that suppliers could
not have predicted. As a result, it is not considered viable to change
targets mid-year.”
48. This additional material gives a clearer picture of the costs and disruption to
the industry if the existing schemes were synchronised for this changeover.
It is persuasive but would be even more convincing if the relative costs of this
disruption were estimated for comparison with the impact on the consumer
and on CO2 savings.
Additional information in the Impact Assessment
49. While the Impact Assessment (IA) was not supplied alongside the published
draft,12 it provides a much broader perspective on the consequences of the
changeover to E10 than the EM.
50. For example, paragraph 43 of the IA indicates that due to lead times the
effects of implementing the two regulations separately may not be as great as
they first appear. However, the EM still clearly indicates a negative impact
on consumers during the changeover period. We asked DfT for clarification
and the Department replied:
“As set out in the IA, we acknowledge that the short gap between the
introduction of E10 and increases to the RTFO target could mean that
the full benefits of the E10 introduction are not immediately realised.
Our analysis indicates there could even be a small reduction in carbon
savings (note that emissions are still reduced compared to fossil fuel
use, just by a lesser degree than in an alternative scenario) however
the position modelled is probably a worst case scenario, with further
12 DfT, Statutory guidance: Regulations to introduce E10 petrol (13 May 2021): https://www.gov.uk/
government/publications/regulations-to-introduce-e10-petrol [accessed 7 July 2021].SECONDARY LEGISLATION SCRUTINY COMMITTEE 13
detail provided below. However, given the overall impact is limited, we
do believe this is the best way to introduce E10. As our consultation
showed and based on subsequent engagement, this view is also shared
by the industry who are supportive of the changes and timelines and
have started to prepare for the changes.
It is also important to highlight that there are still significant uncertainties
as to actual blending rates between September and end of the year, and
accordingly any impact on emission savings. Fuel suppliers have some
flexibilities as to how they comply with their obligations under the RTFO
and the minimum ethanol blending requirement, so the final fuel mix
will be subject to individual business decisions. The modelling used for
the IA necessarily had to use general, simplified assumptions, using for
example historic data, to assess the potential impact and risks. It is not
a projection of what will happen, particularly between September and
January, as the fuel grade switches over. The fuel specification will also
only apply at the point of sale from November, allowing for existing
stocks of petrol to be used first, meaning there will be a short transition
phase that may also effect the rate of change of ethanol blending in the
first months which was not captured in the IA.”
51. If anything, this makes the consequences of transition to E10 less clear and
the House may wish to ask the Minister for a clearer view of the effects
of introducing the two sets of regulations three months apart.
52. Because in this case the IA provided so much additional information, we
recommend that whenever the policy requires an IA, it should made
available alongside the “published draft”.
Quality of the EM
53. The IA raises a number of issues that are glossed over in the EM, for
example the degree to which these changes support the UK’s struggling
ethanol production plants, which in turn benefits markets for feed-wheat in
the North East. (see paragraphs 54 to 64).
54. The EM is also based on the assumption that increased ethanol content
by changing to E10 is the only way forward. The IA discusses at some
length the fact that the greenhouse gas savings from the additional ethanol
are lower than the savings from other biofuels, for example waste-derived
biodiesel. The IA however concludes that, providing the RTFO target is
suitably adjusted, E10 will result in longer term reductions in greenhouse
gas emissions. The House may wish to ask the Minster to explain why
blending petrol with ethanol is perceived as the most effective way to
reduce greenhouse gases.
55. The IA also notes that the core reason for blending biofuels into road fuels
is to reduce greenhouse gas emissions rather than to improve air quality:
“A range of studies have looked at the air quality implications of increased
bioethanol blending with general consensus that a switch between E5 and
E10 has minimal impact in either direction on emissions relating to air
quality.” (IA paragraph 70). The House may wish to ask the Minister
whether other options might have also improved air quality.14 SECONDARY LEGISLATION SCRUTINY COMMITTEE
Costs to Consumers
56. The EM says at paragraph 12.2 that: “Until RTFO targets can be increased,
the policy will cost around £87 million per year and decrease CO2 savings
by around 0.2 megatonnes per year. These costs will be borne by motorists.”
This appears to suggest that the costs to motorists are transitional.
57. What the IA makes clear is that there will be significant long-term costs to
consumers because E10 fuel is less efficient. Although moving from 5% to
10% bioethanol content is not expected to change pump prices, as the energy
content of the fuel will also decrease, motorists will have to buy more litres
of fuel. Paragraph 86 of the IA concludes that fuel costs for petrol cars are
therefore estimated to increase by 2.3% as a result of moving from 5% to 10%
bioethanol content. Scaling this up, the IA estimates additional fuel supply
costs to consumers of E10 petrol of £701 million over 10 years because of the
reduced miles per gallon. (Further costs estimated at £169 million over 10
years will fall to consumers whose vehicles will only accept E5 petrol.)
Conclusion
58. Although the policy area is complex, the EM presents a rather sketchy
view of the rationale for, and the consequences of, the proposed change
to E10 petrol. It assumes that E10 petrol is the only way forward without
explaining why that combination of fuels offers the best outcome. DfT also
assumed the reader has a detailed knowledge of the broader regulation of the
sector and how the RTFO system operates. In particular, because the EM
indicates that there will be negative consequences during the changeover,
the Department’s explanation should have made much clearer how these are
to be offset by other policy outcomes and in the longer term.
59. Although the goal of reducing emissions is a broadly supported, this does not
exempt the Department from fully justifying its policy choices when deciding
how to achieve those reductions. Because the EM provides the House
with an incomplete explanation, we recommend the House reads the
IA before the debate and seeks further clarification of the policy’s
effects from the Minister before reaching its decision.SECONDARY LEGISLATION SCRUTINY COMMITTEE 15
Town and Country Planning (Development Management Procedure
and Section 62A Applications) (England) (Amendment) Order 2021
(SI 2021/746)
Date laid: 24 June 2021
Parliamentary procedure: negative
This Order introduces a requirement for a fire statement to be submitted with
applications for planning permission for developments involving certain high-rise
residential buildings, and for the Health and Safety Executive to be consulted before
planning permission is granted. This is in response to the findings of the Independent
Review of Building Regulations and Fire Safety following the Grenfell Tower fire
which recommended that requirements around fire safety needed to be addressed at
the planning application stage. The Order also reduces certain statutory timescales
to encourage local planning authorities to prioritise applications for public service
infrastructure developments, such as hospitals, schools or prisons, as set out in
the National Infrastructure Strategy. Given that this Order takes forward one of
the recommendations in relation to the Grenfell Tower fire, the House may wish
to explore further the approach the Ministry of Housing, Communities and Local
Government has taken.
The Order is drawn to the special attention of the House on the ground
that it is politically or legally important and gives rise to issues of
public policy likely to be of interest to the House.
60. This Order has been laid by the Ministry of Housing, Communities, and
Local Government (MHCLG) with an Explanatory Memorandum (EM).
61. Amongst other changes, the Order introduces a new requirement for a fire
statement to be submitted with applications for planning permission for
developments involving a relevant high-rise residential building, and for
the Health and Safety Executive (HSE) to be consulted before planning
permission is granted. This is to address the findings of Dame Judith
Hackitt’s Independent Review of Building Regulations and Fire Safety (“the
Independent Review”)13 following the Grenfell Tower fire in June 2017 which
recommended that requirements around fire safety needed to be addressed
at the planning application stage, and that this would require input of those
with the relevant expertise.
62. The Order also reduces certain statutory timescales to encourage local
planning authorities to prioritise applications for public service infrastructure
developments, such as hospitals, schools or prisons.
New requirement for fire statements
63. MHCLG explains that in April 2020 the Government published its response14
to the Building a Safer Future consultation which proposed a new approach
for developments involving a relevant high-rise residential building, so that
fire safety issues which impact on planning, such as emergency fire vehicle
access to a building and the availability of adequate water supplies in the
13 MHCLG, Building a Safer Future: Independent Review of Building Regulations and Fire Safety: final
report (17 May 2018): https://www.gov.uk/government/publications/independent-review-of-building-
regulations-and-fire-safety-final-report [accessed 7 July 2021].
14 MHCLG, A reformed building safety regulatory system, Government response to the ‘Building a Safer
Future’ consultation (2 April 2020): Building a safer future: proposals for reform of the building safety
regulatory system - GOV.UK (www.gov.uk) [accessed 7 July 2021].16 SECONDARY LEGISLATION SCRUTINY COMMITTEE
event of a fire, should be considered before planning permission is granted,
as recommended by the Independent Review.
64. To help the local planning authority in its decision as to whether to grant
planning permission, this Order will require the developer to submit
together with the planning application a fire statement setting out fire safety
considerations specific to the development. According to MHCLG, this will
have the effect of bringing forward consideration of fire safety matters to an
earlier stage in the development process and will result in schemes which
“better integrate thinking on fire safety, as opposed to revisiting and revising
a consented scheme later in the development process due to the impact of
fire safety requirements”.
65. The Order defines relevant buildings to which the new requirement for a fire
statement applies as those which contain two or more dwellings or educational
accommodation and are at least 18 meters high or have seven or more
storeys. Certain developments are exempt, for example, where applications
for planning permission propose material changes to a building which would
mean that the building no longer qualifies as a “relevant building”, such
as a development proposal to turn a residential building that is more than
18 meters high into a storage and distribution warehouse: a fire statement
would not be required because the building would no longer be a relevant
building. MHCLG says that applications for outline planning permission15
will also be exempt from the requirement to submit a fire statement because
matters such as layout and scale can be reserved.
66. MHCLG says that the fire safety matters included in a fire statement will be
those relevant to planning matters (see paragraph 62), and that the level of
detail provided in a fire statement will not be the same as the information that
has to be submitted at building control application stage, which is a separate
process. The requirements of the fire statement will also not duplicate or
require compliance with the building regulations or the Fire Safety Order.
67. The Order also requires that the fire statement is placed in Part 2 of the local
planning authority’s planning register which contains a permanent record
of applications for planning permission and decisions. The Order further
introduces a requirement for HSE to be consulted before planning permission
is granted. MHCLG explains that in the longer-term, the Building Safety Bill
will establish a new Building Safety Regulator within HSE that will enforce
a new, more stringent regulatory regime for relevant high-rise buildings and
also oversee the safety and performance of all buildings.
Prioritising of public service infrastructure development
68. MHCLG says that securing planning permission for public service
infrastructure development16 can take significant time, and that many
decisions by local planning authorities on applications for substantive public
15 An outline planning permission applies where permission on certain matters is reserved until later. It is
particularly used for large multi-phase developments where details of the development are not finalised
at the time of the planning application. Matters which can be reserved are access, layout, landscaping,
appearance and scale. As some of the matters relevant to the completion of a fire statement, such as
layout and access, can be reserved, there is no requirement to submit a fire statement as these details
do not have to be included in an application for outline permission.
16 This Order classifies public service infrastructure developments as a new category of “major
development” which includes developments of sites of one hectare or more, and/or involving one or
more buildings where the floor space to be created is 1,000 square metres or more.SECONDARY LEGISLATION SCRUTINY COMMITTEE 17
service developments take longer than the statutory period of 13 weeks,
leading to project delays and cost increases. According to MHCLG, this
Order makes changes to encourage local planning authorities to prioritise
applications for public service infrastructure development as part of the
Government’s National Infrastructure Strategy.17 The Order shortens the
timescale for representations to be made in relation to certain publicity
and consultation requirements (from the current 21 calendar day statutory
period to a minimum of 18 calendar days with discretion to extend the period
where appropriate), and the statutory period for determining the application
from 13 to 10 weeks. These changes apply where applications are made to
build, extend or alter a hospital, school, further/higher education institution
or criminal justice accommodation (such as prisons but not immigration or
removal detention centres).
69. MHCLG says that to enable the Government to monitor the progress that
is being made in prioritising such developments, the Secretary of State
intends to issue a direction to require local planning authorities to notify the
Secretary of State when they receive a planning application for public service
infrastructure development and to provide information on the timing of the
decision.
Conclusion
70. Amongst other changes, this Order introduces a requirement for a fire
statement to be submitted with applications for planning permission for
developments involving certain high-rise residential buildings, and for HSE
to be consulted before planning permission is granted. Given that this is
in response to a recommendation by the Independent Review following the
Grenfell Tower fire, the House may wish to explore further the approach
taken by MHCLG. The Order is drawn to the special attention of the
House on the ground that it politically or legally important and gives
rise to issues of public policy likely to be of interest to the House.
17 HM Treasury, National Infrastructure Strategy (25 November 2020): https://www.gov.uk/government/
publications/national-infrastructure-strategy [accessed 7 July 2021].18 SECONDARY LEGISLATION SCRUTINY COMMITTEE
INSTRUMENTS RELATING TO COVID-19
Travel
Health Protection (Coronavirus, International Travel and Operator Liability)
(England) (Amendment) (No. 3) Regulations 2021 (SI 2021/731)
71. These Regulations amend the International Travel Regulations:18
• To exempt those who arrive in the UK under the Afghan Relocations
and Assistance Policy or the Afghan Locally Employed Staff Ex-Gratia
Scheme from the requirement to complete the passenger locator form
(PLF).
• To modify the requirement to self-isolate for certain senior officials
from the Union of European Football Associations (UEFA), the
International Federation of Association Football (FIFA) and other
relevant senior figures, such as senior executives of sponsors or
broadcasters, or representatives of competing countries. This is to
enable them to attend Euro 2020 matches and related events, including
meetings with the UK Government or the Football Association (FA).
The Department of Health and Social Care (DHSC) says that these
individuals will still have to complete the PLF, have a negative test
result and book and undertake tests, as required by the International
Travel Regulations. In addition, they will also have to comply with strict
protocols to limit contact with the local population, between attendees
and to reduce the risk of transmission between groups. According to
DHSC, this will include daily testing, private transport and limiting
their stay in the UK, while heads of delegation will have to provide
assurance of compliance to the FA and individuals will have to sign a
code of conduct. Asked about the number of people who will benefit
from the exemption, DHSC told us that this will “extend to a maximum
of 2,000 accredited guests. They would be split as follows, working
with FA/UEFA to ensure compliance with limits etc: 750 permitted to
attend from 5 to 12 July; 250 extra for each semi-final on 6 and 7 July
(limited to 48h in the country) and an extra 750 for the final.”
• To exempt those attending or facilitating the COP26 Ministerial or
the Global Education Summit from the requirement for self-isolation,
managed quarantine, mandatory testing and the PLF. To qualify for
this exemption, individuals will have to agree to comply with specific
health protocols in place for each event, which include daily testing and
tracing procedures.
• To correct a technical error, so that the amount of a Fixed Penalty
Notice for failure to adhere to the duty to possess a managed self-
isolation package on arrival in England in the first instance is £500
rather than £5,000.
18 Health Protection (Coronavirus, International Travel and Operator Liability) (England) Regulations
2021 - Explanatory Memorandum (legislation.gov.uk) (SI 2021/582).SECONDARY LEGISLATION SCRUTINY COMMITTEE 19
Health Protection (Coronavirus, International Travel and Operator Liability)
(England) (Amendment) (No. 4) Regulations 2021 (SI 2021/766)
72. These Regulations further amend the International Travel Regulations19 in
a variety of ways:
• To introduce limited exemptions from the requirements imposed
by those Regulations for: persons invited to the UK by the Foreign
Secretary on official business; engineers etc essential for the operation
of ferry services; in-flight security officers (“sky marshals”); prisoners
being extradited or deported to the UK; certain categories of senior
executives on business visits likely to create or save at least 500 UK jobs
(and authorised by the Secretary of State); and “specially accredited”
persons invited to attend the 2020 UEFA European Football
Championship Final (these are in addition to the UEFA officials listed
in SI 2021/731 above and may add about 1,000 visitors per team);
• To revise the onboard public health announcement on commercial
passenger transport to tell people arriving in England that they must
have a pre-booked testing package for days 2 and 8;
• To update the list of exempt sporting events in Schedules 5 and 11;
• To update the Schedule 1 (green list) countries to add Anguilla,
Antigua and Barbuda, the Balearic Islands, Barbados, Bermuda, the
British Antarctic Territory, the British Indian Ocean Territory, the
British Virgin Islands, the Cayman Islands, Dominica, Grenada,
Madeira, Malta, Montserrat, the Pitcairn Islands, and the Turks and
Caicos Islands;
• To update the Schedule 3 (red list) countries to add the Dominican
Republic, Eritrea, Haiti, Mongolia, Tunisia and Uganda and also to
add the Dominican Republic and Tunisia to the list of countries from
which direct passenger flights are generally prohibited unless landing
at Birmingham Airport or Heathrow Airport; and
• To change the designated terminal at Heathrow Airport for handling
passengers on such flights from Terminal 3 to Terminal 4.
Health Protection (Coronavirus, International Travel and Operator Liability)
(England) (Amendment) (No. 5) Regulations 2021 (SI 2021/795)
73. This instrument makes further amendments to the International Travel
Regulations20 to exempt people from Amber list countries who have been
invited to attend a Euro 2020 event by the Football Association from the
obligation to isolate on arrival into England. They will still be subject to
the wider public health border requirements, including pre-departure test,
Passenger Locator Form, and mandatory testing after arrival and, according
to the Government, they should be in the UK for no more than 24 to 36
hours.
74. The distinction between invitees (exempted by SI 795) and Final attendees
(exempted by 766) is that the Final attendees are to be more closely managed
by law, because they are less closely affiliated to UEFA or the national
19 SI 2021/582 as above.
20 SI 2021/582 as above.You can also read
