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, meet minimum standards in their sensitivity and specificity. 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.
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. 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.
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 that 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. [ … ]
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.”
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.
15.The Department says that the new system will be underpinned by the standard enforcement regime for medical devices. 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 penalties will be applied to retailers and manufacturers which breach their obligations.
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, 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.
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. 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.
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.
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.
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.
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, 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 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, 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.
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. 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.
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 Publication 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.
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.”
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.
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.
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.
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.
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.
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 Report 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 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.
49.While the Impact Assessment (IA) was not supplied alongside the published draft, 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 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”.
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.
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.)
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.
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”) 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.
63.MHCLG explains that in April 2020 the Government published its response 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 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 permission 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.
68.MHCLG says that securing planning permission for public service infrastructure development can take significant time, and that many decisions by local planning authorities on applications for substantive public 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. 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.
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.
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.
3 As specified in 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: .
6 Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment) Regulations 2021 (), see: SLSC, , Session 2021–22 (HL Paper 21), 17 June 2021.
7 NHS England, COVID-19 Vaccinations of Residents and Staff in Older Adult Care Homes by NHS Region [Excel spreadsheet]: [accessed 7 July 2021].
8 NHS England, COVID-19 Vaccinations [Excel spreadsheet]: ) [accessed 7 July 2021].
9 Published in full on our webpage. Secondary Legislation Scrutiny Committee, scrutiny evidence page: .
10 DHSC, (16 June 2021), Section 4.2 Policy Scope.
11 , Session 2021–21 (HL Paper 10).
12 DfT, Statutory guidance: Regulations to introduce E10 petrol (13 May 2021): [accessed 7 July 2021].
13 MHCLG, Building a Safer Future: Independent Review of Building Regulations and Fire Safety: final report (17 May 2018): [accessed 7 July 2021].
14 MHCLG, A reformed building safety regulatory system, Government response to the ‘Building a Safer Future’ consultation (2 April 2020): [accessed 7 July 2021].
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.
17 HM Treasury, National Infrastructure Strategy (25 November 2020): [accessed 7 July 2021].