Twenty-Fourth Report of Session 2021–22

This is a House of Commons and House of Lords Committee Joint Report.

Author: Joint Committee on Statutory Instruments

Date Published: 11 February 2022

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Contents

Instruments reported

At its meeting on 9 February 2022 the Committee scrutinised a number of instruments in accordance with Standing Orders. It was agreed that the special attention of both Houses should be drawn to three of those considered. The instruments and the grounds for reporting them are given below. The relevant departmental memoranda are published as appendices to this report.

1S.I. 2021/1346: Reported for requiring elucidation

National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021

1.1The Committee draws the special attention of both Houses to these Regulations on the ground that they require elucidation in one respect.

1.2These Regulations, which are subject to the negative resolution procedure, require NHS England to turn down routine applications from new pharmacies in a particular Health and Wellbeing Board (HWB) area that offer better access to essential services via extended or different opening hours, if they are satisfied that granting the application would “result in an undesirable increase in the availability of essential services in the area of the relevant HWB” (regulation 5 (inserted regulation 21A(2)). The Committee asked the Department of Health and Social Care to explain, by way of expansion of the matters raised in paragraph 7.4 of the Explanatory Memorandum, how the grant of an application could result in an increase in availability of services that was considered “undesirable” and to specify the criteria for determining undesirability in this context. In a memorandum printed at Appendix 1, the Department explains that in this particular context there is a general understanding of the meaning of undesirability. In particular, rather than applying specific criteria for determining undesirability, the Department would expect NHS England to follow the approach set out in R (Assura) v National Health Service Litigation Authority [2008] EWCA Civ 1356: “questions of adequacy, need and desirability are to be decided by the decision-makers, and provided a proper approach is adopted, the answer will inevitably become a question of fact and degree eminently suitable for resolution by a committee of laymen, and not susceptible to sophisticated legal analyses”. The Department also gives a useful example relating to a supermarket pharmacy opening near to a village pharmacy and the balancing of the interests of the communities served. The Committee is grateful for the thorough exposition provided and accordingly reports regulation 5 for requiring elucidation, provided by the Department’s memorandum.

2S.I. 2021/1374: Reported for failure to comply with proper legislative practice

Statistics of Trade (Customs and Excise) (Modification) Regulations 2021

2.1The Committee draws the special attention of both Houses to these Regulations on the ground that they fail to comply with proper legislative practice in one respect.

2.2These Regulations, which are subject to the negative resolution procedure, ensure compliance with rules under the Northern Ireland Protocol by lowering the threshold under which information on the arrival of goods into Northern Ireland from EU Member states is not required. They are made under section 8C(1)(c) of the European Union (Withdrawal) Act 2018. As instruments made under that power are not subject to a sifting requirement, the Committee asked HM Revenue and Customs to explain why the Explanatory Memorandum contains a sifting statement. In a memorandum printed at Appendix 2, the Department explains that the sifting statement was included in error. The Committee accordingly reports these regulations for failure to comply with proper legislative practice, acknowledged by the Department.

3S.I. 2022/11: Reported for unusual or unexpected use of the enabling power

Health Protection (Coronavirus, International Travel and Operator Liability) (England) (Amendment) Regulations 2022

3.1The Committee draws the special attention of both Houses to these Regulations on the ground that they make an unusual or unexpected use of the enabling power in one respect.

3.2These Regulations, which are subject to the negative resolution procedure, remove border measures introduced in response to the Omicron variant and reintroduce the option for eligible travellers to complete a lateral flow test on or before day 2 of their arrival in England as an alternative to a PCR test. The amendments made by regulation 16(5) require (in the specified circumstances) a photograph of the lateral flow test device taken by the relevant passenger to be provided to the test provider within 15 minutes of the test’s read time. In its Twentieth Report of this Session (in relation to S.I. 2021/1179) the Committee reported these provisions for making an unusual or unexpected use of the enabling power on the basis that there were no criteria to verify that the test in the photograph was taken by the relevant passenger or that the photograph was provided within 15 minutes of the test’s read time. The Committee did not believe that Parliament intended offences to be created that are so unlikely to be capable of being enforced. As the Committee’s Report had not been published at the time these Regulations were made, the Committee asked the Department of Health and Social Care whether it had anything to observe in relation to the effect of regulation 16(5) in the light of that Report. In a memorandum printed at Appendix 3, the Department confirms that it has noted the Committee’s Report and explains that a decision was made to reintroduce an existing scheme rather than recreate the border testing programme and that following a review of the necessity and proportionality of border measures all provisions relating to lateral flow testing will be revoked. For the same reasons referred to in the report on S.I. 2021/1179, the Committee accordingly reports regulation 16(5) for making an unusual or unexpected use of the enabling power.

Instruments not reported

At its meeting on 9 February 2022 the Committee considered the instruments set out in the Annex to this Report, none of which was required to be reported to both Houses.

Annex

Draft Instruments requiring affirmative approval

Draft

European Union (Withdrawal) Act 2018 (Repeal of EU Restrictions in Devolution Legislation, etc.) Regulations 2022

Draft

Flood Reinsurance (Amendment) Regulations 2022

Draft

Combined Authorities (Borrowing) Regulations 2022

Draft

Energy Performance of Buildings (England and Wales) (Amendment) Regulations 2022

Draft

National Minimum Wage (Amendment) Regulations 2022

Draft

Social Security (Scotland) Act 2018 (Disability Assistance and Information-Sharing) (Consequential Provision and Modifications) Order 2022

Instruments subject to annulment

S.I. 2021/1392

Building Regulations etc. (Amendment) (England) (No. 2) Regulations 2021

S.I. 2021/1401

Merchant Shipping (Polar Code) (Safety) Regulations 2021

S.I. 2021/1405

Social Security (Income and Capital Disregards) (Amendment) Regulations 2021

S.I. 2021/1423

Civil Legal Aid (Financial Resources and Payment for Services) (Amendment) Regulations 2021

S.I. 2021/1427

Misuse of Drugs (Amendment) (England, Wales and Scotland) Regulations 2021

S.I. 2021/1440

Agricultural Holdings (Units of Production) (England) (No. 2) Order 2021

S.I. 2021/1451

Non-Contentious Probate Fees (Amendment) Order 2021

S.I. 2021/1453

Statutory Sick Pay (Medical Evidence) Regulations 2021

S.I. 2021/1454

Approved Country Lists (Animals and Animal Products) (Amendment) (No. 2) Regulations 2021

Instruments not subject to parliamentary proceedings not laid before Parliament

S.I. 2021/1412

Wireless Telegraphy (Licence Charges for the 2100 MHz Frequency Band) Regulations 2021

S.I. 2021/1436

Registration of Births and Deaths (Amendment) (England and Wales) Regulations 2021

Appendix 1

S.I. 2021/1346

National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021

1. The Committee has asked the Department of Health and Social Care for a memorandum on the following point:

Explain, by way of expansion of the matters raised in paragraph 7.4 of the Explanatory Memorandum, how the grant of an application could result in an increase in the availability of services that was considered “undesirable” and specify the criteria for determining “desirability” in this context.

2. The notion of an increase in the availability of NHS pharmaceutical services being desirable or undesirable has a long history in the context of pharmaceutical services provision. Prior to the reforms introduced by the National Health Service (Pharmaceutical Services) Regulations 2012 (S.I. 2012/1909, as amended) (“the 2012 Regulations”), which were carried forward in the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (S.I. 2013/349, as amended) (“the 2013 Regulations”), the test applied for allowing a new community pharmacy to open to provide NHS pharmaceutical services was known as the “necessary or desirable” test—reflecting the language of the National Health Service Act 1977.

3. To complicate matters, this language was changed to “necessary or expedient” in the consolidation undertaken by the National Health Service Act 2006 (“the 2006 Act”), but the concept of “desirability” remains a familiar one to the pharmacy sector, even though the wording changed in 2006 and the test for entering the market changed decisively in 2012.

4. A key element of the reforms introduced in the 2012 Regulations and carried forward in the 2013 Regulations was the assessment of applications known as “routine applications” for opening new pharmacy premises against local plans produced (from 2013) by Local Authority Health and Wellbeing Boards. These plans are known as Pharmaceutical Needs Assessments (PNAs). Standard applications for new premises are no longer assessed on the basis of whether the proposed premises are “necessary or desirable” for a particular neighbourhood (or “necessary or expedient”) but against whether, having regard to the local PNA and other matters specified in the 2013 Regulations, granting the application would meet a need for pharmaceutical services, or secure improvements or better access to them (see section 129(2A) of the 2006 Act).

5. The new regulation 21A of the 2013 Regulations (inserted by regulation 5 of S.I. 2021/1346) adds new specified matters to be taken into account when considering routine applications for new premises, and is the provision to which paragraph 7.4 of the Explanatory Memorandum relates. Specifically, the new regulation 21A(2) contains the new duty on the NHS Commissioning Board (now known as NHS England) to have regard to whether granting the routine application would result in an undesirable increase in the availability of essential services (i.e. the core pharmaceutical services, most notably dispensing) in the relevant area.

6. The statutory scheme for the provision of NHS pharmaceutical services under Part 7 of the 2006 Act is predicated on the basis that provision of such services should be planned, rather than following an “any willing provider” model. The presumption is that decision-making based on local planning will help secure effective commissioning which addresses local priorities. This presupposes, as did the old “necessary or desirable” test, that new provision will not necessarily be of benefit to a local community overall.

7. So, for example, if a new supermarket opening near to a village is allowed to have a pharmacy, that may draw trade from a pharmacy within the village, potentially rendering the village pharmacy unviable, notwithstanding that there is a cohort of patients in the village that would have difficulty in accessing services from the new supermarket. However, the new supermarket may be able to offer evening opening hours that the village pharmacy cannot offer—and better access by way of evening opening hours might have been an improvement identified in the PNA for the local area.

8. The leading case on the “necessary or desirable” test was the case of R (Assura) v National Health Service Litigation Authority [2008] EWCA Civ 1356. At paragraph 60, Lord Justice Lawrence Collins stated: “…questions of adequacy, need and desirability are to be decided by the decision-makers, and provided a proper approach is adopted, the answer will inevitably become a question of fact and degree eminently suitable for resolution by a committee of laymen, and not susceptible to sophisticated legal analyses…”.

9. The Department would expect NHS England, and if the matter was appealed, the National Health Service Litigation Authority, to follow the approach set out by Lord Justice Lawrence Collins in Assura when considering whether or not a particular increase in the availability of essential services was “undesirable” for the purposes of regulation 21A(2)—rather than applying specific criteria for determining “desirability” or “undesirability” in that context. So, in the supermarket example above, whether the potential increase in availability of services from the supermarket was actually undesirable, given the potential impact on the access to pharmaceutical services in the round for the communities served, would be looked at simply as a question of fact in the particular circumstances of the case.

Department of Health and Social Care

1 February 2022

Appendix 2

S.I. 2021/1374

Statistics of Trade (Customs and Excise) (Modification) Regulations 2021

1. The Committee has asked Her Majesty’s Revenue and Customs for a memorandum on the following point:

Explain why the Explanatory Memorandum contains a sifting statement when this instrument is not subject to a sifting requirement.

2. The sifting statement was included in error. We apologise for this oversight and regret it was not corrected before the Explanatory Memorandum was laid.

Her Majesty’s Revenue and Customs

28 January 2022

Appendix 3

S.I. 2022/11

Health Protection (Coronavirus, International Travel and Operator Liability) (England) (Amendment) Regulations 2022

1. The Committee has asked the Department of Health and Social Care for a memorandum on the following point:

Confirm whether the Department has anything to observe in relation to the effect of regulation 16(5) in light of the Committee’s Twentieth Report of Session 2021–22 on S.I. 2021/1179 (in relation to the creation of offences that are so unlikely to be capable of being enforced).

2. The Instrument amended the Health Protection (Coronavirus, International Travel and Operator Liability) (England) Regulations 2021 (S.I. 2021/582) (“the ITOL Regulations”).

3. Regulation 16(5) of the Instrument reintroduced provisions which had first been inserted into the ITOL Regulations by the Health Protection (Coronavirus, International Travel and Operator Liability) (England) (Amendment) (No. 16) Regulations 2021 (S.I. 2021/1179) (“the No. 16 Regulations”). The No. 16 Regulations had introduced lateral flow device (LFD) testing for qualifying international arrivals.

4. These provisions were revoked by the Health Protection (Coronavirus, International Travel and Operator Liability) (England (Amendment) (No. 21) Regulations 2021 (S.I. 2021/1339) (“the No. 21 Regulations”) on 30 November 2021. This revocation was part of the Government’s response to the Omicron threat in November/December 2021: the Government reintroduced polymerase chain reaction (PCR) testing at the border for all international arrivals.

5. In early January 2022 the Government decided to reintroduce LFD testing for qualifying arrivals. The Instrument therefore reintroduced the same provisions with effect from 4 a.m. on 9 January 2022.

6. On 14 January the Committee reported regulation 10(7)(b) of the No. 16 Regulations for making an unusual or unexpected use of the enabling power. By this date, the relevant provision had been inserted back into the ITOL Regulations by the Instrument.

7. The Department refers the Committee to its memo dated 14 December 2021 in respect of the No. 16 Regulations. The border testing scheme is predicated on obligations on the part of the traveller, with an enforcement scheme in place for travellers who fail to comply with those obligations.

8. However, the Department has noted the point made by the Committee in its report. The scheme implemented by the Instrument: (1) needed to be operationalised swiftly and (2) was a short-term measure while the necessity and proportionality of border measures more generally were reviewed. A decision was therefore made to reintroduce an existing scheme rather than recreate or change the border testing programme. The particular advantage of this approach was that it minimised confusion for the public, and for the private testing market, by reintroducing a scheme already known to them.

9. The Government has now completed its review of the necessity and proportionality of border measures, and all provisions relating to LFD testing will be revoked in an instrument to come into force at 4 a.m. on 11 February 2022.

Department of Health and Social Care

1 February 2022

Formal Minutes

Wednesday 9 February 2022

Virtual meeting

Members present:

Jessica Morden, in the Chair

Lord Beith

Lord Chartres

Dr James Davies

Baroness D’Souza

Baroness Gale

Lord Haskel

Baroness Newlove

Liz Twist

Draft Report, proposed by the Chair, brought up and read.

Ordered, That the draft Report be read a second time, paragraph by paragraph.

Paragraphs 1.1 to 3.2 read and agreed to.

Annex agreed to.

Papers were appended to the Report as Appendices 1 to 3.

Resolved, That the Report be the Twenty-Fourth Report of the Committee to both Houses.

Ordered, That the Chair make the Report to the House of Commons and that the Report be made to the House of Lords.

Adjourned till Wednesday 23 February at 3.40 p.m.