Twenty-Seventh Report of Session 2021–22

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

Author: Joint Committee on Statutory Instruments

Date Published: 11 March 2022

Download and Share

Contents

Instruments reported

At its meeting on 9 March 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. 2021/1316: Reported for defective drafting

Merchant Shipping (Radiocommunications) (Amendment) Regulations 2021

1.1 The Committee draws the special attention of both Houses to these Regulations on the ground that they are defectively drafted in two respects.

1.2 These Regulations, which are subject to the negative resolution procedure, implement amendments to Chapter IV of the Annex to the International Convention for the Safety of Life at Sea, 1974, relating to radiocommunications requirements for ships engaged on international voyages. Schedule 1 makes consequential amendments to the Merchant Shipping (Radio Installations) Regulations 1998 (S.I. 1998/2070), which will apply to ships not engaged on international voyages. The Committee asked the Department for Transport why paragraph 6 of that Schedule revokes the definition “EPIRB” in regulation 7 of the 1998 Regulations, given that the term remains in use elsewhere in that instrument. In a memorandum printed at Appendix 1, the Department accepts that the definition was revoked in error. The Committee accordingly reports paragraph 6 of Schedule 1 for defective drafting, acknowledged by the Department.

1.3 Schedule 2 sets out the tests required to be carried out on radio equipment on UK ships to which these Regulations apply. Paragraph 5 defines “EPIRB” for the purposes of the Schedule as a beacon capable of transmitting an alert “either through the COSPAS/SARSAT polar orbiting satellite service operating in the 406 MHz band”. The Committee asked the Department to explain what the alternative to the COSPAS/SARSAT service is intended to be. In its memorandum, the Department explains that no alternative is intended and “either” should have been removed from the definition. The Committee accordingly reports paragraph 5 of Schedule 2 for defective drafting, acknowledged by the Department.

(The Department also explains that “COSPAS/SARSAT” is sufficiently well-known by persons to whom the Regulations will be relevant as not to require further definition.)

2S.I. 2021/1443: Reported for failure to comply with proper legislative practice

Official Controls (Extension of Transitional Periods) (England and Wales) (Amendment) (No. 2) Regulations 2021

2.1 The 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.

2.2 These Regulations, which are subject to the negative resolution procedure, delay until 30 June 2022 the implementation of full border checks on imports of sanitary and phyto-sanitary goods and make other changes relating to controls on imports of such goods to England and Wales. The Committee asked the Department for Environment, Food and Rural Affairs why, in regulation 1, paragraph (2) provides for the extent but not the application of regulations 1, 2, 5 and 7, while paragraph (3) provides for the application but not the extent of regulations 3, 4 and 6. In a memorandum printed at Appendix 2, the Department explains that citing extent alone is intended to imply that there is no restriction on application, whereas citing application alone is intended to imply that extent is the same as in the instrument being amended (which, in all cases, is England and Wales). It accepts, however, that a more consistent approach might have been helpful. The Committee agrees. While citing extent or application alone may be appropriate in some contexts, the juxtaposition of different approaches in regulation 1 adds an unnecessary layer of confusion. The Committee accordingly reports regulation 1 for failure to comply with proper legislative practice, acknowledged by the Department.

3S.I. 2021/1452: Reported for requiring elucidation

Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021

3.1 The Committee draws the special attention of both Houses to these Regulations on the ground that they require elucidation in two respects.

3.2 These Regulations, which are subject to the negative resolution procedure, permit medicines authorised for use in Great Britain, but not the European Union, to be supplied to Northern Ireland under the “Northern Ireland MHRA authorised route” (NIMAR). This would not normally be permitted under Directive 2001/83/EC and Regulation (EC) No. 726/2004, which continue to apply in relation to Northern Ireland as a result of the Withdrawal Agreement. The creation of NIMAR therefore relies on the exemption set out in Article 5(1) of that Directive, which permits medicinal products to be:

supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised health-care professional and for use by an individual patient under his direct personal responsibility.

3.3 The conditions under which a NIMAR product may be supplied to Northern Ireland are set out in regulation 14, which inserts new regulations 167A and 167B into Part 10 of the Human Medicines Regulations 2012 (S.I. 2012/1916). The Committee asked the Department for Health and Social Care to explain how those conditions fulfil the requirement in Article 5(1) for the medicinal product to be supplied “in response to a bona fide unsolicited order”. In a memorandum printed at Appendix 3, the Department explains that this requirement is to be construed in line with the leading CJEU judgment: an order must be predicated on an individual assessment of the patient, generally by a registered health-care professional, in a clinical intervention based on therapeutic considerations. While the new regulations do not in themselves impose such requirements, this is achieved by providing for NIMAR products to be classified as prescription only medicines and so within the scope of Part 12 of the 2012 Regulations, compliance with which will have the effect of compliance with the judgment. The Committee accordingly reports regulation 14 for requiring elucidation, provided in the Department’s memorandum.

3.4 The Committee asked the Department to explain how the requirement for the patient to have a direct relationship with an authorised health-care professional is achieved in circumstances where a listed NIMAR product is provided under a patient group direction or a protocol, as permitted by regulations 17 to 22. In its memorandum, the Department explains that professional accountability in relation to patient group directions is achieved by limitations contained in Schedule 16 to the 2012 Regulations as to who can supply a medicinal product and the manner in which they are required to do so. While the supply of vaccines under a protocol is not limited in the same way, the Department asserts that existing supervision requirements and public law principles, including the need to have regard to Article 5(1) when implementing the relevant provisions of the 2012 Regulations in relation to NIMAR products, will be sufficient to ensure compliance. The Committee accordingly reports regulation 14 for requiring elucidation, provided in the Department’s memorandum.

(The Committee welcomes the Department’s undertaking to issue a revised Explanatory Memorandum providing greater clarity on the issues referred to above.)

Instruments not reported

At its meeting on 9 March 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

S.I. Number

S.I. Title

Draft

Boiler Upgrade Scheme (England and Wales) Regulations 2022

Instruments subject to annulment

S.I. Number

S.I. Title

S.I. 2021/1278

Greater London Authority (Consolidated Council Tax Requirement Procedure) Regulations 2021

S.I. 2022/5

Statutory Sick Pay (Coronavirus) (Funding of Employers’ Liabilities) Regulations 2022

S.I. 2022/9

Statutory Sick Pay (Coronavirus) (Funding of Employers’ Liabilities) (Northern Ireland) Regulations 2022

S.I. 2022/30

Occupational and Personal Pension Schemes (Disclosure of Information) (Requirements to Refer Members to Guidance etc.) (Amendment) Regulations 2022

S.I. 2022/62

Carbon Accounting (Provision for 2020) Regulations 2022

S.I. 2022/124

Competition Act 1998 (Health Services for Patients in England) (Coronavirus) (Public Policy Exclusion) Order 2022

S.I. 2022/127

Council Tax (Demand Notices and Reduction Schemes) (England) (Amendment) Regulations 2022

S.I. 2022/141

Countryside Stewardship (England) (Amendment) Regulations 2022

S.I. 2022/144

Pesticides (Revocation) (EU Exit) Regulations 2022

S.I. 2022/154

Jobseeker’s Allowance (Schemes for Assisting Persons to Obtain Employment) (Amendment) Regulations 2022

S.I. 2022/158

Occupational Pension Schemes (Schemes that were Contracted-out) (No. 2) (Amendment) Regulations 2022

S.I. 2022/168

Health Protection (Coronavirus, International Travel and Operator Liability) (England) (Amendment) (No. 3) Regulations 2022

• The Committee asked for a memorandum on these instruments (which are drafted in the same terms) and a satisfactory response was received. The memorandum is printed at Appendix 4.

Instruments not subject to parliamentary proceedings not laid before Parliament

S.I. Number

S.I. Title

S.I. 2022/93

Ivory Act 2018 (Commencement No. 1) Regulations 2022

S.I. 2022/115

Offshore Installations (Safety Zones) Order 2022

S.I. 2022/139

Universal Credit (Work-Related Requirements) In Work Pilot Scheme (Extension) Order 2022

Appendix 1: Memorandum from the Department for Transport

S.I. 2021/1316

Merchant Shipping (Radiocommunications) (Amendment) Regulations 2021

1) The Committee has asked the Department for Transport for a memorandum on the following points:

(1) Explain why paragraph 6 of Schedule 1 revokes the definition of “EPIRB” in regulation 7 of S.I. 1998/2070, given that the term remains in use elsewhere in that instrument.

(2) In relation to paragraph 5 of Schedule 2, explain—

(a) what the alternative to the COSPAS/SARSAT service is intended to be; and

(b) why “COSPAS/SARSAT” is not defined in that paragraph.

2) The Department comments on each point as follows:

1) Regulation 7 of S.I. 1998/2070

The Department accepts that a definition of “EPIRB” should have been retained and that this is therefore an error. The Department will make an amendment to correct this error as soon as possible.

2) Paragraph 5 of Schedule 2 of S.I. 2021/1316

a) The Department can confirm that there is not intended to be an alternative to the COSPAS/SARSAT service. It was the intention to amend the definition of “EPIRB” as it appeared in the preceding version of S.I. 1998/2070 so as to remove the words:

“or through the INMARSAT geostationary satellites operating in the 1.6 MHZ band”,

but the removal of the word ”either” was omitted. The Department will make an amendment to correct this error as soon as possible.

b) COSPAS/SARSAT is a reference to the International Cospas-Sarsat programme, a non-profit, intergovernmental, humanitarian cooperative to assist in the detection and location of emergency position-indicating radio beacons. The expression was not defined in S.I. 1998/2070 and the Department understands that its meaning is readily understood by the shipping industry and those involved in maritime search and rescue operations.

Department for Transport

1 March 2022

Appendix 2: Memorandum from Department for Environment, Food and Rural Affairs

S.I. 2021/1443

Official Controls (Extension of Transitional Periods) (England and Wales) (Amendment) (No. 2) Regulations 2021

1) The Committee has asked the Department for Environment, Food and Rural Affairs for a memorandum on the following point:

Explain why a statement is made as to the extent but not the application of regulations 1, 2, 5 and 7, while a statement is made as to the application but not the extent of regulations 3, 4 and 6.

2) Regulations 1, 2, 5 and 7, which are expressed to extend to England and Wales, do so without any restriction on their application. The Department considers this to be sufficiently clear from this wording without an additional provision to state that the regulations also apply in relation to England and Wales.

3) Regulations 3, 4 and 6 are stated to apply only in relation to England and amend instruments that apply only in relation to England. The Department considers that it is clearly implicit that those regulations, like the instruments they amend, extend only to England and Wales, and that the omission of a statement as to their extent is explained by the fact that their extent is necessarily limited to the extent of the provisions they amend. The Department acknowledges, however, that regulation 1(2) could alternatively have stated: “These Regulations extend to England and Wales.”, and that had it done so this might have been helpful in the interests of precluding any possible initial impression that the instruments mentioned in regulation 1(3) had any different extent. The Department will aim to ensure that in future the extent of provisions which are expressed to apply only in relation to England is stated in addition to their application, including where the instruments they amend apply only in relation to England.

Department for Environment, Food and Rural Affairs

1 March 2022

Appendix 3: Memorandum from the Department of Health and Social Care

S.I. 2021/1452

Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021

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

(1) Explain how the requirement in Article 5(1) of Directive 2001/83/EC for the medicinal product to be supplied “in response to a bona fide unsolicited order” is achieved by regulation 14 (new regulations 167A and 167B).

(2) Having regard to paragraph 6.7 of the Explanatory Memorandum, explain how the direct relationship requirement in Article 5(1) is achieved in circumstances where a listed NIMAR product is provided under a patient group direction or a protocol, as permitted by regulations 17 to 22.

2) As a preliminary point, the Department recognises that the legal position is significantly more complicated than paragraph 6.7 of the Explanatory Memorandum suggests, as this Memorandum seeks to illustrate. The text of paragraph 6.7 will be revised as soon as the Department has had an opportunity to reflect on any observations that the Committee makes in response to this Memorandum.

3) In relation to point (1), in the Department’s understanding, the leading case on the meaning of the phrase, “in response to a bona fide unsolicited order”, which derives from Article 5.1 of Directive 2001/83/EC, is Commission v Poland (Case 185/10, paragraph 35 et seq). As stated by the Court of Justice of the European Union: “the requirement that medicinal products are supplied in response to a ‘bona fide unsolicited order’ means that the medicinal product must have been prescribed by the doctor as a result of actual examination of his patients and on the basis of purely therapeutic considerations.

4) As a consequence of the Northern Ireland Protocol, under ordinary principles of European Union (EU) law, to the extent that these continue to apply in Northern Ireland, Article 5.1 remains binding on the UK Government as regards the results to be achieved by the implementing measures enacted to give effect to it in Northern Ireland. However, in parallel with Competent Authorities in Member States, the Government has the choice of form and methods in relation to implementing Article 5.1, in so far as it is required to do so. Under EU law, a tension has always and necessarily existed, on occasion, between implementing the letter and the spirit of EU Directives, but the Court of Justice has recognised, in terms, the importance of giving effect to their spirit rather than copying out their letter (Commission v Italy Case 258/86, paragraphs 7 to 10).

5) In that light, two important principles need to be extrapolated from Commission v Poland, in a national context where medical decision-making does not necessarily follow the conventional doctor/patient model – and indeed, Article 5.1 of the Directive actually refers to an authorised health-care professional rather than a doctor. Firstly, an unsolicited order needs to be predicated on individual assessment of the patient: (i) by a registered health-care professional, or (ii) in circumstances where it is appropriate and proportionate to the patient’s needs to permit a clinical intervention without the direct involvement of a health-care professional (administration of vaccines by trained staff who are working under appropriate clinical supervision, for example), under the appropriate arrangements for those circumstances.

6) Secondly, it must be a clinical intervention, based on therapeutic (or diagnostic) considerations. If it is not actually a situation where a doctor or another registered health-care professional has taken a treatment decision, the circumstances must be clearly analogous.

7) Because medicines supplied to Northern Ireland via this route (i.e. NIMAR products) will all be prescription only medicines, it is embedded within the requirements of Part 12 of the Human Medicines Regulations 2012 (S.I. 2012/1916) that they will only be supplied in pursuance of a prescription or a direction of an appropriate practitioner (most familiarly, a doctor), or in a range of other situations where the decision to supply is not taken by the patient and the legislative framework governing the supply has the effect of restricting the supply to appropriate clinical interventions, which will most commonly be by or under the supervision of a registered health-care professional.

8) Therefore the requirement (i.e. for a supply in response to a bona fide unsolicited order) is not achieved by the new regulations 167A and 167B but, in its intended effect as explained above, it is embedded in the numerous exceptions in Part 12 of the Human Medicines Regulations 2012 that relate to supply in the absence of a prescription – and in the principle of supply in accordance with a prescription of an appropriate practitioner to which these Part 12 exceptions are made.

9) In relation to point (2), Part 12 of the Human Medicines Regulations 2012 contains provisions relating to protocol and patient group direction (PGD) supply that differ in a number of important respects. The examples given below are intended to illustrate the approach generally, rather than being directly applicable to the other examples of protocol and PGD supply. Both are taken from the Covid vaccination programme because of its general familiarity.

10) The “direct personal responsibility” requirement in Article 5.1 of Directive 2001/83/EC, in the case of PGD supply, is implemented effectively by the limitations on who may conduct PGD supply and how they may conduct it.

11) The limitations on who may supply under a PGD are contained in Part 4 of Schedule 16 to the Human Medicines Regulations 2012, which limits supply under PGDs to some specific groups of registered health-care professionals. Thus, in the case of a Covid vaccine supplied under a PGD, the person administering the product would have to be a health-care professional on that list. The matters to be included in the PGD are contained in Part 1 of Schedule 16, and in part it sets out the content of the detailed algorithm that the registered health-care professional will have to follow, including matters such as referral for medical advice (paragraph 16) and arrangements for record keeping (paragraph 17). The Department considers that this framework clearly establishes the level of professional accountability envisaged by Article 5.1.

12) In the case of a protocol supply of the same Covid vaccine – under a protocol issued under regulation 247A of the Human Medicines Regulations 2012, unlike the PGD supply, the vaccinator may not be a registered health-care professional so the ordinary professional obligation between the treating clinician and patient may not exist. However, regulation 247A(4)(d) requires that the protocol must include “….requirements, where appropriate, for the supervision of [vaccinators]…” and the Minister of Health in Northern Ireland would have to determine what requirements were appropriate. In taking that decision, if the vaccine were a NIMAR product, he/she would have to have regard to Article 5.1, but in any event it is extremely difficult to envisage why he/she would not put detailed arrangements for clinical supervision in place. These protocols have been widely used in mass vaccination centres and have in practice been lengthy with very clear clinical accountability.

13) Accordingly, even in circumstances where the potential exists in principle for an absence of direct responsibility, in practice, ordinary public law principles would provide for it.

14) The approach in Commission v Italy, cited above, was that the Commission was put to proof that the arrangements that gave effect to the spirit of the obligation did not actually do so, and on that occasion they were unable to do so. The Department considers that the courts would adopt a similar approach here, given the elaborate but tightly controlled nature of the exemptions in Part 12 of the Human Medicines Regulations 2012.

Department of Health and Social Care

1 March 2022

Appendix 4: Memorandum from HM Revenue and Customs

S.I. 2022/5

Statutory Sick Pay (Coronavirus) (Funding of Employers’ Liabilities) Regulations 2022

S.I. 2022/9

Statutory Sick Pay (Coronavirus) (Funding of Employers’ Liabilities) (Northern Ireland) Regulations 2022

1) The Committee has asked HM Revenue and Customs for a memorandum on the following point:

Explain what government grants are intended to fall within regulation 3(2)(b), by reference to the precise intended meaning of “furloughed” and by reference to specified government schemes.

2) The term “furloughed” bears its ordinary meaning. The Oxford English Dictionary records its use in the sense of dismissal or suspension from employment, usually due to economic conditions.

3) The government grants intended to fall within regulation 3(2)(b) are those under a type of scheme which gives grants to employers in respect of employees who are not required to work for their employer for a temporary period due to the Covid-19 pandemic. The intention was that if a scheme, such as the Coronavirus Job Retention Scheme, were in operation while these instruments have effect then it would fall within this provision. In fact, no such scheme has been in operation since 30 September 2021.

HM Revenue and Customs

1 March 2022

Formal minutes

Wednesday 9 March 2022

Virtual meeting

Members present

Jessica Morden, in the Chair

Lord Beith

Lord Chartres

Dr James Davies

Baroness D’Souza

Baroness Gale

Lord Haskel

John Lamont

Baroness Newlove

Richard Thomson

Report consideration

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 3.4 read and agreed to.

Annex agreed to.

Papers were appended to the Report as Appendices 1 to 4.

Resolved, That the Report be the Twenty-Seventh 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.

Adjournment

Adjourned till Wednesday 23 March at 3.40 p.m.