SL(6)380 – The National Health Service (General Medical Services Contracts) (Wales) 2023
Background and Purpose
These Regulations revoke and replace the National Health Service (General Medical Services Contracts) (Wales) Regulations 2004 (“the 2004 Regulations”).
The Regulations set out the framework for General Medical Services (“GMS”) contracts under Part 4 of the National Health Service (Wales) Act 2006 (“the Act”). The GMS contractor will hold a common Unified GMS contract (“Unified Contract”) with a local health board (“LHB”) for the provision of NHS primary medical services to patients, against which it is intended that they can easily demonstrate high levels of quality standards and care.
The Explanatory Memorandum to the Regulations states that Unified Contract aims to:
- simplify what services all GP practices in Wales provide as part of the NHS, and how they evidence assurance of service delivery;
- align general practice with developing service models for delivery of care, based around the ethos of prudent healthcare;
- make it easier for patients and healthcare professionals to understand responsibilities for the provision of services;
- reduce administrative bureaucracy;
- free up time and resource for service delivery; and
- enable use of data and technology to help plan resources and delivery of services.
Procedure
Negative.
The Regulations were made by the Welsh Ministers before they were laid before the Senedd. The Senedd can annul the Regulations within 40 days (excluding any days when the Senedd is: (i) dissolved, or (ii) in recess for more than four days) of the date they were laid before the Senedd.
Technical Scrutiny
The following 53 points are identified for reporting under Standing Order 21.2 in respect of this instrument.
The Misuse of Drugs Act 1971 is referenced 6 times in the Regulations but that Act is not defined and no footnote or citation appears anywhere in the Regulations in relation to that Act.
2. Standing Order 21.2(vi) – that its drafting appears to be defective or it fails to fulfil statutory requirements.
There are several instances of terms which are defined in regulation 3(1) not then being used correctly later in the Regulations, including:
a) In regulation 2(a) and Schedule 6 there is reference to the National Health Service (General Medical Services Contracts) (Wales) Regulations 2004. However, this has been defined as “the 2004 Regulations” by regulation 3(1).
b) In regulation 17(1), there is a reference to a “general medical services contract”. However, this has been defined in regulation 3(1) as “GMS contract”.
c) In Schedule 2, in paragraph 1(2)(a) and (3), there are references to “Public Health Wales NHS Trust”. However, this body has been defined as “Public Health Wales” in regulation 3(1).
It is important that defined terms are used consistently or if a different meaning is intended that this is clearly explained.
3. Standing Order 21.2(v) – that for any particular reason its form or meaning needs further explanation.
Regulation 3 provides for a definition of “national disqualification”. The definition contains a sub-paragraph (iv) which states:
sections 83, 86, 103 or 105 (performers of pharmaceutical services and assistants) of the Act
Ordinarily, and in the remainder of the definition, references to statutory provisions are to the section number followed by the section heading. There is no reference to the section headings for sections 83, 86 or 103 in this definition (albeit section 86 is referenced with its full heading earlier in regulation 3 which may explain why the heading for section 86 is omitted here). Further, the heading of section 105 of the Act is “Supplementary Lists”. None of the section numbers referred to in the definition are entitled “Performers of pharmaceutical services and assistants”.
4. Standing Order 21.2(vii) – that there appear to be inconsistencies between the meaning of its English and Welsh texts.
In regulation 3(1), in the definitions of “the 2004 Regulations” and the “Pharmaceutical Regulations”, in the Welsh text, the word “(Wales)” in the titles of those SIs has been incorrectly translated as “(Mawrth)” which can mean Tuesday, the month of March, the planet Mars, or the Roman god of war Mars, depending on the context.
5. Standing Order 21.2(vii) – that there appear to be inconsistencies between the meaning of its English and Welsh texts.
In regulation 3(1), in the definition of “adjudicator”, in the Welsh text, the translation has misinterpreted the meaning of “paragraph 106(5) of Schedule 3” by linking that Schedule to “the Act” mentioned earlier in the reference to “section 7(8) of the Act” in that definition. This is done by adding the female preposition “iddi” after the reference to “paragraph 106(5) of Schedule 3” in the Welsh text. Therefore, the reader of the Welsh text is misled to believe that paragraph 106(5) of Schedule 3 is found in the Act. But, it is referring to the paragraph 106(5) of Schedule 3 found later in these Regulations.
6. Standing Order 21.2(v) – that for any particular reason its form or meaning needs further explanation.
In regulation 3(1), in the definition of “Local Health Board”, the phrase “unless the context otherwise requires” has been used. However, the Welsh Government’s drafting guidelines, Writing Laws for Wales, paragraph 4.8(5), states that it generally is not helpful to the reader to use that phrase and that it should be explained where the definition applies. Further explanation would therefore assist in this regard.
7. Standing Order 21.2(v) – that for any particular reason its form or meaning needs further explanation.
Regulation 3(1) provides for a definition of “online practice profile” which makes reference to the NHS website. “NHS website” is not defined in the Regulations, and as there are numerous NHS websites across the UK and within Wales there may be confusion as to which website is being referred to.
Regulation 3(1) provides for a definition of “optometrist independent prescriber” which includes optometrists registered in the register of visiting optometrists from relevant European States maintained under section 8B(1)(a) of the Opticians Act 1989. Section 8B was repealed by the European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2019 (“the 2019 Regulations”). This repealed provision is also referred to in the definition of paragraph (d) of the definition of “supplementary prescriber”. Clarification is required as to whether the saving provision in the 2019 Regulations applicable to section 8B(1)(a) remains applicable or whether reference to section 8B(1)(a) is now obsolete. If the saving provision remains applicable then further information on this point would have been useful in a footnote.
9. Standing Order 21.2(vii) – that there appear to be inconsistencies between the meaning of its English and Welsh texts.
In regulation 3(1), in the definition of “optometrist independent prescriber”, in the Welsh text, the term “dispensing opticians” has been translated as “optegwyr fferyllol”. This suggests to the reader of the Welsh text that it means “pharmaceutical opticians” or “pharmacy opticians” in the context of the terminology used for “dispensing” elsewhere in these Regulations. The Welsh Government’s website has standardised the translation of the term with status A as “optegwyr cyflenwi”, and “optegwyr gweinyddu” would also appear to be another possibility as “gweinyddu” has been used for “dispensing” in these Regulations.
10. Standing Order 21.2(v) – that for any particular reason its form or meaning needs further explanation.
Regulation 3(1) provides for a definitions of “paramedic independent prescriber”, “registered paramedic”, “registered radiographer” and “therapeutic radiographer independent prescriber”, all of which refer to the Health and Care Professions Council register. Regulation 3(1) also provides definitions for “pharmacist independent prescriber”, “registered pharmacist” and “supplementary prescriber” which refer to the General Pharmaceutical Council Register. Unlike other registers such as these which are referred to in the Regulations, these registers are not defined, nor is there any information included as to the statutory or other basis for the existence of such registers in these definitions.
Regulation 3(1) provides for a definition of “pharmaceutical services” and states that it includes “directed services”, but the Regulations do not define or provide any further information as to the meaning of “directed services”, which would assist the reader in understanding this definition.
Regulation 3(1) provides for a definition of “physiotherapist independent prescriber” which refers to a person who is registered under article 5 of the Health and Social Work Professions Order 2002. There is no such Order. The citation in the footnote indicates that the correct Order is the Health Professions Order 2001.
Regulation 3(1) provides for a definition of “Pre-employment Checks Standards” and states that they must include elements of the NHS Employment Checks Standards published by the NHS Confederation. It appears that these Standards are in fact published by NHS Employers, which is the employers’ organisation for the NHS England. It would be helpful if the Welsh Government could confirm whether this is correct, and why only five of the six Standards are included in the definition of “Pre-employment Checks Standards” (the work health assessments standard being omitted).
14. Standing Order 21.2(v) – that for any particular reason its form or meaning needs further explanation.
Regulation 3(1) provides for a definition of “prescription form” which makes reference to an “NHS Foundation Trust”, but this latter term is not defined in regulation 3(1).
15. Standing Order 21.2(v) – that for any particular reason its form or meaning needs further explanation.
Regulation 3(1) provides for a definition of “regulatory or supervisory body” which includes “any other body listed in section 25(2) of the National Health Service Reform and Health Care Professions Act 2002”. Section 25(2) sets out the functions of the Professional Standards Authority for Health and Social Care and does not include a list of bodies. Clarification is therefore required as to whether the reference should in fact be to section 25(3).
Regulation 3(1) provides for a definition of “repeatable prescription” which makes reference to a “dispensing doctor”. All of the other terms in the definition are defined elsewhere but a definition for the term “dispensing doctor” is not provided. “Dispensing doctor” is also referred to in paragraph 60(2) of Schedule 3. It would be useful for the reader to have clarity on who a dispensing doctor is.
17. Standing Order 21.2(vi) – that its drafting appears to be defective or it fails to fulfil statutory requirements.
In regulation 3(1), in the definition of “repeatable prescriber”, there are drafting errors in paragraphs (b), and (c)(ii) and (iii) where there are references to “the 2006 Act”. However, there is no definition of “the 2006 Act” in these Regulations and it appears to be referring to the defined term “the Act”.
18. Standing Order 21.2(vi) – that its drafting appears to be defective or it fails to fulfil statutory requirements.
Regulation 5(3)(c) refers to the National Health Service (Vocational Training) Regulations (Northern Ireland) 1998. The reference should be to the Medical Practitioners (Vocational Training) Regulations (Northern Ireland) 1998.
In regulations 5(5) and 6(2)(f), in the Welsh text, “December” has been incorrectly translated as the month of “March”.
20. Standing Order 21.2(v) – that for any particular reason its form or meaning needs further explanation
Regulation 6(2)(f) makes reference to a person who has been convicted in the UK of a criminal offence (other than murder) committed on or after 14 December 2001 and has been sentenced to a term of imprisonment of longer than 6 months. Could clarification be provided as to why a specific date is necessary?
21. Standing Order 21.2(v) – that for any particular reason its form or meaning needs further explanation
Regulation 6(2)(g) and paragraph 119(3)(h) of Schedule 3 refers to offence committed on or after 26 August 2002. Could clarification be provided as to why a specific date is necessary?
22. Standing Order 21.2(v) – that for any particular reason its form or meaning needs further explanation
Regulation 6(2)(h) refers to offences committed on or after 1 March 2004. Could clarification be provided as to why a specific date is necessary?
In regulation 17(2)(a), in the English text, “its” has been used without an earlier reference to a noun which means that it is not clear what the “its” is referring to in paragraph (2). In the Welsh text, the phrase “the contractor’s” has been used in the translation in the corresponding place, which is clearer if it has interpreted the meaning correctly.
24. Standing Order 21.2(vii) – that there appear to be inconsistencies between the meaning of its English and Welsh texts.
In regulation 17(4), in the definition of “disease”, in the Welsh text, “three-character” has been translated as “tri-chymeriad”. “Cymeriad” has several meanings in Welsh including the characteristics or reputation of a person or area etc. However, “three-character” in this context refers to a code with letters and numbers used to identify a disease so “cymeriad” doesn’t seem to correctly convey the meaning of “character” in this phrase. Other words such as “nod” or “symbol” would seem to be more appropriate in this context.
25. Standing Order 21.2(vii) – that there appear to be inconsistencies between the meaning of its English and Welsh texts.
In regulation 28(11)(c), there is a difference between the language texts, as all of the closing words in the English text after paragraph (ii) are missing from the translation. As a result, the Welsh translation does not make sense or convey the meaning of the English text. Further, in the Welsh text, “their” in the phrase “(or their equivalent)” has been translated as meaning only “the providers”. If it is referring to both “contractors or providers” or if it is referring to the “unified services” then the translation is incorrect and has misinterpreted the meaning of the phrase.
In Schedule 1, in the second column of Table 1, there is a difference between the English and Welsh texts. In the Welsh text, “Marine” in the title of “Naval and Marine Pay and Pensions Act 1865” has been translated as “Môr” which has several possible meanings including “sea”, “relating to the sea” or “ocean”. However, the “Marine” is referring to soldiers who would be described today as “Royal Marine Commandos”. Therefore, the meaning has been incorrectly interpreted and does not convey the meaning of “Marine” in the title of that Act. Words such as “Morlu” or “Môr-filwyr” would have been more appropriate in the context.
In Schedule 2, in paragraph 1(1)(b), there is a difference between the English and Welsh text. In the English text, there is a reference to “paragraph 78 of Schedule 3”. However, in the Welsh text this reference has been translated as “paragraph 79 of Schedule 3”.
28. Standing Order 21.2(vii) – that there appear to be inconsistencies between the meaning of its English and Welsh texts.
In Schedule 2, in paragraph 7(1)(b), the phrase “such vaccines and immunisations” has been used in the English text. However, in the Welsh text, it has been translated as meaning “such vaccinations and immunisations”. Therefore, there is a difference in meaning between both language texts. The Welsh text appears to be correct as in in paragraph 7(1)(a) and the earlier paragraph 3(2)(b) of this Schedule , the phrase “vaccinations and immunisations” was used in the English text.
29. Standing Order 21.2(v) – that for any particular reason its form or meaning needs further explanation.
Paragraph 3(2)(a) of Schedule 2 requires a contractor to offer to provide vaccinations and immunisations to children. Unlike elsewhere in the Regulations, paragraph 3(2)(a) does not limit this duty to children for whom the contractor has responsibility under the contract. Clarification would therefore be useful as to whether the paragraph 3(2)(a) is intended to impose a duty to make the offer only to children for whom the contractor has responsibility under the contract and, if so, why this is not explicitly stated.
Paragraphs 16, 18 and 19 of Schedule 3 relates to the provision of “services” by a contractor’s cluster and contributions to the GP Collaborative. The word “services” is included in several definitions within the Regulations but is not itself defined. It would therefore assist the reader to have clarity regarding which services are referred to in paragraphs 16, 18 and 20 of Schedule 3.
31.Standing Order 21.2(vii) – that there appear to be inconsistencies between the meaning of its English and Welsh texts.
There is an error in the references contained in paragraph 22(b)(i) of Schedule 3. References in the Welsh version to “baragraff 44(1)(a)” and “baragraff 44(1)(b)” should be to “baragraff 43(1)(a)” and “baragraff 43(1)(b)”. The English version appears to be correct.
There is an inconsistency between the English and Welsh versions at paragraph 39(3) of Schedule 3. The provision in English says “subject to paragraph 41”, whilst the Welsh version says “subject to paragraph 42”. The English reference appears to be correct.
33.Standing Order 21.2(vii) – that there appear to be inconsistencies between the meaning of its English and Welsh texts.
There is an inconsistency between the English and Welsh versions at paragraphs 49(8) and paragraph 50(1)(b) of Schedule 3. The Welsh version of the Regulations contains cross-referencing errors, so that references to paragraph 58 should be to paragraph 57.
34. Standing Order 21.2(v) – that for any particular reason its form or meaning needs further explanation.
Paragraphs 49, 50 and 51 of Schedule 3 refers to the patient’s authorised person in the context of prescriptions. The term “authorised person” is not defined and it is therefore not clear who a patient’s authorised person would be or how someone can be made an authorised person.
35. Standing Order 21.2(v) – that for any particular reason its form or meaning needs further explanation.
Paragraphs 50 of Schedule 3 refers to a contractor’s EPS go live date, but the Regulations provide no information as to what this is or how it is to be determined. Further clarification would assist the reader in this regard.
36. Standing Order 21.2(v) – that for any particular reason its form or meaning needs further explanation.
Paragraph 51(1) of Schedule 3 refers to “DHCW”, but the Regulations do not define this acronym nor is any footnote included to confirm what this is.
37. Standing Order 21.2(vii) – that there appear to be inconsistencies between the meaning of its English and Welsh texts.
In paragraph 79(3) of Schedule 3, “Welsh GP Record” is defined, however in paragraph 79(1) of the English version it is also defined as ‘(WGPR)’ and only ‘WGPR’ is used in paragraph 79(2). This issue does not occur in the Welsh version of the Regulations.
38. Standing Order 21.2(vi) – that its drafting appears to be defective or it fails to fulfil statutory requirements.
Paragraph 92 of Schedule 3 deals with the provision of information to a relevant person. The term “relevant person” is defined in paragraph 92(3) to include a medical officer, nursing officer, occupational therapist or physiotherapist (plus one other not relevant to this reporting point). Paragraph 92(4) goes on the define each of these roles save for nursing officer, a definition for this term is missing and therefore it is not possible to determine who a nursing officer is for the purpose of paragraph 92.
39.Standing Order 21.2(vii) – that there appear to be inconsistencies between the meaning of its English and Welsh texts.
In paragraph 114(4) of Schedule 3, the English version states that the paragraph is without prejudice to any other rights to terminate the contract that the LHB contractor may have. The Welsh version only refers to the contractor and does not include the LHB.
40. Standing Order 21.2(vi) – that its drafting appears to be defective or it fails to fulfil statutory requirements.
Paragraph 117(6) of Schedule 3 makes reference to a Fitness to Practise Panel and an Interim Orders Panel under the Medical Act 1983. That Act has been amended so that a Fitness to Practise Panel is now a Medical Practitioners Tribunal and an Interim Orders Panel is an Interim Orders Tribunal.
41. Standing Order 21.2(v) – that for any particular reason its form or meaning needs further explanation.
Paragraph 119(3)(v) of Schedule 3 permits an LHB to terminate a contract where the contractor has refused to be medically examined due to concerns that they are incapable of providing services under the contract. It goes on to state that such termination may occur in such a case where the contract is with two or more individuals or a company and the LHB is satisfied that the contractor is taking adequate steps to deal with the matter. It appears odd that the LHB has the right to terminate the contract even when it is satisfied that adequate steps are being taken to deal with the matter, therefore clarification is required as to whether this is correct or whether termination should only be an option where the LHB is not satisfied that the matter is being dealt with.
There is an referencing inconsistency between the English and Welsh texts in paragraph 126(1) of Schedule 3. The English version reads ‘123(2)’ and the Welsh version reads ‘123’.
43. Standing Order 21.2(v) – that for any particular reason its form or meaning needs further explanation.
Paragraph 128(4)(a) of Schedule 3 requires the completion of the Clinical Governance Practice Self-Assessment Tool and the Information Governance Toolkit. No further information is provided in relation to these two terms and they are not defined in the Regulations.
44.Standing Order 21.2(vii) – that there appear to be inconsistencies between the meaning of its English and Welsh texts.
There is an inconsistency between the English and Welsh texts in paragraph 135 of Schedule 3. Sub-paragraph (1) of paragraph 135 of the Welsh version is missing. The text is correct but the ‘—(1)’ is missing.
45. Standing Order 21.2(v) – that for any particular reason its form or meaning needs further explanation.
Paragraph 135(2) of Schedule 3 requires the services to be provided in a manner that assists the LHB to comply with the Health and Care Standards and the Duty of Quality Guidance. No further information is provided in relation to these two terms and they are not defined in the Regulations.
46. Standing Order 21.2(vi) – that its drafting appears to be defective or it fails to fulfil statutory requirements.
Paragraph 1(w) of Schedule 4 contains an incomplete reference. It refers to paragraph 60(2)(b) but does not go on to confirm where that paragraph is to be found. There is no paragraph 60(2)(b) in Schedule 4, it appears that it should refer to Schedule 3.
47. Standing Order 21.2(vi) – that its drafting appears to be defective or it fails to fulfil statutory requirements.
Paragraph 1(2) of Schedule 5 amends the definition of “Medical Regulations” in the National Health Service (Performers Lists) (Wales) Regulations 2004. It is presumed that the intention is that the definition will now refer to the Regulations, but as amended the title will be incorrect – it will refer to the “National Health Service (General Medical Services) (Wales) Regulation 2023”, with the word “Contracts” being omitted.
48. Standing Order 21.2(vi) – that its drafting appears to be defective or it fails to fulfil statutory requirements.
Paragraph 1(3) of Schedule 5 amends the National Health Service (Performers Lists) (Wales) Regulations 2004 to make reference in those regulations to regulation 10(6) of these Regulations. However, these Regulations do not include a regulation 10(6).
49. Standing Order 21.2(vi) – that its drafting appears to be defective or it fails to fulfil statutory requirements.
In Schedule 5, in paragraph 2(2)(a)(iii) and (iv)(bb), the description identifies a figure “6” to be substituted by the amendment. However, it can be argued that it is not sufficiently clear as there are references in the definitions of “patient list” and “repeatable prescriber” to “the 2006 Act”. Therefore, the description fails to distinguish between the “6” in “the 2006 Act” and where it occurs on its own in those definitions.
50. Standing Order 21.2(vi) – that its drafting appears to be defective or it fails to fulfil statutory requirements.
Paragraph 2(2)(a)(iv)(aa) of Schedule 5 amends the National Health Service (Pharmaceutical Services) (Wales) Regulations 2002 (“the 2002 Regulations”) to replace references to paragraph 40 of Schedule 6 to the 2004 Regulations with references to paragraph 53 of Schedule 3 to these Regulations. However, the content of paragraph 40 of Schedule 6 is very similar to paragraph 52 of these Regulations, therefore it appears that the reference to paragraph 53 should be to paragraph 52.
51. Standing Order 21.2(vi) – that its drafting appears to be defective or it fails to fulfil statutory requirements.
Paragraph 2(2)(b) of Schedule 5 amends the 2002 Regulations to replace references to paragraphs 47 to 51 of Schedule 6 to the 2004 Regulations with references to paragraphs 60 and 61 of Schedule 3 to these Regulations. Paragraphs 47 to 51 refer to dispensing services, but only paragraph 60 of Schedule 3 to these Regulations refers to such services. It therefore appears that paragraph 61 is referred to in error.
52. Standing Order 21.2(v) – that for any particular reason its form or meaning needs further explanation.
Paragraph 2(3)(a)(ii) of Schedule 5 amends the 2002 Regulations to replace reference to paragraph 42(2) of Schedule 6 to the 2004 Regulations with references to paragraph 56 of Schedule 3 to these Regulations. However, it is not clear whether the intention is to insert a reference to the whole of paragraph 56 of Schedule 3 instead of paragraph 42(2) of Schedule 6, or whether the new reference should only be to a sub-paragraph within paragraph 56. Further, it is also not clear whether the reference to paragraph 56 should be to paragraph 55.
53. Standing Order 21.2(vi) – that its drafting appears to be defective or it fails to fulfil statutory requirements.
Paragraph 2(3)(c)(i) of Schedule 5 amends the 2002 Regulations to replace reference to paragraphs 89A and 90 of Schedule 6 to the 2004 Regulations with references to paragraph 102 of Schedule 3 to these Regulations. However, the content of paragraph 89A of Schedule 6 is very similar to paragraph 101 of Schedule 3 to these Regulations, therefore it appears that the reference to paragraph 102 should be to paragraph 101. On the same basis, paragraph 3(c)(ii) of Schedule 5 seems to incorrectly refer to paragraph 103 of these Regulations where it should refer to paragraph 102.
Merits Scrutiny
The following two points are identified for reporting under Standing Order 21.3 in respect of this instrument.
The Explanatory Note states that the Regulations set out, for Wales, the framework for general medical services contracts under section 42 of the National Health Service Act 2006, which is then defined for the purpose of the remainder of the Explanatory Note as “the Act”. The Act referred to is incorrect, the correct Act is the National Health Service (Wales) Act 2006. Although the Explanatory Note does not form part of the Regulations, which do refer to the correct Act, this error may cause confusion for the reader, particularly as the National Health Service Act 2006 is also an Act of the UK Parliament. Using an incorrect reference for a defined term also means that the remainder of the Explanatory Note contains incorrect references.
55. Standing Order 21.3(ii) – that it is of political or legal importance or gives rise to issues of public policy likely to be of interest to the Senedd.
Although the Committee notes that they do not form part of these Regulations themselves, over 100 typographical, grammatical and footnote errors have been found in these Regulations which have been notified separately to Welsh Government officials. In particular, footnotes are a useful tool for readers of legislation only insofar as they are accurate and the Committee therefore encourages the Welsh Government to ensure that this is the case.
Welsh Government response
A Welsh Government response is required for all reporting points.
Legal Advisers
Legislation, Justice and Constitution Committee
19 September 2023