England and Wales High Court (Administrative Court) Decisions

IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
ADMINISTRATIVE COURT

		Royal Courts of Justice Strand, London, WC2A 2LL
		05 June 2018

Mr Justice Supperstone :

Introduction

1. This is the rolled-up hearing, ordered by Yip J on 20 December 2017, of the Claimant's application to challenge (1) a consultation by the Defendant, known as NHS England ("NHSE") on "Items which should not routinely be prescribed in primary care" ("the consultation paper") published on 21 July 2017, in relation to the proposals relating to homeopathy, and (2) the decision of NHSE made on 30 November 2017 to implement the consultation proposals in respect of homeopathy by issuing guidance ("the Guidance") to Clinical Commissioning Groups ("CCGs").
2. The Guidance recommends that prescribers in primary care (in effect, general practitioners, or "GPs") should not prescribe homeopathic treatments as a new treatment for any patient, and that GPs should be supported in de-prescribing homeopathic treatments for all patients for whom they are currently being prescribed.
3. "Homeopathy" is defined by NHSE for the purposes of the Guidance (at para 4.7) as the treatment of patients "with highly diluted substances that are administered orally".
4. The Claimant is a charity which has the overall objective of ensuring that homeopathy is available to all by means of, amongst other things, ensuring patients have access to homeopathy.
5. The original claim form filed on 20 October 2017 challenged the consultation on the consultation paper published on 21 July 2017. The amended claim filed on 22 January 2018 challenged in addition the decision to implement the consultation proposals made on 30 November 2017.
6. The Claimant's pleaded case included the contention that "the seriously unbalanced and inaccurate views NHS England expressed in relation to homeopathy and/or the decision based on them are in the circumstances irrational" (Claimant's Amended Grounds dated 22 January 2018 ("Amended Grounds") at para 2.9). However, shortly before the hearing, in their skeleton argument dated 16 April 2018, the Claimant stated (at para 14) that it had decided not to pursue that ground.

Relevant Legislative Background

7. Save in relation to the NHSE's power to issue the Guidance (which I consider at paras 97 to 105 below), the relevant legislative background is not in issue. It is helpfully set out at paras 21-34 in the Defendant's Detailed Grounds of Resistance, so far as is relevant:

"(1) The National Health Service Commissioning Board

21. The Defendant was established as a body corporate by s.1H of the [National Health Service Act 2006] ["the 2006 Act"]. Pursuant to s.1H(4) of, and paragraphs 2 and 3 of Schedule A1 to, the 2006 Act, the Defendant has 13 members, comprising a chair and eight members appointed by the Secretary of State (the non-executive members) and four executive members appointed by the non-executive members. The executive members include a chief executive.

23. The Board has a duty to continue the promotion in England of a comprehensive health service designed to secure improvement in the physical and mental health of the people of England, and improvement in the prevention, diagnosis and treatment of physical and mental illness. The Board and the Secretary of State have concurrent duties in this respect (ss.1(1) and 1H(2) of the 2006 Act).

24. For the purpose of discharging that duty, the Board has the function of arranging for the provision of certain services for the purposes of the health service in England (s.1H(3)(a) of the 2006 Act). In particular, the Board must, to the extent that it considers necessary to meet all reasonable requirements, exercise its powers so as to secure the provision of primary medical services throughout England (s.83(1)). In this respect, the Board may make such arrangements for the provision of primary medical services as it considers appropriate; and it may, in particular, make contractual arrangements with any person (s.83(2)). In so far as is relevant for present purposes, primary medical services are services provided by general practitioners ("GPs") pursuant to general medical services contracts ("GMS contracts").

25. The Board also has a duty to exercise the functions conferred on it by the 2006 Act in relation to clinical commissioning groups ("CCGs") so as to secure that services are provided for the purposes of the health service in England in accordance with the 2006 Act (s.1H(3)(b)).

26. Under chapter A1 of Part 2 of the 2006 Act, the Board is subject to various general duties (also referred to as 'secondary duties: R (National Aids Trust) v NHS Commissioning Board [2016] PTSR 1093, paragraph 35 per Green J) relating to how the Board must exercise its functions. In summary, the Board must exercise its functions:

(1) with a view to securing that health services are provided in a way which promotes the NHS Constitution (s.13C);

(2) effectively, efficiently and economically (s.13D);

(3) with a view to securing continuous improvement in the quality of services provided to individuals for or in connection with (a) the prevention, diagnosis or treatment of illness, or (b) the protection or improvement of public health (s.13E);

(4) having regard to the duty to reduce inequalities between patients with respect to their ability to access health services and reduce inequalities with respect to outcomes achieved for them by the provision of health services (s.13H);

(5) with a view to enabling patients to make choices with respect to aspects of health service provided to them (s.13I);

(6) to promote innovation in the provision of health services (s.13K);

(7) to promote research (s.13L);

(8) to promote education and training (s.13M); and

(9) to promote the provision of services in an integrated way where this could improve the quality of services provided and reduce inequalities between persons with regard to their ability to access relevant services and reduce inequalities with regard to outcomes (s.13N(1)).

27. Where any services are, or are to be, provided pursuant to arrangements made by the Board itself, it must make arrangements to secure that individuals to whom the services are being or may be provided are involved (whether by being consulted or provided with information or in other ways): in the planning of commissioning arrangements by the Board; in the development and consideration of proposals by the Board for changes in commissioning arrangements, where the implementation of the proposals would have an impact on the manner in which the services are delivered to the individuals or the range of health services available to them; and in decisions of the Board affecting the operation of the commissioning arrangements where the implementation of the decisions would (if made) have such an impact (s.13Q of the 2006 Act).

(2) Clinical Commissioning Groups

28. CCGs were established by s.1I of the 2006 Act. Each CCG has the function of arranging for the provision of services for the purposes of the health service in England in accordance with the 2006 Act (s.1I(2)).

29. Whilst NHSE is responsible for reimbursing pharmacies for the costs of prescriptions, in practice each CCG receives a pharmaceutical budget for each financial year, and each CCG is then responsible for meeting the costs of prescriptions dispensed to patients within its area.

30. CCGs also support and guide GPs and other primary care prescribers to prescribe efficiently, economically and effectively.

(3) The Board's Power to Issue the Guidance

32. CCGs are not subject to any duty to follow the Guidance, and nor is there any express duty on CCGs to have regard to guidance issued under ss.2 and/or 14Z10 of the 2006 Act (cf s.14Z8(2)). However, pursuant to the general principles of the common law, the Guidance is likely to be a matter that should be taken into account by CCGs when exercising relevant functions.

(4) General Practitioners

33. In order to enable it to discharge its duty to secure the provision of primary medical services throughout England, the Board has power to enter into GMS contracts (s.84(1) of the 2006 Act). Accordingly, responsibility for commissioning GP services rests with the Board, although in many cases this function is either delegated to local CCGs or exercised jointly with them.

34. Under GMS contracts, GPs have responsibility for prescribing drugs and appliances to patients…"

Factual Background

8. Mr Alexander Williams, a Deputy Director in the Medicines, Diagnostics and Personalised Medicine Team of NHSE, who acted as project manager for the project which resulted in the issuing of the Guidance, sets out in his first witness statement the background to the issuing of the Guidance.
9. On 23 February 2017 NHS Clinical Commissioners ("NHSCC"), which is a membership organisation for CCGs, provided to NHSE a paper it had prepared which included a series of proposals which sought to achieve efficiencies in the primary care budget, in the context of the overall allocation to CCGs for prescriptions. One of the proposals was a "recalibration of the rules and policies governing what the NHS will and won't fund on prescription". NHSCC had identified a "basket of products" amounting to some £400m of annual spend in relation to which it considered that savings could be achieved and inconsistencies across the country could be reduced. NHSCC had worked together with its members and PrescQIPP (an NHS-funded not-for-profit organisation which provides information and guidance to CCGs on prescribing) to develop a list of items that they considered should not be routinely prescribed in primary care.
10. On 31 March 2017 NHSE published its "Next Steps on the Five Year Forward View" which included a commitment on behalf of NHSE to support NHSCC and CCGs "in taking action on their top medicines of low clinical value that should not normally be prescribed (which cost £128m a year) by developing national guidance with CCGs".
11. A Joint Clinical Working Group (the "Working Group") was established by NHSCC, NHSE and the Department of Health. Members of the Working Group were selected jointly by NHSE and NHSCC to include the key clinical representatives of the organisations that would be responsible for implementing any guidance issued by NHSE. The Working Group included members of the Royal Pharmaceutical Society, as the general membership body for pharmacists; the Royal College of General Practitioners and the British Medical Association, as the general membership bodies for clinicians (prescribers); the Academy of Medical Royal Colleges; NHSE, NHSCC and CCGs, as commissioners of treatments and medications; and NICE, for advice on clinical safety and effectiveness. The Working Group also included members who are organisational representatives with substantial experience and expertise in their fields.
12. Terms of reference for the working group recorded that:

"Alongside the working group there are various stakeholder organisations who have a keen interest in this area. Rather than including them on the group, making it unwieldy and potentially delaying development of the draft guidance, we will actively engage with them individually and via wider stakeholder meetings. All stakeholder groups will also have the opportunity to be involved in a full consultation of the draft guidance developed."

13. At a meeting between NHSCC, NHSE and the Department of Health on 4 May 2017, it was agreed that NHSE and NHSCC should come to a provisional view on each of the products identified by NHSCC which would then be provided to the Working Group for it to consider.
14. Meetings of the Working Group took place between 16 May and 17 July 2017. When considering what recommendation to make in respect of a particular item, the Working Group considered a number of factors including the "efficacy" of each item. The term "efficacy" is defined in the NICE Glossary as "how beneficial a test, treatment or public health intervention is under ideal conditions (for example, in a laboratory), compared with doing nothing or opting for another type of care".
15. The Working Group's proposals were considered by NHSE's Commissioning Committee and by the Board itself on 21 July 2017. Prior to that on 13 June 2017 a meeting was held to discuss the proposals with certain stakeholders, including representatives of the pharmaceutical industry, the BMA, the GMC, Health Watch England and National Voices. Health Watch England is an independent national organisation which represents the interests of people who use health and social care services. National Voices is a coalition of charities which advocates individuals having as much control and influence as possible over their own health and care.
16. On 21 July 2017 the Board paper dealing with the Working Group's recommendations and the guidance to be issued to CCGs was presented to the Board by Professor Sir Bruce Keogh, the national medical director of NHSE, and Mr Paul Baumann, the chief financial officer. Homeopathy was identified in the Board report as an item of low clinical effectiveness where there was a lack of robust evidence of clinical effectiveness, or where there were significant safety concerns. Following discussion of the Board report, the Board approved the launch of the formal public consultation.
17. The consultation paper set out the background to the consultation, explaining the issue that NHSE was trying to tackle, the objective of the work and what it was doing, to whom the commissioning guidance was addressed, and how far the proposals had been developed.
18. It stated that in the Working Group, items were considered for inclusion if they were:

"Items of low clinical effectiveness where there is a lack of robust evidence of clinical effectiveness or there is significant safety concern;

Items which are clinically effective but where more cost-effective products are available, including products that have been subject to excessive price inflation; or

Items which are clinical effective but, due to the nature of the product, are deemed a low priority for NHS funding."

19. It went on to explain that the Working Group assigned one or more of the following recommendations to items considered:

"Advise CCGs that prescribers in primary care should not initiate [item] for any new patient;

Advise CCGs to support prescribers in de-prescribing [item] in all patients and where appropriate, ensure the availability of relevant services to facilitate this change;

Advise CCGs that if, in exceptional circumstances, there is a clinical need for the item to be prescribed in primary care, this should be undertaken in a co-operation arrangement with the multi-disciplinary team and/or other healthcare professional;

Advise CCGs that all prescribing should be carried out by a specialist; and/or

Advise CCGs that this item should not be routinely prescribed in primary care but may be prescribed in named circumstances such as [item]."

20. The consultation paper stated that the Working Group reviewed each product against certain criteria which, for present purposes, relating to homeopathy, included the following:

"Indication i.e. what condition is it used to treat?

…

Efficacy i.e. is it clinically effective?

…

Alternative treatments and exceptionality for individuals i.e. do alternatives exist and if so, who would they be used for?

…

Financial implications, comprising:

Commissioning/funding pathway i.e. how does the NHS pay for the drug?

Medicine cost i.e. how much does the drug cost per item?

Healthcare resources utilisation i.e. what NHS resources would be required to implement a change?

Annual spend i.e. what is the annual spend on the NHS on this item?

Unintended consequences (see Appendix 2)."

21. Under the heading "2.2 Scope" the consultation document states:

"The following chapter sets out the process for how NHS England and NHS Clinical Commissioners will conduct the process to review and update the guidance to CCGs as appropriate. Chapter 4 sets out draft guidance on 18 products that have been identified as being of low clinical value and/or comparatively expensive for one or more of the reasons outlined in section 1.4. For each, this consultation provides advice to Commissioners based on the latest available evidence and the clinical consensus that has been reached by our joint clinical working group. It seeks views on whether this advice is implementable and clinically sound. Full details of the questions can be seen on the online consultation form and in Appendix 3."

22. In chapter 4 at 4.7 the draft guidance in relation to homeopathy is set out:

4.7 Homeopathy

Background	Homeopathy seeks to treat patients with highly diluted substances that are administered orally. (MHRA detailed guidance)
Annual Spend	£92,412 (NHS Digital)
Rationale for recommendation	In 2010 a report by the House of Commons Science and Technology Committee, found that the use of homeopathy was not evidence based and any benefits to patients was down to placebo effect. The group agreed with the findings of the committee for the lack of evidence and considered homeopathy suitable for inclusion in the proposed guidance.
Category	Products of low clinical effectiveness, where there is a lack of robust evidence of clinical effectiveness or there are significant safety concerns
Recommendation	Advise CCGs that prescribers in primary care should not initiate homeopathic items for any new patient. Advise CCGs to support prescribers in deprescribing homeopathic items in all patients and, where appropriate, ensure the availability of relevant services to facilitate this change.

23. Appendix 3 to the consultation document contains consultation questions. Under the heading "Equality and Health Inequalities" there are the following questions:

"Do you feel there are any groups, protected by the Equality Act 2010, likely to be disproportionately affected by this work?

Yes (please tick all that apply) No

Age / Disability / Gender Reassignment / Race / Religion or Belief / Sex /Sexual Orientation / Marriage and Civil Partnership / Pregnancy and Maternity

Please provide further information on why you think this might be the case.

Do you feel there is evidence we should consider in our proposals on the potential impact on health inequalities experienced by certain groups e.g. people on low incomes; people from BME communities?

Yes/No

Please provide further information on why you think this might be the case.

Homeopathy:

Do you agree with the proposed recommendation for homeopathy?

Agree/Neither Agree Nor Disagree/Disagree/Unsure

If needed, please provide further information."

The Consultation Exercise

24. NHSE published the consultation document on its website on 21 July 2017, and on the same day a press release was issued by NHSE to announce the consultation. The press release included the following:

"NHS England has today published detailed plans – drawn up with family doctors and pharmacists – to cut out prescriptions for ineffective, over-priced and low value treatments. Helping to trim hundreds of millions from the nation's rapidly growing drugs bill will create headroom to reinvest all savings in newer and more effective NHS medicines and treatments.

A formal public consultation is being launched on new national guidelines which state that 18 treatments – including homeopathy and herbal treatments – which together cost taxpayers £141,000,000 a year should generally not be prescribed.

Simon Stevens, NHS England's chief executive, described homeopathy as 'at best a placebo and a misuse of scarce NHS funds'.

…

Dr Graham Jackson, GP, NHS Clinical Commissioner Co-Chair and Clinical Chair of NHS Aylesbury Vale CCG, said:

'… we need to have an honest conversation with the public, patients and clinicians on what the NHS should provide and this consultation around the medicines spend – an area with the potential to unlock huge resource – is an important part of that. We are pleased to have worked with NHS England identifying products that could be considered low priority for NHS funding, for reasons including limited clinical effectiveness or the availability of cost-effective alternatives. We now hope to hear from as many people and organisations as possible so that the final guidance can properly take these views into account and result in our member CCGs being given national support in prioritising medicines and services that make the best use of the NHS pound'."

25. During the consultation period NHSE held a number of engagement meetings. Representatives of the Claimant attended the 5 September 2017 meeting, as did representatives of other bodies with an interest in homeopathy. On 18 October 2017 a meeting was held at the Claimant's offices. Those in attendance included Mr Williams and Mr MacKenna, a Specialist Pharmacist, on behalf of the Board, and representatives of the Claimant together with their lawyers and other bodies with an interest in homeopathy. Mr Williams confirmed to all attendees that no final decisions had been taken by NHSE and that all responses would be carefully looked at and taken into account by the working group, although the final decision would be taken by the Board.
26. In addition to attending the two meetings the Claimant submitted an on-line response to the consultation exercise on 20 October, and submitted written representations and evidence under cover of a letter dated 21 October. Mr Williams summarises those two written responses in his first witness statement:

"113. In its online survey response, the Claimant stated that it considered individuals with the protected characteristics of age and disability would be disproportionately affected by the proposals. This was because, it said, the number of patients affected by the proposals would be largely older or disabled people. The Claimant also contended that such people would be affected because, they said, the consultation was only available online, which would affect their ability to give views. Further, the Claimant suggested that NHS England should seek to obtain feedback from chronically ill patients' NHS providers.

114. In regards to homeopathy specifically, the Claimant confirmed that it disagreed with the working group's recommendations and stated that homeopathy is a low cost treatment with 'amazing patient outcomes'. The Claimant also considered that NHS England had not taken on board various evidence as to clinical effectiveness, including randomised controlled trials, outcomes studies, and patient experiences. The Claimant developed these arguments in its substantive written response to the consultation, which referred to various evidence sources including patient-reported outcome surveys, a précis of evidence prepared by Dr Peter Fisher, and randomised controlled test evidence. The Claimant also sought to summarise what it considered to be a growing evidence base supporting the effectiveness of homeopathy, and noted its concerns with NHS England's citation of the Select Committee Report in the consultation document."

27. As a result of the material submitted by the Claimant and the consultation responses received in relation to homeopathy generally, the co-chair of the Working Group, Dr Bruce Warner, considered that further scrutiny was required, and it would be appropriate to commission a review of the clinical evidence for homeopathy. Accordingly the NHS Specialist Pharmacy Service ("the SPS") was commissioned to conduct a review of that evidence.
28. On 3 November 2017 the SPS provided its report to the Working Group. Mr Williams notes (first witness statement, para 120) that:

"In carrying out their review, SPS referred in part to the systemic evidence review undertaken by the Australian National Health and Medical Research Council ('the NHMRC') in 2015, which concluded that there was no condition for which there was a high level of confidence in the clinical effectiveness of homeopathy. The SPS also identified ten additional systemic reviews which had been published subsequent to the NHMRC review, nine of which were summarised and assessed for methodological quality by the SPS (the remaining review could not be obtained). In addition the SPS had regard to the various studies referred to in the Claimant's response to the consultation and noted all but three of the studies had been either considered as part of the NHMRC review or were of insufficient quality. The remaining three studies were appraised by the SPS as part of its review. All systematic reviews were assessed by the SPS against the AMSTAR tool for scoring methodological quality of systematic reviews. AMSTAR ('A Measurement Tool to Assess Systematic Reviews') is a critical appraisal tool for systematic reviews (including randomised or non-randomised studies of healthcare interventions, or both) which is used to develop and evaluate quality reviews. The outcome of the SPS review supported the Working Group's original assessment that there was a lack of robust evidence of the clinical effectiveness of homeopathy."

29. The Working Group then met again for a final time on 13 November 2017 to discuss the recommendations to be made and to consider the draft guidance to be issued. Mr Williams states (first witness statement, para 123) that:

"The Working Group discussed wider implications of the recommendations, including those relating to cost and patient factors, but concluded that the evidence review did not need to proceed beyond the clinical effectiveness conclusions. Following this discussion, the Working Group agrees that the final recommendations for homeopathy to be referred to the NHS England Board should remain unchanged from the consultation document."

30. In parallel with the review of the consultation responses and the development of draft guidance, NHSE also considered the impact of each of the proposals on patients with the protected characteristics identified in the Equality Act 2010 ("the 2010 Act"). The equalities and health impact analysis was accordingly updated in light of feedback received from consultees.
31. The results of the consultation exercise were presented to the Board on 30 November 2017, at a meeting held in public, along with the recommendation that the Board approve the issuing of final guidance. The Board was provided with a copy of the SPS review and an updated Equalities Analysis. Nine non-executive members of the Board (including Prof. Sir Malcolm Grant, the Chairman) were in attendance; and seven executive directors (including Mr Stevens).
32. The proposals for the guidance to be issued to CCGs were presented to the Board and led by Professor Sir Bruce Keogh, who introduced a number of documents to the Board, including a Board paper explaining the recommendations and the approvals sought from the Board; the report of the consultation findings; the homeopathy evidence review undertaken by the SPS; the draft guidance for CCGs which had been prepared by the Working Group following its review of the consultation feedback; and the updated equality and health inequalities analysis.
33. The Board agreed with the recommendation, and the Guidance was issued on the same day, together with a press statement which said, in relation to homeopathy, that there is "no clear or robust evidence to support its use".

Grounds of Challenge

34. The Claimant's Amended Grounds identified (at para 42) nine issues that they contended arose to be determined. However in addition to the Claimant's decision not to pursue the rationality challenge (see para 6 above), the Claimant in their skeleton argument also stated that they would no longer pursue the grounds that (1) NHSE misdirected itself by misconstruing s.13Q(2) and/or s.13C(a) of the 2006 Act; and (2) NHSE failed to follow its own policy and failed to provide a good reason for not doing so.
35. Further, having issued an application notice on 11 April 2018 for permission to rely upon a witness statement from Dr Fisher dated 10 April 2018 as expert evidence, at the start of the second day of this hearing Mr Richard Clayton QC, for the Claimant, informed me that he would not be pursuing that application. As a consequence of that decision, as I understand it, the Claimant no longer pursues the ground of challenge that NHSE has acted unfairly in depending on the SPS report in rejecting the clinical evidence in favour of homeopathy treatment by relying so heavily upon the Australian NHMRC 2015 Report.
36. Essentially three grounds of challenge remain from the Claimant's amended grounds: (1) NHSE has failed to consult fairly by failing to provide consultees with sufficient information to enable them to give a meaningful response to the consultation and failing fairly to summarise the homeopathy issues the consultation was considering and/or NHSE misled consultees and/or failed to consult on alternatives; (2) NHSE failed to consult at a time when proposals were still at a formative stage and/or there was a substantial risk that it had pre-determined its decision to withdraw support for homeopathy; and (3) NHSE has breached the public sector equality duty contrary to s.149 of the 2010 Act.
37. Shortly before the hearing Mr Clayton raised a new ground of challenge, namely that NHSE has no power to issue the Guidance, as it purported to do, under s.14Z10 of the 2006 Act (Ground 4).

Ground 1: failure to consult fairly (Gunning (2))

38. The Claimant's over-arching contention is that the consultation lacked fairness. This contention has various elements to it. In summary Mr Clayton makes the following submissions: (1) NHSE has failed to give sufficient reasons for its proposal to permit of intelligent consideration and response; (2) NHSE failed fairly to summarise the homeopathy issue the consultation was considering; (3) having placed reliance upon the 2010 Report of the House of Commons Science and Technology Committee ("the 2010 report") NHSE failed to place the report properly in context; and (4) NHSE misled consultees and/or failed to consult on possible alternatives to its proposal.
39. In R (Moseley) v Haringey LBC [2014] 1 WLR 2947, the Supreme Court endorsed "the Sedley criteria". In R v Brent LBC, ex p Gunning [1985] 84 LGR, Hodgson J said, at p.189:

"Mr Sedley submits that these basic requirements are essential if the consultation process is to have a sensible content. First, the consultation must be at a time when proposals are still at a formative stage. Second, that the proposal must give sufficient reasons for any proposal to permit of intelligent consideration and response. Third … that adequate time must be given for consideration and response and, finally, fourth, that the product of consultation must be conscientiously taken into account in finalising any statutory proposals."

Lord Wilson (at para 25) noted that Hodgson J accepted Mr Stephen Sedley QC's submission, and that the Court of Appeal had expressly endorsed them, first in R v Devon County Council, ex p Baker [1995] 1 All ER 73, and then in R v North and East Devon Health Authority, ex p Coughlan [2001] QB 213, where the Court of Appeal, in a judgment delivered by Lord Woolf MR, elaborated (at para 112):

"It has to be remembered that consultation is not litigation: the consulting authority is not required to publicise every submission it receives or (absent some statutory obligation) to disclose all its advice. Its obligation is to let those who have a potential interest in the subject matter know in clear terms what the proposal is and exactly why it is under positive consideration, telling them enough (which may be a good deal) to enable them to make an intelligent response. The obligation although it may be quite onerous, goes no further than this."

40. In R (on the application of Beale) v Camden LBC [2004] HLR 48, Munby J (as he then was) made clear (at para 19) that consultation does not involve as a legal requirement an articulation of both sides of the argument. He said:

"Proper consultation requires sufficient reasons to be given for the particular proposals to enable those consulted to give intelligent consideration and an intelligent response to the proposals. But it is not said that consultation requires sufficient information to be given about any objections to the proposals to enable those consulted to give intelligent consideration and an intelligent response to the objections."

41. Lord Wilson in Moseley (at para 25) agreed with the Court of Appeal in R (on the application of Royal Brompton and Harefield NHS Foundation Trust) v Joint Committee of Primary Care Trusts [2012] 126 BMLR 134 that the Coughlan formula is "a prescription for fairness" (para 9). Arden LJ, delivering the judgment of the court in that case, continued:

"9. … It is an aspect of fairness that a consultation document presents the issues in a way that facilitates an effective response…

10. Another aspect of fairness is that it must present the available information fairly. … A further aspect of fairness lies in the presentation of the information on which the views of consultees should be sought. The options for change must be fairly presented. Nonetheless, the decision maker may properly decide to present his preferred options in the consultation document, provided it is clear what the other options are…

11. The object of requiring fairness is to ensure high standards in decision-making by public bodies and to enable responses to be made which will best facilitate a sound decision as a result. In addition, it must achieve the statutory objective of s.242(2)(b) of the National Health Service Act 2006 of engaging users. …

13. If it is alleged that a consultation process is unfair, clear unfairness must be shown. As Sullivan J pointed out in R (on the application of Greenpeace Ltd) v Secretary of State for Trade and Industry [2007] EWHC 211 (Admin) … it must be shown that the error is such that there can be no proper consultation and that 'something [has] gone clearly and radically wrong'.

14. On the other hand, it is sufficient to show that the unfairness affects only a group of the persons affected by the consultation: see R (on the application of Medway Council) v Secretary of State for the Environment [2002] EWHC 2516 (Admin). Unfairness to the general body of consultees is not required."

42. In R (Baird) v the Environment Agency [2011] EWHC 939 (Admin) Sullivan LJ said (at para 41):

"… It is important to bear in mind that one of the principal purposes, if not the principal purpose, of any consultation exercise is to enable consultees to identify and draw to the attention of the decision maker relevant factors which the decision maker may, either by accident or design, have overlooked when deciding upon a preferred option for consultation. The Coughlan principles do not require as their starting point an omniscient decision maker who will have correctly identified each and every relevant factor at the outset; there would be little point in having a consultation if that were to be the underlying assumption. If a consultation document makes it clear that a decision maker has not considered a particular factor, 'factor X', when deciding upon a preferred option, and a consultee contends that factor X should have been taken into account, and in response to that representation the decision maker agrees that factor X should be considered, then that is an example not of a flawed consultation process, but of a consultation process that has done the job that it was intended to do."

The parties' submissions and discussion

43. The Claimant's pleaded case in its amended grounds in relation to NHSE's alleged failure to give sufficient reasons for its proposal to permit of intelligent consideration and response is that:

"… the express and sole rationale for consultation paper's recommendation in respect of homeopathy is the 2010 report which was seriously unbalanced and inaccurate, and its conclusion was highly contentious. In those circumstances NHS England conspicuously has failed to give sufficient reasons for its proposal so as to permit intelligent consideration of the proposal and a response" (para 59).

Similarly in relation to the allegation that NHSE has failed fairly to summarise the homeopathy issues, the Claimant's pleaded case in its amended grounds (at para 61) is that:

"… the express and sole rationale for consultation paper's recommendation in respect of homeopathy is the 2010 report which was seriously unbalanced and inaccurate and NHS England acted unfairly in failing to provide a fair summary of the complex issues it was consulting upon."

44. In his skeleton argument, in relation to the allegation that NHSE failed to give sufficient reasons for the proposal to permit of intelligent consideration and response Mr Clayton submits that the information presented to consultees in the 2010 report was not "in a form which consultees could readily understand and which facilitated an effective response" (para 50). Further Mr Clayton submits in relation to the failure to give sufficient reasons and the failure to fairly summarise the homeopathy issue that NHSE had failed to indicate that there is a legitimate scientific debate as to the effectiveness of homeopathy.
45. Mr Clayton says in his skeleton argument (at para 57) that:

"The difficult nature of the scientific debate concerning homeopathy required from consultees is recognised by NHS England and the evidence of Alexander Williams – who acknowledges the distinction between 'effectiveness' and 'efficacy', but then conflates these two quite distinct concepts, stating that 'the consultation document and the Guidance accordingly included a short explanation of "efficacy" as "is it clinically effective"' and this is the sense in which effectiveness is used throughout."

46. Mr Clayton submits that the 2010 report was misleading by suggesting that there was no legitimate scientific debate to be had concerning homeopathy's effectiveness, and the consultation was equally misleading. Accordingly NHSE's consultation breached the Moseley principles.
47. Two additional points made in the skeleton argument in relation to the alleged failure to give sufficient reasons for the proposal are that (1) NHSE identified no alternative substitute treatments, thereby disabling consultees from evaluating both the merit and/or financial implications of the proposal for homeopathy; and (2) the proposal asked a single question concerning homeopathy even though it in fact applied to over 3,500 different homeopathic medications.
48. Mr Clayton is critical of NHSE's reliance upon the 2010 report. As a Parliamentary report he contends it conferred additional status on NHSE's proposal, notwithstanding that the report was regarded as seriously unbalanced and inaccurate, its analysis was supported by very few members of the House of Commons' Science and Technology Committee, and its conclusions were severely criticised by Parliamentarians. On 23 February 2010, the day following the report's publication, Early Day Motion 908, signed by 70 cross-party MPs, was tabled which expressed concern at the conclusions of the 2010 report and called on the government "to maintain its policy of allowing decision-making on individual clinical interventions, including homeopathy, to remain in the hands of local NHS service providers and practitioners who are best placed to know their community's needs". Further, the "Government Response to the Science and Technology Committee Report (CM7914)" presented to Parliament in July 2010 took issue with a number of the 2010 report's recommendations. The Claimant relies upon the following paragraphs in the government response:

"8. We agree with many of the Committee's conclusions and recommendations. However, our continued position on the use of homeopathy within the NHS is that the local NHS and clinicians, rather than Whitehall, are best placed to make decisions on what treatment is appropriate for their patients – including complimentary or alternative treatments such as homeopathy – and provide accordingly for those treatments…

24. There remains, as demonstrated by the submissions to the Committee, some controversy, since there are peer-reviewed reports that therefore have the support of some scientists, that suggest there may be limited evidence of efficacy of homeopathy in certain circumstances. Given the depth of feeling on each side of the debate, it is unlikely that this controversy would be resolved by further analysis of literature or research on the efficacy of homeopathy.

25. The Government Chief Scientific Adviser and Professor Harper, as recommended, will meet to discuss the issue further, including the overall weight of evidence, and its communication to the public…"

It does not appear that the Government's Chief Scientific Adviser and Professor Harper did meet to discuss the issue further.

49. In his oral submissions Mr Clayton developed his contention that the presentation of the 2010 Report was not fair because it was not set properly in context alongside the Parliamentary criticism of the Report, in particular in the early day motion and in the government response.
50. Summarising the Claimant's case on day one of the hearing, at the outset of his oral submissions, Mr Clayton described it as a fairness challenge to the consultation based on the view in the consultation document that homeopathy is not clinically effective. He said that the consultation process was unfair because it misrepresented the true position; there is, he contended, plain evidence that homeopathy treatment does work in particular cases; and what the case boils down to is a debate about scientific method.
51. However at the start of day two of the hearing, having stated that he would not be proceeding with the application to adduce expert evidence (see para 35 above), Mr Clayton summarised his case on Gunning (2) as being that the 2010 report was not intelligible to the ordinary consultee. Throughout his oral submissions Mr Clayton criticised the distinction between efficacy and effectiveness in the 2010 report, querying how intelligible this distinction was to a consultee. At paragraph 18 of the report it is said that "it is more important to know whether a treatment works – its efficacy – than how it works". Paragraph 29 of the report states: "The answer to why a medicine can be effective without being efficacious lies with the phenomenon known as the placebo effect"; and paragraph 79 states: "we proceed on the basis that homeopathy is not supported by evidence of efficacy and is therefore no more than a placebo treatment, albeit a popular one". Mr Clayton criticises that last statement as being tautological and fallacious. He makes the same criticism of paragraph 82 which states: "we do not doubt that homeopathy makes some patients feel better. However, patient satisfaction can occur through a placebo effect alone and therefore does not prove the efficacy of homeopathic interventions".
52. The consultation paper equates "efficacy" with being "clinically effective". However the term "clinically effective" does not appear in the 2010 report. The report therefore does not proceed on the basis that efficacy means "clinically effective".
53. Paragraph 32 of the 2010 report adopts Dr Brody's definition of the placebo effect as "a change in a patient's illness attributable to the symbolic import of a treatment rather than a specific pharmacologic or physiologic property". Mr Clayton describes that definition as unintelligible to the ordinary person. In any event, the Committee do not appear to have used that definition as a working definition. At paragraph 20 the Committee state: "we consider the conclusions about the evidence on the efficacy of homeopathy should be derived from well designed and rigorous randomised controlled trials".
54. Mr Clayton submits that NHSE should have produced a short, snappy document, written in clear English, rather than a consultation document which referred to a lengthy, unbalanced and unintelligible report. Moreover, being available only online it would have made the reading of the highly technical and detailed report even more difficult for the ordinary consultee.
55. I reject Mr Clayton's submissions on the Gunning (2) criteria, essentially for the reasons advanced by Mr Jonathan Moffett QC, who appears for NHSE. I agree that the information that was provided to consultees was sufficient to enable them to give a meaningful response. Supporters of homeopathy could not have been left in any doubt that they needed to provide NHSE with evidence that homeopathy actually works; and this is exactly what the Claimant sought to do.
56. I do not agree that the consultation document is not intelligible. The 2010 report sets out its conclusions and recommendations in clear terms, in particular in the following paragraphs:

"2. We considered the conclusions about evidence on the efficacy of homeopathy should be derived from well designed and rigorous randomised controlled trials…

4. We have set out the issue of efficacy and effectiveness at some length to illustrate that a non-efficacious medicine might, in some situations, be effective (patients feel better) because of the placebo effect. That is why we put more weight on evidence of efficacy than of effectiveness.

11. In our view, the systematic reviews and meta-analysis conclusively demonstrate that homeopathic products perform no better than placebos.

16. We do not doubt that homeopathy makes some patients feel better. However, patient satisfaction can occur through a placebo effect alone and therefore does not prove the efficacy of homeopathy interventions."

57. It was made clear to consultees that the reason why NHSE was proposing to include homeopathy on the list of items that should not routinely be prescribed by GPs was the lack of robust evidence that it actually works. Consultees therefore knew that, if they opposed the proposal, they should point to evidence that homeopathy actually works, and they were afforded the opportunity to submit such evidence. The fact that the Claimant did exactly this indicates that certainly it had sufficient information to provide an informed response.
58. In relation to homeopathy the consultation document asked consultees a broad open-ended question: "do you agree with the proposed recommendations for homeopathy?". The consultation document also afforded consultees an opportunity to provide further comments.
59. I agree with Mr Moffett that in general consultees are likely to have understood what is meant by the use of the terms "effectiveness", "efficiency" and "placebo", from the summary in the Report. Consultees could look at the body of the Report for a more detailed analysis if they wished to do so. At paragraph 26 of the report the Committee set out Dr Fisher's explanation of the distinction between efficacy and effectiveness; and at paragraph 66 of the Report there is reference to "conflicting opinions on whether homeopathic products are efficacious" received by the Committee.
60. The consultation document attempted to define the key factor, in the present case, of "efficacy" by describing it in ordinary language as "clinically effective". Mr Moffett accepted that maybe in retrospect that description should not have been used as it was not used in the Report. On the other hand, he noted that Dr Fisher had actually used the words "clinically effective" in his report that was submitted with the Claimant's response to the consultation document. Furthermore, it did not appear from the consultation responses that the use of the terms "efficacy", "clinically effective", and "placebo" were thought to be misleading, as was suggested by Mr Clayton in his oral submissions (see above). Indeed there is no evidence of any consultees actually being confused by the terminology used in the consultation document which went out to hundreds of consultees, some, of course, more sophisticated than others.
61. Mr Clayton argues that there is "a legitimate scientific debate" as to whether homeopathy works. However I agree with Mr Moffett that it would not be appropriate for the court to pass judgment on the legitimacy or otherwise of the view that homeopathy works. NHSE accepts that there is a body of opinion, to which some practicing clinicians adhere, that homeopathy works (and that there is evidence to that effect), as the Select Committee report made clear. On the other hand, as Mr Moffett points out, representatives of professional organisations such as the Royal College of General Practitioners, the Royal College of Pharmacists, the British Medical Association and the Academy of Royal Medical Colleges sat on the Working Group and were involved in the development of the guidance. In any event the legitimacy or otherwise of the debate is not relevant to the issues before the court. What NHSE was consulting on was its provisional view that there was no robust evidence that homeopathy actually works.
62. During the course of Mr Moffett's submissions Mr Clayton clarified that he was not saying that the consultation document had to set out arguments for and against the proposal, but that in order to be balanced it had to put the 2010 Report in a proper setting. However so far as the Claimant maintained, which it did, its position that the failure to refer to the Parliamentary response made the consultation document unbalanced, I reject that contention. The 2010 Report made clear that there were opposing views on whether homeopathy works (see above). The Government response did not present any new evidence that it did work. Indeed it took the view that "it is unlikely that this controversy could be resolved by further analysis of literature or research on the efficacy of homeopathy" (see para 48 above).
63. Mr Moffett rejected the contention that the 2010 Select Committee Report was referred to because of its imprimatur. It was chosen because it contained a reasoned analysis of the evidence and by cross-referring to it NHSE set out their own views. He did however accept the criticism that it may have been better if the NHSE had set out their views in a shorter document without reference to the Report, but that was not the test. It was inevitable that some of the information provided would be complex. That evidence could, and was, responded to by expert consultees such as Dr Fisher, and in other specialist responses.
64. I do not accept there was an unlawful failure to consult on alternatives to the proposal. As the Claimant accepts, a decision maker is only required to put forward potential alternatives to its preferred proposal where it is necessary to do so in order to ensure that the consultation is fair (see R (Robson) v Salford City Council [2015] PTSR 1349 (at para 35, per Richards LJ)).
65. Even if NHSE was required as a matter of law to draw attention to arguments against its proposal, it in fact sufficiently did so in this case. Consultees were made aware that they could argue that homeopathic treatments should not be included in the Guidance at all or, if they were to be included, that they should be the subject of different specific recommendations such that a particular treatment could continue to be prescribed in particular circumstances (see para 19 above).
66. It is significant that the Government response does not say that it disagreed with the Report on the evidence. The Government thought that the report sets out the evidence and opinion "on each side" (para 2). If the consultees considered that NHSE were mistaken in their reliance on the Select Committee report they had an opportunity to say so. In fact, as a result of the Claimant's contention in its consultation response that NHSE should consider particular evidence which it said showed that homeopathy works, NHSE instructed SPS to consider the matter further.
67. I have reached the clear conclusion that the consultation document presents a fair and balanced view of the information required for a lawful consultation process as required by Gunning (2).

Ground 2: failure to consult at the proper time (Gunning (1)), and bias/pre-determination

68. The Claimant contends (1) that NHSE failed to consult at a time when proposals were still at a formative stage (Gunning (1)); and (2) NHSE expressed views concerning homeopathy throughout the consultation which show that (a) there is a substantial risk that it is biased in relation to homeopathy, and/or (b) had pre-determined its decision to withdraw support for it.
69. Appearing on BBC Radio 4's Today programme on 31 March 2017 Mr Stevens was questioned about NHS spending on homeopathic medicine and whether it was a good use of money. He answered "No. I mean, they are placebo at best". The interviewer then asked: "So it would be absurd if anybody is prescribing homeopathic medicine?". Mr Stevens replied: "In my opinion, yes. I agree with the Chief Medical Officer" [who the interviewer had said had described them as "rubbish"]. However this interview took place before it was decided to include the prescription of homeopathic medicines in the consultation proposal.
70. Mr Clayton confirmed in his oral submissions that in relation to all three ways of putting this ground the Claimant relies on the statement made by Mr Stevens on 21 July 2017 in the NHSE press release, launching the consultation, describing homeopathy as "at best a placebo and a misuse of scarce NHS funds" (see para 24 above). The Claimant's real complaint is about what Mr Stevens stated as recorded in the press release.
71. With regard to that statement, Mr Clayton made the following points: (1) homeopathy was the only treatment about which such a negative view was expressed, which was strange considering that only £92,000 per year is spent on homeopathy, when the 18 treatments subject to the proposal together cost taxpayers £141m per year. Yet only homeopathy was targeted for criticism. (2) There is no evidence that this was a provisional view. (3) It was a view which NHSE as a corporate entity expressly endorsed.
72. Mr Moffett submits that the difficulty with these allegations is that they focus on a statement which, although as he accepts was phrased in robust terms, accurately reflected the state of the evidence before NHSE at that stage. There is nothing, he submits, in the statement which suggests that NHSE would not properly consider other evidence should it be submitted and, indeed, when further evidence was submitted by the Claimant and other consultees it was considered, which led to a report by SPS and consideration of that report before a final decision was taken (see paras 27-29 above).
73. The test to be applied in the case of each of these grounds of challenge are clear: (1) in relation to the allegation that the consultation exercise did not take place at a time when the proposal was at a formative stage (Gunning (1)), the test is whether NHSE had already made up its mind to adopt the proposal, or whether it was willing to reconsider its proposal in the light of the consultation process if a case to do so was made out (R (Bailey) v Brent LBC [2011] EWHC 2572 (Admin), per Ouseley J at para 90); (2) in relation to the allegation of predetermination, the test is whether the fair minded and informed observer would think that there was a real possibility that the decision maker had pre-determined the matter, in the sense of closing its mind to the merits of the matter (R (Lewis) v Redcar and Cleveland BC [2009] 1 WLR 83, per Rix LJ at paras 96-97); and (3) in relation to the allegation of bias, the test is whether a fair-minded and well-informed observer might conclude from all the circumstances that there was a real possibility that NHSE was biased (Porter v Magill [2002] 2 AC 357).
74. In his oral submissions in reply, whilst not formally abandoning his case on pre-determination or bias, Mr Clayton said the ground which he pressed was Gunning (1). He said that there was never any indication that NHSE had changed its views on homeopathy; and at no stage did it qualify the remarks made by Mr Stevens about homeopathy.
75. I reject this submission. In circumstances where NHSE was putting forward the proposal to consultees on the basis of an assessment of the evidence as to whether homeopathy actually works, I consider that NHSE was entitled to form a view on the state of the evidence before going out to consultation. It does not follow from that that NHSE had closed its mind to any further evidence that might be provided by consultees or that it would not objectively assess that evidence if it were received. The evidence is that NHSE engaged with the Claimant during the consultation exercise (see para 25 above), that the Claimant's written response was given careful consideration and that the SPS was instructed to conduct a specialist review of it (see para 27 above). Ultimately the decision of NHSE was made at a Board meeting and each Board member agreed with the decision. It has not been suggested that Mr Stevens exerted any undue influence over other members of the Board.
76. In any event, the press release must be read as a whole. The Co-Chair of NHSCC is recorded as making clear that NHSE "[hoped] to hear from as many people and organisations as possible so that the final guidance can properly take these views into account" (see para 24 above). Read as a whole the press statement, in my view, makes clear that NHSE was expressing (albeit in Mr Stevens' case in robust terms) a provisional view.
77. I am satisfied that NHSE consulted at a time when proposals were still at a formative stage. There is no evidence of bias or predetermination on NHSE's part.

Ground 3: breach of the public sector equality duty

78. The Claimant contends that NHSE breached the public sector equality duty under s.149 of the 2010 Act in various respects:

i) First, the consultation process was exclusively online and, therefore, excluded some people with protected characteristics from answering the online consultation and from attending face to face events because the only way to find out about them or book a place was online.

ii) Second, NHSE failed properly to inform itself and to take the necessary reasonable steps to gather relevant information in relation to specific protected groups.

iii) Third, the EIA at no stage considered the impact of removing the exemption on paying NHS prescriptions on those with protected characteristics, particularly the elderly and those with disabilities.

iv) Fourth, the consultation did not differentiate between removing single items of medication which treat one or two conditions from the prescribed list and removing the entire range of homeopathic treatments which are used to treat a very significant number of conditions.

v) Fifth, the EIA failed to identify the increased impact on those with protected characteristics which results from de-prescribing homeopathic treatments, unlike other medications listed in the consultation paper, for which one or more identified alternatives are readily available.

79. Mr Moffett makes the point that the first of these criticisms, that the consultation process was exclusively online, can only be a challenge to the decision as to how the consultation exercise was to be carried out. That decision was taken by the Board at its meeting on 21 July 2017. However, that aspect of the Board's decision was not challenged in the claim filed in October 2017; it was not raised until the amended grounds were filed on 22 January 2018, six months after the relevant decision. The explanation for the delay given by Mr Clayton is that it was not until shortly before the filing of the claim that the Claimant received letters from two individuals which put it on notice as to the problem. However this does not explain why the claim was not amended to include this complaint long before it was. The Burkett principle, on which Mr Clayton relies, does not assist the Claimant in the present case where the decision to consult took effect when the consultation commenced. I would therefore dismiss this ground of challenge on grounds of delay alone.
80. In any event, I agree with Mr Moffett that there is no merit in this ground of challenge.
81. Mr Williams describes the detailed steps taken by NHSE to raise awareness of the consultation (in his first witness statement at para 86) which included the following:

"(a) a press release was issued by NHS England to announce the consultation, including a media Q&A document and reference to the consultation document;

(b) telephone calls were made by NHS England to key stakeholders such as National Voices and the Patients' Association representing patients, members of the public, the primary care sector, and industry involvement to discuss the recommendations being consulted on;

(c) website content was generated to be displayed on NHS England partner channels, including Q&A documents and infographics;

(d) key patient and public stakeholders were invited by NHS England and/or NHSCC to consultation meetings;

(e) briefings were given to CCGs by NHSCC member/non-member bulletins and networks;

(f) letters were sent to various stakeholders jointly by NHS England and NHSCC, including to the Claimant, to explain the consultation and recommendations;

(g) there was engagement with patients and the public digitally via the NHS England website and Twitter account."

82. In addition on 1 August 2017 Mr Williams and his colleague, Lauren Hughes, met with Healthwatch to discuss how "hard to reach people could be reached through Healthwatch's local groups". They also met with National Voices on 10 August 2017 to discuss how they could better involve patients in the consultation and get access to "hard to reach" groups.
83. Consultees were asked a number of questions in response to the consultation document which could be provided either online or in writing.
84. Insofar as the Claimant relies upon the evidence of two older persons being disadvantaged by the fact that the consultation exercise was carried out primarily online, the Claimant's own evidence is that those individuals did in fact participate in the consultation exercise.
85. The remaining four criticisms (see para 78 above) involve consideration of "whether the equality impact assessment ('EIA') considered by the Board on 30 November 2017 breached the public sector equality duty under s.149".
86. Section 149(1) provides:

"A public authority must in the exercise of its functions, have due regard to the need to—

(a) eliminate discrimination, harassment, victimisation and any other conduct that is prohibited by or under this Act;

(b) advance equality of opportunity between persons who share a relevant protected characteristic and persons who do not share it;

(c) foster good relations between persons who share a relevant protected characteristic and persons who do not share it."

87. The relevant principles to be applied to s.149 were summarised by McCombe LJ in Bracking v Secretary of State for Work and Pensions [2013] EWCA Civ 1345, at para 25 (approved by the Supreme Court in Hotak v Southwark LBC [2016] AC 811, per Lord Neuberger at para 73) as follows:

"(1) As stated by Arden LJ in R (Elias) v Secretary of State for Defence [2006] 1 WLR 3213 at [274], equality duties are an integral and important part of the mechanisms for ensuring the fulfilment of the aims of anti-discrimination legislation.

(2) An important evidential element in the demonstration of the discharge of the duty is the recording of the steps taken by the decision maker in seeking to meet the statutory requirements: R (BAPIO Action Ltd) v Secretary of State for the Home Department [2007] EWHC 199 (QB) (Stanley Burnton J (as he then was)).

(3) The relevant duty is upon the Minister or other decision maker personally. What matters is what he or she took into account and what he or she knew. Thus, the Minister or decision maker cannot be taken to know what his or her officials know or what may have been in the minds of officials in proffering their advice: R (National Association of Healthstores) v Department of Health [2005] EWCA Civ 154 at [26-27] per Sedley LJ.

(4) A Minister must assess the risk and extent of any adverse impact and the ways in which such risk can be eliminated before the adoption of the proposed policy and not merely as a 'rearguard action' following a concluded decision: per Moses LJ, sitting as a judge of the Administrative Court, in Kaur v Shah and LB Ealing [2008] EWHC 2062 (Admin) at [23-24].

(5) These and other points were reviewed by Aitkens LJ, giving the judgment of the Divisional Court, in R (Brown) v Secretary of State for Work and Pensions [2008] EWHC 3158 (Admin), as follows:

(i) the public authority decision maker must be aware of the duty to have 'due regard' to the relevant matters;

(ii) the duty must be fulfilled before and at the time when a particular policy is being considered;

(iii) the duty must be 'exercised in substance, with rigour, and with an open mind'. It is not a question of 'ticking boxes'; while there is no duty to make express reference to the regard paid to the relevant duty, reference to it and to the relevant criteria reduces the scope for argument;

(iv) the duty is non-delegable; and

(v) is a continuing one.

(vi) It is good practice for a decision maker to keep records demonstrating consideration of the duty.

(6) [G]eneral regard to issues of equality is not the same as having specific regard, by way of conscious approach to the statutory criteria." (Per Davis J (as he then was) in R (Meany) v Harlow DC [2009] EWHC 559 (Admin) at [84], approved in this court in R (Bailey) v Brent LBC [2011] EWCA Civ 1586 at [74-75]).

(7) Officials reporting to or advising ministers/other public authority decision makers, on matters material to the discharge of the duty, must not merely tell the Minister/decision maker what he/she wants to hear but they have to be 'rigorous in both enquiring and reporting to them': R (Domb) v Hammersmith & Fulham LBC [2009] EWCA Civ 941 at [79] per Sedley LJ.

(8) Finally, and with respect, it is I think helpful to recall passages from the judgment of my Lord, Elias LJ, in R (Hurley and Moore) v Secretary of State for Business, Innovation and Skills [2012] EWHC 201 (Admin) (Divisional Court) as follows:

(i) At paragraphs [77-78]

'(77) Contrary to a submission advanced by (Counsel), I do not accept that this means that it is for the court to determine whether appropriate weight has been given to the duty. Provided the court is satisfied that there has been a rigorous consideration of the duty, so that there is a proper appreciation of the potential impact of the decision on equality objectives and the desirability of promoting them, then as Dyson LJ in Baker (para [34]) made clear, it is for the decision maker to decide how much weight should be given to the various factors informing the decision.

(78) The concept of "due regard" requires the court to ensure there has been a proper and conscientious focus on the statutory criteria, but if that is done, the court cannot interfere with the decision simply because it would have given greater weight to the equality implications of the decision than did the decision maker. In short, the decision maker must be clear precisely what the equality implications are when he puts them in the balance, and he must recognise the desirability of achieving them, but ultimately it is for him to decide what weight they should be given in the light of all relevant factors. If (Counsel)'s submissions on this point were correct, it would allow unelected judges to review on substantive merits grounds almost all aspects of public decision making.'

(ii) At paragraphs [89-90]

'(89) It is also alleged that the PSED in this case involves a duty of inquiry. The submission is that the combination of the principles in Secretary of State for Education and Science v Thameside Metropolitan Borough Council [1977] C 1014 and the duty of due regard under the statute requires public authorities to be properly informed before taking a decision. If the relevant material is not available, there will be a duty to acquire it and this will frequently mean that some further consultation with appropriate groups is required. (Counsel) referred to the following passage from the judgment of Aitkens LJ in Brown (para [85]):

"… the public authority concerned will, in our view, have to have due regard to the need to take steps to gather relevant information in order that it can properly take steps to take into account disabled persons' disabilities in the context of the particular function under consideration."

(90) I respectfully agree…"

88. In R (Unison) v Lord Chancellor [2016] ICR 1, Underhill LJ stated (at para 16):

"An EIA is a working tool designed to ensure that decision makers pay due regard to (as a shorthand) the equality impact of their decisions and to act as a record that they have done so or at least that those impacts have been drawn to their attention. It will not typically be drafted by lawyers, nor typically should it be. To the extent that views are expressed on matters requiring assessment or evaluation the court should go no further in its review than to identify whether the essential questions have been conscientiously considered and that any conclusions reached are not irrational. Inessential errors and misjudgement cannot constitute or evidence a breach of the duty."

89. In complying with s.149 NHSE must apply its own guidance for NHS Commissioners on equality and health inequalities legal duties (the "NHS equality guidance") (see Mandalia v Secretary of State for the Home Department [2015] 1 WLR 4546). Paragraph 4.3 of the NHS equality guidance states:

"Decision makers should ensure that they give real consideration to these aims and think about the impact of policies with rigour and with an open mind, in such a way that might influence the final decision. They should do this before and during policy formation and when a decision is taken. Addressing equality in this way should be considered business as usual, not an exceptional activity.

Case law establish that what is important is not the preparation of a particular document, but that officials give proper, informed consideration to equality issues at the right time and they keep a record of that consideration."

90. Paragraph 4.4 of the NHSE equality guidance identifies the steps to be taken to obtain evidence of due regard and states:

"In order to demonstrate compliance with equalities legislation and, specifically, the PSED, you will need to provide any evidence you have that demonstrates the impact or potential impact your work may have on people sharing protected characteristics.

This evidence could be in the form of policy papers, project documentation or background research that takes into account what you know about the equality implications of your work. The important thing is that any conclusions arising from your equality analysis are able to influence your work and the material produced. You may also have evidence from earlier consultations and stakeholder engagement."

91. The information in relation to NHS equality delivery framework November 2013 also refers to EIAs:

"4.2 Papers that come before the Board and other major committees identify equality-related impacts including risks, and say how these risks are to be managed."

92. The equality and health inequalities analysis (updated November 2017) states, so far as is material:

"Part A: General Information

3. Who will be affected by this project, programme or work?

Patients – who received a prescription for items listed in the Guidance.

4. Which groups protected by the Equality Act 2010 and/or groups that face health inequalities are very likely to be affected by this work?

Proposals for CCG commissioning guidance

The 18 defined items within the review could potentially be prescribed to anyone in the population requiring them to treat a medical condition, therefore covering all characteristics. This is the case for all items included, apart from once daily TADALIFIL which would only be prescribed to men.

The profile of people who are currently being prescribed each item can only be interrogated accurately for age and sex as national prescribing data (Source: NHS Business Services Authority) is only available for these two characteristics.

Overall this prescribing data for 2016 indicates that on average, more females (61.3%) are prescribed the defined list of medicines than males (38.7%). …

Looking at the age profiles of patients prescribed medications in 2016 (see 5.1) on average, for adults, the prevalence of these medicines increases with age. This pattern is seen in both females and males with no significant differences in prevalence between age groups by gender. In most cases, the proportion of prescriptions for children is very small at around one or two percent, except for herbal (19.3%), and homeopathic medicines (14.7%). …

A literature review was also undertaken to explore research evidence including prevalence of patient characteristics for disease areas rather than individual medications such as chronic pain, hypertension and depression. …

It is important to note that not doing this work also has an impact on all characteristics. Some of the drugs in the review are shown to be unsafe, ineffective or have a more cost effective alternative. Without review and implementation by CCGs, inequalities as to the wider population are likely…

Part B: Equalities Groups and Health Inequalities Groups

5.1 Age

Does the equality group face discrimination in this work area?

As people get older they are more likely to be taking prescribed medications, however there is no evidence to suggest that this prescribing is due to discrimination and is more likely due to increasing prevalence of various diseases related to increasing age. …

Age is also reported as a protected characteristic likely to be disproportionately affected by this work by 56% of those responding to the question 'Do you feel there are any groups, protected by the Equality Act 2010, likely to be disproportionately affected by this work?'…

5.2 Disability

Does the equality group face discrimination in this work area?

There is no routinely collected data on prescribing and disability so we cannot definitively assess fully at a national level. Studies have identified that people with disability are more likely to suffer from chronic pain however it is unknown if this is applicable to the population taking the medications within the review.

During the consultation, responses were monitored to ascertain if there are any unintended consequences on this protected characteristic, see Appendix C for results. The demographic analysis of the patients who responded to the online consultation showed that the patients who reported having a disability particularly disagreed with the proposals for herbal treatments, homeopathy… Disability was also reported as a protected characteristic likely to be disproportionately affected by this work by 63% of those responding to the question 'Do you feel there are any groups, protected by the Equality Act 2010, likely to be disproportionately affected by this work?' which puts the highest reported protected characteristic for this question. A number of themes also emerged relating to disability including a concern that the proposal could adversely affect those who require considerable care (for example people with disabilities).

Could the work tackle this discrimination and/or advance equality or good relations?

This guidance, if adopted by CCGs, should prompt review of treatments meaning more people with a disability will receive reviews to optimise their treatment. It could assist in potentially reducing harm caused by certain medicines.

Could the work assist or undermine compliance with the public sector equality duty (PSED)?

There is the potential that it could assist in reducing harm caused by certain medicines if a person with a disability is more likely to receive them.

Does any action need to be taken to address any important adverse impact? If yes, what action should be taken?

Taking into account the consultation results and based on the clinical evidence, the CCG guidance has been updated to include a number of exceptions that take account of potential inequality e.g. immediate release fentanyl for cancer and palliative care patients and liothyronine for patients with hypothyroidism, who, in exceptional circumstances, have an ongoing need for liothyronine as confirmed by a consultant NHS endocrinologist.

CCGs will be required to assess the impact on their population with regard to the particular demographics of the population they serve. …

5.8 Sex or gender

Could the work tackle this discrimination and/or advance equality or good relations?

Overall this prescribing data for 2016 indicates that on average, more females (60%) were prescribed these medicines than males (40%). This indicates the reviews and potential for de-prescribing may be most commonly required in women for the majority of medications, …

Could the work assist or undermine compliance with the public sector equality duty (PSED)?

There is the potential that it could assist in potentially reducing harm caused by certain medicines which particular genders are more likely to receive.

Does any action need to be taken to address any important adverse impact? If yes, what action should be taken?

Taking into account the consultation results and based on the clinical evidence, the CCG guidance has been updated to include a number of exceptions for liothyronine.

Part F: Summary analysis and recommended action

21. Contributing to the second PSED equality aim

Can this policy or piece of work contribute to advancing equality of opportunity? Please circle as appropriate

Yes

Yes

Currently patients could be receiving medications that are unsafe, ineffective or where there is a more cost effective alternative available. By setting a national direction on a set of defined medications this project encourages CCGs to implement policy that encourages review of patients taking these medications to ensure that their treatment is optimised. This enables patients to have access to the most effective medications to achieve the best outcomes. If more cost effective options are utilised this frees up funding for other care and treatment to optimise wider population benefit and outcomes."

93. I agree with Mr Moffett that it is clear from the equality and health inequalities analysis that the Board addressed itself to the relevant statutory equality objectives, and concluded that the Guidance would not have an adverse impact on those objectives, indeed in some respects it was likely to enhance them (see section 21 in Part F set out at para 92 above). Having abandoned its irrationality challenge, Mr Moffett observes that the Claimant has to accept that this is a conclusion that the analysis was entitled to reach. It is not suggested that the Board did not properly take the analysis into account when reaching its decision.
94. In any event I reject Mr Clayton's contention that NHSE should have individually reviewed each prescription slip for a homeopathic treatment to ascertain whether it was given to a patient who is exempt from paying prescription charges, and extrapolated from that information to determine whether it was likely that the individual patient was part of a group that shared a particular protected characteristic. Mr Clayton accepts that the proposal made by Mr Anthony Pinkus, the managing director of Ainsworths Homeopathic Pharmacy, in this regard, to gather information from pharmacists' monthly claim forms in relation to protected patient groups may not be wholly practicable. I agree with Mr Williams that it would have been disproportionate for NHSE to have separately reviewed all prescription forms held by NHS Business Services Authority to extrapolate data relating to homeopathic medicines dispensed to each category of exemption. Further, I consider the suggestion that relevant information could have been obtained from unspecified "desktop" research suggested by the Claimant would have created a disproportionate administrative burden for NHSE given the inability to obtain accurate and complete data from the exercise.
95. As for the other three criticisms made by the Claimant (see para 78(iii)-(v) above) it is clear that the EIA did consider the impact of removing the exemption on paying NHS prescriptions on those with protected characteristics. The analysis proceeded on the basis that the effect of the guidance would be that patients who were previously prescribed homeopathic treatments would instead be prescribed the most effective medications that would achieve the best outcomes. That accords with the Claimant's consultation response which stated that patients who no longer receive homeopathic treatments on prescription will continue to use NHS services and move on to other prescription medications. The Claimant has not identified any further information that should have been obtained in relation to persons with conditions that are specific to particular protected characteristics.
96. I am satisfied that NHSE was rigorous in the discharge of the duty to have "due regard" to relevant matters, and that it was entitled, on the evidence before it, to conclude that the Guidance would not have an adverse impact on the statutory equality objectives, but rather, as the Analysis found, "would [enable] patients to have access to the most effective medications to achieve the best outcomes". That being so, I agree with Mr Moffett, it was not necessary to consider mitigation measures, it being NHSE's view that there would not be any discrimination.

Ground 4: the vires issue

97. Shortly before the start of this hearing, in a note dated 24 April 2018, the Claimant contended for the first time that NHSE had no power to issue the Guidance under s.14Z10 of the 2006 Act, despite the fact that when issuing the Guidance on 13 November 2017 NHSE made clear that in so doing it relied upon its powers under ss.2 and 14Z10.
98. During his opening submissions Mr Clayton formulated this ground in the following terms:

"A. In its consultation document NHS England stated that it was going to introduce Guidance under s.14Z8. However, on 30 November 2017, NHS England purported to issue guidance under s.14Z10.

B. It is respectfully submitted that NHS England acted ultra vires by purporting to issue guidance under 14Z10 because it had a specific power to issue guidance under s.14Z8."

99. The provisions relied upon by NHSE as conferring the power to issue the Guidance provide as follows:

"2. General Power

… The Board … may do anything which is calculated to facilitate, or is conducive or incidental to, the discharge of any function conferred on that person by this Act."

"14Z10 Power of Board to provide assistance or support

(1) The Board may provide assistance or support to a clinical commissioning group.

(2) The assistance that may be provided includes—

(a) financial assistance, and

(b) making the services of the Board's employees or any other resources of the Board available to the clinical commissioning group.

(3) Assistance or support provided under this section may be provided on such terms and conditions, including terms as to payment, as the Board considers appropriate.

(4) The Board may, in particular, impose restrictions on the use of any financial or other assistance or support provided under this section.

(5) A clinical commissioning group must comply with any restrictions imposed under sub-section (4)."

100. Section 14Z8 states:

"(1) The Board must publish guidance for clinical commissioning groups on the discharge of their commissioning functions.

(2) Each clinical commissioning group must have regard to guidance under this section.

(3) The Board must consult the Healthwatch England Committee of the Care Quality Commission—

(a) before it publishes guidance under this section, and

(b) before it publishes any revised guidance containing changes that are, in the opinion of the Board, significant."

101. Section 14Z7 states:

"(7) In this section and s.14Z8, 'commissioning functions' means the functions of the clinical commissioning groups in arranging for the provision of services as part of the health service."

102. Mr Clayton submits that as there is a specific power to issue guidance under s.14Z8, by virtue of the maxim "generalibus specialia derogant" (special provisions override general ones), a general provision such as s.14Z10 is not to be taken to override that specific provision (see Vinos v Marks & Spencer [2001] 3 All ER 784, per May LJ at para 27). This maxim, he submits, gives rise to rule of thumb for dealing with such a situation because the more detailed the provision is, the more likely it is to be tailored to fit the precise circumstances of the case falling within it (see Bennion on Statutory Interpretation, 7^th ed, at para 21.4).
103. I reject the Claimant's contention that because s.14Z8 expressly provides for NHSE to have a power and duty to give guidance on certain matters, s.14Z10 cannot be interpreted as also covering a power to give guidance. I agree with Mr Moffett that the Claimant's argument is based on an erroneous application of the maxim on which Mr Clayton relies (see the principles summarised Bennion at pp.518-519). At the CCGs' request NHSE issued guidance to them to assist them in supporting and guiding primary care prescribers, which, Mr Moffett submits, is not a commissioning function. CCGs do not have the function of arranging for the provision of primary medical services: this is a function of NHSE. Accordingly, as Mr Moffett explained, the guidance is not guidance on the discharge by CCGs of their commissioning functions, and it was for that reason that NHSE took the view that it was not covered by s.14Z8, and instead NHSE should rely upon its powers under ss.2 and 14Z10.
104. The Claimant contends that the "assistance" to which s.14Z10 refers is limited to "funding, goods and services". I do not accept it is so limited. There is nothing in s.14Z10 to indicate that the giving of guidance to bodies which consider that it would be of assistance to them to have such guidance does not constitute the provision of both assistance and support to those bodies.
105. In any event, if it were necessary to rely on s.2, I agree with Mr Moffett that the issuing of the Guidance was clearly calculated to facilitate, or was conducive or incidental to, NHSE's functions under ss.1 (continuing the promotion in England of a comprehensive health service), 83 read with 13E (duties to secure the provision of primary medical services and to secure continuous improvement in those services) and 223BC (NHSE's duty to balance its books).

Conclusion

106. I consider that the grounds of challenge advanced at this hearing are arguable, albeit in the case of the vires ground, only just arguable. Permission will be granted on all four grounds. However, for the reasons I have given, none of the grounds of challenge are made out. Accordingly this claim is dismissed.