QUEEN'S BENCH DIVISION
Strand, London, WC2A 2LL
B e f o r e :
| THE QUEEN
on the application of
BRITISH HOMEOPATHIC ASSOCIATION
|- and -
|NATIONAL HEALTH SERVICE COMMISSIONING BOARD
|- and -
|(1) FACULTY OF HOMEOPATHY
(2) PATIENTS AND FRIENDS OF ANTHROPOSOPHICAL MEDICINE
(3) PORTLAND CENTRE FOR INTEGRATIVE MEDICINE
(4) FRIENDS OF THE ROYAL LONDON HOSPITAL FOR INTEGRATED MEDICINE
Jonathan Moffett QC (instructed by Bevan Brittan) for the Defendant
The Interested Parties were not represented
Hearing dates: 1-4 May 2018
Crown Copyright ©
Mr Justice Supperstone :
Relevant Legislative Background
"(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  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…"
"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."
- "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."
- "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]."
- "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)."
"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."
|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.
"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?
Please provide further information on why you think this might be the case.
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
"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'."
"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."
"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."
"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."
Grounds of Challenge
Ground 1: failure to consult fairly (Gunning (2))
"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  1 All ER 73, and then in R v North and East Devon Health Authority, ex p Coughlan  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."
"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."
"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  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  EWHC 2516 (Admin). Unfairness to the general body of consultees is not required."
"… 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
"… 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."
"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."
"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.
"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."
Ground 2: failure to consult at the proper time (Gunning (1)), and bias/pre-determination
Ground 3: breach of the public sector equality duty
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.
"(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."
"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."
"(1) As stated by Arden LJ in R (Elias) v Secretary of State for Defence  1 WLR 3213 at , 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  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  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  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  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  EWHC 559 (Admin) at , approved in this court in R (Bailey) v Brent LBC  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  EWCA Civ 941 at  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  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 ) 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  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 ):
"… 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…"
"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."
"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."
"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."
"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."
"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
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?'…
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
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."
Ground 4: the vires issue
"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."
"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)."
"(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."
"(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."