QUEEN'S BENCH DIVISION
Strand, London, WC2A 2LL
B e f o r e :
| THE QUEEN
On the application of
(1) DR COLIN HUTCHINSON
(2) PROFESSOR ALLYSON POLLOCK
(3) PROFESSOR SUE RICHARDS
(4) DR GRAHAM WINYARD
|- and -
|THE SECRETARY OF STATE FOR HEALTH AND SOCIAL CARE
THE NATIONAL HEALTH SERVICE COMMISSIONING BOARD
Clive Sheldon QC and Holly Stout (instructed by the Government Legal Department) for the First Defendant
Fenella Morris QC and Rose Grogan (instructed by DAC Beachcroft LLP) for the Second Defendant
Hearing date: 23 and 24 May 2018
Crown Copyright ©
MR JUSTICE GREEN:
(i) The dispute
(ii) How the issues have arisen
(iii) The issues
(i) Issue I: What is the ACO policy?
(ii) Issue II: Is the ACO policy ultra vires?
(iii) Issue III: Does the ACO policy breach the principle of clarity and transparency?
(iv) Issue IV: Must the claim for judicial review fail for prematurity?
(v) Issue V: Must the claim for judicial review fail for delay?
(vi) Issue VI: Do the Claimants have locus to bring the claim for judicial review?
"We have several concerns regarding ACOs, including the lack of clarity and accountability surrounding their development, the risk of privatisation they present, whether the Government will provide the level of NHS funding and investment required for them to work, and how they will ensure services are based on a foundation of strong primary care"
C. Relevant statutory powers and duties
(i) Duties and powers of CCGs
(ii) Duties and powers of NHS England
(iii) The mandate given by the Secretary of State to NHS England
D. Relationship between the ACO policy and present CCG contracting models
(i) Population needs assessments: ACOs will usually hold contracts to deliver a greater proportion of services delivered in any one geographical area than was previously the case and, consequently, they will be incentivised to invest in greater levels of prevention population health analytics for the purpose of prevention of illness and will be required, like existing contract holders, to work with CCGs to draw together a regular population health needs analysis by the provision of data.
(ii) Resource allocation and priority setting: The distinction between "arranging services" (which is the responsibility of the CCG) and "provision" will be retained under the ACO model contracts. It will remain the function of CCGs to determine "overall funding dedicated to any one contract building in projections about population age, diseases, mortality and expectations against demand". This will remain the position in relation to ACOs who will be expected to allocate their budgets to deliver the outcomes detailed in the ACO contract.
(iii) Service development: This relates to the manner in which the public is involved in the planning, development, and decision-making processes upon changes to service proposals. Statutory duties in this respect are imposed upon CCGs, NHS Trusts and Foundation Trusts. These obligations are imposed under existing NHS Standard Contracts and are also imposed on ACOs under the draft ACO model contract.
(iv) Service delivery: At present services are often provided through "alliance agreements" whereby providers create joint organisational structures with CCGs to achieve a higher degree of integration. Under the draft ACO model contract Mr Waller observes: "Of course the key element of change in an ACO scenario is that the provider to provider engagement to develop shared clinical protocols will often no longer be required, since the ACO will be the sole provider, rather than one of a number of providers. Organisational barriers will be removed, and even where there are replaced by sub-contracting relationships, the ACO will be able to put in place smooth pathways between services provided by (and sub-contracted by) the ACO".
(v) Managing performance: This relates to how commissioners and lead-providers manage and monitor performance of those they have respectively arranged to provide services. Under present arrangements it is the CCGs who are responsible for monitoring and managing lead providers; and for lead providers to do the same viz a viz subcontractors. Under the draft ACO model contract the CCGs retain responsibility for monitoring performance by the ACO and it would be the ACO that is responsible for this monitoring function in relation to those to whom it sub-contracts provision.
(vi) Patient choice: CCGs presently, under statute and under the NHS Constitution, ensure patient choice. Under the existing NHS standard contract providers are required to adhere to relevant guidance regarding patient choice of provider and consultant and the draft ACO model contract imposes equivalent (and no less onerous) obligations.
E. Issue I: What is the ACO policy?
(i) The issue
(ii) The Claimants' submissions on the content of the policy
a) there will be a single organisation (the ACO) which;
b) will be given "responsibility for delivering health and care services for the whole local population"; and where,
c) the single provider organisation will be allowed to "make most decisions" about,
d) how to "allocate resources and design care for its local population".
"…an ACO is where the commissioners in that area have a contract with a single organisation for the great majority of health and care services and for population health."
"A few areas – particularly some of the MCP and PACS vanguards – are on the road to establishing an ACO. An ACO model simplifies governance and decision making, brings together funding streams and allows a single provider organisation to make most decisions about how to allocate resources and design care for its local population."
The same document stated that: "…the Contract is now usable for accountable care models generally" (emphasis added).
"The range of services that can be the subject of the Contract is extremely wide: embracing Accident and Emergency Services, Acute Services, Cancer Services, Community Services, Continuing Healthcare Services, Diagnostic, Screening and/or Pathology Services, End of Life Care Services, Mental Health and Learning Disability Services, Radiotherapy Services and Urgent Care/Walk-in Centre Services/Minor Injuries Units, Primary Medical Services or "All Services". It is, moreover, clear from NHS England's published documentation that the intention is that all (or the great majority of) services within the local area will become the responsibility of the ACO.
The proposed Service Conditions provide, at condition 1.8, that "The Provider may, within the scope provided by this Contract, use and allocate its resources and deliver the Services in such manner as it determines will best serve the needs of the population", provided only that "it does not do or fail to do anything which would; 1.8.1 place any Commissioner in breach of any statutory duty in relation to the Population; 1.8.2 render any Commissioner liable to challenge under the Public Contract Regulations 2015 or otherwise; or 1.8.3 constitute an unlawful delegation of any function by any Commissioner".
The ACO is required to "develop and implement strategies to improve the health and wellbeing of the Population" (condition 3.2) and to "maintain a documented, current and thorough assessment of the health [and social] care needs of the Population".
Under the ACO contract, the ACO will not be paid through the pricing mechanism specified in the national tariff but by means of a "payment approach", comprising a "Whole Population Annual Payment" (WPAP) to the ACO, a "'gain/loss share agreement' to align financial incentives across services provided for the care model population" and an "Improvement Payment Scheme" designed to incentivise improved outcomes".
(i) That ACOs are a new form of contracting:
(ii) That there is no single definition of an ACO either in explanatory documentation or in the draft regulations which accompany the published explanatory documents.
(iii) That the objective of an ACO is to "dissolve the divides that exist between services provided by different parts of the health and care system".
(iv) That NHS England will "designate" an ACO as local monopoly entities. Draft regulations defined an ACO as a body which has been "designated by the National Health Service Commissioning Board [i.e. NHS England] because it is providing or arranging the provisions of services under the 2006 Act under contractual arrangements which: … (b) allow a single provider organisation to make most decisions about how to allocate resources and design care for its local population".
(v) The proposal thus entails (a) a process of designation by NHS England; (b) whereby the designated ACO would be providing "or arranging the provision of services under the 2006 Act"; and (c), where a single provider organisation would make most decisions about how to allocate resources and design care for a defined population.
"… we note that:
The proposed definition is very broad. While this may be intended to accommodate a range of different types of ACO, subsection (b) in particular is problematic as it may suggest that an ACO can usurp or exercise the statutory duties of a clinical commissioning group. This is not the case. An ACO will not commission services.
The draft definition refers to NHS England 'designating' an ACO. However, it is not clear what this is intended to mean and NHS England has not suggested such a process. A body would become an ACO if it is awarded an ACO contract rather than being 'designated' as such."
"Changes to definitions used across the amendments to regulations
Before proceeding with an explanation of the post-consultation revisions for each of the proposed sets of amendments to regulations, it is important to address comments received by NHS England that applied to all the draft amendments to regulations and have resulted in changes.
The draft amendments to regulations included a number of different definitions of ACOs and related terms:
• Definitions of Integrated Services Provider Contract and Integrated Services Provider are provided in the proposed amendments to the National Health Service (General Medical Services Contracts) Regulations 2015 and the National Health Service (Personal Medical Services Agreements) Regulations 2015. The proposed amendments to the National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012 cross-referred to that definition,
• 'accountable care organisation' or ACO was defined in the proposed amendments to the National Health Service (Travel Expenses and Remission of Charges) Regulations 2003, the National Health Service (Charges for Drugs and Appliances) Regulations 2015 and the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009 and
• a different definition of 'accountable care organisation' as given in the proposed amendments to the Medical Profession (Responsible Officers) Regulations 2010.
• NHS England's response commented on the definitions used in the draft amendments to regulations, "(We) would suggest that some amendments are made to the drafting to ensure that the policy aims are achieved. Amongst these… we note that multiple different definitions of accountable care organisation, integrated services provider and related terms are currently used in the draft regulations…These different terms and definitions may cause some confusion and we would query whether it is necessary to distinguish in legislation between accountable care organisations and integrated services providers." NHSE also said of one specific definition which referred to NHS England 'designating' an organisation as an ACO and to an ACO being an organisation that makes "most decisions about how to allocate resources and design care for its local population" that it was "not clear" what designating was intended to mean and that the definition was "problematic as it may suggest that an ACO can usurp or exercise the statutory duties of a clinical commissioning group. This is not the case. An ACO will not commission services."
• We acknowledge the points made by NHS England and wish to ensure that any definition used in the draft amendments to regulations cannot be misinterpreted as suggested by NHS England. This particular definition of ACO used in the consultation version of the proposed amendments has been changed, and is no longer contained in any of the final proposed amendments to regulations. These definitions will not mandate what form an ACO should take or what an ACO's responsibilities will be. Instead the definitions of an integrated services provider (ISP) and an integrated services provider contract (ISPC) are now used (revised draft set out in italics below). In the consultation document, the definition of "integrated services provider contract" appeared as a separate definition in the relevant definition section. The original intention was that an integrated services provider contract was a defined term to be used only in respect of an ACO contract under which primary medical services were being provided. However, following NHS England's comments, we have reconsidered the relevant definitions within the proposed set of amendments. Given the aim of the new ACO contract is to commission integrated health and care services, we have taken the view that transparency and clarity is best served by maintaining a consistent definition that sets out who may be the commissioners of such a contract on the one part, and what services may be provided under or pursuant to that contract. The definition of integrated services provider contract has now been refined so that it now applies in all contexts to the contract which will be used by an ACO for the provision of integrated health and care services regardless of whether primary medical services are included in those services. The revised definitions also ensure that there can be no scope for misunderstanding about what is entailed by the ACO contract. By cross-referencing 'integrated services providers' to 'integrated services provider contracts', the new definitions make clear that the ACO contract does not create a new legal entity. Under an ACO contract, the 'ACO' will not commission services. An 'ACO' is simply a provider of health care services which enters into an integrated service provider contract. The definition that is to be inserted into Schedule 3A to the National Health Service (General Medical Services Contracts) Regulations 2015 is set out below."
F. Issue II: Is the ACO policy ultra vires?
(i) Issue and conclusion
(ii) The Claimant's submissions
i) NHS England cites section 14Z2 NHSA 2006. This imposes a duty on CCGs to secure public involvement in: (a) "planning of the commissioning arrangements"; (b) "development and consideration of proposals by the group for changes in the commissioning arrangements"; and (c), "decisions of the group affecting the operation of the commissioning arrangements". This provision imposes no duties upon an ACO. Moreover, it is far from clear that a CCG would be required to consult on a reconfiguration led by an ACO in circumstances where it had already planned and entered into a long-term contract with the ACO and was not itself proposing any changes to the terms of the arrangement; and was not itself making any decisions affecting operation of the arrangement.
ii) NHS England refers to its own Service Change Guidance. CCGs are under a statutory duty to have regard to this Guidance (section 14Z8). But there is no statutory duty upon an ACO so to do. The Guidance states that substantial service change consultation will usually be commissioner-led; but this does not preclude provider-led change and does not identify anything that would legally preclude an ACO from reconfiguring services on its own initiative.
iii) NHS England points to the role of Health and Wellbeing Boards ("HWBs"). CCGs must, in exercising their functions, have regard to relevant Joint Strategic Needs Assessments ("JSNAs") and Joint Health & Wellbeing Board Strategies ("JHWSs") developed by their local HWBs (per section 116B Local Government and Public Involvement in Health Act 2007). An ACO is under no such duty.
iv) NHS England argues that "…both NHSE and NHS Improvement have, in relation to different bodies, assurance roles in any service reconfiguration process". Whilst it is true that NHS England has an assurance role in respect of CCGs, and NHS Improvement has an assurance role in respect of NHS Trusts and these roles are underpinned by statute, neither would have any statutory power to intervene in, or oversee, the decision-making processes of an ACO in this regard.
v) NHS England relies upon the Local Authority (Public Health, Health and Wellbeing Boards and Health Scrutiny) Regulations 2013 which require consultation with local authorities and provide an oversight role for the Secretary of State. They would not give CCGs any control over the activities of an ACO. Under regulation 23, where a "responsible person" has under consideration a substantial development of, or variation in, the health service in the area of a local authority, it is required to consult that local authority. A "responsible person" means a "relevant NHS body" or "relevant health service provider" (cf regulation 20(1)). It is accepted that an ACO is likely to fall within the definition of a "relevant health service provider" under section 244(3) NHSA 2006, and the provider's duty to consult under the regulations may have to be discharged by the CCG (reg. 23(12)), but this does not place any legal limits on what an ACO can do by way of service reconfiguration under a contract.
vi) A local authority can refer a proposal to the Secretary of State (regulation 23(9)) and the Secretary of State can take a decision on the matter referred (regulation 25(1)). Where the Secretary of State makes such a decision, the regulations empower NHS England to give directions to a CCG in respect of the proposal (regulation 25(2)). They do not, however, confer any power on the Secretary of State, NHS England or a CCG to direct the actions of a provider under contract. GC16.5.2 permits unilateral variation of the contract to comply with a direction given by the Secretary of State under NHSA 2006 Act but does not permit unilateral variation to comply with a direction from NHS England.
(iii) Defendants' submissions
"The Provider must at its own cost provide all support and assistance reasonably required by the Commissioners in relation to the performance of their duties under section 14Z2 of the 2006 Act in connection with this Contract, the Services or any reconfiguration of them, and/or the provision or reconfiguration of any other services to the Population."
SC16 contains provisions relating to variations and these include clauses permitting a CCG to vary the contract without the provider's consent where necessary to ensure compliance with the NHSA 2006 or other regulations made pursuant the Act or directions given by the Secretary of State (SC16.5). Detailed provisions also exist permitting the CCG to impose variations to remedy a persistent or material failure by a provider of: any Operational Standard or National Quality Requirement; any Local Quality and Outcome Requirement; or any other material obligation on its part under this Contract. In the event of disagreement between the provider and CCG over such matters dispute resolution mechanisms are provided. In short the draft ACO model contract specifically addresses the issue of the need for CCGs to implement changes in circumstances through contract modifications.
(iv) Analysis: Introductory points
(v) Analysis: The statutory constraints
"arrange" and "arranging" / "provision"
The limits imposed by other statutory functions
"2. While CCGs' role will continue to evolve, there will remain a need for an effective commissioning function in the NHS. This includes acting as funder, setting local priorities and incentives to ensure that the needs of local patients are met, oversight of contracts, ensuring best value for the taxpayer, and ensuring the provision of a comprehensive local NHS within the available resources. CCGs need to ensure that they have the capacity and capability to continue to discharge their functions once an ACO is established"
"7. CCGs will continue to be responsible and accountable for the delivery of their functions. They have the flexibility to decide how far to carry out activities related to these functions themselves; including in groups (e.g. through lead CCG arrangements); or through external commissioning support. They may also require, through contract provisions, an ACO provider to take action to support the discharge of certain CCG duties (e.g. to reduce inequalities or ensure patient choice). However, in all these instances the CCG will retain responsibility for its functions. These cannot be delegated. As part of the process of establishing an ACO, CCGs will need to assure themselves and NHS England of their ability to discharge their statutory functions."
"1.8 The Provider may, within the scope provided by this Contract, use and allocate its resources and deliver the Services in such a manner as it determines will best serve the needs of the Population, provided that it does not do or fail to do anything which would:
1.8.1 place any Commissioner in breach of any statutory duty in relation to the Population;
1.8.2 render any Commissioner liable to challenge under the Public Contract Regulations 2015 or otherwise; or
1.8.3 constitute an unlawful delegation of any function by any Commissioner."
"11. How will the roles of commissioners change?
The establishment of ACOs may lead to a shift in the activities of both providers and commissioners but will not dissolve the established boundary between commissioning and provision. CCG statutory functions will not change, and CCGs will not be able to delegate responsibility for their statutory functions to the integrated provider."
The CCGs duty to perform assessment
The extent of ACO decision making
(iv) Conclusion: Pulling threads together
(i) The max version of the ACO policy is intra vires the powers of CCGs and the Defendants.
(ii) Arranging to award a contract via a commissioning process to a single entity covering the entirety of service provision for its population is within the statutory powers of a CCG. Nothing in the Act restricts the ability of a CCG to appoint single providers covering the entirety of a relevant locality. CCGs have a broad power of arrangement and are required to act innovatively in this respect.
(iii) Arranging to award a contract via a commissioning process to a single entity for the whole of a CCG's geographical territory for the full suite of health services for which a CCG is responsible is also within the statutory powers of a CCG. Whether a CCG concludes a contract of this breadth will, in part, depend upon the assessment it makes in advance of local need and how it can be best provided for. But once again there is nothing in the legislation which prevents this.
(iv) Equally nothing in the Act prevents a CCG from entering a contract pursuant to which the provider is, then, required to arrange for the provision of health care services. The concept of "provision" is sufficiently broad to encompass arranging for sub-provision/contracting. In the course of argument the Claimants did not dispute this and, indeed, the draft ACO model contract has provisions for sub-contracting and supervision thereof by CCGs.
(v) It necessarily follows that it is within a CCG's powers to permit an ACO to take all the decisions which must be taken to perform that ACO's contractual duties. Provided the ACO contract itself is lawful then the extent of the decision making under that lawful contract raises no separate issues.
(vi) There is a statutory duty on both NHS England and CCGs to promote the provision of integrated services and accordingly a policy which has this as one object is within the statutory scheme. It is not argued by the Claimants that the ACO policy does not have this as an object or that, in principle, a single provider with a long-term contract for all relevant health services could not improve integration. In my judgment the rationale behind the ACO policy is a lawful one. Equally a further object of the ACO policy is the enhancement of efficiency and the way in which the ACO policy is framed is, in my view, also apt to fall within this statutory object such that the pursuit of this policy is lawful on this basis also. It is possible that the ACO policy could also be justified under other provisions of the NHSA 2006. But I do not need to conduct any broader analysis.
(vii) Nothing in the draft ACO model contract either represents the unlawful delegation to ACOs of non-delegable functions or has the effect of precluding CCGs from fulfilling their statutory functions. The Claimants have made some cogent points about the drafting of the model contract and I have little doubt but that the draft can be improved. However, this is not a reason why the model per se should be ultra vires. I am clear that the ACO model is within the powers of the Defendants to propose and the CCG to adopt and use. It fully recognises the non-delegable nature of the CCG functions and it includes measures (eg monitoring, supervision and enforcement) specifically designed to ensure that ACOs act in a manner consistent with the CCG's functions.
(viii) There is one final point to make. The Defendants relied, albeit lightly, upon section 2 NHSA 2006 in the event that the express powers did not suffice. I deal with this briefly. Since I have concluded that the express powers suffice there is no power to have recourse to section 2. Section 2 provides: "General power: The Secretary of State the Board or a clinical commissioning group 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". The scope and effect of this was considered in Justice for Health v Secretary of State for Health  EWHC 2338 (Admin) ("Justice for Health") which considered earlier authorities (cf paragraphs -). I held in that case that the power should only be used "to plug gaps and lacunas"; if there is express power to do something then that express power should be used. This was in accordance with the standard principle of statutory interpretation ("generalibus specialia derogant") that where the literal or express meaning of an enactment covered a situation for which specific provision was made then it was presumed that the situation was intended to be dealt with by the specific provision. Whenever section 2 is prayed in aid the first question should therefore be: Does the Secretary of State or NHS England or a CCG have an express power? If the answer is "yes" then section 2 could not be used: cf paragraph .
G. Issue III: Does the ACO policy breach the principle of clarity and transparency?
(i) The issue
"… a high standard of certainty, transparency and clarity is required in the context of policy-making and decision-making regarding the structural reorganisation of the NHS, the potential abolition of the internal market, the potential for the dissolution of health and social care boundaries and the transfer to non-statutory, unaccountable (and potentially private) bodies of the responsibility for decision-making about resource allocation and the design of care. These are all vitally important matters affecting services that are of the highest concern to the public. Yet the Claimants (as well-informed and knowledgeable individuals) have had to try to piece together the picture from a range of different sources and there is an absence of clear information about the precise nature of ACOs."
(ii) The Claimants' submissions
(a) It is a "requirement of good administration" that "public bodies ought to deal straightforwardly and consistently with the public": Nadarajah v Secretary of State for the Home Department  EWCA Civ 363 at paragraph 68 (per Lord Justice Laws).
(b) It is a fundamental requirement of the rule of law that policies on the exercise of statutory criteria be both transparent and clear, in order to avoid arbitrary and unlawful results, and that decisions taken by public officials in the exercise of their duties are also required to be transparent and clear. See, e.g., R (Lumba) v. Secretary of State for the Home Department  UKSC 12,  1 AC 245, at paragraph  (per Lord Dyson): "The rule of law calls for a transparent statement by the executive of the circumstances in which the broad statutory criteria will be exercised." In the same case Lord Phillips at paragraph  held that not only was the Minister required to have a policy but that the policy be published. This flowed "…from the standards of administration that public law requires…".
(c) In R (Limbu) v. Secretary of State for the Home Department  EWHC 2261 (Admin), at paragraph  Blake J stated: "Transparency, clarity, and the avoidance of results that are contrary to common sense or are arbitrary are aspects of the principle of legality to be applied by the courts in judicial review …". He also stated, at paragraph  that "… transparency and clarity are significant requirements of instructions to immigration and entry clearance officers that are published to the world at large". He concluded that the policy under challenge in that case either irrationally excluded material and potentially decisive considerations or "… was so ambiguous as to the expression of its scope as to mislead applicants, entry clearance officers and immigration judges alike as to what was a sufficient reason to substantiate a discretionary claim to settlement here."
(d) These principles were recently accepted as a correct statement by the Court of Appeal in R (Oboh) v. Secretary of State for the Home Department  EWCA Civ 514 per Richards LJ at paragraphs -; and by Jay J in R (Richmond Pharmacology Ltd) v The Health Research Authority  EWHC 2238 (Admin) in which the judge held that "…the Defendant's public utterances fail the public law test of certainty and transparency" (cf paragraphs  and .
(e) In Justice for Health (ibid) I accepted that the principle of transparency applied to pronouncements and decisions by the Secretary of State as to the contracts to be offered to junior doctors, observing that "[t]he principle of transparency is a component of the broad principle of 'good administration', the 'rule of law' and 'legal certainty'… it would take a powerful legal and policy argument for these to be disengaged from a decision such as that in dispute and I can discern none" (paragraph ).
i) On 4th August 2017 NHS England publicly stated that an ACO: "allows a single provider organisation to make most decisions about how to allocate resources and design care for its local population". This was a radical proposal. Supporting documents were published alongside the draft ACO contract but none explained what ACOs are and are not or set out how the contract operated within the NHS as a whole or addressed how the existing statutory duties of NHS commissioners and providers would be performed under it or set out how public accountability and patient choice would be preserved.
ii) In September 2017 the Secretary of State published draft regulations which indicated that an ACO would be "designated by the National Health Service Commissioning Board [i.e. NHS England] because it is providing or arranging the provisions of services under the 2006 Act under contractual arrangements which: (a) have the objective of integrating care and having a single, systematic approach to using the resources for a local population to improve quality of health outcomes; and (b) allow a single provider organisation to make most decisions about how to allocate resources and design care for its local population". (Emphasis added). The Secretary of State referred to directions which were not published and identified an unknown process of designation of ACOs by NHS England.
iii) In October 2017 NHS England's response to the Secretary of State's consultation identified errors and confusion in the analysis of the Secretary of State it being unclear what was meant by designation and because the definition of an ACO "…. may suggest that an ACO can usurp or exercise the statutory duties of a clinical commissioning group".
iv) On 25th January 2018 NHS England announced that it intended to launch, in the spring, a 12-week consultation on ACOs, which would "…set out how the contract fits within the NHS as a whole, address how the existing statutory duties of NHS commissioners and providers will be performed under it (including how this will work with existing governance arrangements) and will set out how public accountability and patient choice will be preserved". But even now (May/June 2018) nothing has been published. The Secretary of State and NHS England have failed to make it clear to the public that the ACO model means a switch of resources and decision-making power to new legal entities, distinct from any established NHS bodies, which could be wholly or partly private, would be non-statutory, and would not be subject to the duties imposed on CCGs by Parliament.
v) In March 2018 the Secretary of State accepted that the previous definition of an ACO "did not accurately reflect the policy intention" but failed to explain what the policy intention in fact was or how such an error came to be made.
vi) NHS England's position before the Court is encapsulated in the curious statement (in its written submissions) that it "will, if it assists the Court, not use these words to describe the policy in the future", a position that fails to provide any clarity as to NHS England's actual policy intention.
(iii) Submissions of the Secretary of State
"141. The principle of transparency has evolved out of Strasbourg jurisprudence, but it is now well established as a common law principle. It is said to amount to a component of the "rule of law" and the principle of "legal certainty". In Nadarajah v Secretary of State for the Home Department  EWCA Civ 363 at  Lord Justice Laws stated that it was a "requirement of good administration" (to which the courts would give effect) that "public bodies ought to deal straightforwardly and consistently with the public". The principle serves a number of important purposes. A law or policy should be sufficiently clear to enable those affected by it to regulate their conduct i.e. to avoid being misled. Such a law or policy should also be sufficiently clear so as to obviate the risk that a public authority can act in an arbitrary way which interferes with fundamental rights of an individual. Clear notice of a policy or decision is also required so that the individual knows the criteria that are being applied and is able to both make meaningful representations to the decision maker before the decision is taken and subsequently to challenge an adverse decision (for instance by showing that the reasons include irrelevant matters). Where the principle applies it might require the publication of the policy that a decision maker is exercising; it might require that the policy be spelled out in greater detail so that the limits of a discretion may be demarcated; it might require the decision-maker to be more specific as to when he/she will or will not act."
(iv) Scope of the principle: Is it limited to fundamental and constitution rights only?
"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."
Later, at paragraph , Lord Wilson identified two contextual factors which could affect the specificity of the consultation. The first was the identity of the addressees:
"Two further general points emerge from the authorities. First, the degree of specificity with which, in fairness, the public authority should conduct its consultation exercise may be influenced by the identity of those whom it is consulting. Thus, for example, local authorities who were consulted about the government's proposed designation of Stevenage as a "new town" (Fletcher v Minister of Town and Country Planning  2 All ER 496 at p 501) would be likely to be able to respond satisfactorily to a presentation of less specificity than would members of the public, particularly perhaps the economically disadvantaged…."
(v) Standard of assessment
(vi) Does the principle apply to health policy?
7. The NHS is accountable to the public, communities and patients that it serves
The NHS is a national service funded through national taxation, and it is the government which sets the framework for the NHS and which is accountable to Parliament for its operation. However, most decisions in the NHS, especially those about the treatment of individuals and the detailed organisation of services, are rightly taken by the local NHS and by patients with their clinicians. The system of responsibility and accountability for taking decisions in the NHS should be transparent and clear to the public, patients and staff. The government will ensure that there is always a clear and up-to-date statement of NHS accountability for this purpose.
"Patients and the public: your rights and the NHS pledges to you
Everyone who uses the NHS should understand what legal rights they have. For this reason, important legal rights are summarised in this Constitution and explained in more detail in the Handbook to the NHS Constitution, which also explains what you can do if you think you have not received what is rightfully yours. This summary does not alter your legal rights.
The Constitution also contains pledges that the NHS is committed to achieve. Pledges go above and beyond legal rights. This means that pledges are not legally binding but represent a commitment by the NHS to provide comprehensive high quality services."
(vii) The principle is not yet engaged
H. Issue IV: Prematurity
I. Issue V: Must the claim for judicial review fail for delay?
J. Issue VI: Do the Claimants have locus to bring the judicial review?
"… where permission to bring judicial review proceedings has been given, then, unless it is appropriate to deal with standing as a preliminary issue, there is likely to be little point in spending valuable court time and costs on the issue of standing. In that situation, we would not encourage the court to embark on a complex argument about standing".
"In my opinion it would be a very retrograde step now to hold that the EOC has no locus standi to agitate in judicial review proceedings questions related to sex discrimination which are of public importance and affect a large section of the population. The determination of this issue turns essentially upon a consideration of the statutory duties and public law role of the EOC as regards which no helpful guidance is to be gathered from decided cases. I would hold that the EOC has sufficient interest to bring these proceedings and hence the necessary locus standi".
"101. The claimant contends that it has sufficient interest. Sufficient interest is the remedy afforded by judicial review; in this case the quashing of the reconfiguration decision on the grounds that the consultation process was unfair and flawed. The claimant plainly has an interest in that remedy. The majority, if not all of the individuals who have contributed to the fighting fund, together with the Directors of the claimant, would have a direct sufficient interest in their own right had they brought the claim as individuals. Some of those individuals are clinicians, others are members of the public. The adverse costs in litigation are such that no citizen of ordinary means would prudently contemplate bringing this litigation as an individual. Incorporation was and is the proper means of allowing the interests of a substantial number of persons who consider the defendant's position to be unfair and unlawful to be jointly represented. There is no better placed challenger, in fact there is no other challenger.
102. I am satisfied that the claimant has sufficient interest in these proceedings. The claimant represents many individuals who have contributed financially in order to bring these proceedings. It includes individuals who have been or could be directly affected by the closure of the Leeds Unit and clinicians who work within the unit. Incorporation, following the intervention of the Charity Commission, was a proper means of allowing the interests of a substantial number of such persons to pursue this litigation".
"7. It is not difficult to identify people with standing to bring the challenge since virtually everyone in the United Kingdom or with British citizenship will, as we explain at paragraphs 58 and following, have their legal rights affected if notice is given under Article 50. The claimants and interested parties comprise a range of people whose interests are potentially affected in different ways."
Note 1 In addition to the present judicial review a claim was filed alleging that the payment system proposed for ACOs was unlawful. Permission was granted on 21 December 2017. The claim was dismissed on 15th May 2018 in Shepherd v National Health Service Commissioning Board  EWHC 1067 (Admin). [Back] Note 2 The Claimants observe that the NHSA 2006 expressly identifies, in section 3 together with Part 2 of the 2012 Regulations, the persons for whom the CCG has responsibility. The ACO policy and contract however introduce a new concept (not in the NHSA 2006) of “the Population” to whom the ACO provides services (e.g., SC1.1) “The Population” comprises “All Registered Service Users” (and others permanently or temporarily resident within the contract area who are not registered with any other provider of primary medical services) (Schedule. 2A). “Registered Service User” is in turn defined as a person “who is recorded by NHS England as being on the Provider’s … List of Service Users”. To receive health care services a person will have to be registered with the ACO, a matter not provided for in the statutory framework), as a person “who the Provider ... has accepted for inclusion on its List of Service Users, whether or not notification of that acceptance has been received by NHS England”. This latter provision allows an ACO to include any person within its Population and thus provide services to that person, whether or not they are a person for whom the CCG has responsibility under section 3. [Back]
Note 1 In addition to the present judicial review a claim was filed alleging that the payment system proposed for ACOs was unlawful. Permission was granted on 21 December 2017. The claim was dismissed on 15th May 2018 in Shepherd v National Health Service Commissioning Board  EWHC 1067 (Admin). [Back]
Note 2 The Claimants observe that the NHSA 2006 expressly identifies, in section 3 together with Part 2 of the 2012 Regulations, the persons for whom the CCG has responsibility. The ACO policy and contract however introduce a new concept (not in the NHSA 2006) of “the Population” to whom the ACO provides services (e.g., SC1.1) “The Population” comprises “All Registered Service Users” (and others permanently or temporarily resident within the contract area who are not registered with any other provider of primary medical services) (Schedule. 2A). “Registered Service User” is in turn defined as a person “who is recorded by NHS England as being on the Provider’s … List of Service Users”. To receive health care services a person will have to be registered with the ACO, a matter not provided for in the statutory framework), as a person “who the Provider ... has accepted for inclusion on its List of Service Users, whether or not notification of that acceptance has been received by NHS England”. This latter provision allows an ACO to include any person within its Population and thus provide services to that person, whether or not they are a person for whom the CCG has responsibility under section 3. [Back]