ON APPEAL FROM THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
Strand, London, WC2A 2LL
B e f o r e :
LORD JUSTICE RICHARDS
SIR STEPHEN SEDLEY
| THE QUEEN (ON THE APPLICATION OF ROYAL BROMPTON AND HAREFIELD NHS FOUNDATION TRUST)
|- and -
|JOINT COMMITTEE OF PRIMARY CARE TRUSTS & ANR
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Mr Alan Maclean QC & Mr David Scannell (instructed by Hempsons Solicitors) for the Respondent
Hearing dates : 19/20 March 2012
Crown Copyright ©
Lady Justice Arden:
Legal framework for the consultation exercise
"8. …. Sections 1 and 3 of the National Health Service Act 2006 (the "Act"), oblige the Secretary of State for Health to provide or secure certain medical services. By regulation 3 of the National Health Service (Functions of Strategic Health Authorities and Primary Care Trusts and Administration Arrangements) (England) Regulations 2002 (SI 2002/2375) (the "2002 Regulations"), as amended, that function has for the most part been delegated to Primary Care Trusts ("PCTs"), of which there are 152 in England.
9. PCTs commission services from "providers", including NHS Foundation Trusts to meet the needs of the populations for which they are responsible.
10. Section 242 (2) (b) of the Act imposes a duty on each body to which it applies, which includes PCTs, to consult persons to whom services are being or may be provided on "the development and consideration of proposals for changes in the way those services are provided".
"108. It is common ground that, whether or not consultation of interested parties and the public is a legal requirement, if it is embarked upon it must be carried out properly. To be proper, consultation must be undertaken at a time when proposals are still at a formative stage; it must include sufficient reasons for particular proposals to allow those consulted to give intelligent consideration and an intelligent response; adequate time must be given for this purpose; and the product of consultation must be conscientiously taken into account when the ultimate decision is taken (R v Brent London BC, ex p Gunning (1985) 84 LGR 168)."
Provisional decision-making and preparation for consultation
(a) History: the Bristol Royal Infirmary Report and the Monro Report
(b) The Safe and Sustainable Review 2008 and continuing
(c) The role of the JCPCT and SCGs
(d) The organisational structure established to carry out the Review
"35. Day to day management of the Review has been led by a project team of the NSCG (the "NSCG Team"), assisted by a number of specialist working groups, in particular:
1. a Steering Group;
2. a Standards Working Group (a sub-group of the Steering Group) and
3. an Independent Assessment Panel ("the [Kennedy] Panel")
The Steering Group
36. The Steering Group was chaired by Dr Patricia Hamilton, past President of the Royal College of Paediatrics and Child Health and Director of Medical Education in England. It comprised about 25 – 30 members drawn from professional and lay associations and commissioners representing a broad geographical spread. The original membership included Dr (now Professor) Shakeel Qureshi, a consultant paediatric cardiologist at the Evelina and then President elect of the British Congenital Cardiac Association (BCCA). It was subsequently expanded to include Professor Martin Elliott, a consultant paediatric cardiothoracic surgeon at GOSH, and a senior member of the BCCA.
37. The role of the Steering Group was originally to steer the development of proposals, reporting to the NSCG on, inter alia, the appropriate model of care, standards, and criteria for the designation of services.
38. Proposals for reconfiguration were initially to be developed by the SCGs organised into four regional zonal teams ("The SCG Collaboratives") reporting to the Steering Group. London was included within the South Eastern Zone which also comprised the East of England and SE Coast SCGs. The SCGs Collaboratives were charged with identifying reconfiguration options within their zones.
The Standards Working Group
39. The Standards Working Group was a multi-disciplinary panel of experts, set up as a sub-group of the Steering Group, to research and develop a framework of clinical and service standards. Draft Standards were to be presented to the Steering Group, then to the NSCG for endorsement. Once agreed, they were to be used to assess the existing 11 centres and their ability to provide a high quality service in the future.
The [Kennedy] Panel
40. The Kennedy Panel, chaired by Professor Sir Ian Kennedy, was tasked with reviewing each of the existing 11 providers of PCCS services and evaluating their compliance with the proposed service standards. Panel membership comprised experts in paediatric cardiac surgery, paediatric cardiology, paediatric anaesthesia/paediatric intensive care, paediatric nursing, paediatrics and child health, together with lay representatives and NHS commissioners. It was a requirement that members should have no existing or direct relationship with any of the 11 current providers.
41. In the Spring of 2009 concerns emerged as to how the arrangements for the Review would work in practice. It was considered that the process by which SCG Collaboratives would recommend centres within their zones might not result in an appropriate distribution of services. Secondly there was a question as to whether there was a body with authority to take decisions as to implementation of the Review.
42. At the end of 2009, and in the light of such concerns, the governance structure of the Review was revised. The SCG Collaboratives were disbanded. Secondly the NSCG recommended the establishment of a Joint Committee of Primary Care Trusts to act as a single body with delegated powers of consultation and decision making. In April 2010 the NHS Operations Board endorsed the proposed JCPCT subject to ministerial approval which was obtained in July 2010. Although the JCPCT was not formally constituted until it received ministerial approval, I shall refer to it throughout as the JCPCT.
43. With the creation of the JCPCT, the Steering Group's mandate was no longer to "steer" the Review, but to advise the JCPCT, the sole decision maker acting on behalf of all English PCTs, on clinical matters, including the design of the proposed congenital heart networks. The change was reflected in the Steering Group's revised Terms of Reference published in June 2010."
(e) Establishing the stages for the Review
i) In January 2010, the centres which provided paediatric cardiac surgical services were asked to provide "baseline" information. This sought information as to each centre's role in research, including a list of the areas in which its research interests lay and the number of papers in peer reviewed journals published by members of the centre's paediatric cardiac surgical centre in 2008/9. According to the second witness statement of Mr Jeremy Glyde of the NSCG, the responses, together with corresponding SCG commentaries and the earlier baseline information, submitted by the centres were provided to the Kennedy Panel for information only and not for the purpose of scoring.
ii) According to the same witness statement, if there were two centres in London, these being GOSH and Evelina Children's Hospital, and Royal Brompton's existing caseload were distributed on the same lines as current distribution patterns, of the 1,482 projected procedures per year, GOSH would do 910 procedures and Evelina Children's Hospital 572.
iii) In March to April 2010, the Standards Working Group published their proposed national quality standards. They endorsed the concentration of specialist expertise into larger teams at Specialist Surgical Centres, recommending that each such centre should meet certain threshold criteria:"C4 . . . must be staffed by a minimum of four full time consultant congenital cardiac surgeons;C6 . . . must undertake a minimum of 400 paediatric surgical procedures per year to avoid 'occasional practice';C7 . . . should perform a minimum of 500 paediatric surgical procedures each year."
2. an assessment by the Kennedy Panel;
3. a 'configuration options assessment' to establish a shortlist of options.
(f) Stage 1: Self-assessment
"Safe and Sustainable Self Assessment Template
1. Introduction and process
At the request of the NHS Management Board, the NHS Medical Director has asked the National Specialised Commissioning Group (NSCG) to undertake a review of the provisions of paediatric cardiac surgical services in England with a view to reconfiguration.
Safe and Sustainable has been set up to take this forward.
The objectives of the programme are:
- To ensure a safe paediatric cardiac service now and in the future.
- To ensure equality of service provision across England, where patient access to services is reasonable and appropriate.
This will be achieved by:
- Developing criteria for the designation of specialist paediatric congenital cardiac services.
2. Evaluating process and scoring
The evidence you supply in this exercise will be assessed as part of the evaluation process we will undertake, and therefore will ultimately inform the final recommendation.
The entire evaluation process has 2 discrete stages- Assessment Evaluation and Configuration Evaluation. This process will fulfil the first stage of the assessment evaluation.
The second stage of the Assessment Evaluation will be visits by the Assessment Panel to each centre. …
It should be noted that the criteria and scoring process for the Configuration Evaluation have not yet been determined. This will be communicated to all stakeholders in due course. However, the criteria and scoring for the Configuration Evaluation is separate from the Assessment Evaluation. The information supplied in the assessment stage of the process will not have any direct bearing on the scoring of the configuration evaluation process." (emboldening added)
"For the Self Assessment Evaluation Stage, each question within the 9 self assessment criteria will be scored individually, as indicated below:
|1||Inadequate (no evidence to assure panel members)|
|2||Poor (limited evidence supplied)|
|3||Acceptable (evidence supplied is adequate, but some questions remain unanswered or incomplete)|
|4||Good (evidence supplied is good and the panel are assured that the centre has a good grasp of the issue)|
|5||Excellent (evidence is exemplary)|
Each question within that criterion will then be weighted according to the stated multiplier, in order to reach a final score for each question. The sum of these final scores will be the total score for that criteria.
The total scores for each criterion will come together as a final score for each centre.
It should be noted that a score of below 3 for any question may raise concerns about the centre's ability to be successful during the Configuration Exercise."
- "Each Tertiary Centre must have a dedicated management group for the internal management and coordination of service delivery. The group must comprise the different departments and disciplines delivering the service.
- All clinical teams will operate within a robust and documented clinical governance framework that includes clinical audit, including in outreach centres.
- Each Tertiary Centre must have, and regularly update, a research strategy and programme that documents current and planned research activity, the resource needs to support the activity and objectives for development. The research strategy must include a commitment to working in partnership with other centres in research activity which aims to address research issues that are important for the further development and improvement of clinical practice, for the benefit of children and their families.
"Please attach the following documents in support of this core requirement:
- Clinical governance framework and process
- Research strategy and programme"
"[Royal Brompton] has a clear and accountable research strategy and infrastructure (appendix 20e). Our willingness to work with other centres is evidenced by several of our recent studies including several national epi-immunological studies in congenital heart disease and the National multi-centred NIHR-funded "Chip" trial which ran at Royal Brompton …. The Trust has recently restructured its research and development arrangements including the recruitment of a new Associate Director of Research. A key aim of these changes is to improve the alignment of the Trust research activity with the objectives of the NHS at large."
(g) Stage 2: Assessment by the Kennedy Panel
(h) Configuration options assessment from short listing to finalisation of the options
(i) Short listing the options
i) Four seven site options with two centres in London (as at the previous meeting).
ii) Four six site options with two centres in London (one of which had been presented at the last meeting).
iii) Four three London centre options.
(ii) Setting the weighted evaluation criteria
"(1) Quality: (a) centres will deliver a high quality service; (b) innovation and research are present; (c) clinical networks are manageable;
(2) Deliverability: (a) high quality NCSs will be provided; (b) the negative impact on other interdependent services will be kept to a minimum, as will negative impacts on the workforce;
(3) Sustainability: centres are likely to perform at least 400-500 procedures; will not be overburdened and will be able to recruit and retain newly qualified staff.
(4) Access and travel times: negative impact of travel times for elective admissions are kept to a minimum; retrieval standards are complied with."
Royal Brompton 2
(iii) Identifying the best options: determining the preferred two-centre option for London
(iii) Determining which two of the London centres was to be included in the preferred two-centre option
Royal Brompton 264
(iv) Finalising the decision to put the options out to consultation
"Let me say categorically, the consultation exercise is what it says on the tin. We are open minded about the outcome, we are prepared to listen to alternative views, as we said on three occasions during the course of the afternoon, and we will move forward with further discussions in the autumn ..."
The consultation document
[7 sites – 2 for London]
2 for London]
2 for London]
3 for London]
3 for London]
[Top 7 sites scoring
2 for London]
|Access and travel||56||14||42||14||42||14|
[error: should have been 231]
[error: should have been 231]
"The final recommended options for consultation are:
- Option 2 is viable as it is consistently the highest scoring potential option
- Option 14 is retained…
- Option 6 is viable
- Option 8 is viable"
It was recommended to the Joint Committee of Primary Care Trusts that Options 10 and 12 (which included 3 centres in London) should not form part of the public consultation for the following reasons:
- The Joint Committee of Primary Care Trusts recommends that two designated centres is the ideal configuration for the population of London, East of England and South East England. The question of whether two centres in London is the right number will be asked during consultation.
- The forecast activity levels for London and its catchment area (currently around 1,250 paediatric procedures per year) mean that two centres would be well placed to meet the proposed ideal number of 500 procedures a year. This could only happen with three London centres if patients were diverted from neighbouring catchment areas into London. Our analysis shows this would significantly, and unjustifiably, increase travel times and impact on access for patients outside of London, South East and East of England.
- The advice of the Safe and Sustainable Steering Group is that two centres, rather than three, are better placed to develop and lead a congenital heart network for London, South East and East of England according to the Safe and Sustainable model of care."
|GOSH weighted score||Evelina Children's Hospital weighted score||Royal Brompton weighted score|
|Access and travel times||42||42||42|
The proposed score for the Evelina Children's Hospital reflects the results of Sir Ian Kennedy's panel assessment of its capacity for 'research and innovation' (refer to map on page ).
Similarly Great Ormond Street Hospital and the Royal Brompton Hospital were ranked equally by the panel, but the higher score for Great Ormond Street is due to its capacity for 'research and innovation'. Because they are already close together, there is unlikely to be an impact on the sub-criterion of 'manageable networks'.
As Great Ormond Street Hospital would retain three nationally commissioned services in their current location (cardiothoracic transplantation, ECMO and complex tracheal surgery) we recommend it scores higher in potential configuration options. Because the PICU at the Royal Brompton Hospital exists predominantly to support cardiac surgery, we propose it is scored lower than the Evelina Children's Hospital on the sub-criterion involving 'the negative impact for the provision of paediatric intensive care and other interdependent services is kept to a minimum'."
The response form
"Q7 Before answering this question, please read pages 93-96 in the Safe and Sustainable Consultation Document. Do you support the proposal for two Specialist Surgical Centres in London?
PLEASE TICK ... ONE BOX ONLY
... Yes – support the proposal for two Specialist Surgical Centres in London
... No – do NOT support the proposal for two Specialist Surgical Centres in London
... Don't know
ALL TO ANSWER
Q8 What, if any, comments do you have on the number of Specialist Surgical Centres in London?
PLEASE SUMMARISE YOUR KEY COMMENTS IN THE BOX BELOW
ALL TO ANSWER
Q9 Before answering this question, please read pages 93-96 in the Safe and Sustainable Consultation Document
It is proposed that the two Specialist Surgical Centres in London will be Great Ormond Street Hospital for Children NHS Trust (GOSH) and Evelina Children's Hospital – Guy's and St Thomas' NHS Foundation Trust.
If there were to be only two Specialist Surgical Centres in London, please indicate whether you support this choice (i.e. GOSH and Evelina Children's Hospital), or whether you think that the Royal Brompton & Harefield NHS Foundation Trust should replace one of these other two London hospitals?"
Further consultation document and processes during the consultation period
"At this half way stage in the public consultation on the future of children's congential cardiac services, now is an appropriate time to look at the issues that have been raised so far and focus on the unique situation in London. Every other surgical centre is the sole centre in its city or region; London has three centres close together."
Responses to consultation
The judge's judgment
Rescoring of research by the Kennedy Panel – February 2012
"While recognising [Royal Brompton's] reputation in the field of clinical research, in the panel's opinion the evidence submitted by [Royal Brompton] is limited in its references to paediatric cardiac surgical services and paediatric interventional cardiology services."
The issues on this appeal and the respondent's notice
Discussions and conclusions
(i) Professor Qureshi and Professor Elliott
"The consultation was unfair in that it was tainted by apparent bias arising from the involvement in the Steering Group (the recommendations of which were accepted by the JCPCT) of senior consultants from the two London hospitals which were ultimately favoured by the JCPCT, i.e. Evelina and GOSH. The Royal Brompton tried its best to secure a place on the Steering Group for one of its clinicians, but these efforts were rebuffed. There is evidence that some members of the Steering Group were concerned about the bias aspect, but these concerns were swept aside."
"it is clear from the minutes of the meetings of the JCPCT and from the witness statement of Sir Neil McKay that it arrived at its decision as to its preferred options after a full and proper consideration of the material before it, and was not simply rubber-stamping the recommendations of the Steering Group."
(ii) Mr James Monro
Royal Brompton's additional grounds for upholding the judge's order
|6 sites||6 sites||7 sites
|Top 7 scoring|
|London (per centre)||721||741||741||494||494||580|
Relief granted by the judge