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England and Wales High Court (Technology and Construction Court) Decisions |
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You are here: BAILII >> Databases >> England and Wales High Court (Technology and Construction Court) Decisions >> Perinatal Institute v Healthcare Quality Improvement Partnership [2016] EWHC 2626 (TCC) (26 October 2016) URL: http://www.bailii.org/ew/cases/EWHC/TCC/2016/2626.html Cite as: 170 Con LR 128, [2016] EWHC 2626 (TCC) |
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QUEEN''S BENCH DIVISION
TECHNOLOGY AND CONSTRUCTION COURT
Strand, London, WC2A 2LL |
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B e f o r e :
____________________
PERINATAL INSTITUTE |
Claimant |
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- and - |
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HEALTHCARE QUALITY IMPROVEMENT PARTNERSHIP |
Defendant |
____________________
Miss Rebecca Haynes (instructed by My Business Counsel) for the Respondent/Claimant
Hearing dates: 5th October 2016
____________________
Crown Copyright ©
Jefford J:
The parties
The background
Events
Principles
- Is there a serious issue to be tried?
- If there is, are damages nonetheless an adequate remedy?
- If damages are not an adequate remedy, where does the balance of convenience lie?
Serious issue to be tried
The Invitation to Tender
(i) under “"Element 1: web-based tool for perinatal mortality reviews”":
“"The perinatal mortality review tool is to be developed for use by NHS maternity and neonatal units in England, Scotland and Wales. Data will be inputted by midwives, obstetricians, perinatal pathologists, neonatologists and data clerks. The data will be available locally at unit level.
For each case review the tool will need to be able to produce a taxonomy based on responses to the questions in the data-set, which includes a grading of case and generates a local action plan for improvements in the provision of care. It is expected that the tool will generate reports for discussion and learning within organisations and that there will be a process to feed these reports up to networks
Specifically, following input of the data by the user, the tool will need to be able to:
- be compatible for use across all Trusts and Health boards in England, Scotland and Wales
- prompt for when and how to seek parents input into the review and when to communicate with parents about outcomes
- validate use input and notify errors
- generate case reports listing risk factors and learning actions
- allow users to generate customised report
- generate maternity unit-level reports on common themes and learning actions
- print PDF summaries of records
- have access permission
- enable multiple users to access and input data from different sites, at the same time
- provide system back-up
....”"
I have underlined the item that, as will be seen, is relied on particularly by PI.
(ii) Further, under “"Information Governance and Duty of candour”":
“"From 1 April 2015, all registered providers must meet the new duty of candour regulation. The aim is to ensure that providers are open and transparent with people who use services. It also sets out specific requirements when things go wrong with care and treatment, including informing people about an incident, providing reasonable support, providing truthful information and an apology. …..
Bidders must provide details on how they will manage patient identifiable information in England, Scotland and Wales. This should include details on how they would secure approval requirements relating to Section 251 support under the Health and Social Care Act, ….. “"
(iii) Under element 4: Service user involvement:
“"The perinatal mortality review tool should incorporate the parents’' perspective about the care they and their baby received during the antenatal, intrapartum and postnatal period and any concerns they raised about their care. However, the parents’' perspective will be inputted into the tool through health professionals – parents will not have direct access to the tool.
Parents must be fully informed about the outcomes of the review.”"
“"Data confidentiality. How will good practice be followed in ensuring patient confidentiality?
Will section 60/section 251 Health and Social Care Act/ NHS act approval be required from the Confidentiality Advisory Committee (CAG) or will explicit patient consent be sought? Is there a plan for acquiring approval?”"
17. The references to section 251 are to the relevant section of the National Health Service Act 2006. To summarise the position:
(i) Under subsection (1), the Secretary of State may make regulations for the processing of patient information as he considers necessary or expedient in the interests of improving patient care or in the public interest.
(ii) Subsection (4) provides:
“"Regulations under subsection (1) may not make provision requiring the processing of confidential patient information for any purpose if it would be reasonably practicable to achieve that purpose otherwise than pursuant to such regulations, having regard to the cost of and the technology available for achieving that purpose.”"
(iii) Pursuant to this power, the Secretary of State has made the Health Service (Control of Patient Information) Regulations 2002.
(iv) Under these regulations, confidential patient information may be processed for specified types of or aspects of medical research if that processing has been approved by the Health Research Authority (“"HRA”").
(v) HRA has itself established a Confidentiality Advisory Group (“"CAG”") to advise it on applications for approval.
(vi) HRA published “"Principles of Advice”" which sought to clarify the position of CAG in its approach to public interest and “"reasonably practicable alternative”". Paragraph 2 of this document, presumably referring to s. 251(4), says that: “"The regulations cannot be used to set aside the common law duty of confidence if it would be “"reasonably practicable”" to achieve the purposes of the processing “"otherwise than pursuant to the regulations”". …………. Typically, when considering its advice on the issue of reasonable practicability the question that CAG has to consider is: Is it reasonable to expect the applicant, in practice, to either seek consent for the proposed use of confidential patient information or to achieve their purposes using data in a de-identified form. “"
(vii) PI also identifies a position paper published by the HRA which, amongst other things, states that “"s.251 support to access the confidential patient information of the living, without consent, cannot usually be given if a patient has been asked to give explicit consent to that processing and has not responded to the request.”"
PI’'s case on patient consent
(i) In respect of PI’'s proposals, the decisions stated that “"the panel was not assured that obtaining individual patient consent would be the best way to address participation and patient confidentiality. The panel would have liked to have seen more consideration of the challenges inherent in seeking patient consent.”"
(ii) In respect to NPEU’'s bid, the decision stated that “"the University of Oxford provided the panel with greater assurance because of their plans to use s. 251 approval to address patient confidentiality. The panel felt that this would ensure the best possibility for participation and rolling out the programme nation-wide.”"
(i) That HQIP has misdirected itself as to the law relating to s. 251 in that approval under the Regulations is not available where it is practicable to obtain patient consent.
(ii) That HQIP has misdirected itself and/or erroneously or irrationally concluded that patient consent cannot be obtained in circumstances where its own specification and the duty of candour necessarily renders patient consent a practicable option.
(iii) That HQIP has selected a bid which will not or is unlikely to gain approval
The time bar
Scoring
PI’'s case: the evaluation panel
Are damages an adequate remedy?
“"(a) If damages are an adequate remedy, that will normally be sufficient to defeat an application for an interim injunction, but that will not always be so ….
(b) in more recent times, the simple concept of the adequacy of damages has been modified at least to an extent, so that the court must assess whether it is just, in all the circumstances, that the claimant be confined to his remedy of damages …”"
“"In my view, a non-profit making organisation, which has bid for a contract making no allowance for profit at all, and a minimal amount for overheads, is entitled to say that, in such circumstances, damages would not be an adequate remedy.”"
(i) The work done for the Council in relation to domestic violence amounted to a third of BMLL’'s total turnover. Without this contract, BMLL would suffer catastrophic harm.
(ii) BMLL provided a range of services dealing with linked problems of domestic violence, sexual violence and mental health. The lifting of the suspension would disconnect the services in respect of domestic violence.
(iii) This part of BMLL’'s work could not be replaced so there would be a knock on effect to the provision of services in other locations.
(iv) If the suspension was lifted, BMLL would be locked out from this core element of its work for the 3 to 5 years of the contract which would also have a knock on effect on other services.
(v) The lifting of the suspension would have a significant effect on BMLL’'s reputation.
Coulson J. described these consequences as catastrophic. He concluded that damages were not an adequate remedy.
(i) PI’'s Schedule of Offer showed that some of the costs of clinical lead and other staff were allocated to this project and included sums, albeit not large ones, for overheads, including, under the heading “"Office Accommodation and Other Costs”" for accommodation and for “"HR, Finance and Legal (in house)”".
(ii) The Tender Response Document identified the project team and stated that the team would have ongoing support from other members of the Institute “"all easily accessible in our open plan offices”" including the director, finance manager, IT support, the head of midwifery and other project midwives.
(iii) In answer to tender clarification questions, PI said that all the staff listed in the original submission work within support teams in the Institute, those teams being identified as the Midwifery Team, the IT Team, the Data Team and the Administrative Team.
Balance of convenience
61. For completeness I should also deal with two further points that were raised in this context.
62. Firstly, PI argued that there had been undue delay by HQIP in making this application and that that should weigh in the balance against lifting the suspension. I do not consider that there was any undue delay. After the decision was made, the parties engaged in correspondence to explain their positions to each other and see if they could resolve their differences. In a letter dated 18 August 2016, HQIP’'s solicitors stated that they were preparing an application to lift the suspension; HQIP’'s Defence was served on 30 August 2016; and this application was made on 21 September. Given the need to have the support of the Department of Health and the devolved governments for this application and that much of these events took place over the holiday period, I cannot see that there was any undue delay, and even if there were it would not be enough to tip the balance.