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||Neutral Citation Number:  EWHC 2238 (Admin)
||Case No: CO/1338/2015
IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
MANCHESTER CIVIL JUSTICE CENTRE
||Royal Courts of Justice
Strand, London, WC2A 2LL
B e f o r e :
MR JUSTICE JAY
|| The Queen (on the application of Richmond Pharmacology Ltd)
||The Health Research Authority
||Sense about Science
David Lock QC and David Blundell (instructed by LHS Solicitors LLP) for the Claimant
Parishil Patel (instructed by DAC Beachcroft LLP) for the Defendant
Jonathan Price (instructed by Bryan Cave LLP) for the Interested Party
Hearing date: 16th July 2015
HTML VERSION OF JUDGMENT
Crown Copyright ©
Mr Justice Jay:
- By this application for judicial review, Richmond Pharmacology Ltd ("the Claimant") seeks to challenge certain public statements by the Health Research Authority ("the Defendant") in relation to the latter's characterisation of the duties of those sponsoring and carrying out clinical trials: specifically, the Claimant contends that the Defendant is wrongly asserting that those in its position are under legal duties to register their trials on publicly available websites and to publish data about the outcome of such trials.
- The issue raised in these proceedings is narrow and turns on fine textual analysis. When these proceedings were launched, and permission was subsequently granted by HHJ Pelling QC, the issues were much broader, and arguably of greater public interest. Masses of paper have been spawned by the litigation, most of which is no longer relevant in the light of the issues which have fallen away. However, I was informed by Mr David Lock QC for the Claimant that this judicial review continues to attract keen interest and concern in the pharmacological research world.
- The Claimant is a leading clinical research company established in 2001. It carries out a wide range of early phase clinical trials of new medicines. The present case is concerned with "phase 1 trials", namely those which aim to test the safety, as opposed to the efficacy, of medicinal products.
- The Defendant was originally established in 2011 as a Special Health Authority. On 1st January 2015 the Defendant was established as a statutory body corporate under the Care Act 2014. Its main functions under that statute are adumbrated below, but at this juncture I should state that these include the regulation of the research ethics committees ("RECs") under its aegis. Under the legislative regime, the HRA is empowered to require RECs to impose conditions on approvals for clinical trials (described as "favourable opinions" in the relevant secondary legislation).
- Sense about Science is a UK charity founded in 2002 with the aim of equipping the public with the means of making sense of science and evidence. It runs the AllTrials campaign for clinical trial transparency. Holgate J permitted Sense about Science to intervene in these proceedings by filing written submissions, and I am grateful for Mr Jonathan Price's detailed contribution. The line his clients were taking diverged from the position of the regulator. Given the potential importance of the issue he raised, I invited Mr Price to address me briefly upon it.
The Essential Factual Background
- Clinical trials are conventionally divided into four phases: as previously indicated, the current proceedings are solely concerned with early phase, or phase 1, trials designed to ascertain the safety and tolerability of a new medicine. The complex web of regulatory provisions governing all clinical trials has its source in EU Directives and domestic legislation. At this stage, the position may be summarised in this fashion: there is no rule of EU or domestic law which requires phase 1 trials to be registered on a publicly accessible database, or for the results of these trials to be published. There is a European database of clinical trials ("EudraCT") on which phase 1 trials need to be registered, but only in its "private" section. Since 2004, phase 2-4 clinical trials have to be registered in the public fields of EudraCT. Pursuant to Regulation (EU) No. 536/2014, the registration and transparency requirements in relation to phase 1 trials are likely to change in May 2016. On my understanding, these Regulations will not create an absolute duty to publicise phase 1 trials, but an obligation subject to stated exceptions including commercial confidence.
- There are two competing interests in play: the private interests of the sponsors of clinical trials (and of those who carry them out) to preserve commercial confidentiality for as long as possible, and the wider public interest favouring greater openness and transparency. There is certainly a powerful school of thought which holds that it is decidedly in the interest of the public to enable its gaze to be opened onto all clinical trials, since that ensures that as much information as possible enters the public domain as early as possible, with consequent public health benefits.
- Since 2008 the then National Research Ethics Service has been favouring the school of thought that espouses greater openness and transparency, although recognition has continued to be accorded to the demands of commercial confidence in appropriate cases.
- In May 2013 the HRA published its paper, "The HRA Interest in Good Research Conduct", containing the following proposal:
"The HRA will make trial registration for clinical trials a condition of REC approval from September 2013. The HRA will consider and agree which categories on [sic] studies on the IRAS (Integrated Research Application System) will fall within the condition, and also agree a reasonable timeframe for the registration as part of the condition. Clinical trials are studies with any clinical intervention, including drug trials."
- This proposal was implemented with effect from 30th September 2013 (i.e. not retroactively), and included phase 1 clinical trials. The standard conditions imposed by RECs required not merely registration but publication of the details of such trials on publicly available websites. A revised sponsor's declaration, which included a commitment to abide by the publication requirements, was introduced for applications considered by an REC after 30th September 2014. To be clear: the declaration applied to all trials approved after September 2013, but not before.
- The Claimant does not question the Defendant's power to direct RECs to impose these standard conditions. Mr Lock submitted, and I agree, that the locus of this power is within the HRA's general regulatory powers as set forth in the Care Act 2014, read in conjunction with regulation 15(3A) of the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004 No. 1031) ("the Clinical Trials Regulations").
- In October 2014 the HRA announced that in April 2015 it proposed to "extend registration requirements to all trials in active recruitment in the UK". The exact nature of the proposal emerged from a document entitled "Transparency Next Steps", the salient parts of which stated as follows:
"The HRA is proposing that the sponsor declaration is updated to require the sponsor to declare that all clinical trials in active recruitment have been registered, including those which were approved before September 2013 i.e. before it was a condition of the REC opinion. (01 April '15)[my emphasis]"
- Thus, the HRA appeared to be saying that as from 1st April 2015 the wording of the sponsor's declaration would be changed so that it would now have retroactive effect. That interpretation is borne out by other provisions in this publication which refer to "retrospective registration". The "Next Steps" document also made clear that under the post-April 2015 regime the REC will require the declaration to be completed as a condition of favourable opinions for new applications made by the sponsor.
- The new regime was indeed introduced with intended effect from 1st April 2015 there were initial website glitches. The new-form sponsor's declaration placed on the IRAS (being the online vehicle for applying for clinical trial approvals) read, insofar as is material:
"I confirm that
9. Specifically, all clinical trials, given a favourable opinion by a [REC] within the Health Department's Research Ethics Service since 30 September 2013 and those given a favourable opinion prior to this date and currently in active recruitment in the UK, have been registered on a publically accessible register in accordance with existing duties of sponsors and the [HRA] requirements and extended compliance checks. [i]"
- There was an information button on the web-page (designated by the "i" above) which, if pressed, linked into the following webpage:
"HRA Requirement to Register Clinical Trials as a Condition of REC Favourable Opinion
On 30 September 2013 registration of clinical trials in a publicly accessible database became a condition of the REC favourable opinion. The studies for which registration is mandated are the first four categories on the IRAS filter question number 2
[including the phase 1 clinical trials germane to these proceedings]
From 30 September 2014, Sponsors are asked when submitting REC applications that they have registered trials as per the above requirement.
From 01 April 2015, the HRA will extend compliance checks against this existing responsibility to all trials in active recruitment, including trials receiving favourable opinion before 30 September 2013. Sponsors unable to provide that assurance should contact the HRA and arrange for deferrals to be put in place according to the procedures established in September 2013. Please note this process will not affect the decision on the current application at this time, although sponsors should be aware that measures to support compliance may be introduced in due course subject to further consultation.
For further information and detailed guidance about this requirement, including examples of accepted registers and the process for requesting deferral of registration, please refer the HRA website at: http://www.hra.nhs.uk/resources/during-and-after-your-study/transparency-registration-and-publication."
- Accessing the website referred to above yields the following additional information:
How the HRA is improving transparency within research
The HRA has a duty to promote transparency and we developed plans for transparency in health research which were first published in May 2013. The HRA is leading on practical measures to ensure the duties of researchers and sponsors to register studies and to make findings available are fulfilled, and that patients and the public can have confidence that they do.
Clinical trial registration
The HRA introduced a simple check on sponsor compliance with duties to register on 1 April 2015. This uses the sponsor declaration on a new Research Ethics Committee (REC) application to set out the duties and to ask for sponsors to confirm that they are compliant. Sponsors unable to declare compliance may advise the HRA and request a deferral through the HRA registration policy. Please refer to the linked information below for more information and guidance on this requirement.
Researchers should note that the HRA registration policy expects registration before the first participant is recruited and sets out it is a breach of the favourable ethical opinion if clinical trials are not registered within 6 weeks of the first participant being recruited. Increasingly others such as funders and publishers are setting standards for transparency. Some publishers will not publish studies where the study is not registered before the first participant is recruited.
The HRA is separately developing plans for further measures and potential sanctions for non-compliance, which it expects to consult on later in 2015. These would run in shadow form until the new EU Clinical Trial Regulation comes in to force, which will require sanctions for non-compliance with Regulation's transparency requirements.
Request for deferral of requirement to register:
In recognition of the need to ensure transparency as well as maintaining UK competitiveness applicants may request to defer registration and the HRA is maintaining a register of these requests.
The HRA acknowledges that within Phase 1 research particularly, there is sensitivity of some commercially confidential information. The EU Clinical Trials Regulations are expected to come into force in 2016 / 2017. The European Medicines Agency (EMA) has consulted on proposals for transparency rules to implement in the IT infrastructure, which will support the implementation of the new EU Clinical Trials Regulation. These included proposals to allow the possibility of a short deferral of registration for Phase 1 healthy volunteer studies.
Further information and guidance:
Our key messages and Questions & Answers on transparency (Version 4.0 PDF July 15)
- Clicking on the "our key messages and Questions & Answers on transparency" (as I have done for the purposes of preparing this judgment) produces the following additional advice:
"HRA and Research Transparency
Clinical trial registration
Key messages and Q&A
Please note this document supersedes previous versions. The HRA is a listening organisation and this latest Q&A may not be fully consistent with previous consultation documents but does represent an accurate position when written.
22 May 2015
The HRA has a duty to promote transparency and researchers, sponsors and funders correspondingly having responsibilities to participants in research, patients and the wider public and research communities.
In order to fulfil its statutory responsibilities to promote transparency, the HRA introduced a simple compliance check on sponsor duties to register on 1st April 2015. This uses the sponsor declaration on new Research Ethics committee (REC) applications to ask sponsors to declare that they are compliant. Sponsors unable to declare compliance may advise the HRA and seek a deferral through the existing HRA registration policy.
Researchers should note that the HRA registration policy expects registration before the first participant is recruited and sets out that it is a breach of the favourable ethical opinion if clinical trials are not registered within 6 weeks of the first participant being recruited. Increasingly others such as funders and publishers are setting standards for transparency. Some publishers will not publish studies where the study is not registered before the first participant is recruited.
The HRA is separately developing plans for further measures and potential sanctions for non-compliance which it expects to consult on later in 2015, and run in shadow form until the new EU Clinical Trial Regulation (EU Regulation 536/2014) comes in to force, which will require sanctions for transparency alongside other good and safe practice for clinical trials. The compliance check introduced by the HRA will not affect existing or new REC applications at this time. The HRA will though actively monitor and report on compliance.
1. Key messages
1.1. Transparency is fundamental to the role of the HRA to promote and protect the interests of patients and the public in health research. The HRA has a duty to promote research registration and sponsors and investigators have existing responsibilities to register to meet governance and best practice requirements.
1.2. The HRA expects registration of all clinical trials before the first participant is recruited in line with the WHO, Declaration of Helsinki and Research Governance Framework.
1.3. Many journals require registration before the first participant is recruited. Failure to do so may prevent publication in key journals, such as the BMJ, which actively implement that requirement.
1.4. Since 30 September 2013 the HRA has identified trial registration as a specific ethical requirement within the existing duties of the sponsor, and it has been a condition of the Research Ethics Committee (REC) opinion to register clinical trials. Failure to do so within 6 weeks of the recruitment of the first UK participant is therefore a breach of the favourable ethical opinion unless a request to defer registration has been granted by the HRA and is still valid.
1.5. The HRA has offered a deferral option where there is not currently a legal requirement (see 2.5) to register, noting the commercial sensitivities of some areas of research, notably within early phase trials.
1.6. Since 1 April 2015, the HRA has updated the sponsor declaration to provide a compliance check point on sponsor duties for registration.
1.7. The HRA considers that a sponsor is meeting registration requirements when either the research has been registered in a publicly accessible trial registry (including that provided from EudraCT) or when an application has been made to the HRA for deferral of registration and if agreed, is still valid.
1.8. The HRA is extending the compliance assurance to all studies in active recruitment in the UK in line with its duties under the Care Act to promote research registration. Assurances are expected to be made based on governance procedures by sponsors in line with arrangements for other key governance requirements to ensure good and safe conduct of health research.
1.9. Sponsors unable to provide such assurances may apply for deferral of registration of studies approved before September 2013 in line with the HRA deferral policy.
2. Q and A
2.4. Q: Do clinical trials include all phases of clinical trials / Does it include clinical trials in healthy volunteers as well as patients / Does it include commercial and non-commercial trials?
A: Yes, although the HRA recognises the need to maintain UK competitiveness and so we have put in place a simple mechanism to request deferral of registration where there are, for example, concerns of commercial confidentiality and there is not currently a legal requirement for registration. This is a deferral with a commitment to register later, not an exemption. Where a deferral is allowed, the expectation is that the trial will be registered at the point where the reason for the deferral request is no longer valid. For example, where the request for deferral of registration of a phase 1 clinical trial is agreed due to reasons of commercial sensitivity, registration is expected once the trial reaches phase 2 or immediately should the trial be terminated.
2.5. Q: How do the HRA registration requirements compare with current EU Clinical Trials legislation and future EU Clinical Trials Regulation?
A: The EU Clinical Trial Regulation (Regulation 536/2014) has not been implemented yet. However, the HRA requirements are consistent with the current legislation for clinical trials of medicines in patients, they extend the requirements for other clinical trials and the simple deferral option maintains UK competitiveness. The proposals also prepare the early trial community for the requirements that will be in the new EU Regulation. Registration is an existing duty for the sponsors of research of all clinical trials, even where it falls short of being a legal requirement in European legislation or regulation.
2.6. Q: Has the HRA introduced an option for exemption or deferral of registration?
A: The HRA has introduced a simple mechanism to request deferral based on a justification of the need for delay in registration and assurances that the studies will be registered later. The HRA may consider requests for exemption from registration, but has set out that it does not expect to grant exemption although it does recognise the need for deferral to maintain UK competitiveness, particularly for early phase trials.
2.7. Q: How can a sponsor representative realistically declare that all trials have been registered when the responsibility for doing so may sit with others rather than the individual signing the REC declaration?
A: In line with many other equally important governance requirements, the HRA would expect the assurance to be based on policies, procedures and controls.
2.8. Q: If the sponsor cannot provide the assurance will it delay my application?
A: No, the sponsor can sign either to provide the assurance or by notifying through the deferral process that they cannot provide assurance and need to request deferral for previous studies in active recruitment. Sponsors and researchers should note the intention of the HRA to consult on administrative measures later in 2015 and that the new EU Clinical Trial Regulations will introduce sanctions for non-compliance with the Regulation's transparency provisions. There are no sanctions in place at this time and the compliance check will not affect new or existing REC approvals.
2.9. Q: Why is the HRA taking these steps now ahead of the new EU Clinical Trial Regulations?
A: Transparency sits at the heart of the HRA's duties to patients and the public, pragmatic solutions and promoting transparency is a specific duty for the HRA under the Care Act. Progress made now also prepares the UK for the forthcoming EU Clinical Trial Regulations and have enabled the UK to contribute to the discussions and debate on the transparency provisions from an informed position.
2.15. Q: How do sponsors of multiple clinical trials ensure they are complying with HRA requirements?
A: Assurances are expected to be based on sponsor policies and procedures and appropriate controls, as would be undertaken with any important governance requirements for an organisation.
2.16. Q: If a sponsor has registered all clinical trials since September 2013 will they have complied?
A: Since 1 April 2015 sponsors need to have complied with requirements in place since September 2013 and in addition will need to provide assurance for any research given a favourable ethics opinion prior to September 2013 and still in active recruitment, or to notify the HRA through the deferral mechanism if they are not able to provide that assurance.
2.17. Q: What does HRA consider is the acceptable timeframe for registration?
A: Unless a request to defer registration has been submitted and agreed by the HRA, the latest registration is expected to occur is 6 weeks after the recruitment of the first UK participant.
The HRA expects earlier registration and sponsors will be aware that some journals require registration ahead of the first participant being recruited. This is expected best practice.
2.18. Q: What happens if a Sponsor does not comply with registration requirements?
A: Registration is a condition of the REC favourable opinion for that trial, so if a Sponsor does not register the clinical trial or does not put in place a deferral of registration with the HRA then the trial will be in "serious breach". Where the HRA becomes aware that a clinical trial is in serious breach action will be taken in accordance with REC standard operating procedures.
2.19. Q: What sanctions are there for non-compliance?
A: There are currently no specific sanctions although the HRA will actively monitor and report on compliance. Failure to register could technically enable the REC to reconsider its ethical opinion in line with REC SOPs, the HRA does not expect the REC to take such action and is working with REC members, other stakeholders and with legal advice on a set of administrative measures for further consultation later in 2015. The new EU Clinical Trials Regulations will require Member States to have legal sanctions for non-compliance with transparency provisions of the Regulation.
2.21. Q: How do sponsors confirm to HRA that their clinical trial is registered?
A: If the sponsor has registered the trial before the application for ethical review is submitted then the details of registration should be included in the application form. Where registration occurs after submission of the initial application the sponsor does not need to tell the REC immediately but registration should be confirmed and details provided at the first opportunity (i.e. submission of substantial amendment or progress report, whichever is earlier).
2.22. Q: (May 2015) Why has the additional text been added to the sponsor declaration?
A: The further clarification is consistent with the information on IRAS that remains as updated on 1st April to extend the compliance checks to studies in active recruitment in the UK. The update, further distinguishes where the clauses on the declaration relate to important terms that are not at this time a consideration for the REC. These are the long established HRA transparency provisions to publish a research summary and registration of studies approved before September 2013 as part of the HRA statutory duties to promote transparency." [N.B. the significance of the bold italics is explained under paragraph 47 below]
- It may be seen that the paragraph 2.22 of the Q&As was added on 22nd May 2015, which was the date the sponsor's declaration came to be revised in the circumstances more fully explained below. Intriguingly, a paragraph 2.23 was put on the website on the date of the hearing (16th July 2015). I have noted its terms, but ultimately nothing turns on them.
- The Claim Form in these proceedings was filed on 19th March 2015, following pre-action correspondence in line with the protocol, and sought to challenge the new sponsor's declaration which was due to come into effect on 1st April. Five judicial review grounds were advanced. On 5th May 2015 HHJ Pelling QC granted permission on four out of the five grounds, but refused it on the third ground. He considered that it was arguable that the Defendant had made an application for approval for clinical trial A conditional on changing the terms under which trial B was being conducted. He did not consider that it was arguable that the new wording had made the grant of a favourable REC opinion conditional on the registration of previous clinical trials.
- The Defendant's position was that it had not intended, by the change of wording of the declaration, either to impose a retrospective condition or make the grant of favourable REC opinion conditional. However, it was intent on avoiding further debate on the issue and the cost of fully-blown judicial review proceedings. In those circumstances, the Defendant decided to change the wording of the sponsor's declaration with effect from 22nd May 2015, to read as follows:
"I confirm that:
6. The duties of the sponsors set out in the Research Governance Framework for Heath and Social Care will be undertaken in relation to this research.
7. The statutory responsibilities of sponsors set out in the Medicines for Human Use (Clinical Trials) Regulations 2004 will be undertaken in relation to this trial.
Please note: The declarations below do not form part of the application for approval above. They will not be considered by the REC.
9. Specifically, for submissions to the RECs, I declare that any and all clinical trials approved by the HRA since 30 September 2013
have been registered on a publically accessible register in compliance with the HRA registration requirements for the UK, or that any deferral granted by the HRA still applies."
- Thus, it may readily be seen that paragraph 9 of the sponsor's declaration has been materially amended in two respects: first, the clause "and those given a favourable opinion prior to this date and currently in active recruitment in the UK" has been removed; secondly, the clause "or that any deferral granted by the HRA still applies" has been inserted. Furthermore, the italicised sentences under paragraph 7 are new.
- Otherwise, the HRA did not change the webpage revealed by pressing the information button (see paragraph 15 above), or any of the website wording (see paragraphs 16 and 17 above), save to the minor extent identified under paragraph 18 above.
- On my understanding, the Claimant does not take issue with the revised wording of the sponsor's declaration as such, but does with some of the information which continues to be disseminated by the HRA through its website. Following Holgate's Order on 30th June 2015, the Claimant indicated that it was no longer pursuing its five original grounds, but filed an amended ground 6, which reads as follows:
"Further or alternatively, the HRA have acted unlawfully and are continuing to act unlawfully by:
(a) asserting that sponsors and those conducting clinical trials are under a legal duty to register their trials on a publicly accessible website and/or to publish data about the outcome of the trial where no enforceable commitment has been given to trial publication and publication has not been included as a condition of a REC favourable opinion; and
(b) regulating or seeking to regulate sponsors and those conducting clinical trials against this supposed legal duty."
- On 30th June 2015 Holgate J gave the Claimant leave to file and serve the Amended Statement of Facts and Grounds by adding ground 6, and directed that the issue of whether permission should be granted to apply for judicial review under ground 6 be adjourned to the rolled-up hearing before me. He made further directions in the judicial review, including a direction that Sense about Science be permitted to intervene by written submissions only.
The Legal Framework
- Section 110 of the Care Act 2014 provides, insofar as is material:
"The HRA's Functions
(1) The main functions of the HRA are
a) functions relating to co-ordination and standardisation of practice relation to the regulation of health and social care research;
b) functions relating to research ethics committees.
(2) The main objective of the HRA in exercising its functions is
a) to protect participants and potential participants in health and social care research and the general public by encouraging research that is safe and ethical, and
b) to promote the interests of those participants and potential participants and the general public by facilitating the conduct of research that is safe and ethical (including by promoting transparency in research).
(6) A reference to research that is ethical is a reference to research that conforms to generally accepted ethical standards.
(7) Promoting transparency in research includes promoting
a) the registration of research;
b) the publication and dissemination of research findings and conclusions;
c) the provision of access to data on which research findings or conclusions are based;
- Section 111, sub-sections (5) and (6) of the Care Act 2014 provide:
"(5) The HRA must
(a) keep under review matters relating to the ethics of health and social care research and matters relating to the regulation of such research;
(6) The HRA must publish guidance on
(a) principles of good practice in the management and conduct of health and social care research;
(b) requirements, whether imposed by enactments or otherwise, to which persons conducting health or social care research are subject."
- The Clinical Trial Regulations, as amended by the Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006 No. 1928), were intended to give domestic effect to the Clinical Trials Directive (2001/20/EC) and (as regards the amended Regulations, the Good Practice Directive 2005/28/EC).
- The second preamble to the Clinical Trials Directive provides:
"The accepted basis for the conduct of clinical trials in humans is founded in the protection of human rights and the dignity of the human being with regard to the application of biology and medicine, as for instance reflected in the 1996 version of the Helsinki declaration.
- The Helsinki declaration is not mentioned in the main declaratory provisions of the Directive. However, it does feature in Section 1 of Chapter 2 to Commission Directive 2005/28/EC, which provides:
"Good Clinical Practice
1. The rights, safety and well being of the trial subjects shall prevail over the interests of society.
2. Each individual involved in conducting a trial shall be qualified by education, training and experience to perform his tasks.
3. Clinical trials shall be scientifically sound and guided by ethical principles in all their aspects.
4. The necessary procedures to secure the quality of every aspect of the trials shall be complied with.
The available non-clinical and clinical information on an investigational medicinal product shall be adequate to support the proposed clinical trial.
Clinical trials shall be conducted in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the General Assembly of the World Medical Association (1996)."
- By regulation 12 of the Clinical Trials Regulations, a clinical trial, which includes a phase 1 trial, may not be started without a favourable opinion from an REC and authorisation by the licensing authority (the Medicines and Healthcare Products Regulatory Agency). By regulation 15(3A), an REC is empowered to impose conditions on its favourable opinion, and by regulation 15(3B) an REC is to be treated as having given a favourable opinion in relation to that trial only if the conditions are met.
- By regulations 28 and 29 of the Clinical Trials Regulations, no person shall conduct a clinical trial otherwise than in accordance with (i) the conditions and principles of "good clinical practice", and (ii) the terms of the application for an REC opinion, including any conditions the REC may impose. A breach of these regulations is a criminal offence.
- By regulation 29A of the Clinical Trials Regulations, the sponsor of a clinical trial is required to notify the licensing authority of any serious breach of the conditions and principles of "good clinical practice" in connection with the trial.
- The conditions and principles of "good clinical practice" are specified in Part 2 of Schedule 1 to the Clinical Trials Regulations. Insofar as is material to these proceedings, the conditions and principles in play are those said to be derived from the Clinical Trials Directive, and include the following:
"1. The rights, safety and well-being of the trial subjects shall prevail over the interests of science and society.
2. Each individual involved in conducting a trial shall be qualified by education, training and experience to perform his tasks.
3. Clinical trials shall be scientifically sound and guided by ethical principles in all respects.
4. The necessary procedures to secure the quality of every aspect of the trial shall be complied with.
5. The available non-clinical and clinical information on an investigational medicinal product shall be adequate to support the proposed clinical trial.
6. Clinical trials shall be conducted in accordance with the principles of the Declaration of Helsinki. [NB. the original wording of the 2004 Regulations provided "Clinical trials shall be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with good clinical practice and the requirements of these Regulations."]"
- In paragraph 2 of Part 1 of Schedule 1 of the 2004 Regulations, "Declaration of Helsinki" is defined for the purposes of the Schedule as:
"the Declaration of Helsinki adopted by the World Medical Assembly in June 1964, as amended by the General Assembly of the Association in October 1975, October 1983, September 1989 and October 1996."
The Declaration of Helsinki was subsequently amended in 2000, 2008 and 2013, with certain "clarifications" to articles 28 and 29 (not relevant for our purposes) being made in 2002 and 2004. The 2013 version of the Declaration, adopted in Fortaleza, Brazil, included the following:
"35. Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.
36. Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of their research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available.
This wording did not appear in the 1996 version. The wording of paragraph 35 appeared for the first time in the 2008 version (under paragraph 19). The wording of paragraph 36 also appeared in the 2008 version (under paragraph 30) but the word "researchers" was missing.
- Mr Price for Sense about Science drew my attention to other directory and regulatory provisions which I have in mind, but which it is unnecessary for me to set out.
- A considerable body of evidence has been filed by the parties: two witness statements of Dr Ulrike Lorch (for the Claimant); three witness statements of Dr Janet Wisely (for the Defendant); and a witness statement of Dr Mark Edwards (for the Defendant). Virtually all of this evidence is not strictly relevant to the narrow issues I have to decide, and some of it is somewhat partisan in tone.
- It is Dr Lorch's basic contention that phase 1 trials are more heavily regulated in the UK than elsewhere, and that this distortion of the playing field has led to a diminution in competitiveness and, consequently, in business. She asserts that the HRA's published material is very closely scrutinised, parsed and considered by sponsors deciding on whether to use companies such as the Claimant, rather than go elsewhere. To my mind, paragraph 40 of her second witness statement is particularly important:
"40. The HRA are the sector regulator for the clinical research community in the UK. It is thus vital that they are clear in their statements about what companies engaged in this field are required to do as a matter of law and what practices the HRA recommend the clinical research community to follow but which are not legal requirements. There is, I regret, a marked lack of transparency by the HRA in identifying the difference between "rules" and "recommendations of good practice". Understanding the difference between mandatory rules and recommendations of good practice is vitally important for the clinical research community. We are obliged to follow rules in every case, regardless as to whether we agree with the rule or not. However, if something is regarded by the HRA as being "good practice" there can be sound reasons in an individual case why it should not be followed for a particular piece of clinical research. Statements of general good practice in one area may well not be appropriate in a particular case or even be wholly inappropriate. We need to be able to tell whether we can make a case to justify a departure from a recommended form of good practice or have to comply with a rule, regardless as to how inappropriate it appears in an individual case."
- In paragraphs 6-8 of her third witness statement, Dr Wisely says:
"6. The HRA does not assert that there is a legal duty to register a trial where there is neither a specific REC condition of registration or an express promise of registration in the REC application. This has already been explained to the Claimant, most recently in the HRA's response to the application to amend (see paragraphs 57-60), and a letter from the HRA's solicitors to the Claimant's solicitors.
7. I do not discuss the nature of the duties on those sponsoring or conducting trials where a condition of registration is in place as part of the REC's favourable ethical opinion, as the Claimant does not take issue with our action in relation to these trials: see paragraph 7 of Mr Wright's witness statement.
8. However, the HRA does assert that sponsors and all those involved in research with human participants (consistent with wording in the [RGF]) have other responsibilities and standards to ensure that trials are registered. It is over-simplistic and inaccurate to argue, as the Claimant does, that the only obligations on researchers are to comply with legal requirements, with respect to registration or even more broadly."
- Dr Wisely then draws my attention to the position of the WHO, the wording of the RGF, and to the Declaration of Helsinki which "in turn requires the registration of trials" (see paragraph 20). This Delphic reference to the Declaration of Helsinki tends (at least to my eyes) to suggest that it is the HRA's view that the registration of trials forms part of "good clinical practice" within the meaning of the Clinical Trials Regulations, an impression fortified by one reading of paragraph 18 of the skeleton argument of Mr Parishil Patel (but cf. his footnote 7 and his oral argument, which did not go that far). As Dr Wisely well knows, the Declaration of Helsinki (1996 edition) did not require the registration of clinical trials.
- Although paragraph 6 of her third witness statement contains the first express refutation of any legal duty to register, I agree with Mr Patel that in previous witness statements and pre-action correspondence it had never been asserted in terms that there was such a duty.
- Finally, I should draw attention to paragraphs 6 and 8 of the witness statement of Dr Mark Edwards:
"6. However, it appears to me that the Claimant is suggesting that sponsors and others conducting clinical trials are only obliged to register those trials, or are only subject to regulation or to an obligation to describe or explain their actions where there are relevant legal requirements. While I do not comment on the legal merit of these allegations, what I would say is that there can be many requirements for a clinical trial to be registered. These requirements are not limited to legal duties. In fact, sponsors and those conducting clinical trials have other responsibilities to register a clinical trial, such as ethical and moral responsibilities, standards, and good practice.
8. Furthermore, in case it is not obvious to the court, I should explain the importance of trial registration. Put simply, without it, the research and medical community cannot be sure it has the full picture on the benefits and dangers of any drug. Suppose ten unregistered trials are conducted on a drug. Seven demonstrate positive results, and are published in the literature. Three demonstrate no real benefits, and are not published, or are abandoned early.
Unless there is a way to establish at the least that ten trials were initiated, a doctor reviewing the literature will be misled by seeing only the ten positive trials into believing that the drug is more universally beneficial than is the case
I do not lose sight of the point that phase 1 trials are not designed to assess efficacy.
The Claimant's Case
- The gravamen of the Claimant's case is that the Defendant is continuing to assert that sponsors are required (i.e. are under a legal duty) to provide an assurance to the Defendant that research given a favourable ethical opinion before 30 September 2013 and still in active recruitment has been registered on publicly accessible databases, or to have notified the Defendant through the deferral mechanism if they are unable to give that assurance.
- It is common ground that sponsors are under a legal duty to register their trials on a publicly accessible database where this has been expressly promised in an application to a REC, or made a specific condition of REC approval. As I have said, this obligation arises under regulation 15(3A) of the Clinical Trials Regulations.
- Mr Lock accepts that the Defendant is empowered to publish statements of guidance under section 111(6)(a) of the Care Act 2014 as to principles of good practice in the manner and conduct of clinical trials, and that such guidance may include recommendations in relation to registration and publication. Although the Defendant is separately empowered to publish guidance as to the requirements to which persons conducting clinical trials are subject (see s.111(6)(b)), it cannot permit the one to be masqueraded as the other. Thus, so the Claimant's submission runs, to present "principles of good practice" as if they were "requirements" is unlawful. "Requirements" are obligations imposed by force of law (e.g. the obligation to register and publish in relation to post-30th September 2013 approvals); they are normatively distinct from the weaker sort of obligation which flows from the application of generally accepted ethical standards.
- Mr Lock submits that it is quite clear that, by introducing the revised sponsor's declaration on or about 1st April 2015, the Defendant was intending to and did introduce a retroactive condition: see the language of the "Next Steps" paper (paragraph 13 above); the language of the webpage brought up by pressing the information button (see paragraph 15 above), in particular, the rubric "HRA Requirement to Register Clinical Trials as a Condition of REC Favourable Opinion"; and the text of the sponsor's declaration itself. This is an important stepping-stone in the Claimant's case, because Mr Lock submits that the position was not adequately corrected on and after 22nd May.
- Mr Lock does not challenge the new sponsor's declaration viewed in isolation, but he does seek to assail the webpage (paragraph 15 above in particular, the rubric and the words "existing responsibility" in the third paragraph of the webpage) and various parts of the key messages and Q&A document.
- Although in oral argument, possibly under considerably pressure from me, Mr Lock identified only paragraphs 2.16 and 2.19 of the Q&A document as being unlawful, upon re-reading his skeleton argument I can see that he had gone further. Accordingly, the passages I have highlighted in bold italics represent in my view those which the Claimant says go too far. In short, they cross the line because they indicate that sponsors are required (i.e. legally obliged) to register phase 1 trials whereas the limit of the Defendant's powers was to provide condign encouragement in the context of an ethical obligation.
- In his reply, but consistently with his written argument (albeit not expressly flagged up in his Amended Ground 6), Mr Lock emphasised an alternative submission which was that if, contrary to his primary submission, the Q&A document in particular was not suggesting that there was a legal duty, the Defendant's public utterances are ambiguous and thereby offend the principle of legality, and its well-established incidents, the principles of certainty and transparency: see R(Limbu) v SSHD  EWHC 2261 (Admin) (paragraphs 61-72), R(Lumba) v SSHD  1 AC 245 (paragraphs 34-35, per Lord Dyson JSC) and R(Oboh) v SSHD  EWCA Civ 514 (paragraphs 28-31, per Richards LJ).
- Finally, Mr Lock submitted that the deferral mechanism did not provide a sufficient answer to his client's complaint, for three reasons. First, by making a deferral application, the sponsor is giving a commitment to publish in due course under a legal requirement to do so. Secondly, the deferral mechanism passes control from the holder of confidential information to the Defendant, with no guidance being given as to its exercise. Thirdly, this procedure passes control of the timing of dissemination of confidential information to the Defendant.
The Case of the Interested Party
- In a clear and impressive written submission, Mr Price on behalf of the Interested Party observes that this case is in danger of evaporating into a disappointing semantic wrangle over the nuanced meaning of various passages in websites. However these passages are to be construed, the Interested Party is concerned that the Defendant is taking a stance which is juridically incorrect. The right analysis is that there is a legal requirement arising under EU and domestic law to register and publish the results of phase 1 trials. In particular, the second preamble to Directive 2001/20/EU uses the phrase "as for instance reflected" in the context of the Declaration of Helsinki; the original version of Part 2 of Schedule 1 to the Clinical Trials Regulations refers to "ethical principles that have their origin in the Declaration of Helsinki"; and Article 2(3) of the Good Practice Directive (Commission Directive 2005/28/EC) refers to "ethical principles" which must be a concept broader than that embraced within the Declaration of Helsinki (1996 edition) mentioned in Article 3.
The Case for the Defendant
- The point of departure for the able submissions of Mr Patel for the Defendant was that since 2008, if not before, registration and publication of phase 1 trial information has been a "generally accepted ethical standard" within the research community for the purposes of section 110(6) of the Care Act 2014. Mr Patel relies on the 2008 version of the Helsinki Declaration which he submitted was not materially revised in 2013.
- Mr Patel further submitted that the Defendant's remit goes beyond legal requirements stricto sensu and also covers ethical standards and responsibilities. The promotion of registration and transparency is one of the Defendant's express functions under section 111 of the Care Act 2014. This provision neatly dovetails with section 110(6).
- By April 2015 the Defendant's remit in this regard could be described as: (i) ensuring that those carrying out and sponsoring research met their legal obligations, and (ii) investigating whether those carrying out and sponsoring research were doing so in accordance with current best practice and/or in line with their ethical obligations. Accordingly, the Defendant could properly inquire of sponsors whether they were meeting their best practice obligations, and could expect an answer.
- Although he recognised that the Interested Party's submission was arguable, Mr Patel did not feel able to embrace it. The relevant domestic legislation had tethered "good clinical practice" to the 1996 iteration of the Declaration of Helsinki, and not to any subsequent versions.
- In his oral argument, Mr Patel did not seek to persuade me that the 1st April wording of the sponsor's declaration was defensible, although he did not concede that the Claimant's case was well-founded. The issue, he said, had become academic.
- His core submission was that the Defendant's published documents, read as a whole in the context of their intended readership, did not assert that there was a legal duty to register and publish the results of phase 1 trials. Paragraph 2.16 of the Q&A document drew a clear distinction between the Defendant's requirements (in connection with which strict legal obligations did arise see, for example, section 111(6)(b) of the 2014 Act) and other matters (in connection with which ethical or good practice obligations arise see, for example, sections 110(6) and 111(6)(a) of the 2014 Act). Not merely had the Defendant fallen short of expressly asserting the existence of the postulated legal duty, it could not reasonably be inferred that the Defendant was somehow saying that such a duty existed. Put another way, but to the same effect, the Defendant has made it sufficiently clear to its readership what the nature of the obligation is.
Discussion and conclusions
- The Claimant's Amended Ground 6 is arguable and I grant permission upon it.
- I confess that I have changed my mind about this case during the course of my extensive post-hearing deliberations.
- My starting-point is that the Defendant's readership is knowledgeable and sophisticated, and may reasonably be expected to have recourse to legal advice. Furthermore, the Defendant's internet materials need to be read in context and of a piece. It is not right to cherry-pick a narrow pathway through these documents and to seek to construe them as if they were statutes. On the other hand, the informed reader is entitled to a reasonably clear set of explanations which are free from internal contradiction and ambiguity.
- It is convenient at this stage to address the Interested Party's submission that sponsors are under a legal obligation to register and publish the results of all phase 1 trials, whether it be a duty arising under EU law or subordinate legislation.
- Mr Price's duty could only arise under domestic legislation if either the reference to the "Declaration of Helsinki" in the Clinical Trials Regulations 2004, as amended, must be deemed to include a reference to the 2008 and/or 2013 version of that Declaration, or the "ethical principles" in paragraph 3 of Part 2 of Schedule 1 to these Regulations must be deemed to include these declaratory requirements or the principles vouched in other international instruments.
- Mr Price's duty could only arise under EU law on the basis of a super-teleological approach which would hold that the "Declaration of Helsinki" means "whatever the current version of that Declaration happens to be", and Article 2(3) of the Good Clinical Practice Directive has an extremely broad meaning.
- Although initially attracted by Mr Price's arguments, I cannot accept them. Given that a breach of the requirements of good clinical practice attracts criminal sanctions, sponsors and researchers are entitled to clarity and precision as to what exactly is entailed. The Clinical Trials Regulations, both as originally drafted and as amended, clearly refer to the 1996 version of the Declaration of Helsinki and to none other. Mr Lock told me that subsequent versions are viewed in the pharmacological community as "controversial", but I have seen no proper evidence of that. In any event, Schedule 1 to the 2006 version of the Clinical Trials Regulations matches word for word the language of the Good Practice Directive, enacted in 2005, and that refers in terms to the 1996 iteration of the Declaration. In my judgment, there is no basis for holding that subsequent versions of the Declaration of Helsinki may be brought into account. Further, I do not accept that the general and imprecise reference to "ethical principles in all respects" (see paragraph 3 of Part 2 to Schedule 1) enables me to say that sponsors and researchers are somehow bound by a specific obligation to register and publish: the fact that the matter is not catered for in the 1996 version of the Declaration is a factor which points strongly the other way. To my mind, the "ethical principles" being referred to in paragraph 3 must be those principles which are so clearly established that they may be regarded as having close to universal concurrence.
- The position is, on analysis, no different under EU law, particularly given the terms of Article 3 of the Good Practice Directive. Furthermore, even if the UK has incorrectly transposed EU Directives into subordinate legislation, that would not convert something which is not good clinical practice within the terms of domestic law into something which is.
- Accordingly, it follows that registration and publication is not a legal requirement in relation to pre-September 2013 approvals, because (i) such were not promised or made a condition of such approvals, and there is no power under the Clinical Trials Regulations to amend conditions or impose them retroactively, and (ii) such are not part of good clinical practice within the meaning of Regulation 28 and Schedule 1.
- The amended sponsor's declaration, dated 1st April 2015, did not say in terms that there was a legal requirement to register and publish the result of phase 1 trials approved before 30th September 2013. Indeed, some of the wording of the webpage under the information button (see paragraph 15 above) is arguably to the contrary effect ("please note this process will not affect the decision on the current application at this time, although sponsors should be aware that measures to support compliance may be introduced in due course"). However, I accept Mr Lock's submission that this is entirely to ignore the practical realities. A sponsor was required to sign the declaration in this form in order to make the application in question. Unless the sponsor could warrant that pre-September 2013 approvals had been registered etc., the form could not properly be signed. Thus, in my judgment the effect of the amended sponsor's declaration (whether it was intended or not) was to make the current application contingent on the pre-September 2013 application having been registered. In such circumstances, the Defendant was correct to withdraw the amended sponsor's declaration in May.
- The revisions introduced on 22nd May cured the specific problem which arose out of the sponsor's declaration. In my view, the critical revisions were the removal of the clause, "and those given a favourable opinion prior to that date and currently in active recruitment in the UK", and the addition - for the avoidance of doubt - of the italicised sentences after paragraph 7. It follows that the de facto condition, created by the linking of the new application to the old in the language of the April 2015 version of declaration 9, has disappeared. The addition of the clause regarding deferrals (pace HHJ Pelling QC) is not the key point. If the sole amendment had related to deferrals, the declaratory wording would still have been objectionable.
- The key questions which arise in relation to the post-May regime are the juridical status and content of the sponsor's obligations in relation to pre-September 2013 approvals, and whether that status and content have been clearly, fairly and accurately communicated to informed readers.
- Two significant matters need to be underscored at this juncture. First, the Defendant has never clearly accepted that the April 2015 amendments to the sponsor's declaration were unlawful. Instead, it has sought to finesse the issue by withdrawing the amendments and, through Dr Wisely, contending solely that it wishes to avoid legal cost and expenditure of management time. However, without specifically recognising the nature of the problem which existed, the Defendant has left an element of uncertainty. Secondly, it has perpetuated the possible dubiety by failing fully to explain the revisions it has made and the reasons for them, and by leaving virtually the entirety of its website materials unchanged. In my judgment, the Defendant has pursued a strategy which concedes as little as possible in the judicial review, with the aim no doubt of enhancing its position on costs and (possibly) avoiding potential embarrassment.
- In my judgment, the difference between legal and ethical obligations in this specific context is as follows. A legal obligation flows from the imposition of a specific requirement of the Clinical Trials Regulations (see Regulation 28), a breach of which carries with it certain consequences, including an obligation to notify (see Regulation 29A) and criminal sanctions (see Regulation 49). As I have already pointed out, the conditions and principles of good clinical practice fall within this rubric.
- An ethical obligation (in this context, being an obligation falling short of amounting to good clinical practice) flows from the application of standards which have national or international backing, including standards which are imposed by the regulator. Furthermore, the regulator would be entitled to set out the consequences of breach of an ethical obligation, although in the present context it has not done so. It is trite law that the entity being regulated is entitled to a clear statement of what those consequences may be.
- The vice of muddying the metaphorical waters, and failing to keep these normative streams clear and separate, is that the entity being regulated will not know exactly where it stands in relation to the consequences of any breach.
- I agree with Mr Patel that nowhere has the Defendant stated in unequivocal terms that sponsors are under legal duties to register and publish phase 1 trials. Furthermore, there are passages in the "Key messages and Q&A" document which are more consistent with there being no such legal duty: see, in particular, the reference to "ethical requirement" in paragraph 1.4; the language of paragraph 1.5 ("
where there is not currently a legal requirement"); and, paragraph 2.5 (but see further below). In my view, these passages, read either individually or cumulatively, lend support for the proposition that the Defendant views registration and publication as an ethical or good practice obligation, rather than one which sounds in the strict legal sanctions set out in the Clinical Trials Regulations.
- Moreover, although Mr Lock dedicated a number of submissions to a criticism of paragraphs 2.18 and 2.19 of the Q&A document, in my view they do not bring home his case. Paragraph 2.18 is dealing only with the situation where there is a requirement to register: see the reference to "registration requirements", and the use of the term, "condition". Indeed, it is possible to go further: the fact that paragraph 2.18 does not mention the consequences of failing to provide an assurance for any research given a favourable ethics opinion before September 2013, or of failing to apply for a deferral, rather suggests that the condition cases are envisaged as falling into a different category. Paragraph 2.19 is less happily worded because (i) the first and second sentence have the appearance of cutting across the second sentence of paragraph 2.18, (ii) the second sentence could in any event make it clearer that it applies only to registration requirement cases, and (iii) the final sentence is somewhat anomalous in this specific context because it applies only to the pre-September 2013 cases. However, in my judgment these textual infelicities are not serious enough to justify judicial action.
- There are other aspects of the Defendant's published materials which cannot be so indulgently regarded.
- Turning first of all to the webpage under the information button (see paragraph 15 above), I have already noted that it was not revised on 22nd May 2015. In the seven weeks before then, the Defendant was asserting that there was an "existing responsibility" in relation to all trials in active recruitment, including those approved before September 2013. Thus, not merely is the nature and content of this "responsibility" represented to be the same across the board, the Defendant's relevant compliance checks were being made in the same way, namely through the sponsor's declaration. The legal and the ethical are indistinguishable, the ameliorating measures are the same in both cases (viz. the need to arrange for a deferral), as are the consequences vis-ΰ-vis the current application (viz. none).
- How should this webpage be interpreted post-22nd May? The webpage appears to be entirely oblivious to the revisions which were made on that date; it predicates that the sole material event occurred on 1st April. As from 22nd May, sponsors were no longer being asked on the declaration form to confirm that they had registered pre-September 2013 trials still in active recruitment. However, it is clear from the "Key messages" document that sponsors were being told that they needed to provide an assurance to that effect, or apply for a deferral. Anyone reading the third paragraph of the webpage would be forgiven for thinking that this was an "existing responsibility" which was tantamount to a "requirement". The determiner "this" (before "existing responsibility") must refer back to "requirement", thereby importing a legal duty. Nowhere is the mechanism for giving this assurance specified. I cannot read "existing responsibility" as meaning "ethical obligation", because the whole context of the webpage is "HRA Requirement" (see the heading). In my judgment, this is defective, confusing wording which falls well short of the certainty and transparency obligations which are incidental to the rule of law. Nor is the matter notionally saved, from the Defendant's perspective, by reference to later sentences in the third paragraph, or to the fourth paragraph.
- Turning now to the basic website information (see paragraph 16), the same fundamental criticisms may be made of the paragraph immediately after the heading, "Clinical trial registration". Again, this paragraph is sublimely indifferent to the May revisions. In my judgment, it is misleading to state that the mechanism of compliance is through the sponsor's declaration when that is no longer the case. Elsewhere, sponsors are expected to give assurances in relation to pre-September 2013 approvals, but they would be forgiven for thinking that this was a "requirement" which somehow fell within the text of this paragraph. That impression is confirmed by the reference in that paragraph to deferrals, which the Defendant has made clear applies to pre-September 2013 approvals. In my judgment, the paragraph currently under scrutiny is very difficult to harmonise with paragraph 1.5 of the "Key messages" document.
- Exactly the same criticisms fall to be made of the first bold italicised passage in the "Key messages" document (see paragraph 17 above), as well as paragraph 1.6. Mr Lock did not expressly impugn paragraph 1.7 but in my view it is far from satisfactory. On the natural and ordinary meaning of this paragraph, the "registration requirements" within contemplation are said to apply to all cases without differentiation, including those where there is, apparently, no legal requirement. On the other hand, I can just about accept that paragraph 1.7 comes so soon after paragraph 1.5 that it may be read in the light of it.
- Reading these in isolation, I have no difficulty with paragraphs 1.4 and 1.5. Indeed, as I have already observed, they provide some support for Mr Patel's submissions. Paragraph 1.4 recognises the difference between specific ethical and legal requirements (as does paragraph 1.4), although after 1st April and before 22nd May these came close to being co-extensive. The second sentence of paragraph 1.4 is somewhat (albeit not fatally) confusing in that it refers to requests for deferral in the context of the legal requirement (there cannot be "a breach of the favourable ethical opinion" in any other context), whereas paragraph 1.5 indicates that the deferral option is for the non-legal requirement cases.
- Paragraph 1.5 may also be read in conjunction with paragraph 2.5, much of which in my view is helpful to the Defendant's case. However, the reference to "the HRA requirements" in the second sentence is singularly unhelpful, because this noun phrase should in my view be reserved for strict legal obligations.
- Paragraphs 1.8, 1.9, 2.8 and 2.15 refer to sponsor "assurances" without making it entirely clear what these are, and how they are to be furnished. Between 1st April and 22nd May these assurances were given through the sponsor's declaration, but subsequently the Defendant has presumably been expecting sponsors to provide them separately. In my view, it would have been far preferable, and more transparent, for the Defendant to have spelled out the expectation in precise and clear website wording. Even so, I am not driven to conclude that the wording of these paragraphs is so unsatisfactory that judicial intervention is required.
- The same point falls to be made in relation to paragraph 2.16. This formed the centre-piece of Mr Lock's submissions, but it does not of my analysis. The wording of paragraph 2.16 is far from being pellucidly clear, but in my judgment it is not being asserted that there is a legal requirement to provide the "assurance" in relation to the pre-September 2013 cases, notwithstanding the double deployment of the verb "need".
- In my judgment, paragraph 2.22 is somewhat mealy-mouthed, but no judicial review point arises from that fact alone.
- The question arises whether the combined effect of paragraphs 1.8 to 2.22 of the "Key messages" document negatives or cancels-out the misleading, confusing and unclear purport of the passages I have highlighted. In my judgment, it does not, for at least three reasons. First, there are too many passages which are defective. Secondly, the informed reader is entitled to reach the end of these public documents without being left in a state of confusion and dubiety. Thirdly, during the course of this judgment I have identified certain passages which are not so unclear or confusing that their revision is in my view mandated, but which are far from ideal. In my judgment, this is a factor which weighs in the balance against the Defendant. In any event, given the specific faults I have identified, I would now expect the Defendant as a responsible public body to cast a self-critical eye over the whole of its website material in this domain.
- I should make explicit the legal criteria I have been applying, and the basis for my decision having applied those criteria. I am not holding that the Defendant has expressly stated that there is a legal obligation in relation to the pre-September 2013 approvals, or that this is clearly to be inferred from what the Defendant has said. I am holding that the Defendant's public utterances fail the public law test of certainty and transparency as explained in the jurisprudence mentioned under paragraph 48 above. Specifically, I am content to hold that these are (to the extent I have specified) "so ambiguous as to the expression of its scope as to mislead" the informed reader (see Blake J in Limbu, paragraph 69). I question whether the test is or ought be quite that stringent, but it is unnecessary for me to decide that point.
- I invite submissions from Counsel as to the appropriate form of any relief.
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