Lewis v Secretary of State for Health & Anor

The broad issue raised by this application is whether certain documents relating to deceased patients, including their medical records, should be disclosed to a confidential Inquiry co-sponsored by The Secretary of State for Business, Enterprise and Regulatory Reform and The Secretary of State for Health and, if so, upon what terms.

The Claimant is a medical practitioner to whom a request for disclosure of documents and records has been made on behalf of The Inquiry. He is prepared and willing to accede to the request, but is concerned that to do so might breach his own duty of confidentiality to the patients concerned and that of the doctors and medical personnel they consulted when alive. He seeks the authority of the court to disclose the material requested.

The application is uncontested. Indeed, not surprisingly, it is actively supported on behalf of The Inquiry (as I shall continue to call it). However, it is plain that no court can simply give permission to proceed as desired by the parties before it in such a case unless satisfied that the course proposed is lawful and, even if lawful, that proper safeguards as to confidentiality are in place if disclosure is permitted.

In the early part of 2007 it emerged that some individuals who had worked in the nuclear industry at Sellafield in Cumbria and who had died between November 1962 and August 1991 had had tissues removed for analysis. The analysis was to determine the presence, if any, of a radionuclide content of the organs. Initially, 65 cases in which tissues had been taken in this way were identified. The circumstances in which these events occurred, including whether the next-of-kin of those affected knew or were asked for their consent, has appeared uncertain. Accordingly, in a statement to the House of Commons on 18 April 2007 the then Secretary of State for Trade and Industry said that he had asked Mr Michael Redfern QC, who had conducted the ‘Royal Liverpool Children’s Inquiry at Alder Hey’, to carry out an independent investigation with a view to finding out what happened and why.

It emerged later that tissue had been taken from those who had worked at other nuclear installations including Harwell, Dounreay and the Atomic Weapons Establishment (AWE) at Aldermaston, formerly known as the Atomic Weapons Research Establishment (AWRE).

The scope of the Inquiry was enlarged to cover these matters, the Inquiry itself became co-sponsored, as previously indicated, and its terms of reference finalised in February 2008 as follows:

“(a)

Having regard to the provisions of the Human Tissues Act 1961, the Coroners’ Rules 1984, the Coroners’ Act 1988 and predecessor legislation, to enquire into the circumstances in which, from 1955, organs/tissue were removed from individuals at NHS or other facilities, and sent to and analysed at nuclear laboratory facilities.

(b)

In particular, to establish so far as practicable;

(i)

when, where by whom and by what means the taking of organs/tissue was requested and authorised;

(ii)

whether the taking of organs/tissue was based on informed consent by the family and/or surviving relatives;

(iii)

the purpose to be achieved by the retention and analysis of the organs/tissue removed; the generic results of analysis; and the identity of all publications in which the results were presented and commented upon;

(iv)

whether the families or surviving relatives were informed of the results of the analysis, or the identity of the relevant publications;

(v)

when, where and by whom the retention, storage, transportation, analysis, reporting and disposal of the organs/tissue was authorised;

(vi)

the circumstances in which the organs/tissue were retained, store, transported, analysed, reported upon and disposed;

(vii)

the general purpose to be served by such retention, storage, analysis and publication of results;

(viii)

when this activity ceased, and the circumstances in which it ceased.

(c)

To consider such other issues in connection with the above matters as the Secretary of State may direct.

(d)

To report to the Secretary of State as soon as possible.

(e)

To make recommendations.”

The Inquiry has come to be known as ‘The Redfern Inquiry into human tissue analysis in UK nuclear facilities’. As I have already indicated, I shall refer to it throughout as The Inquiry. The procedures for The Inquiry have been promulgated. The then Secretary of State for Trade and Industry determined that it is to be “confidential and its process inquisitorial.” It will conduct its investigations in private. It has not been set up under the Inquiries Act 2005 and, accordingly, has no statutory power to order disclosure of documents or to compel any person to provide it with documents.

The Claimant, Dr Nicholas Lewis, is a medical practitioner who specialises as an occupational health physician. He is a director and shareholder in the company that now provides occupational health services to those who work at AWE Aldermaston. Those services include annual health assessments of radiation workers and emergency medical response to staff exposed to ionising radiation. The present services are provided by two other medically qualified personnel in addition to Dr Lewis and other staff, including nursing staff.

The Claimant is also the custodian of the occupational health records of about 30,000 former employees at AWE Aldermaston, many of whom are now dead, those records being stored on the AWE site. Those records may include a copy of the death certificate, correspondence with the Coroner in certain cases and also occupational health records made by Dr Lewis, his colleagues and their predecessors. The records may record information about medical issues that were not work-related that might have been relevant to the particular consultation.

The Claimant is of the view, about which there is no dispute, that those receiving the information and who were responsible for compiling the records would be bound by the usual obligation of confidence owed by a doctor to a patient.

Mr Alex Leslie, a partner in the firm of Radcliffes Le Brasseur, who the Claimant consulted, had been in correspondence with the solicitor to The Inquiry, Mr Stephen Jones, a partner with Pannone LLP, from January this year onwards about the assistance being sought. Following a request by Mr Leslie to him in a letter dated 23 May, Mr Jones in a letter to the Claimant dated 28 May made a formal request for disclosure by him of “occupational health, medical, health physics, dosimetry and personal radiation records” in relation (a) to certain named deceased former employees of AWE, (b) certain “test veterans” if those records were within his possession, custody or control and (c) certain other former employees of AWE in respect of whose cases it was not possible to provide a great deal of detail, but whose names were given.

It is plain that records of this nature will assist The Inquiry. It is equally plain, and common ground between the parties before me, that the information contained in these records is “confidential patient information” within the meaning of s.251 (10) and (11) of the National Health Service Act 2006. I will return to the significance of that below.

As I have said, the Claimant is prepared to afford disclosure of such of the documents as are in the possession, custody or control of AWE if the court is prepared to sanction such disclosure. I have been told that documents in relation to categories (a) and (c) under paragraph 11 exist, but not category (b).

As I have indicated, subject to my being satisfied as to the legality of what is proposed, both parties invite me to authorise the disclosure sought. To that extent, there is no general issue between them. However, there is an issue about the legal foundation for any such authorisation. The Inquiry, through Mr Roussak, argues that sufficient authority has already been given by virtue of the approval of the Secretary of State given on 30 May this year to a recommendation of the Patient Information Advisory Group to the effect that “confidential patient information” of the kind involved should be made available to The Inquiry. Disclosure via this route would be made under the Health Service (Control of Patient Information) Regulations 2002 and the approval given by the Secretary of State is known colloquially as “section 60 support”. The Patient Information Advisory Group (PIAG) exists to advise the Defendant in respect of applications made for section 60 support. Dr Lewis, through Mr Angus Moon QC and those who instruct him, questions whether that is sufficient authority in the circumstances of this case and says that, if authority is to be granted, it is for the court to grant it under its general powers having balanced the competing interests in the manner demonstrated in, for example, A Health Authority v X and Ors [2001]Lloyd’s Rep Med 349 and [2002] Lloyd’s Rep Med 139. Whichever route is adopted, the invitation to the court is to grant an advisory declaration in appropriate terms. That procedural course is plainly an appropriate course: see, eg, per Sir Thomas Bingham MR in In Re S (Hospital Patient): Court’s Jurisdiction [1995] Fam 1, 18.

It is acknowledged by Mr Roussak that there are unlikely to be any practical implications for this particular Inquiry whichever foundation for the giving of such authority is adopted. However, the issue has been raised and I must deal with it. I will do so in paragraphs 32-56 below.

If I am persuaded that one or other, or both, of these foundations for giving permission arise, and I give permission for disclosure, The Inquiry invites me to authorise, on appropriate terms as to confidentiality, the onward disclosure of the material thus disclosed to those parties described as “stakeholders” in this Inquiry. I will deal with this at paragraph 59 below.

None of these considerations arise if there is no continuing obligation of confidence following the death of a patient. All those individuals whose records are sought are now no longer alive. Accordingly, it is necessary to consider as a preliminary matter whether the obligation does exist or arguably exists. I will deal with that first.

With slightly differing strengths of emphasis, Mr Moon and Mr Roussak submitted that I should proceed to determine this application on the basis that it is arguable that the duty of confidentiality does survive the death of the patient. They tell me that there is no authority binding upon me that determines the issue one way or the other. That being so, and bearing in mind that I have not had the advantage of sustained submissions on each side of the argument, I am anxious to confine myself to deciding no more than is necessary to determine this application. For my part, I agree with Mr Moon and Mr Roussak that I need go no further for present purposes than to reach the conclusion, if I do, that it is arguable that the duty does survive the patient’s death. I shall say immediately that I have indeed reached that conclusion for reasons that I shall set out in paragraphs 19-31 below.

There is no doubt that it is the view of those who administer the medical profession, both in the United Kingdom and worldwide, that the professional obligation of the doctor is to maintain the medical confidences of the patient after the patient’s death. The Hippocratic oath, the Declaration of Geneva (“I will respect the secrets that are confided in me, even after the patient has died”) and guidance given by the General Medical Council all point to this professional obligation. The content of an obligation imposed upon a professional by his profession is not, of course, necessarily coterminous with the obligation imposed by law in similar circumstances although it may be a useful indicator of the perceived values by which the relationship of the professional to his client (in this case, patient) are to be judged.

In the course of argument, I ventured the proposition that if anyone is asked whether they thought that something said in confidence to their doctor would remain confidential after their death, the answer would almost certainly be “yes”. That seems to me to accord with contemporary notions of what is accepted practice and indeed it might even reflect notions of what the law, not merely professional ethics, may require.

There is a further dimension beyond merely the professional expectations of the medical profession and the expectations of individual members of the public of the medical profession. It was articulated lucidly by the European Court of Human Rights in Z v Finland, as quoted by Baroness Hale of Richmond in Cambell v MGN Ltd [2004] 2 AC 457. At paragraph 145 Baroness Hale said this:

“It has always been accepted that information about a person's health and treatment for ill-health is both private and confidential. This stems not only from the confidentiality of the doctor-patient relationship but from the nature of the information itself. As the European Court of Human Rights put it in Z v Finland 25 EHRR 371 , 405-406, para 95:

"Respecting the confidentiality of health data is a vital principle in the legal systems of all the Contracting Parties to the Convention. It is crucial not only to respect the sense of privacy of a patient but also to preserve his or her confidence in the medical profession and in the health services in general. Without such protection, those in need of medical assistance may be deterred from revealing such information of a personal and intimate nature as may be necessary in order to receive appropriate treatment and, even, from seeking such assistance, thereby endangering their own health and, in the case of transmissible diseases, that of the community."”

That quotation, albeit dealing only with the doctor-patient relationship during the patient’s lifetime, articulates strong policy grounds for upholding the importance of the confidential relationship on the basis of a wider public interest.

My attention has also been drawn to the view of the learned authors of Toulson and Phipps on ‘Confidentiality’ (2^nd ed., 2006). At para 3-191 they say this:

“If a doctor who treated a celebrity suffering from AIDS during his final illness were subsequently to sell to a newspaper intimate details which had been revealed to him by his former patient in confidence, and in the expectation that the doctor would continue to respect that confidence after the patient’s death, it is likely that a court would regard the obligation of confidence as subsisting after his death; and would grant to the personal representatives (depending on the circumstances) an injunction and /or an account of profits as the only effective means of enforcing the obligation. In such a case it could not be said that the deceased would suffer detriment from the publication, but it would seem contrary to justice that the doctor should make a windfall from his breach of his obligation. Privilege may survive in favour of a deceased’s estate and it is hard to see why a court should not recognise the survival of an obligation of confidentiality. The period for which any duty of confidentiality could reasonably be expected to continue would depend on many circumstances, including the nature of the relationship, the nature of the information and any harm which might be caused to the deceased’s estate or, possibly, those whom the deceased would reasonably have wished to protect, as well as any grounds for justifying disclosure.”

Further, in paragraphs 11-053 and 11-054 they say this:

“The ethical obligation recognised in the Declaration of Geneva (“I will respect the secrets which are confided in me, even after the patient has died”) is repeated in Confidentiality: Protecting and Providing Information (Footnote: ¹) at para.30:

“You still have an obligation to keep personal information confidential after a patient dies. The extent to which confidential information may be disclosed after a patient’s death will depend on the circumstances…”

Equity may impose a duty of confidentiality towards another after the death of the original confider. The question is not one of property (whether a cause of action owned by the deceased has been assigned) but of conscience.

It is open to the courts to regard divulgence by a doctor of information supplied in confidence by a patient who has since died as being unconscionable as well as unprofessional. If so, there is no reason in principle why equity should not regard the doctor as owing a duty of confidence to the deceased’s estate, consonant with the maxim that equity will not suffer a wrong to be without a remedy.”

Those views are strong pointers towards the acceptance of the proposition that an obligation of confidence imposed on the conscience of the confidant does survive, or at least is capable of surviving, the death of the confider.

That view was accepted by the Information Tribunal in Bluck v The Information Commissioner and Epsom and St Helier University NHS Trust, (2007) 98 BMLR 1. The decision was given on 17 September 2007 and the tribunal was presided over by the Deputy Chairman, Chris Ryan. The relevant paragraphs of the decision are as follows:

Whilst that decision is not, of course, binding upon me, it does, if I may say so with respect, set out clearly and lucidly the competing arguments and reaches a conclusion which, for my part, I would be content to adopt. However, I would merely say that, for present purposes, it lends support to the proposition that it is arguable that the obligation of confidence is capable of surviving the death of the patient.

The case of Éditions Plon v France [2004] ECHR 200 concerned the revelation by the doctor of the late President Mitterrand shortly after his death of the cancer he suffered for virtually the whole term of his Presidency. I need not recite the details of the case. However, it supports the proposition that the obligation of confidentiality survived the death of the patient, albeit that the obligation is not one that is necessarily permanent. That will depend on the circumstances. As the quotation from paragraph 3-191 of Toulson and Phipps (see paragraph 23 above) suggests, the period for which the obligation can be expected to continue will depend on many circumstances. On the assumption that I make for this purpose that this is an accurate statement of the law, one such circumstance, in my judgment, would be the nature and result of any examination that the patient has undergone. The more intimate and sensitive the type of examination, and the more sensitive the kind of results obtained, the more onerous and prolonged would be the obligation to maintain confidence.

In the present case, of course, The Inquiry will be looking into the question of post-death examinations of those who may not in life have given advance consent to any such examination taking place following death. To that extent those affected will have had no expectation vis-à-vis the medical practitioners concerned about issues of confidentiality. Equally, if the next-of-kin were not similarly asked for consent, they will have had no expectation vis-à-vis the medical practitioners concerned. However, that cannot be (and has not been suggested to be) any answer to the emergence of an obligation of confidence on the part of the medical practitioners who were responsible for the examination and the subsequent analysis of the tissues obtained. In my judgment, the kind of examination that appears to have been conducted in this case would certainly rank high in the league of intimacy and sensitivity. Obtaining tissues from a dead body reflects a unique form of intimacy and the results of any examination that might reveal exposure to ionising radiation, with the connotations that such exposure will have in the minds of those exposed to it or of those related to the person who had been so exposed, make the results extremely sensitive. The making public of these matters by the person affected or by those representing that person’s interests is, of course, perfectly possible if, with full knowledge of the circumstances, the person or his or her next-of-kin decide to do so. However, the presumption must be that those matters are sufficiently sensitive to require a high degree of confidentiality and one that endures for many years after the death of the individual concerned.

It is that broad consideration that has, perfectly properly, driven the approach of The Inquiry to these matters. Mr Jones’ witness statement for the purposes of this application contained the following passage that is worth recording in this context:

“The Inquiry has been contacted by a number of families from whose deceased relatives organs were taken at post-mortem examination and analysed at UK nuclear facilities. In those cases appropriate consent can be taken from the next of kin before any request is made of any individual or organisation for disclosure of confidential patient information. Clearly if consent is not granted then disclosure cannot be pursued. In a number of other cases however, the Inquiry is aware that organs have been taken at post-mortem examination but the relevant families have not contacted the Inquiry. It would not be appropriate for the Inquiry to contact those families, even if their contact details could be ascertained, because they may not wish to know whether their deceased relative was involved in this way and proactive contact by the Inquiry could cause untold distress. Indeed, I am aware of media coverage following the announcement that the Inquiry had been established which made it clear that at least one named individual did not want to be told of any potential involvement in such matters. Access to confidential patient information in those cases is however, required to enable the Inquiry to observe its Terms of Reference. There is also a third group of cases where it is not known at this stage whether organs were taken at post-mortem examination and where that issue can only be resolved by scrutiny of confidential patient information. Again, it would be inappropriate to contact such families when it is unknown whether they may or may not be directly involved.”

As will be apparent, it is likely that some of the material the subject of the request for disclosure will relate to examinations and analyses going back many years. It is, of course, just possible that there are, in some cases, no living next-of-kin of those affected. However, for my part, I would not regard that, or indeed the passage of time generally in a matter of this nature, as eradicating or diminishing significantly the strength of the obligation of confidentiality which, as I have concluded, arguably exists in each of the cases in respect of which disclosure is sought.

These conclusions are sufficient to demand a basis for permitting that obligation of confidentiality to be overridden to enable disclosure of the material requested. It is to that broad issue, and to the two possible bases for granting permission, that I now turn.

The issue that arises in this connection (see paragraph 14 above) depends upon whether it can be said that purpose of The Inquiry is one that falls within the terms of the Health Service (Control of Patient Information) Regulations 2002 (“the 2002 Regulations”). If so, authorisation has already effectively been given by the Secretary of State: see also paragraph 14 above.

The 2002 Regulations were made by the Secretary of State using the powers conferred by section 60 of the Health and Social Care Act 2001. This section was repealed by the NHS (Consequential Provisions) Act 2006: see section 6 and Schedule 4. Its statutory successor is section 251 of the National Health Service Act 2006 to which I will refer in paragraph 34 below. The 2002 Regulations remain in force. I will refer to the relevant parts in paragraphs 35 and 36 below.

The relevant subsections of section 251 of the National Health Service Act 2006 provide as follows:

Regulation 5 of the 2002 Regulations provides as follows:

Regulation 7 is in these terms:

The Schedule to the 2002 Regulations (which is referred to in Regulation 5) lists various circumstances in which information may be processed, one of which (at paragraph 5) is in these terms:

The argument advanced on behalf of The Inquiry is that the purposes for which the patient information are sought are “medical purposes” (namely, the management of health and social care services: section 12(a)) and that it is to be processed for the purpose of the “audit, monitoring and analysing of the provision made by the health service for patient care and treatment”: see paragraph 37 above.

In support of those arguments Mr Jones, in his witness statement, has contended that there is nothing within section 251 of the National Health Service Act 2006 restrict the ambit of “medical purposes” to such management functions as are carried out by those involved in delivering the National Health Service, but that it can extend to inquiries into the management of health and social care services. He submits that The Inquiry, in addressing its Terms of Reference (see paragraph 6 above), inevitably has to review the circumstances in which post-mortem examinations were undertaken and whether proper pathological processes were followed within the NHS. He contends that The Inquiry is, therefore, mandated to consider the provision of pathological health services. He submits also that the same considerations apply when determining whether the terms of paragraph 5 of the Schedule to the Regulations are met.

Mr Roussak has supplemented that argument by contending that The Inquiry is investigating, amongst other matters –

He submits that that those matters are properly characterized as “the management of health ... services” and, accordingly, that The Inquiry’s objectives are “medical purposes” within the meaning of the Act and that, as he put it, that hurdle is “comfortably cleared”.

He contends also that The Inquiry’s investigations, whilst not concerned with the medical treatment of the individual undergoing the post-mortem examination, are concerned with –

He submits that The Inquiry’s processing of confidential patient information will be in accordance with the Regulations.

As I have indicated previously, whilst not challenging the legitimacy of having the relevant information put before The Inquiry, those advising and representing Dr Lewis have questioned whether these arguments are valid. Mr Moon argued that The Inquiry is not concerned with the management of health and social care services (as required by section 251(12)) and that it is far from clear that The Inquiry is involved in the “audit, monitoring and analysing of the provision made by the health service for patient care and treatment”, an expression which, he submits, should not be read disjunctively. He contends that it is stretching the definition of “patient care and treatment” to suggest that such care and treatment can be provided after death and Mr Leslie, in his witness statement, raises doubts as to whether Dr Lewis and Trident Medical Services, for which company Dr Lewis works, are part of the National Health Service or that The Inquiry is carrying out an “audit, monitoring and analysis of patient care and treatment.”

Mr Moon has told me, and it has not been controverted, that the provisions of the Health and Social Care Act 2001 concerning patient confidentiality, which led to 2002 Regulations, arose from concerns about the provision for commercial purposes of patient information by a company called Source Informatics to the pharmaceutical industry: see R v Department of Health, ex parte Source Informatics Limited [2000] Lloyd’s Law Rep. Med 76. Indeed this is confirmed to the extent that it is possible for me to consider it by the helpful commentary in Current Law Statutes when dealing with the 2001 Act. Its says this :

“The issue of confidentiality of patient information and the consent of patents to treatment are central to the relationship between clinicians and patients within the NHS. The concept of consent has been developed in common law and is comprehensively summarised in the GMC guidelines published in July 2000. The NHS routinely collects and processes patient information based on the theory of implied consent by the patients to such processing. Processing of patient data is now covered by the Data Protection Act 1998. Additional provisions in this Act were prompted by the commercial activities of company called Source Informatics, which was attempting to obtain information on GP prescribing practises in order to create a data base for marketing purposes by pharmaceutical companies. Its activities resulted in a judicial review… which prevented the collection of such data without the express consent of patients. This decision clearly had a knock on effect to much of the epidemiological activity of the NHS. The government wished to protect the NHS from the kind of commercial pressure that Source Informatics would have encouraged. At the same time, the government did not wish to disrupt the free flow of information which is necessary for planning services, public health and research purposes and for the maintenance of services of benefit to individual patients such as cancer registries. The Data Protection Commissioner, established under the Data Protection Act, had also expressed concern about the manner in which patient information was dealt with in the NHS. As a result, the Act has created a system for regulating the distribution of patient information and created a Patient Information Advisory Group to conduct annual reviews of the way in which the system is working.”

Against that background, and bearing in mind that the 2001 Act and its successor, the 2006 Act, appear to set out to ensure a proper framework by which patient information generated within the NHS may be distributed, the natural assumption is that the information to which the Act and the consequent Regulations apply is indeed information arising when a patient is seen within an NHS context. As I understand it, one of the concerns raised on Dr Lewis’ behalf is that at least some of the records that form the subject of the request for disclosure could not be said to emanate from such a source. Without a detailed analysis of each and every case in respect of which disclosure is sought, it would not be possible to categorise those cases which, as it were, came within the NHS umbrella and those which did not. Taking what is, I trust, a sensible and pragmatic approach, the chances are that most, if not all, the records will have at least some element that was generated within the NHS and, accordingly, would on this basis fall for consideration within the statute and the Regulations if the statute and Regulations otherwise apply.

I have noted that Mr Jones argues that the Act and Regulations are not restricted to management issues within the NHS and that, accordingly, patient information could, as I understood his argument, be processed for the purposes of the management of private health services if the appropriate authority was given.

I respectfully agree that there is nothing explicit in the Act and or Regulations confining the information concerned to NHS-generated information but, as I have said, the whole context would seem to suggest this. Had the matter been fundamental, I would doubtless have been invited to look more closely at the whole Act, and, perhaps, its legislative history and background. In the course of the relatively short argument, I have not been so invited and, accordingly, can express no view other than that which I have expressed.

If I was forced to conclude, on the arguments I have heard, whether the procedures afforded by the Act and the Regulations are available for the authorisation of the use of confidential patient information generated outside the NHS, I would have to conclude that it did not. However, for the pragmatic reasons I have put forward previously, I do not think that the issue in truth is likely to arise in any significant way in any of the individual cases with which this application is concerned.

The other issue, put compendiously, is whether the confidential patient information that is sought by The Inquiry is to be processed for the purposes of “the management of health care services” in the sense that it will be subject to “audit, monitoring and analysis of the provision made for patient care and treatment.”

I do not think it is in dispute that what happened in relation to the taking of tissues after death cannot amount to “treatment”. As I have said, Mr Moon says it is stretching things to say that it amounts to “care and treatment”. Mr Roussak says that what occurred (a) reflected care of the deceased person and (b) represented one step in the process of enabling improved care to be given to other patients by virtue of the information obtained from the post-mortem examination carried out.

It would, in my judgment, be wholly artificial and, perhaps, to some at least, an affront, to suggest that care for a patient ends at the moment of death; but equally it does have to be acknowledged that active care and treatment in the normally accepted sense of the expression does come to an end at that point. The answer of most people to the question “do you regard the removal of tissues from a deceased person for the purposes of analysis is part of the care and treatment of the patient?” would surely be “no”. If that is so and it reflects the correct legal interpretation of the expression, the information obtained from this procedure – whether it be audited, monitored or analysed or a combination of all three – would not be being processed for a “medical purpose” prescribed by the Regulations.

However, if that view should be wrong and it be the case that information of this nature is to be treated as information available for the purpose of paragraph 5 of the Schedule to the Regulations, the next question is whether The Inquiry itself, on proper analysis, is or will be engaged in the “audit, monitoring and analysing of the provision made by the health service” for the post-mortem analysis of tissues taken in the circumstances involved here.

For my part, I am not persuaded that, despite the use of the word “and” in paragraph 5, that expression cannot and should not be read disjunctively. It is not impossible to envisage a process by which an “audit” of patient information may be carried out, without the information being “monitored”. An audit may be conducted of a specific chronological period in the past whereas “monitoring” connotes an ongoing process, as indeed does the word “analysing” (which is used in contradistinction to the word “analysis”). It is clear that one of the purposes of The Inquiry, perhaps its most fundamental purpose, is to inquire into and investigate what happened in the past : see what the then Secretary of State said in Parliament (paragraph 4 above) and the terms of reference (paragraph 6 above). To that extent, it could be said to be conducting an “audit”. However, I do consider that it does strain the normal meaning of the word “audit” to embrace what The Inquiry will be setting out to do and, whilst I accept that The Inquiry is called upon to make recommendations, its principal focus is to discover what happened and why so that those affected, directly or indirectly, will have some explanation. If paragraph 5 of the Regulations read along the following lines then there would be no need for a strained interpretation :

“The investigation of acts done or omitted to be done in relation to any person, whether before or after that person’s death, by the health service “

I think that Mr Moon had a fair point when he asserted that the Regulations were almost certainly drafted without an inquiry such as The Inquiry in mind. That is quite understandable, but it helps to underline the point that endeavouring to bring the purposes of The Inquiry within the language of regulations drafted for a different purpose is a little difficult and does, in my view, involve a step too far.

I might have had more hesitation in reaching the view if I had thought that it would result in The Inquiry not being able to proceed. However, even then, I would have been obliged to take the Regulations as I found them and reach a conscientious view as to their meaning. But I am comforted by the fact that I am in a position to give the necessary authority via another route which, I make clear, I am proposing to do.

Before I leave this particular area, I would make this comment: whilst my view of the effect of the Act and the Regulations is as I have indicated, I can see that others might take a different view and that the converse view is at least reasonably arguable. Had the issue been of importance (which, for the purposes of this particular inquiry, it is not), I would have granted permission to appeal so that the views of the Court of Appeal could have been obtained. Since, however, the matter is essentially academic, I propose to leave matters there.

Although, for the reasons I have given, I have rejected the statutory basis for the authority to disclose the material sought, I have not the slightest doubt that this is an appropriate case in which to hold that the public interest in disclosure of the material sought outweighs the other public interest, namely, that of maintaining the confidentiality of medical records and information, provided, of course, proper safeguards are put in place to ensure that no inappropriate information becomes public.

In support of this conclusion I would merely say that there is plainly a public interest (and by that I mean not just “the interest of the public”) in determining what happened and why in connection with the very difficult and sensitive issue that arise from these matters. Those families that know broadly what happened are entitled to fuller answers to the questions raised if they wish to have them and there is a wider public interest in maintaining confidence in the NHS and the nuclear industry, a confidence that may be fortified either by the results of the investigation of The Inquiry or by the recommendations of The Inquiry if past practices are found to have been wanting and improvements are suggested. As Mr Roussak said, The Inquiry is sponsored by two Secretaries of State answerable to Parliament and that of itself is compelling evidence of the public interest in enabling The Inquiry to have the fullest facilities to carry out its functions.

So, for those reasons, shortly expressed, I am prepared to authorise disclosure of the material requested by The Inquiry which Dr Lewis has available for disclosure. I am also persuaded that it is appropriate to permit the onward disclosure of that material to other participants in The Inquiry (the “stakeholders”) who could not assist The Inquiry without the opportunity of considering and commenting upon the disclosed material. However, that onward disclosure will also need to be on strict terms as to confidentiality. In that connection I have received a letter dated 17 September 2008 from Mr Jones, the substance of which appears in Annex 2 to this judgment, which makes clear the extent of the proposed disclosure and provides considerable reassurance that the confidentiality of the disclosed material will be respected.

Mr Moon and Mr Roussak kindly undertook to draft an order that gives effect to this decision if I was minded to give authority for disclosure, such order to incorporate appropriate provisions as to confidentiality. The product of their discussions appears in Annex 1 to this judgment and I will make an order in those terms with the addition of permission to apply in the terms indicated.

This judgment has been more lengthy than might seem justified having regard to the essentially uncontested nature of the application.

I make no apology for that for essentially two reasons :

I would conclude by expressing my appreciation to Mr Moon and Mr Roussak and their respective teams for their assistance.