Final Report

< Back to final report index page

Chapter 32

An Investigation into the Systems in Place for Informing Patients about the Risks - Ethical Context


Scope of this part of the Report

32.1 This part of the Report comprises four chapters. They explore the issues raised by Terms of Reference 2 and 3 for the Inquiry:

2. To investigate the systems in place for informing patients treated by the NHS in Scotland of the risks associated with the use in their treatment of blood or blood products with particular reference to the risks of infection with the Hepatitis C virus and HIV.

3. To investigate the systems in place in Scotland for obtaining consent from, and testing for infection with Hepatitis C and HIV, patients treated with blood or blood products, and informing patients found to be so infected.

32.2 This chapter looks at the development of the relationship between clinician and patient during the reference period. Chapter 33 deals with various aspects of the information provided to patients on HIV/AIDS and at the testing of patients for HIV. Chapter 34 deals with the same matters in respect of NANB Hepatitis/Hepatitis C. Chapter 35, An Investigation into the Steps Taken to Identify the Individuals who were Infected (Look-back), deals with the methods available to identify patients put at risk of HCV transmission by treatment with blood or blood products, and the steps taken in that regard.

Background to this part of the Report

32.3 As stated in Chapter 4 of the Preliminary Report, it was a recurring theme in the witness statements which the Inquiry obtained from patients and their relatives that many patients felt that they were given little or no information from their treating clinicians about the risk of infection to which they were exposed as a result of their treatment with blood or blood products. Many of the patient witnesses who received blood transfusions in the 1970s, 1980s and in the 1990s stated that they were not warned of the risk of transmission of infection. The reasons for patients receiving blood transfusions varied, as did the circumstances in which they required medical care. In some cases the circumstances surrounding a surgical procedure will hardly have been conducive to a rational discussion of the long-term risks potentially associated with transfusion, but in others, such as planned medical procedures, there would have been more ample opportunity for discussion of risks. Most patients with a blood disorder who provided statements commented that they were not warned of the risk of infection with HTLV-III/HIV or non-A non-B Hepatitis from the blood products they received, including cryoprecipitate and factor concentrates.

32.4 The investigations discussed in this part of the Report arose against this background, and reflected the questions that the experiences of many patients and their relatives naturally and understandably prompted. At the most general level, there was a need to know how it came about that materials subsequently found to be infectious were used in treatment without the patient being made aware that there was a risk of transmission of viral infection. Questions expressing that need have ranged from simple, but sometimes desperate, pleas for information to enable people to understand how they, or their relatives, came to be infected with HCV or HIV, to accusations, sometimes angry, against clinicians responsible for prescribing therapeutic materials capable of transmitting infection. Some patients felt that, as a result of not being warned of the risks of infection from their treatment, they were denied the opportunity to make an informed choice about the treatment they received.

32.5 Furthermore, many patients complained that they were tested for HIV and/or Hepatitis C without their consent and knowledge. A large number of the witnesses expressed dissatisfaction about the manner in which their diagnosis with HIV and/or Hepatitis C was conveyed to them and about the information which they were given about these viruses. Many witnesses felt that the health implications of the viruses and other matters, such as secondary infection, were not adequately explained to them.

32.6 In very general terms, the clinicians' position, set out in submissions on behalf of the NHS in Scotland, was that: 'In their interactions with patients, clinicians made every effort to communicate effectively in unprecedented circumstances'.[1] Further it was noted that testing blood samples without express consent was commonplace and acceptable by the ethical standard of the time.[2] With regard to advising patients of the results of their test results, it was stated on behalf of the NHS for Scotland that: 'the preponderance of evidence strongly suggests that patients were told of their diagnosis'.[3] They highlighted evidence which indicated the difficulties for patients of absorbing information, particularly bad news.

32.7 The Scottish Government recognised, in its closing submissions, that communication between doctor and patient: 'is an important and sensitive topic. Good communication is fundamental to the clinical relationship, and a critical factor in obtaining informed consent to medical treatment or surgical procedures'.[4] It also recognised and welcomed the fact that attitudes to communication and consent had 'progressed significantly' in the last 25 years.

32.8 These brief comments reflect differences in the evidence of fact: what actually happened in the course of clinical procedures over long periods of time; what protocols were in place for communication between clinician and patient; and whether the differences in recollection and report can be resolved. In this chapter, evidence relating to the development of generally recognised ethical rules and practices will be discussed. Controversial issues emerged and some of them have to be discussed at length in an attempt to define the professional standards in place from time to time. In later chapters these standards inform discussion of the evidence of what probably did happen as between clinician and patient in the particular cases reported. This chapter explores the issues more generally. Resolving the competing evidence of experts proved to be difficult.


32.9 For the purpose of exploring the range of issues discussed in the four chapters of this part of the Report at the Oral Hearings of the Inquiry, the following topics were defined:


  • The information given to patients (or their parents) about the risk of AIDS before their treatment with blood or blood products.
  • The tracing and testing of patients who might have been exposed to the virus through their treatment with blood or blood products.
  • The information given to patients who might have been infected, or who were found to be infected, and their families.

Hepatitis C

  • The information given to patients (or their parents) about the risk of non-A non-B Hepatitis before their treatment with blood or blood products.
  • The tracing and testing of patients who might have been exposed to the virus through their treatment with blood or blood products.
  • The information given to patients who might have been infected, or who were found to be infected, and their families.

Evidence on these topics was taken from the written and oral evidence of patients and their relatives, doctors, nurses, other professionals, and officials.

Expert guidance

32.10 It was recognised that the Inquiry would require expert guidance on medical ethics and Professor Vivienne Nathanson and Dr Charles Hay were asked to assist in this respect. Professor Nathanson had been the Director of Professional Activities at the British Medical Association (BMA) for 16 years before coming to give evidence. Before working for the BMA she qualified and practised as a specialist registrar in general medicine. Dr Hay was Chairman of the United Kingdom Haemophilia Centre Doctors Organisation (UKHCDO). He was an experienced haemophilia clinician with a long and distinguished career in haemophilia care.

32.11 Professor Nathanson attended the Inquiry twice to give evidence on ethical issues and provided two reports in which she answered a series of questions posed by the Inquiry team. The first report[5] dealt with HIV and AIDS. The second report[6] dealt with NANB Hepatitis and Hepatitis C. Dr Hay prepared a report[7] on the communication of information to patients about hepatitis in which he explained his opinion of the information patients should have been given about NANB Hepatitis/HCV against the background of the changing scientific knowledge of the condition in the period 1974-1995. In addition, Dr Hay set his evidence on the relationships between haemophilia patients and their doctors squarely in the context of his clinical experience. He gave oral evidence, based on his experience in practice in haematology medicine from mid-1977 to the present day, on the information and advice he personally gave to patients, or their parents, of the risks of contracting, and the severity of, NANB Hepatitis/HCV.

Scope of this chapter

32.12 Although the separation between the two viruses, HIV/AIDS and NANB Hepatitis/HCV, will be maintained in discussion in the following chapters, it is appropriate to set the scene for particular discussion of the questions that have arisen from the evidence by a more general discussion. It is necessary to understand the nature of the doctor-patient relationship at the beginning of the reference period and to follow some of the developments thereafter as background to the discussion of the provision of information to patients.

32.13 The accepted understanding of the way in which doctors should interact with their patients developed during the reference period, as knowledge of the viruses emerged and changed, and clinical practice was adapted to reflect that understanding. In her written reports and in oral evidence, Professor Nathanson commented on the development of the core elements of the ethical practice of medicine during the reference period, as she saw them, such as consent to treatment and testing and communication with patients. In oral evidence she expanded on the interaction of developing medical knowledge and ethical practice:

I think the important issue here is that when you look at ethics, not only has ethics changed during the period in question, or at least the practice of ethics, what we would regard as best practice and what we would expect as the minimum standard but that that has also had to reflect the change in scientific understanding during that period, and the two things have to come together.[8]

32.14 In considering the response of clinicians to the needs of patients for information it is necessary to bear in mind these two distinct, if interrelated, factors.

32.15 The clinical settings confronted by medical practitioners vary widely. Most of the discussion in this chapter will relate to the treatment of patients with coagulation disorders, typically Haemophilia A or B, managed over long periods of time. Monitoring patients at regular hospital attendances in that context afforded opportunities for discussion and the informed selection of materials for therapy that would not exist in many other situations involving transfusion, such as surgery or general medical procedures. The treatment of general medical and surgical patients may involve single or multiple sessions with more or less opportunity for discussion, depending on the circumstances. Transfusion in a surgical setting may be elective, providing an opportunity for discussion, or in an emergency setting in which prolonged discussion of options could threaten the life the surgeon is anxious to save. Sometimes a patient is unconscious before the need to give a blood transfusion, possibly to save his or her life, becomes apparent. It is necessary to bear in mind that issues raised by urgency or the immediate demand for relief of suffering may be very different from those that arise from care of patients with chronic conditions. In the first place, however, the focus will be on therapy in relief of blood coagulation disorders.

32.16 It was to become apparent that, while there was a very substantial overlap between the underlying ethical principles and rules applicable as they developed from time to time, their application to the doctor-patient relationship varied in relation to the specific viruses to which the Terms of Reference relate, HIV/AIDS and NANB Hepatitis/Hepatitis C. Patients were exposed to the risk of transmission of these viruses over very different periods (see Chapter 2, Patients at Risk) and the factors driving changes in professional standards varied as between them, both in terms of chronology and in the context of developing medical knowledge.

32.17 This chapter will therefore deal with what the Inquiry has learned and been told about the history of the doctor-patient relationship from the 1970s to the present day and then more specifically with the development of the ethical background to information given to patients about the tests they were undergoing, the illnesses from which they suffered and about relevant treatment, again from the 1970s onwards. It deals principally with the evidence on those aspects of medical ethics that are of specific importance for the purposes of the Report. It is not a history of medical ethics generally. Nor does it provide a critique of the witnesses' general evidence. Differences between Professor Nathanson and Dr Hay are examined where they are material to the Terms of Reference.

32.18 In general, it cannot be emphasised too strongly that, as the history of events in Scotland and elsewhere unfolded, in relation to information to patients and the way doctors were expected to interact with patients, the changes that occurred were sometimes dramatic. In relation to knowledge of the relevant diseases, not only were there significant changes over time in the understanding among clinicians of their respective aetiologies and natural histories, developments in knowledge were not consistent across all relevant disciplines. Knowledge among many clinicians inevitably lagged behind cutting-edge research to some degree at any particular point in time. The scientific and clinical developments are fully dealt with in Chapters 8 to 10 (HIV/AIDS) and Chapters 13 to 16 (viral Hepatitis). In this context it is particularly important to avoid being wise after the event and to avoid viewing events and developments in the light of later insights - applying up-to-date clinical knowledge and ethical standards to periods when such rules as applied were at best inchoate versions of later statements of principle and developments in practice.

Sources of ethical guidance


32.19 There is no central UK committee on healthcare ethics. Clinical advice to practising doctors is provided by the BMA and the General Medical Council (GMC).[9] The BMA has had a committee looking at medical ethics since 1849.[10] The committee provides general advice to doctors in the form of guidance notes and leaflets. In the course of the reference period there were a number of landmark stages, reflected in published guidance documents, which help trace developments. Less formal means of providing guidance to doctors were also adopted. As Director of Professional Activities at the BMA, part of Professor Nathanson's job consisted of answering questions from doctors in practice about ethical dilemmas - advising doctors on what they should do in the specific circumstances brought to her attention.[11] Contemporaneous published guidance from the BMA and the GMC was not the only means of providing advice and was therefore not the exclusive test available of what was considered to be ethical practice. However, published guidance provides an accessible measure of the formal steps taken by representative medical authorities to inform doctors of their ethical duties and assists in setting a chronological framework for discussing other issues.

32.20 Professor Nathanson recounted the history of medical ethics over the last 40 years in her first report to the Inquiry. It is not necessary to trace all developments in this field for present purposes as the nature and extent of the developments that are relevant can be demonstrated more briefly.

32.21 At one level, the requirement for patients to have necessary information relating to their treatment was referred to in documents from as early as the 18th century. Professor Nathanson referred to a quotation from the case of Slater v. Baker and Stapleton in 1767 which stated in the context of surgery (before the advent of anaesthesia) that it was 'reasonable that a patient should be told what is about to be done to him, that he may take courage and put himself in such a situation as to enable him to undergo the operation'.[12] This case was referred to in the BMA publication Medical Ethics Today: Its Practice and Philosophy (1993) in which it was observed that the comment:

[P]erhaps foreshadows current thinking that most people fare best when they have a clear view of what is being proposed and its implications.[13]

32.22 Professor Nathanson also referred to the rules on medical research promulgated in 1949 after the Nuremberg trials, stating that they were the first explicit modern statement of the right of every patient to consent to and therefore refuse any medical treatment. Rule 1 of the Nuremberg Code provided:

[T]he person involved should have the legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision.[14]

32.23 The context for the Rule was medical research and, in particular, experimentation on human subjects. Professor Nathanson commented:

Following the Nuremberg trials legal rules on medical research were put in place. While these were not then well known to doctors throughout the world [Rule 1] was the first explicit modern statement of the right of every patient to consent to, and hence to refuse, any medical treatment.[15]

32.24 Until 1949, the BMA and its ethics committee resisted preparation of an ethical code.[16] In 1949, the BMA Council produced a 16-page booklet mainly concerned with relationships between doctors and members of other professions.[17] In 1974 it produced a booklet of 50 pages, including a full reprint of the current GMC rules, the Hippocratic Oath and relevant ethical codes, including the Declaration of Helsinki.[18] Professor Nathanson suggested that, at a very basic level, the change in the approach to ethics could be illustrated in the difference in scale between the 50-page 1974 booklet and the current edition which is produced on a CD-ROM and is just under 1000 pages.[19] While superficially attractive, that could only be a sufficient measure of change if the publications were the sole source of guidance on ethical practice. However, as stated in paragraph 32.19 above, the BMA also produced specific advice sheets and guidance notes to its practitioners on a variety of areas and gave advice to doctors who contacted its ethics advice services. The proliferation of less formal advice suggests that the scale of change was even greater. However, on any view, the change in scale of the handbook reflects an appreciation of a growing need for formal written advice over the period that is relevant to this Report.

32.25 More fundamentally, the nature of the advice given by the BMA to members has varied widely, reflecting the ethical mores and standards of the times. A reviewer of the 2003 edition of Medical Ethics Today, perhaps cynically, captured the flavour of the BMA's 1974 booklet from a modern medical perspective:

The 1974 edition ... provided guidance on important matters such as whether a consultant or a GP should enter the room first when both visited a patient.[20]

32.26 Both the hierarchical structure of the profession and the paternalistic attitude towards patients were reflected in the 1974 guide. The culture of the time was summed up in a quotation from Dr CO Hawthorne who was the Chairman of the BMA Central Ethical Committee for many years. He was reported to have written between the wars that:

In the relations of the practitioner to his fellows, while certain established customs and even rules are written and must be written, the principal influence to be cultivated is that of good fellowship. Most men know what is meant by 'cricket' and the spirit of the game. Difficulties and differences will arise, but most of them can be successfully met by mutual goodwill and recognition of the other fellow's point of view.[21]

32.27 As Professor Nathanson noted, this statement seemed to envisage a practitioner who already knew what the ethical rules were. At that time there was little in the way of specific guidance. She noted that the only reference to patient consent in the first edition of this guide related to the particular issue of organ donation. Academic texts discussed consent but it was rare for patients to question doctors' advice and consent was seen as a non-contentious issue.[22]

32.28 In her evidence, Professor Nathanson undermined the notion that it could be assumed that practitioners would know the ethical rules. By way of background, she said that, in reality, the teaching of ethics lacked consistency and was of variable quality. In the 1970s, for more general ethics teaching, most medical students in London were educated by attending voluntary lectures given by the London Medical Group, an informal group of practitioners. Studies by the Institute of Medical Ethics in 1987 and 2006 demonstrated a continuing deficiency in ethics teaching of medical students and noted that, although the topic was a course requirement, it was rarely part of the final examination. The subject was taught in every medical school but there was, and remains, concern at the BMA about the consistency and quality of teaching. Although the teaching of medical ethics could be an independent part of the course structure, often it has rather depended on interested and knowledgeable clinicians teaching ethics as an additional element within a clinical discipline.[23]

32.29 The publication of Ian Kennedy's 1980 Reith lectures, 'The Unmasking of Medicine', had a profound impact.[24] It advocated a more patient-centred approach to medicine in which patients were seen as partners in investigation, management and treatment decisions.

32.30 According to Professor Nathanson, there was a shift in the period between 1974 and 1980 towards more guidance on specific ethical issues in response to clusters of queries about the correct approach to take in particular clinical situations.

32.31 With regard to blood transfusion, 'Notes on Transfusion' issued to UK hospitals by the Department of Health and Social Security in 1973 required a record of every transfusion to be made in the patient's case notes.[25] It emphasised that 'the main reason for accurate recording is the protection of the patient'. No mention was made in these notes or their revised version in 1984 of patient information or of consent.[26] According to Dr Derek Norfolk '[i]nformed consent for blood component transfusion does not appear to have been a major issue for clinicians in the 1970s although there was increasing awareness following the emergence of HIV in the 1980s'. In the UK consent for transfusion has not been formalised and, in the surgical setting, has been regarded as part of the normal process of obtaining consent for the overall procedure.[27]


32.32 The first BMA handbook on medical ethics was published in 1980 and revised in 1981 and 1984.[28] The 1980 BMA handbook, which was written by a sub-committee of doctors, gave more situation-specific advice and, in addition to the handbook, the BMA continued to produce advice sheets and guidance notes (sometimes on broad issues and sometimes focused on very specific issues) for its practitioner members on a variety of areas and gave advice to doctors who contacted its ethics advice services.

32.33 The style of the 1980s publications before 1988 was to give ethical guidance through a list of generally agreed precepts. That style was abandoned in 1988, when, according to the 1993 publication Medical Ethics Today: Its Practice and Philosophy, the handbook set out 'the influences which give rise to the general moral and ethical order and set out principles as a basis for studying practical problems'.[29] The approach adopted by the BMA in 1988 is important for the purposes of this Inquiry, having regard to the evidence of the two principal witnesses dealing with ethical issues, and in particular the use by Professor Nathanson of the 1988 texts to explain wider ethical issues. However, reviewers were not uniformly of the view that the book succeeded in its objectives, as noted below (paragraph 32.45).

32.34 In addition to BMA guidance, the GMC also published advice. In 1980 the advice produced by the GMC took the form of a list for doctors of what might constitute poor practice and lead to allegations of professional misconduct. By way of contrast, today the GMC produces detailed advice of what constitutes good practice rather than bad. The GMC advice on consent has developed the concept of patient autonomy and, in this area also, the GMC now gives advice on what builds good practice rather than listing bad practice that could result in disciplinary issues. The change in emphasis and approach is stark: over time the GMC's guidance on ethics has become more prescriptive, directing doctors as to what best practice requires.[30]

32.35 If the brief BMA ethics booklet published in 1974 reflected the attitudes of doctors and patients at the time, little appears to have changed in relation to general attitudes by 1980. Professor Nathanson contrasted BMA advice in 1980 with the more developed position in 1988.[31] In relation to consent, in 1980, the BMA stated:

The patient's trust that his consent to treatment will not be misused is an essential part of his relationship with his doctor.[32]

In 1988, the equivalent passage (quoted in full at paragraph 32.44 below) stipulated for patient consent before any investigation and treatment was carried out.

32.36 In terms of good ethical practice, as at 1980 there was no specific requirement for consent, or any related procedure. Consent to treatment was still assumed rather than prescribed. By 1988, as Professor Nathanson observed, there was 'increasing comfort in using formal ethics language and concepts in describing the basic principle'.[33]

32.37 In the interval between 1980 and 1988, a significant development was the adoption by the World Medical Association in October 1981 of the Declaration of Lisbon, a statement on the rights of the patient which provided that:

A mentally competent adult patient has the right to give or withhold consent to any diagnostic procedure or therapy. The patient has the right to the information necessary to make his/her decisions. The patient should understand clearly what is the purpose of any test or treatment, what the results would imply, and what would be the implications of withholding consent.

The patient has the right to refuse to participate in research or the teaching of medicine.[34]

32.38 The Declaration was the earliest significant, and relevant, general statement on patient consent drawn to the attention of the Inquiry. The rights of a mentally competent adult patient were comprehensively formulated. It was a clear indication, from the autumn of 1981, of recognition by the international medical community of the patient's right to information relevant to, and to participate in any decision on, investigation and treatment, and participation in research. However, acceptance of the statement as part of a definitive code of ethical conduct would inevitably depend on its adoption by national authorities for their own jurisdictions. In the event, the Declaration came after and was not reflected in the BMA's 1980 statement. So far as drawn to the attention of the Inquiry, BMA publications did not reflect the general Lisbon principle of explicit and informed consent until 1988.

32.39 In May 1988, the GMC set out guidance specifically in relation to HIV and AIDS in a publication entitled HIV Infection and Aids: the Ethical Considerations (the GMC Guidance of 1988).[35] It narrated the Council's expectations of doctors intending to carry out investigative procedures related to these conditions and stipulated the need for patient consent, whether explicit or implied, to the procedures being undertaken. The guidance stated that the Council believed that the same principles should apply generally. It appears from Professor Nathanson's explanation of the immediate past history of the guidance on AIDS that the guidance may have related more to what the GMC wished doctors to aspire to rather than to established and generally recognised rules of behaviour.

32.40 As Head of Ethics at the BMA between 1987 and 1989, Professor Nathanson attended a GMC meeting in April 1987 as an observer, ensuring cross-representation in the discussion of ethical issues. A paper on the benefit of routine testing and testing without consent, probably written by GMC staff on the basis of debate at previous committee meetings, was discussed. One of the members, a doctor in general practice, advocated that doctors should be able to test patients for HIV infection without consent. After debate it was decided that it would be unethical to carry out such tests without consent. Professor Nathanson recollected, however, that in about 1986-87 the BMA had actually voted for a policy which allowed doctors to test without consent. As soon as the policy was agreed the BMA took legal advice and they were advised that testing without consent was illegal. The policy was reversed the next year at the BMA's annual meeting of 600 representative doctors. In fact the BMA had received conflicting advice from two QCs on the topic. The rationale of the advice which was followed was that because the HIV test was not a standard test the implied consent given for more general tests, like a full blood count, did not apply and specific consent was therefore required.[36] These discussions, in committee and more broadly, eventually resulted in the GMC Guidance of 1988.

32.41 It is worthy of comment that, in the legal opinion followed by the GMC, reasons specific to the HIV test were persuasive, differentiating it from 'standard' testing. Specific consent was required for anti-HIV testing, implicitly recognising that 'standard' testing was in a different position. Professor Nathanson's anecdote demonstrated clearly that, until the BMA meeting in April 1987 and the GMC Guidance of 1988, the question of consent to investigation and treatment was capable of generating serious debate even among the members of representative bodies' ethics committees, quite apart from dividing the BMA's legal advisers.

32.42 That debate was not reflected in the publications in 1988. (In addition to HIV Infection and AIDS: the Ethical Considerations a BMA publication Philosophy and Practice of Medical Ethics was revised that year - see paragraph 32.43). In the GMC Guidance of 1988, in a section headed 'Consent to Investigation or Treatment', the GMC stated:

12. It has long been accepted, and is well understood within the profession, that a doctor should treat a patient only on the basis of the patient's informed consent.[37] Doctors are expected in all normal circumstances to be sure of their patient's consent to the carrying out of investigative procedures involving the removal of samples or invasive techniques, whether those investigations are performed for the purposes of routine screening, for example in pregnancy or prior to surgery, or for the more specific purpose of differential diagnosis. A patient's consent may in certain circumstances be given implicitly, for example by agreement to provide a specimen of blood for multiple analysis. In other circumstances it needs to be given explicitly, for example before undergoing a specified operative procedure or providing a specimen of blood to be tested specifically for a named condition.


13. The Council believes that the above principles should apply generally, but that it is particularly important in the case of testing for HIV infection, not because the condition is different in kind from other infections, but because of the possible serious social and financial consequences which may ensue for the patient from the mere fact of having been tested for the condition.[38]

32.43 The BMA publication Philosophy and Practice of Medical Ethics (in revised format in 1988) provided BMA guidance of more general application.[39] It discussed for the first time the underlying philosophical basis of medical ethics.[40] Professor Nathanson said that this allowed doctors to make a judgment for themselves when they came across a situation which had not been specifically detailed, based on the general principles underlying specific guidance. Each subsequent edition of this book has also included a section about unresolved dilemmas where the correct approach was still held to be in the balance. The 1st edition already recognised that there were many situations where the nuancing of the particular patient's situation was so important that doctors had to be given information to help them understand how to judge different things, and to recognise that medical ethics was not fundamentally about whether one or another approach or action was correct, but was about balancing different people's rights, responsibilities and duties.

32.44 In relation to consent, the passage in the 1988 BMA ethics guide equivalent to the brief statement in the 1980 publication quoted in paragraph 32.35 had become more specific, apparently reflecting the thinking in the Declaration of Lisbon. It stated:

The basis of any discussion about consent is that a patient gives consent before any investigation and treatment proposed by the doctor. Doctors offer advice but the patient decides whether to accept it.[41]

32.45 The 1988 guide did not meet with universal approval. In a review article in the Journal of Medicine and Philosophy,[42] written from a US point of view, it was stated:

Handbooks of medical ethics serve to put a little flesh on the bare bones of a professional code that is necessarily brief. Indeed in its previous incarnations (1980 and 1984) this is just what the British Medical Association's Handbook sought to do. The latest edition, retitled Philosophy and Practice of Medical Ethics, has a more ambitious aim: " set out the arguments and counter-arguments which lead either to universally accepted ethical principles or to consensus views" (... emphasis added). ... Unfortunately, the B.M.A's attempt fails. "Unfortunately", because there is a real need in Britain for thoughtful discussion of these issues, and especially for one that can reach Britain's doctors. For despite the work of the London Medical Group, and its progeny around the country, and of the efforts of the Institute of Medical Ethics and its Journal, doctors and their patients are very rarely exposed to principled arguments concerning issues such as ... informed consent and treatment decisions ... (all topics mentioned in the B.M.A book).

Viewed from a US perspective, the handbook failed to fill the gap in teaching of ethics already noted at paragraph 32.28 above. Perhaps of greater importance, it failed, in the reviewer's opinion, to meet its own aim of providing material for the debate required for consensus to emerge on ethical principles.


With effective screening of donations for anti-HCV from 1 September 1991, the cohort of patients who were carriers of the virus or its antibody as a result of previous therapy but who remained untested for anti-HCV necessarily grew smaller in a relatively short space of time. Most of them would have had a history of testing with the technology available over previous years and would have known that their medical histories reflected the results of tests for anti-Hepatitis B, other virus infections and liver function and other biometric tests. However, in large part due to the debate on testing for HIV, there was, in Professor Nathanson's words, a sea change in the approach to medical testing, and in relation to consent to treatment.[43]

32.46 The BMA's Medical Ethics Today: Its Practice and Philosophy (1993) was the first relevant publication in the 1990s. It offered a summary of the ethical background to the advice set out, as well as the advice itself. The legal basis of the advice was said to have been set out in Rights and Responsibilities of Doctors published by the BMA in 1992. The 1993 text stated that, as a prerequisite to choosing treatment, 'patients have the right to receive information from doctors and to discuss the benefits and risks of appropriate treatment options'.[44] The clinicians assisting the patient in making their decision must offer information in an appropriate manner to ensure the patient understands its relevance and is able to ask questions. In Professor Nathanson's view, an understanding developed from the late 1980s to early 1990s that meaningful consent was important. The patient should have the opportunity to make a free and sufficiently informed decision and a doctor could not do anything to a conscious and competent patient without their agreement.

32.47 In terms of content, and expression, the 1993 handbook reflected development of the philosophical underpinning of the doctor patient relationship. In relation to consent, now expressly twinned with refusal of consent, it stated:

The relationship between doctor and patient is based on the concept of partnership and collaborative effort. Ideally, decisions are made through frank discussion, in which the doctor's clinical experience and the patient's individual needs and preferences are shared, to select the best treatment option. The patient's consent to be examined and to receive treatment is the trigger which allows the interchange to take place .... [T]he basic premise is that treatment is undertaken as a result of patients being actively involved in deciding what is done to them.[45]

32.48 Professor Nathanson sought general support for her views on the doctor-patient relationship in relation to therapy from the GMC advice on Serious Communicable Diseases published in October 1997.[46] She quoted the second half of paragraph 4 from that document:

Some conditions, such as HIV, have serious social and financial, as well as medical, implications. In such cases you must make sure that the patient is given appropriate information about the implications of the test and appropriate time to consider and discuss them.[47]

32.49 This paragraph was said by Professor Nathanson to be particularly important. It was the first reference (as late as 1997) by the GMC to the non-medical, as well as the medical, implications of diseases. There are conditions other than HIV with social, financial and other similar implications and, while many practitioners may well have thought that 'best practice' implied these should be discussed, this was the first time the GMC made that obligation explicit. Though the title of the booklet was Serious Communicable Diseases, Professor Nathanson thought that the guidance set out in this particular section applied to other conditions where there were equivalent consequences. In those cases also the consequences should be discussed. By way of example, she referred to a diagnosis of epilepsy, which would have immediate serious implications, but is not a 'serious communicable disease'. It would, in her view, nonetheless come within the scope of paragraph 4 of the Serious Communicable Diseases advice leaflet. She stressed that the consequences of a diagnosis (of any condition) are not solely medical and that other factors such as family circumstances, a patient's role in the community and the workplace have to be considered. In her view, paragraph 4 reflected good practice generally.[48]

32.50 In 1998, long after the events that are relevant to the Terms of Reference of the Inquiry, the position on consent became more explicit and clear. The GMC produced Seeking patients' consent: the ethical considerations.[49] This highlighted the patient's right to information about their condition and the treatment options available, the complexity of the treatment and the risks associated with the treatment procedure, going into some detail about the information which patients might want to have or ought to know before reaching a decision. It provided:

Successful relationships between doctors and patients depend on trust. To establish trust you must respect patients' autonomy - their right to decide whether or not to undergo any medical intervention even where a refusal may result in harm to themselves or in their own death. Patients must be given sufficient information, in a way that they can understand, to enable them to exercise their right to make informed decisions about their care.[50]

32.51 In 2001 the Department of Health produced a reference guide to consent. In reviewing some of the existing sources of advice the guide commented that the 1998 GMC publication had gone further than the case law required in stating that doctors should do their best to find out about patients' individual needs and priorities when providing information about treatment options and in emphasising the duty to provide truthful answers if a patient asks specific questions about procedures and associated risks.[51] The reference guide noted more generally that the standards expected of health professionals by their regulatory bodies may at times be higher than the minimum required by law.

32.52 The Scotland Act 1998 and the Human Rights Act 1998 gave direct legal effect in the United Kingdom to the rights enshrined in the European Convention on Human Rights. The Department of Health's Reference Guide to Consent for Examination or Treatment mentioned above, set out the Department's understanding of the English common law relating to consent and the possible implications of the Human Rights Act 1998 for English medical law.[52] For present purposes differences between Scots and English law are not material. Among the Articles of the Convention that were thought likely to be relevant to the law, existing and developing, were Article 2 (protection of right to life), Article 3 (prohibition of torture, inhuman or degrading treatment), and Article 5 (right to liberty and security).

32.53 In 2003 the BMA published general ethics advice as the second edition of Medical Ethics Today.[53]

32.54 The published texts on ethics noted thus far reflect increasing sophistication in the analysis of ethical issues and in the presentation of rules and guidance for doctors to follow in ensuring good ethical standards. Each stage in the development provides focus for discussion as to whether the progression was simply expressive of an ethical standpoint that had been reached independently and was recognised in the published text or reflected innovative thought and the introduction of ideas that would not necessarily have been recognised by doctors generally prior to adoption by the BMA or the GMC as formal statements for publication.

The development of relationships between doctors and patients from the 1970s

32.55 Medical practice up to the 1970s was described as having been 'paternalistic': doctors felt that they had the necessary knowledge to deal with patients' needs and, as Professor Nathanson put it:

[D]octors would tell patients what they thought the patient ought to know and they would tell the patient what they were going to do as doctors to the patient.[54]

32.56 Many of the medical witnesses who gave evidence to the Inquiry confirmed Professor Nathanson's description of the paternalism that was endemic at the beginning of the reference period. Dr Winter, who was for most of his career a Haemophilia Director, gave as an example the fact that, when he was working as a leukaemia doctor in 1980, it was by no means standard that a patient would be told about the diagnosis of a serious condition. At that time, it would be normal to speak to the patient's family first to find out if the patient would want to know about the diagnosis. Sometimes the next of kin would say that they did not want the patient to be told. He explained that there was no culture of doctors and nurses working with patients. A patient was 'a passive vehicle with an illness'. The patient went into hospital where an 'active vehicle' - the doctor or the nurse - made the patient better. A patient was not expected to have a view about treatment; rather, they would be told their treatment and would not be offered any choices about it. Dr Winter thought that this was particularly the case with haemophilia patients who had usually been seeing the same nurse and same doctor at the same centre for years. This made patients with haemophilia very trusting of their doctors and more passive.[55]

32.57 Professor Nathanson put the matter bluntly:

In the late 1970s many doctors did not tell patients the whole truth, especially where that truth was of a diagnosis of an incurable illness. This was the well-intentioned legacy of Thomas Percival's influential text on medical ethics.[56] The intent was to shield patients from disturbing information. The duty of beneficence was interpreted as an obligation to be reassuring rather than honest.[57]

32.58 Professor Forbes acknowledged the existence of paternalism in the early days.[58] This position was also confirmed by the one of the patient witnesses in her written statement. She was a retired nurse who contracted HCV from a blood transfusion in the late 1980s. She captured the atmosphere of the period when she was in employment and provided an illustration of the 'paternalistic' doctor-patient relationship that persisted at the material time:

When I received the blood transfusions, nothing was discussed with me regarding the benefits and risks of a blood transfusion. This was not done in those days. When I worked as a nurse in the 1970s and the early 1980s, I gave blood to patients. You never discussed the risks or benefits of this with patients although you maybe told them to watch for a reaction. I was not informed of a risk of infection from any of the blood transfusions. I was not given an opportunity to refuse the blood transfusions. You just did what you were told.

32.59 Professor Nathanson noted that there has been a continuing move from this essentially paternalistic, 'doctor-knows-best' culture to a working relationship where the patient is fully involved in decision-making, or 'patient-centred medicine'. The emergence of AIDS appears to have accelerated this move. Changes occurred, according to her evidence, due to improvements in doctors' education and training, including improved teaching of medical ethics and training in communication skills so that doctors could speak with patients and relatives in a sensitive manner.[59] Although, in general, '[t]he earlier the time frame under consideration the commoner an essentially paternalistic approach would have been'[60] progress has not been uniform: the attitudes and practices of individual doctors changed at different rates within a broad pattern of historical change.

32.60 Professor Nathanson commented that many doctors had begun to depart from the historic, paternalistic, approach early in the reference period and began instead to develop a more equal relationship with patients.[61] From the whole evidence on this topic, it appears that the culture of paternalism subsisted beyond the end of the 1970s and characterised practice widely, if not universally, in the early 1980s when formal ethical statements began to appear. The timing of these changes, and the timing of general acceptance that ethical principles had changed, are issues in this chapter.

32.61 It was not suggested that the BMA handbooks published in 1980, 1981 and 1984 pointed to a significant change in or development of general principles. The advice given in these handbooks was situation-specific until 1988.

32.62 In the period between 1980 and 1988 the AIDS epidemic struck and the advent of that disease brought about a major change in perception of the relationship between doctor and patient and in clinical practice. It is probably fair to say that the emergence of AIDS and the public and medical responses to it have had a more profound effect on relationships between doctors and patients than any other single event. Not only did it affect attitudes generally, it also impacted on a wide range of specific ethical issues, such as the need for informed consent to testing and treatment. Statements on medical ethics, published in and after 1988 after AIDS became a reality for coagulation disorder patients in the UK, reflected those changing attitudes.

32.63 As noted above (paragraph 32.42) the statements in the GMC and the BMA 1988 publications were introduced as reflecting long accepted practice. In formulating new rules, as in 1988, it is understandable that bodies such as the BMA and the GMC should seek support in principles thought to be implicit in earlier practice. It is an important stage in the development of any system of regulation of professional behaviour when one can distil from accumulating evidence of particular instances of conduct, on one side of acceptability or the other, a principle or rule of general application. However, the formulation adopted may nevertheless understate what may be a considerable degree of innovation, especially where a regulatory or representative body is seeking clearly to express current expectations of practitioners' approaches to practice.

32.64 When the stage is reached at which formal expression of principles and rules is appropriate, it is not unusual to find precedents cited.

32.65 It would not, however, be appropriate to infer from the juxtaposition of the references in Professor Nathanson's evidence that there was a common basis for advice spanning two centuries. The context of the Slater case (see paragraph 32.21) conjures up an image of procedures, life-threatening in themselves, requiring the patient to prepare for all eventualities rather than a rational discussion of options: the doctor had to tell the patient what he was about to do and warn of possible outcomes. The modern approach to providing information and supporting patient choice has much more recent origins.

32.66 Professor Nathanson's observation, that Rule 1 of the Nuremberg Code (see paragraph 32.22) was the 'first explicit modern statement' of the right of every patient to consent to and hence to refuse any medical treatment, points to a problem inherent in her approach to describing generally accepted standards of ethical conduct. She construed Rule 1 of the Nuremberg Code as expressing the right of every patient to accept or refuse medical treatment. She accepted, however, that the rules would not have been well known to doctors, not just in the United Kingdom but throughout the world. Since this was, on her approach, the first explicit modern statement of the rules, it became necessary to consider the evidence which had a bearing on a broadly based ethical obligation to recognise the patient's rights, apart from their formulation in formal statements in the 1980s.

32.67 Given the clear evidence noted above of the 'paternalistic' attitude of doctors to patients, it is not possible, on the evidence before the Inquiry, to form a view that in the 1970s proper ethical practice depended on, or drew heavily on, the Nuremberg Rules, or historical judicial observations adapted to particular situations.

32.68 It is perhaps not surprising that the Nuremberg Rules were not well known to doctors. It would be difficult to read them as a code intended to regulate general clinical practice, rather than specifically concerning experimentation on human subjects, the specific context for which they were drawn up. While one can see reflections of part of the language of Rule 1 in later statements of practice and while it can be accepted that those who drafted later the BMA and the GMC guidance may well have drawn on the language of the Code, it cannot be maintained as a matter of language or substance that Rule 1 was an explicit statement of the right of every patient to consent to and hence to refuse any form of medical treatment. As Professor Nathanson recognised, the modern rule on consent is not unqualified: public health requirements may over-ride individual patient interests, for example.[62] The Nuremberg Code was unqualified because it dealt with a particular and limited context in which more or less absolute rules were appropriate.

32.69 In contrast to these sources, ethical principles and rules may often be influenced by judicial decisions. Decisions declaratory of the common law are, in principle, not innovative, and may support the view that a professional response, in stating or re-stating current ethical requirements, is an expression of the pre-existing position. Medical Ethics Today: Its Practice and Philosophy (1993) stated (in the language of English law):

In many aspects of medicine, the legal and ethical requirements are separate and ethical guidance need make no reference to law. Consent, however, is an issue which binds the two since failure to seek patient consent is not only a moral failing but leaves the doctor liable in the crime or tort of battery or in the tort of negligence.[63]

In Scots law, the doctor might be liable to criminal proceedings for assault or open to a claim for damages for negligence.

32.70 Some landmark decisions were relevant to the consideration of generally accepted standards of ethical conduct:

  • In Bolam v Friern Hospital Management Group (1957) it was noted that the test of negligence in treatment of a patient had long been whether the doctor's practice conformed to that of a responsible body of opinion among practitioners skilled in the relevant field.[64]
  • In Scotland, similar principles had been expressed in 1955 by Lord President Clyde in Hunter v Hanley. The test was said to be whether the doctor has been guilty of such failure as no doctor of ordinary skill would be guilty of if acting with ordinary care.[65]
  • The legal standard for deciding whether adequate information had been given to the patient was held in Sidaway v Board of Governors of the Bethlehem Royal Hospital (1985) to be the same as in negligence.[66]

32.71 It is possible that there had been a professional standard relating to explicit and informed consent prior to 1988 that was higher than the standard in negligence. However, Lord Scarman's comments in the Sidaway case, quoted in Medical Ethics Today (1993), suggest that that would have been difficult. Of the test in negligence, he said:

Ideally, the court should ask itself whether in the particular circumstances the risk was such that this particular patient would think it significant if he was told it existed. I would think that, as a matter of ethics, this is the test of the doctor's duty. The law, however, operates not in Utopia but in the world as it is: and such an inquiry would prove in practice to be frustrated by the subjectivity of its aim and purpose.[67]

32.72 In Medical Ethics Today: Its Practice and Philosophy (1993), at page 11, it was commented:

Thus ideally, the doctor should inform the patient about any risks inherent in the treatment which might be particularly important to that patient as well as explaining the risks and benefits of alternatives and of non-treatment.[68]

32.73 It is not unlikely that a doctor, also operating in the world as it is in treating a patient, might be as frustrated by the ideal question as is the law. One might think it necessary that a regulatory or advisory body stipulating that the clinician should ask 'whether in the particular circumstances the risk was such that this particular patient would think it significant if he was told it existed' should also provide guidance on how to approach the question and gather the information required for a rational analysis. The 1993 guidance attempted to do that, but that was after the material period for this Inquiry.

32.74 The Inquiry was not provided with published evidence that there was a generally accepted rule of practice up to 1988, of sufficient specificity, that was more demanding than the test of negligence (namely, did the doctor's practice conform to that of a responsible body of opinion among UK practitioners skilled in the relevant field) and specifically a test requiring a doctor to treat a patient only on the basis of the patient's explicit and informed consent. On the best view of the publications and Professor Nathanson's evidence, the 1988, and then the 1993, publications were the first specifically to adopt that formulation.

32.75 Professor Nathanson adopted the position that each of the BMA and the GMC 1988 publications represented the general comments on consent as reflecting long accepted practice, well understood within the profession. Though focussed on HIV infection, she considered it clear that paragraph 12 of HIV Infection and Aids: the Ethical Considerations, quoted above at paragraph 32.42, described the basis of treatment for all illnesses and not just HIV.[69]

32.76 Professor Nathanson commented that the best practice standard in 1988 was that doctors only treated patients with their consent. Patients made the decisions and the doctor offered advice and guidance and might assist an individual in deciding between treatments but ultimately it was the patient who made the decision:

[I]t was quite clear to me from published information that we would expect that patients would be given information to make decisions for themselves, certainly about treatment.[70]

32.77 In presenting her evidence, Professor Nathanson did not distinguish testing from treatment. The 1988 statement in the GMC publication HIV Infection and Aids: the Ethical Considerations reflected the Council's view that consent was required for treatment, but spelled out specifically its view of the need for consent to investigative procedures. Professor Nathanson thought that the approach of the publication reflected more general changes in attitude among doctors during the 1980s. This led to discussion. Professor Nathanson said that it was a highly complicated issue. In the mid 1980s the BMA sought legal advice from counsel whether consent to treatment included consent for testing (specifically with regard to HIV testing). Counsel's opinion was explicit that treatment included testing, in that it was a necessary implied part of treatment.[71]

32.78 Professor Nathanson commented in oral testimony:

We had expected that to be the case because you don't do testing if you are not thinking of doing something with that test result and you can't carry out treatment without having done testing, and they are so integrated that treatment is held, and I think in most of medical practice would be held, to include that process of seeing the patient, examining them, taking a history and so on, doing various tests and carrying out treatment and monitoring that treatment and modifying it, and that that is all-encompassed under that word "treatment".[72]

32.79 So far as related to periods before 1988, the representation that the statements concerning consent published in 1988 were long-accepted practice became a focus for disagreement between Professor Nathanson and other experts. Having regard only to Professor Nathanson's evidence of the background circumstances in which the GMC came to adopt the guidance of 1988 relating to HIV testing, it would be difficult to accept the statements in the 1988 publications as an indication of a generally accepted standard of ethical conduct in, say, 1984, a significant year in the investigation of the prevalence of HTLV-III/HIV infection in the haemophilia population. Professor Nathanson considered that later publications such as Medical Ethics Today: Its Practice and Philosophy (1993) also expressed what was already accepted or established as proper ethical conduct by the time of publication.

32.80 On the evidence available to the Inquiry, the formal documents published by the BMA and the GMC remain the best sources of evidence of when the process of development of thought crystallised into rules of general ethical practice, what those rules were, and how they were regarded by the medical profession, in the material period.

Testing for HIV and the communication of test results

32.81 As events were to prove, the risk of transmission of NANB Hepatitis/HCV was present before and continued after the AIDS period (broadly 1981 to 1985 in the case of coagulation disorder patients). However, there are questions as to whether AIDS was so significantly different from other viral diseases that the scientific and clinical response to it marked a step change in ethical practice that not only affected later ethical standards relating to hepatitis, but also innovated on previous accepted standards. If the answer to these questions is in the affirmative there is a further question as to whether one can infer from views expressed during and after the AIDS period what the direction of change in standards had been or was likely to have been in relation to NANB Hepatitis/HCV.

32.82 As already noted, the statements of 1988 narrated that the guidance then set out reflected 'long accepted practice'. There is a temptation, to which those seeking to drive forward professional standards are perhaps irresistibly exposed, to make assertions to that effect. The response to an emerging problem such as AIDS may provide an opportunity for a wider and more general re-assessment of standards: anything that disturbs the equilibrium of a more or less static social group can open the way to radical change. Both factors are apparent in the 1988 documents.

32.83 The impact of AIDS was swift and significant following the first reports in 1981. Dr Hay said 'the presentation itself was fairly dramatic and ... it was associated with death from the very beginning'.[73] Some patients with haemophilia died early in this period. In the mid-1980s an HIV test became available for use and it became apparent that 50% of UK patients with severe haemophilia were infected. There were patches of the UK (and in Scotland in particular) where the concentration of infection was lower.[74] However, under these circumstances, HIV/AIDS became the principal concern of both haemophilia clinicians and their patients. Dr Hay said:

This overshadowed hepatitis, which was considered benign and of little concern at the time to the extent that patients were not counselled to the same degree about non-A, non-B hepatitis as they had been in the immediately preceding period.[75]

32.84 He also commented that:

The implications of a +ve HIV test could be perceived as a death sentence, led to loss of insurance, marriage breakdown, and even in some cases suicide.[76]

32.85 Speaking about communication with patients, Dr Mark Winter stated that the culture of medicine 'was completely changed by AIDS'.[77] Many of the clinicians who lived through the period have also stressed that the arrival of HIV and AIDS was responsible for changing medical practice irrevocably. It is important to remember the effect of AIDS when examining the practices and decisions taken by clinicians during the reference period, and the suddenness with which they were confronted by this new disease. Even so, it was 1988 before the GMC responded with the publication of HIV Infection and Aids: the Ethical Considerations.

32.86 The circumstances leading up to the publication of HIV Infection and Aids: the Ethical Considerations have been described in paragraph 32.40 above. HIV testing was distinguished from other conditions for which patients were tested. The question of consent to investigation first became prominent in the second half of 1984 when research assays were used to investigate the prevalence of HTLV-III/HIV in a broad range of cohorts including haemophilia patients, and then more generally in early to mid-1985 when the first diagnostic test for antibodies to the virus became available and the significance of the results began to be appreciated. It is not necessarily the case, however, that there would have been widespread appreciation of the issue throughout the medical profession.

32.87 Professor Nathanson emphasised the small number of AIDS cases that would have been seen by non-specialist medical professionals, even by 1986 and 1987 when the BMA committee on standards and ethics was considering the topic that resulted in the guidance of 1988.[78] The science on AIDS was at an early stage and still evolving. The majority of doctors in the UK had never seen a patient who was HIV-positive or who had AIDS. Many doctors might have known the symptoms: they would have known the theory but they may not have been completely up to date.

32.88 There were specialists with intimate practical experience and knowledge of HIV. Infectious diseases doctors and haemophilia clinicians were among those who did see a disproportionate number of patients with HIV and Professor Nathanson's views on the ethical requirements for testing have particular relevance in the context of the management of their patients.

32.89 Considerable debate developed over whether those for whom a test for HIV might be considered clinically relevant needed to be asked for consent to the test. In the early days of testing many doctors believed that HTLV-III antibody tests could and should be carried out without consent and that taking blood for the test at the same time as other routine medical tests would mean that 'necessarily implied consent' had been given. In her report Professor Nathanson commented:

If patients are aware that they are routinely and regularly being tested for a panel of infections, for example blood borne viruses, it was certainly arguable that testing for hepatitis C was no different from other such routine tests. Many would then have considered testing for HIV in the same way, given that there was at the beginning of the period considerable doubt as to its nature, transmissibility and relevance to the newly emerging medical condition of acquired immune deficiency.[79]

32.90 Professor Nathanson commented on what specific consent requires:

The General Medical Council's advice is that consent requires that the patient understands what you are doing, why you are doing it, what the consequences are and what you will do about it. It's a counsel of perfection. How much we all, as individual patients, remember about what we are told is always variable and arguable, but certainly all that information should be made available and should be offered to the patient and there should be no limit .... You should be prepared to tell the patient everything.[80]

32.91 She also described what was meant by 'necessarily implied consent':

Necessarily implied consent really means that the patient is doing something which makes it clear that nobody would argue that they are doing anything other than consenting to that test. The interesting issue around this was, for example, if you go in to see a doctor and the doctor says, "I want to take some blood tests" and you roll up your sleeve and hold your arm out to have the blood taken, then you are clearly necessarily implying [consent] to having a needle stuck in your arm and some blood taken.[81]

32.92 In relation to HTLV-III/HIV testing, Professor Nathanson's own view was unequivocal. Put simply, testing required specific consent. The concept of necessarily implied consent could not be held to apply to testing for this virus. In principle, implied consent could only be held to apply to procedures in hand and not to new procedures.

32.93 How that related to the general clinical environment can perhaps best be understood in the light of Professor Nathanson's observations on the steps she considered it was necessary for her to take as head of ethics at the BMA:

[O]ne of the first things I did in April 1987 - when I took over as head of ethics, I was involved ... in developing a series of videos for doctors, which Wellcome actually sponsored, and we got pharmaceutical reps to take it around the country into every GPs surgery: three films on testing for HIV, including getting consent, upon all the issues around control of blood-borne infections and particularly the kind of advice that they could give to families. We were developing a lot of advice to individuals, but also schools and churches were contacting the BMA for advice on the risks of cross-infection and there was just a lack of good solid, simple consolidated information on the science for the non-experts and the people who might be seeing a case for the first time.[82]

32.94 The observations are significant. They reflect the lack of previous advice from regulatory, advisory and other official sources; they underline Professor Nathanson's own role among those driving developments in ethical practice; they provide a reference date for the provision of effective advice about HIV to the wider profession; they define the background to the publication of the BMA's advice in 1988; and they express the lack of relevant knowledge of the disease among the medical profession generally. Finally, they reflect the contemporaneous understanding among those leading the development of professional thought, that guidance on questions such as consent was required.

32.95 At this time, the BMA was moving towards the provision of explicit advice generally. Professor Nathanson commented, specifically in relation to testing, but with wider relevance:

Throughout medicine, consent was obtained for most things that are done. The question was always about whether a test was something that was so much inherently part of the treatment, including the diagnosis, of that patient that it was covered by necessarily implied consent or whether it was something that was less common, less usual, less standard and therefore needed to be explicitly taken out of that and to be absolutely explicitly the subject of consent. We were in the process of moving towards being as explicit as possible about everything that is done and that included the HIV test, and many people who were content with the concept of necessarily implied consent for many other tests were not content for it on HIV, for example, because of other reasons, not necessarily purely medical ones but because of the consequences of the test result.[83]

32.96 Pre-test counselling for HIV raised specific issues. Professor Nathanson explained:

Pre-test counselling is a little different. When you are testing for some conditions, what you would then do is say, "In this one area of testing there are some very specific things which you need to understand about the limits of the test or the implications of the test". With HIV we really started to discuss pre-test counselling in a very formal basis, not necessarily because of the diagnosis clinically but predominantly because of the social and economic consequences. So the inability, for example, to get life insurance, mortgages, those sorts of things, for patients. And particularly early on, when we didn't know whether people would survive or not ....[84]

32.97 The 1988 guidance highlighted the specific non-medical consequences of a positive result, such as social stigma or employment and financial consequences. Professor Nathanson noted that such consequences may emerge and develop over time; they may not be recognised when a procedure is first introduced, although HIV did quickly come to have obvious and serious non-medical consequences, essentially financial and social.

32.98 By 1988 it was also recognised that consent was particularly important in the case of testing for HIV infection because of the possible serious social and financial consequences which might ensue for the patient from the mere fact of having been tested for the condition, irrespective of the result of that test.

32.99 Professor Nathanson explained that the modern approach is to offer full information to a patient about the results of a test but not to oblige them to receive that information if they indicate that they do not want to know.[85] Where there are health benefits to a patient from knowing their diagnosis or where a third party (such as a sexual partner) could benefit from knowing about the diagnosis, a clinician can and should press harder to encourage a patient to agree to be told of their results. However, she said that she would be reluctant to 'force' a patient to know the results of any given test, but that a medical practitioner should use appropriate communication skills to assist the patient in understanding the implications and to agree a plan of action. She explained that in some circumstances a clinician might increase the 'amount of weight' that they put in to persuading a patient about the benefits to them of receiving results.[86] She said that most clinicians in these circumstances found that patients: 'don't ever say they don't want to know something when you are telling them that there is a benefit to them in knowing'.[87] She acknowledged that it is 'extraordinarily difficult' for a doctor to approach the question of positive test results without signalling to the patient that they have bad news to impart.

32.100 Professor Nathanson explained that it was essential for the doctor to let the patient know that s/he has information about him, that tests had been done, and that results were available, and to ask whether the patient wanted the results. She said that it became easier to communicate results as time went on because coagulation disorder patients, who had access to the literature, and were a well-informed group, knew what was happening and realised that 'more and more of their number were being found to be positive'.[88]

32.101 The GMC guidance in 1988 stated that:

The Council takes the view that any doctor who discovers that a patient is HIV positive or suffering from AIDS has a duty to discuss these matters fully with the patient.[89]

32.102 In relation to the Council's view, Professor Nathanson said:

I think that that's the first time that the GMC was as explicit as this and I'm not aware in any of their earlier publications that they had been as explicit, in any condition, about informing the patient. It had been implicit in a great deal of what they have said but not explicit. So certainly at that time, in 1988, it would have been clear to all doctors on the basis that the GMC advice goes literally to all doctors on the register.

It didn't go into any more detail about it but I think that the duty to discuss these matters fully is pretty explicit and would make it clear that you had to discuss all the relevant matters.[90]

32.103 She contrasted the position adopted with what had generally been the situation previously. The Council's published view of the doctor's duty to discuss with the patient, in her view:

[R]ecognised, of course, that that hadn't been the case in the past. If all doctors had always told all patients the full details, fully informed, fully discussed, then they wouldn't have needed to make the statement or the statement would have been made something like, "As with all other conditions," or something of this form.

The fact that they felt it necessary showed that they recognised that doctors didn't always tell patients everything or fully discuss and that this was essential. And certainly in the late 1970s, it would have been extremely rare to tell patients everything but this was part of this evolution towards patient-centred care that I described earlier, that this was becoming a commoner practice anyway.[91]

32.104 That period, in Scotland and indeed generally, was a time of great change in coagulation disorder therapy. HTLV-III/HIV infection had been identified in haemophilia patients and widely publicised, causing great disturbance. The majority, if not all, of haemophilia patients in Scotland (at least in the two major regions with centres in Glasgow and Edinburgh) had been tested using stored samples from routine management of their primary condition. Virus inactivation processes in the manufacture of Factor VIII concentrates were quickly devised at the end of 1984 and implemented from January 1985, changing the context in which risks associated with continuing therapy might be discussed: patients newly diagnosed with Haemophilia A after January 1985 were not exposed to risk of transmission of HIV by SNBTS concentrates. The emphasis was changing from testing (in many cases a past event) to repeat testing of established patients and the communication to them of test results. While Professor Nathanson's evidence was uncompromising that patient consent to testing was necessary, in the short period when risk was at its highest (roughly from 1982 to the end of 1984) the context for providing information and advice and seeking consent to investigation was changing rapidly. Her own actions on appointment as Head of Ethics in April 1987 were clearly innovative.

32.105 In the circumstances, it is difficult to infer from Professor Nathanson's evidence alone that there were generally accepted ethical standards relating to the management of patients actually or potentially exposed to risk of HIV infection in the critical, short, period between 1982 and the publication of the 1988 guidance.

32.106 Other evidence on this topic indicated that there were variations in approach. Dr Winter said that in 1984 and 1985 the way that results of HIV tests were communicated to patients varied very widely. At his Centre he personally met with each of his patients to give them news of the outcome of tests.

32.107 In a paper produced in response to Professor Nathanson's first report, Dr Hay commented on consent to testing and the communication of test results.[92] He said that paragraph 4 of the 1988 GMC Guidance HIV Infection and Aids: the Ethical Considerations, which dealt with obtaining consent to testing, reflected normal practice for HIV infection only from the late 1980s onwards. He explained that most haemophilia centres counselled patients at the time of HIV testing, from 1985, and then communicated the results in face-to face interviews. Much of what the patients were told in those interviews turned out to be incorrect but it was the best information or opinion available at the time. Some centres took a different approach. He said that in Liverpool and Manchester HIV results were communicated to the patient by letter. He commented:

This practice was widely considered reprehensible, even at the time, and left an understandable and enduring legacy of anger and bitterness in the affected families. There was no agreed policy about this at the time, however. Counselling for HIV testing became more formalised and universal in the later eighties.[93]

32.108 In that respect, the management of patients exposed or potentially exposed to risk of HIV infection was not distinguished from practice in relation to viral infection generally. It appears to be clear that Professor Nathanson's observations relating to the doctor's duty to discuss HIV with patients were equally applicable to the wider context. There was no settled ethical standard relating to NANB Hepatitis, for example, available to the BMA or the GMC as a model or point of reference for the development of standards specific to HIV.

Testing for NANB Hepatitis/HCV and the communication of test results

32.109 The evidence of Dr Hay and Professor Nathanson in respect of testing for NANB Hepatitis/HCV and the provision of information to patients is recounted below. It will become apparent that there were some differences between them.

Testing for NANB Hepatitis/Hepatitis C

Dr Hay

32.110 So far as haemophilia and other coagulation disorder patients are concerned, Dr Hay's approach to HCV testing and the provision of information did not vary according to the therapeutic products that had been administered, though he commented on the different levels of risk to which those receiving large-pool products were exposed in comparison with those who had received single donor products, and transfusion patients.

32.111 Dr Hay's assessment of the risk of HCV transmission by way of large-pool blood products was clear: 'Patients treated with pooled blood products prior to the introduction of viral attenuation in 1985-87, will have been infected with hepatitis C'.[94] With donor pools for manufacturing concentrates containing 20,000-50,000 donations in the commercial sector, even with a low prevalence of infection in the donor population,[95] inevitably there would be a number of infected donations in each plasma pool. He reiterated the point in oral testimony: 'all the concentrates prior to viral attenuation would transmit Hepatitis C'.[96] Given the large number of donor units in each pool,[97] there was realistically no difference, in terms of HCV-infectivity, between different product brands sourced from the UK, mainland Europe or the USA or between large-pool products based on paid or voluntary donations.[98]

32.112 By contrast, the risk of HCV transmission for transfusion patients (or haemophilia patients using cryoprecipitate) was considerably lower. Dr Hay described a methodology for estimating the risk of transmission of HCV from single-donor blood products:

The risk of transmission of hepatitis C from ... single-donor blood products depends on the number of units transfused, the year in which the donations were collected and the prevalence of hepatitis C in the relevant donor population at that time .... The prevalence was considered relatively high in the USA and in Southern Europe but relatively low in Northern Europe: the UK, France and Holland.[99]

32.113 As applied to the UK around 1982-84, Dr Hay estimated the risk as 'probably significantly in excess of 0.4% .... This would place the risk during 1983-4 at between 0.6% and 1% per unit of single-donor blood product transfused, say 0.75%'.[100] On this assessment of risk, many coagulation disorder patients would have been infected with HCV before they were given concentrate, especially those with severe haemophilia who were regularly treated with cryoprecipitate.[101]

32.114 The situation changed from around the mid-1980s with the introduction of donor self-exclusion for at-risk groups and HIV testing of blood donated for clinical use.[102] Some evidence suggested an approximately tenfold reduction in the risk of post-transfusion HCV transmission as a result. Although Dr Hay observed that this would not make much difference to the risk from concentrates derived from large donor pool plasma, for the reasons already given, the risk of transmission from single donor units such as cryoprecipitate or red cells was considerably reduced.[103]

32.115 The mid-1980s marked the point at which there was growing appreciation of the severity of the risks associated with NANB Hepatitis. For transfusion patients that was off-set to some extent by the reduced risk of transmission but the risk of transmission was not materially reduced for those receiving large-pool concentrates. For all patients, the risks of progressive liver disease became more fully understood in about 1991, when anti-HCV testing was introduced, and there was a further step change in understanding in 1995 when the link between HCV and hepatocellular carcinoma was established.

32.116 Dr Hay said that from the mid-1970s to the early 1980s very little would have been said to patients about NANB Hepatitis because little was known about the condition and because, insofar as it was understood, it was not thought to be a serious clinical concern.[104]

32.117 Although local practices varied, in Dr Hay's experience haemophilia centres had started to check liver function tests regularly in about 1980.[105] Patients may have had 'persistently' or 'intermittently' abnormal liver function test results. At this time, if a patient had at least two abnormal liver function tests over at least six months, the condition was described as 'chronic'. Dr Hay said:

From the late 1970s onwards, most regularly reviewed patients would have had liver function tests conducted and I would expect most of those affected to have been told that they had non-A, non-B hepatitis but that it was probably nothing to worry about.[106]

32.118 Advice on NANB Hepatitis in the mid-1980s was similar to the advice given in the previous period. Dr Hay commented that in the mid-1980s patients would have been told that NANB Hepatitis was, comparatively at least, nothing much to worry about at around the same time as they were being informed of life-threatening HIV in the blood supply. The risk of HIV/AIDS had come to dominate thinking.

32.119 Dr Hay said in oral evidence that he provided counselling for patients prior to testing for HCV. In his haemophilia centre, the staff informed patients they were testing them for Hepatitis C, discussed the result face-to-face with them when available and wrote to their GP and documented the discussion.[107]

32.120 The patient would have the opportunity to refuse the test. Although some patients did not want to be tested for HIV, Dr Hay could not recall anyone refusing an HCV test. Clinicians would have had an idea of the likely results when patients were tested for HCV for the first time on the basis of a history of abnormal liver function tests. Dr Hay said that he would discuss the implications of a positive HCV test result and, if the patient had a history of abnormal liver function tests, he would have prepared them to expect a positive result.[108] He explained:

[I]f I was testing for hepatitis C, I would tell the patient that I was going to conduct the test. I would take the opportunity to talk to them again about hepatitis C. I would have expected that conversation would already have taken place about liver disease. I would not take written consent for the test.[109]

32.121 Dr Hay compared the national guidelines for testing patients for HIV.[110] The circumstances surrounding HIV testing required a much longer and more involved conversation, having regard to the wider consequences for the patient, and patients should have been given the opportunity to go away and think about it before providing a blood sample for a test.[111]

32.122 The implications of a positive HCV test result were, and are, quite different from those associated with a positive test for HIV and the pre-test conversation would be different in each case. Dr Hay considered that pre-test counselling for HIV was not an appropriate model or point of useful comparison for HCV testing. The discussion with a patient prior to an HCV test would typically take five minutes, unless the patient had a great many questions.[112] Now, the discussion tends to be about the side-effects and relative merits of treatment. That would not have been part of the subject matter prior to the introduction of Interferon in the mid 1990s. Dr Hay was of the view that haemophilia clinicians talked more about HCV tests with their patients than hepatologists would, in part because of their experience with HIV testing. He thought this may have created an expectation of what 'counselling' entails in that patient group different to that in the general population. He thought that, when thinking of the HCV test, haemophilia patients tended to draw a parallel with their experience of counselling related to HIV and respond critically, in comparison, to the discussion that took place prior to HCV testing. In reality, according to Dr Hay, there were probably never any guidelines on taking consent for Hepatitis C testing.[113]

32.123 Dr Hay commented on the differences in approach adopted by hepatologists and haemophilia practitioners respectively.[114] In his view, a hepatologist was likely to tell a patient more assertively that they intended to test for hepatitis viruses because the patient's liver function was abnormal. A haemophilia clinician was more likely to tell a patient they thought a test for HCV was appropriate since it was a probable cause of their signs of liver disease. He acknowledged that there was a distinction between the approaches, but he did not agree that the approach of haemophilia practitioners involved asking for the patient's consent to test. He thought it was more likely to be down to the style of the individual doctor involved.[115]

32.124 He considered that haemophilia clinicians were obliged to test everyone for HCV and would be open to criticism if they did not. If a patient had said 'no' to a test, there would have been a further conversation and in Dr Hay's view consent would have been obtained by persuasion. In reality, he thought that some of his colleagues may have tested for HCV without informing the patient specifically that they were testing for the virus.[116] They may have regarded it as just another liver function test and with this came the view that there was no need to discuss it or to request consent.[117]

Professor Nathanson

32.125 Professor Nathanson's view was that the best practice standard of 1988, that a patient give consent to any investigation and treatment proposed by the doctor, still applied in the 1990s. In her view the best practice in the early 1990s, when an HCV test became available, would have been for the patient to be told they were being tested for Hepatitis C before a sample of blood was taken for that purpose. She said:

So it was quite clear to me from published information that we would expect that patients would be given information to make decisions for themselves, certainly about treatment. The question that always comes then is whether testing is counted as treatment, and the best practice advice, again from the 1980s, is very much that it does, that testing is the beginning of medical treatment. It is the precursor to actually offering a treatment, whether that treatment is surgery or drugs or whatever else it is, that you have to first establish a diagnosis and that testing is part of that process. So you would expect the patient to consent to that test.[118]

32.126 However, she said that much would depend on the individual patient. For all but new patients introduced to testing for the first time the history of prior testing was an important factor. If the patient had already been informed on the basis of previous monitoring that it was likely that they had NANB Hepatitis, the HCV test became in effect a confirmatory test for a specific virus. Professor Nathanson explained that the preference in those circumstances would be for patients to have been told specifically that they were being tested for one of the viruses that appeared to cause NANB Hepatitis:

That didn't mean you went back to first principles every time you did a repeat test; it just meant that the patients already knew that they had non-A non-B Hepatitis. It might simply have been, "We now have a test for a particular type of non-A non-B and we are going to carry out that test for you ...."[119]

32.127 However, she would expect that at that time there would be some clinicians who would not have given patients that explanation.[120] Some doctors embraced the new ethical imperatives more quickly than others.

32.128 Telling a patient that they were being tested for HCV would have involved counselling the patient about the test before it was performed, a provision that left considerable scope for flexibility in dealing with individual patients. She explained that counselling prior to HCV testing was a means of giving patients the information they needed to help them make a choice on whether to have the test or not.

32.129 Professor Nathanson was asked about the information relating to HCV that should have been given to patients before a test was carried out after 1997. She explained that much depended on the specialist carrying out the test. From 1997, a liver specialist seeing a patient on referral from another clinician would not have to explain to a patient that they had liver function problems. The aim of the liver specialist was to carry out a series of tests to ascertain what could be done to determine the cause of and to treat the abnormalities for which the patient had been referred. A clinician seeing a patient earlier in the process, when it was unclear what their medical condition was, would have a different approach and would discuss with the patient the need to have their liver function examined. Much of the counselling would have been done before the patient was referred to the liver specialist.[121]

32.130 Professor Nathanson said that, in comparison with pre-test counselling for HIV, she would expect pre-test counselling related to HCV to be relatively brief for most patients. Some patients would require a longer time if they found the diagnosis more difficult to accept. She would expect patients to be told it was a kind of hepatitis that had a long natural history and that it could be treated. The treatment could be unpleasant but it could be successful. If the patient's HCV test proved to be positive, it would be advisable to have further tests and almost certainly treatment would be offered.

32.131 She would not expect there to be have been much of a discussion of non-medical implications unless the testing doctor was aware of something specific for a particular patient. If a patient was a healthcare worker, for example, there would be particular concerns regarding the possible risk of transmitting the virus through their work. She was uncertain about advice to patients regarding sexual transmission as her understanding was that the evidence showed that HCV was not readily transmitted that way. The very limited evidence that it could be transmitted could be mentioned to the patient so that they would have the ability to protect their partner from any risk of transmission.

Communication of results

Dr Hay

32.132 As detailed in paragraph 32.116 above, from the mid-1970s to the early 1980s very little would have been said to patients about NANB Hepatitis. The general message to a patient diagnosed with NANB Hepatitis would have been reassuring. In his report Dr Hay summarised the position relating to NANB hepatitis at this stage:

In the late 1970s and early 1980s patients should have been told what was known about this type of hepatitis at that time. This would include:-

a. Patients were generally asymptomatic

b. That it was benign and non-progressive

c. There was no test [for the condition]

d. It was thought not to be readily transmissible

e. There was no treatment at that time

f. Patients should minimise alcohol intake.[122]

32.133 As noted above, however, understanding of the natural history and severity of NANB Hepatitis had developed by the mid 1980s and the information available to clinicians, and therefore their patients, had improved. Dr Hay set out what haemophilia patients infected with NANB Hepatitis ought to have been told in this period:

In the mid 1980s most affected patients will have been told:-

a. That they had non-A, non-B hepatitis,

b. But since hepatitis was still considered non-progressive they would have been told that it was benign and non-progressive in most patients

c. That a minority, perhaps 20%, developed cirrhosis eventually

d. That it was generally asymptomatic.

e. That it was slowly progressive if it did progress

f. That there was no test or treatment

g. But we needed to monitor the liver disease systematically

h. That they should minimise alcohol intake[123]

32.134 Most patients received their first HCV test result in 1992 or 1993, shortly after tests became available.[124] Dr Hay explained that many patients had gained the false impression that they contracted HCV in 1992 or 1993 because that was the date of their first specific positive HCV test. In fact, as discussed above, clinicians had been aware of NANB Hepatitis for some years through routine monitoring of liver function tests. Dr Hay believed that patients with intermittent or persistently abnormal liver function tests should already have had that discussed with them and been given a diagnosis of NANB Hepatitis, although they may have forgotten that earlier diagnosis. Whether or not a clinician had previously told a patient that they were infected with NANB Hepatitis, and whether or not the patient remembered any such conversation, because of a history of abnormal liver function tests[125] it was assumed by clinicians that these patients had hepatitis and the newly developed HCV test in 1992 acted as a confirmatory test.[126]

32.135 Dr Hay said that from the early 1990s clinicians were seeing more severe liver disease in HCV-positive patients. This was particularly so in patients co-infected with HIV since HCV progresses more rapidly in an immunosuppressed patient. Conversations about liver disease became more frequent and adopted a higher profile. Dr Hay summarised what patients were being told by the mid-1990s:

a. That the condition was benign and non-progressive in most patients

b. That there was eventual progression to cirrhosis in up to 30% of patients

c. That HIV was a co-factor for hepatitis C progression as was alcohol

d. That there was a small risk of liver cancer

e. That there was treatment available with interferon but the treatment lasted six months and response-rate was only 25%

f. That we needed to monitor the liver disease systematically[127]

32.136 The background understanding against which to consider Dr Hay's evidence of practice in relation to the provision of information to patients differed as between coagulation disorder patients treated with concentrates and cryoprecipitate users and transfusion recipients of blood components. Notwithstanding the differences in risk, Dr Hay did not describe differences in approach to patients depending on whether they had received low or high risk therapy. It appears that if the circumstances indicated the need for an HCV test the same approach was adopted.

32.137 Developments in the 1990s also led to a change in the advice given to patients about the risks of sexual transmission of HCV. Dr Hay explained that, until then, nothing was said to patients about the risks of sexual transmission as, without a specific test for the disease, very little was known about the possibility of sexual transmission. Clinicians were not advising patients to use barrier contraception unless they were HIV-positive.[128] The advice to patients in this regard did not change until a test for HCV infection became available. It then became apparent that there was a small risk of sexual transmission and the partners of HCV-positive patients were offered tests.

32.138 The mid-1990s also saw the introduction of therapeutic treatment for HCV infection, with Interferon available from 1995-96, and this became an important part of discussions with patients. The response rate to treatment at that time was low (early literature suggested a possible 25% response rate but a lower response rate of 10% was actually experienced by clinicians). Many patients were, and continue to be, put off by side-effects of Interferon treatment, which can be particularly unpleasant and debilitating, and many patients still refuse treatment altogether. Discussions about Interferon were often delayed for patients co-infected with HIV; partly because their response rate was even lower, partly because HIV was a sufficient burden for them to carry and partly because the clinicians were waiting for improvements in treatment. In contemporary practice, all patients are offered anti-HCV treatment. Current combination therapy is much more effective than the treatment used in the late 1990s.

Professor Nathanson

32.139 Professor Nathanson said that, during the period between 1991 and 2000 the correct way of communicating results of a test for HCV was essentially the same as it is today. However, while the theoretical approach was the same, it had to be recognised that medical practice and ethics were still evolving from the paternalistic basis of earlier in the twentieth century to the patient-centred model embraced today. Doctors were increasingly expected to conform to best practice, but adapted to this at different rates, not always related to their own age.[129]

32.140 She also explained that it was important to recognise that in the 1980s there was great uncertainty throughout the medical profession about what a diagnosis of infection with NANB Hepatitis/HCV meant. There was a slow emergence of understanding of the disease and the very long natural history of the illness. In the early period of making a diagnosis of NANB Hepatitis/HCV this natural history was still emerging and uncertain. She explained that while doctors are used to dealing with uncertainty, including risks, many patients and relatives find that very difficult.[130]

32.141 Professor Nathanson and Dr Hay had a common position relating to the patient's response to information. Dr Hay noted that some patients later denied that the conversations he described as taking place in the 1970s and early 1980s occurred. There might be no physical record detailing the conversations that did happen: he said that '[m]any of these conversations will have been forgotten and may not have been documented'.[131] He stated that most counselling of patients in the early 1980s was completely dominated by HIV. In addition, in the case of HCV, up to 40 years may have passed from the time of the original diagnosis of NANB Hepatitis to clinically significant manifestation of the disease. It is doubtful that, in the late 1970s and early 1980s at least, a treating doctor would have reminded their patient of their NANB Hepatitis diagnosis at every appointment in the intervening period. By way of contrast, Dr Hay told the Inquiry he now discusses his patients' liver function tests with them at every meeting and reminds them of the date of their next ultrasound.[132]

32.142 In his report, in discussing what he considered to be a vital distinction between pre-test counselling for HCV as compared to the equivalent process before testing for HIV, Dr Hay noted:

Some patients have complained, many years after the event, that they were tested "without their permission". In some cases they may, indeed, have been tested without being specifically informed and in other cases it is documented that they were informed both that they were being tested and of the result. The idea that a hepatitis C test should engender prolonged pre-test counselling derives from the practice adopted after 1985 by most centres of counselling prior to HIV testing. The implications of a +ve HIV test could be perceived as a death sentence, led to loss of insurance, marriage breakdown, and even in some cases suicide. There is no comparison between this and hepatitis C testing. For that reason, there has never been a specific consent process attached to hepatitis C testing even though it would be normal practice to inform the patient that they were being tested and to inform them of the result.[133]

32.143 In the mid-1980s, AIDS overshadowed hepatitis. He said of his patients that:

If they were counselled about hepatitis in the context of a consultation also about AIDS they would often "deny" hepatitis C and deny that it had been discussed. Denial is a common psychological defence mechanism. I have found that patients commonly deny that they have been counselled about hepatitis C even when such counselling has been documented in the notes.[134]

32.144 In the mid-1980s clinicians telling patients that NANB Hepatitis was, comparatively at least, nothing much to worry about at around the same time as they were being informed of life-threatening HIV in the blood supply may well have contributed to the phenomenon of patients forgetting their initial diagnoses with NANB Hepatitis, particularly for those co-infected with HCV and HIV. HIV would have assumed much greater importance compared to a disease about which little was known and which was suspected of being relatively benign. In the course of a single consultation a number of things would be discussed: a patient's haemophilia, the frequency and location of bleeds, as well as their hepatitis and HIV. If they had HIV, that would be the issue with immediate importance. Discussion was dominated by HIV - a condition that rapidly led to illness and then death - for which there was no test or treatment.[135]

32.145 Dr Hay added that these conversations about NANB Hepatitis would have been short and not particularly memorable. Patients would have been advised that NANB Hepatitis was not thought to be particularly infectious and that, unless they also had HIV, condoms were not required. Spouses were generally not tested at that time.[136] This advice differs slightly from the advice given to patients in the late 1970s to early 1980s.[137] The advice to patients in that earlier period of time would have been 'relatively reassuring'.[138] Dr Hay added that, even if clinicians quoted the 20% risk figure, this may well have been regarded as reassuring; again, he knew of patients who could not remember these conversations at all. Even with discussion of a risk of progression to serious liver disease, he thought that many patients left with the impression that they would not themselves be amongst those who progressed to that stage.[139]

Dr Hay's Commentary on Professor Nathanson's second report

32.146 Dr Hay was invited by the Inquiry to comment on Professor Nathanson's report on practice relating to HCV management (discussed above) and he produced a commentary on it.[140] In general terms, he noted that, of the four publications she referred to, two, the GMC Guidance on Serious Communicable Diseases (1997) and Consent: patients and doctors making decisions together (2008) were not contemporaneous with the period under discussion. None of the four was specific to HCV and only the 1997 Guidance made a (single) mention of the disease.[141] Dr Hay said that there had never been any specific advice from the GMC, the BMA, or any other body relative to consent or counselling for HCV testing.

32.147 He observed that, although Professor Nathanson acknowledged that the approach to consent to testing would be tempered by knowledge of HCV at any particular point in time, she did not develop this point in her report and offered no opinion on the way in which changing states of knowledge would have affected consent at specific times. Professor Nathanson had not offered any evidence of the extent to which the GMC 1997 Guidance had ever been applied to consent for HCV testing. He also questioned whether HCV was a 'serious communicable disease' in terms of the 1997 publication of that name.[142]

32.148 Professor Ludlam also disagreed with the view that HCV was a serious communicable disease in terms of the GMC 1997 Guidelines. In his view:

HCV was known to be a slowly progressive disease in some individuals, treatment was effective in some, the chance of death was small, in the early 1990s it was not known to be sexually transmitted (and even with current information sexual and needle stick transmission is rare), it rarely affects the type of employment, it does not affect the ability of individuals to travel and does not reflect sexual orientation.[143]

32.149 Dr Hay also commented on Professor Nathanson's reliance on a comparison between testing for HIV and HCV and, in line with the comments noted above, suggested that the situation for HCV was different in a number of important respects. First, most patients with haemophilia had been monitored for liver function from the late 1970s and would (or should) have been told that they had NANB Hepatitis if their liver function tests were abnormal and other causes had been eliminated. In such cases, an HCV test would have been confirmatory and, if discussed with the patient, may well have been presented as such. Once the Hepatitis C virus had been isolated in 1989 it was assumed to be the cause of most abnormal liver chemistry in this group. Secondly, at the time routine testing was introduced in 1992-93, treatment was available and the prognosis, even without treatment, was regarded as generally very good, in marked contrast to HIV/AIDS before the introduction of HAART in 1995.[144]

32.150 He commented that in most cases it was likely that HCV testing would have been mentioned in passing in the early 1990s, as a test they intended to carry out. Formal consent for testing would not necessarily have been sought and the patient would (or should) have been told the result at their next clinic visit. He again contrasted the practice of hepatologists and haematologists. He stated:

I should also point out that hepatologists have never had a policy of taking specific consent for HCV testing. I have discussed this with our current Hepatologist and his two predecessors all of whom told me that it would be just one of a battery of [perhaps 15-20] tests conducted as part of the investigation of every patient they investigated for abnormal liver function tests and that each of these tests would not be discussed with the patient individually. As our current Hepatologist said: "Everyone checks the Creatinine [test of kidney function] all the time and that is never discussed with the patient in advance and yet the prognosis of a patient with an elevated Creatinine is very much worse than the prognosis of a patient with HCV". He re-iterated the point that HCV is potentially curable and even untreated has a generally very good prognosis and that there is no specific guidance.[145]

32.151 In contrast to hepatologists, Dr Hay understood that haematologists tended to tell their patients that they were testing for HCV and discussed the condition prior to testing. That was his practice. It was influenced by experience with HIV but counselling for HCV testing was never as involved or as prolonged as for HIV testing.[146]

32.152 As Dr Hay understood it, most HIV and HCV tests are currently conducted in community or STD clinics where the counselling which now always takes place can be 'relatively perfunctory'.[147] It will often take the form of the patient being given an information leaflet and being asked prior to testing whether they have any questions arising from reading the leaflet. Routine testing of blood donors follows the same pattern.

32.153 Having also considered Professor Nathanson's first report (on HIV/AIDS), Dr Hay took up her comparison of the position in the USA. He said:

Professor Nathanson makes the very valuable point that: "In general the UK, unlike the USA, does not have a legal requirement for treatment to require fully informed consent. Ethics advice [in the UK] over three decades has been that the patient must have sufficient information to understand the choice they are making and to make that choice freely." We tell patients about common complications, not every possible thing that could possibly happen, however unlikely. By the same token, we do not go into chapter and verse about every single test we do. If we did, we would do nothing else. There are practical limitations to informed consent.[148]

32.154 These practical limitations are (a) the time required to provide full information and take full consent for every test (over 20) to be conducted following a routine appointment for someone co-infected with HIV and HCV would take two or three hours for every patient and even then would be incomplete; and (b) given that first limitation, the difficulty in selecting which of those tests to explain and obtain consent for.[149] The definition of a life-changing result from testing was not straightforward and perceptions changed over time. He noted that the consent process for HIV infection had actually been 'downgraded' since 1995, when the disease became well-controlled.

Professor Nathanson's views on Dr Hay's commentary

32.155 Professor Nathanson was referred to Dr Hay's commentary on her Inquiry statement.[150] Her analysis of Dr Hay's comments led her to believe that her use of the word 'counselling' was perhaps the cause of the sticking point between their two views.

32.156 Dr Hay's practice was described to Professor Nathanson by counsel, namely that he would advise patients that he wanted to carry out an HCV test, give them an 'exposition' of the disease, and effectively secure their agreement to proceed. Professor Nathanson said that that accorded with best practice for counselling in the period relating to HCV testing.[151]

32.157 Leaving aside the semantics that occupied some time at the Oral Hearing of her evidence, Professor Nathanson's views on the appropriate approach to patients offered HCV testing emerged clearly. In the first place she distinguished the requirements for pre-test counselling from those developed for HIV testing. HIV presented a much more complex situation and a correspondingly complex level of information was necessary. Some people assumed that that level of information was necessary for every test but that was never the position in practice. Counselling had to be appropriate to the test in question. HCV and HIV/AIDS were different conditions, with very different medical and social outcomes.[152]

32.158 She thought that Dr Hay had considered that she was 'writing from an ivory tower' without considering the practicalities and that he had missed the nuances in her report: best practice was about being sensitive to the needs of the particular patient and the elements of the medical condition in question.[153] She said that, because the UK does not have informed consent as a legal requirement for almost any treatment, the BMA continued to refer to 'real or valid consent' which means that patients must understand enough about the options to be able to make a choice, and to then make that choice. Doctors give patients information, helping them to understand what options are available to exercise their choice. She considered that pre-test counselling was, ultimately, a very simple concept: it was the process of giving people enough information to make an informed decision.[154]

32.159 Professor Nathanson suggested that Dr Hay appeared to assume 'full consent' was analogous to lengthy pre-test counselling and that a practitioner was expected to give every single piece of information on testing to a patient. She stated that she was not saying in her report that patients need to be told everything about testing in order to consent but rather that information has to be adapted to their individual requirements. Professor Nathanson concluded this aspect of her evidence by stating: 'The problem is that ... consent is not necessarily a highly complicated process. It just has to be a process that is specific and appropriate for that patient and that test'.[155]

32.160 Professor Nathanson's attention was then drawn to Dr Hay's view that, if informed consent was required for every test that a doctor did, it could take up most of the day and normal work would not be done. In response, Professor Nathanson remarked one had to establish what was meant by 'real consent'. A doctor may not necessarily explain to the patient all of the tests that would be done on a blood sample. The doctor's skill would be in communicating with the patient that a series of tests will have to be done on a blood sample and tailoring further information to the individual patient. Some patients will simply want to get on with those tests and not ask for an explanation of them at this stage; others may want to know from the beginning what all of the tests are, in which case the doctor should recognise that they have to explain them and what their purpose is. The doctor should respond to the requirements of the individual patient.[156]

32.161 Professor Nathanson noted that some tests are more risky or hazardous. For example there are specific risks with performing a biopsy and those risks should always be explained to the patient. However, in her view, a doctor may not necessarily go into all of the risks associated with every intervention with a patient but, rather, should explore the most common and the most serious of the risks in the first instance. If, after that, a patient wants to have more information then it should be provided. Professor Nathanson summarised her position:

[S]ome patients will want to know more and some patients will want to know very little, and that is consent, because that is valid because the patient has been offered information and the opportunity to ask questions and has said, "That satisfies my need."[157]

32.162 Professor Nathanson was asked to comment on Dr Hay's distinction in approach taken by different specialists and, in particular, the example given of the difference between a hepatologist and a haemophilia clinician in obtaining consent to conduct tests. She agreed that patients are referred to a hepatologist because they already have abnormal liver function and the hepatologist would then carry out the appropriate investigations. It is likely that such a patient will have already been treated by another clinician who made the referral to the specialist so that the patient should have knowledge that there is something wrong with their liver and consent to further investigatory tests is implied. Professor Nathanson would consider this to be 'necessarily implied consent'.[158] She would expect a hepatologist to obtain specific consent for a liver biopsy, because of the specific, well-documented and occasionally serious risks associated with the procedure, but not for tests carried out on blood samples. She would expect a hepatologist to explain that blood was being taken for testing to try to identify the cause of the liver disease and also expected that the patient would acquiesce to that general statement and, in those circumstances, that in her view would constitute consent.[159]

32.163 Professor Nathanson was also referred to the final section of Dr Hay's commentary where he listed the main differences between HIV and HCV that he felt were relevant to counselling:[160] Dr Hay's comparison is shown in Table 32.1 below.

Table 32.1: Dr Hay's comparison of characteristics of HIV and HCV

Incurable, even now Curable in 40-100%
70% Mortality prior to 1995 Mortality <2% prior to 1995
Prior to 1995 expected 100% mortality Good prognosis, slow or no progression
Treatment ineffective prior to 1995 No treatment until late eighties
Ready sexual transmission Low infectivity
Symptomatic when advanced Generally asymptomatic until end-stage
Causes AIDS 30% cirrhosis, eventually 5% hepatocellular carcinoma
Uninsurable May have an adverse effect on premium

32.164 Professor Nathanson agreed with the details Dr Hay had listed in his table and accepted the distinctions he had made between the two viruses and, in particular, their relevance to counselling. She observed this was 'an entirely appropriate background to the way in which you would talk to the patient about consent or indeed about what the diagnosis would mean to them'.[161]

Dr Alexander

32.165 Dr Alexander was Consultant Hepatologist at Addenbrooke's NHS Trust from August 2003 and had extensive experience in hepatology prior to that appointment. He provided the Inquiry with a report about the tracing and testing of patients who might have been infected with Hepatitis C and the information given to patients who might have been or were infected with the virus.[162] Dr Alexander was asked how he advised patients that they had a positive HCV test, both in the early days of testing and after 1995. He had a similarly pragmatic approach to Dr Hay. He said that the introduction of HCV testing was a major step forward, allowing him and his colleagues to separate patients into those who had probably cleared the infection from those with ongoing infection. There were, however, concerns about the quality of the tests themselves and a lack of knowledge of the natural history of Hepatitis C.[163]

32.166 Dr Alexander said that in the early 1990s patients with positive HCV tests were warned that the doctors did not understand fully the implications of the test and as a consequence patients underwent regular testing for HCV. In his centre in Cambridge all HCV-positive patients were also offered the opportunity of a liver biopsy. Patients with liver damage were offered close follow-up and regular liver biopsies. At this time there was no available therapy for such patients.[164]

32.167 He observed that knowledge gained by physicians seeing patients with NANB Hepatitis may not have been applicable to dealing with patients when HCV tests were introduced. He commented:

It was not possible to transpose the information we gained from non-A, non-B hepatitis epidemiology studies to HCV infection because introduction of testing had identified a far greater spread and number of patients than we had imagined prior to 1991.[165]

32.168 Dr Alexander also commented on changes in the information given to patients from 1995 onwards. In his statement he said that 'issues such as the natural history were still being resolved but studies of vertical transmission and sexual transmission were allowing us to fine tune the information given to patients'.[166] He added in oral testimony that in this time period the clinicians could advise on the effect on HCV of co-factors such as age, gender and obesity.[167]

Differences of opinion regarding the provision of information to patients about NANB/Hepatitis C

32.169 It appeared from the written statements of Professor Nathanson and Dr Hay that there might have been significant differences of opinion between them concerning proper ethical practice in relation to the provision of information to patients about NANB Hepatitis and HCV and about the proper approach to discussions about testing in that context. Dr Hay was concerned that Professor Nathanson, despite acknowledging changes in scientific knowledge throughout the period, had not properly taken into account the significance of those changes. Professor Nathanson thought that Dr Hay had misinterpreted her evidence as prescribing a higher level of counselling than she had intended to convey was necessary. That there were differences is obvious but, in the end, after their oral testimony is taken into account, the differences appear to be largely differences of expression rather than of substance.

32.170 Professor Nathanson acknowledged that best practice had to reflect changes in scientific understanding over time. Dr Hay, as a haemophilia practitioner with experience of dealing with those changes, gave considerable weight to their significance and in particular emphasised the chronology of emerging knowledge as it bore on practice.

32.171 It is consistent with Dr Hay's evidence that by 1985, when the first diagnostic test for HTLV-III/HIV was becoming available, neither the GMC nor the BMA had published specific guidance on NANB Hepatitis in the management of patients. There was no test for any NANB Hepatitis virus and therefore no trigger for discussion of the implications of testing patients. Thereafter, as Dr Hay put it, there was 'much discussion and a plethora of guidelines issued over the years to cover HIV-testing',[168] culminating in the GMC publication HIV Infection and AIDS: the Ethical Considerations (1988). It would be impossible to hold that, before the AIDS era began, there was a generally recognised obligation on doctors to single out NANB Hepatitis as a subject for specific discussion with patients, either in the course of haemophilia therapy or more generally.

32.172 Professor Nathanson recognised that dealing with HIV/AIDS changed the way that medicine was practised. Dr Hay emphasised that HIV/AIDS overshadowed hepatitis. In the critical period, 1982 to the mid-1980s, patients were not counselled about NANB Hepatitis to the same degree as had been common in the immediately preceding period. There was growing knowledge that a proportion of patients with NANB Hepatitis were developing severe progressive liver disease but it was still believed that the majority would have a non-progressive or very slowly-progressing disease and, as noted, HIV/AIDS assumed a position of paramount importance at this time.

32.173 So far as formal statements of practice are concerned, the ethical position relating to NANBH/HCV remained relatively ill-defined, depending on general rather than specific guidance even in 1988. UKHCDO guidance was related primarily to the selection and use of therapeutic products. Professor Nathanson's views were largely based on the 1988 Guidance. That BMA publication did not refer specifically to hepatitis, however. By 1988 it was understood that NANBH/HCV was a disease with a potentially serious prognosis, as set out in Dr Hay's table (Table 32.1). If the 1988 Guidance had been intended to specify proper ethical practice in relation to that disease it would have required discussion and express guidance, not least to differentiate the guidance offered from that applicable to HIV/AIDS. The debate over the need for 'counselling' and what that meant in different contexts makes that clear.

32.174 Further, Professor Nathanson's view that much would depend on the individual patient is inconsistent with the notion that there was a well-developed and understood ethical rule requiring haemophilia clinicians invariably to adopt a particular approach to procedures relating to testing patients as a matter of general practice in the early 1990s. Implementing the general guidance left much to the discretion of the clinician in managing patients.

32.175 Examination of proper practice in the period from 1997 further undermined the case for a specific duty to advise patients before testing for HCV infection at any earlier period. Dr Hay stated that hepatologists have never had a policy of taking specific consent to HCV testing: it was just one of a battery of tests to be performed routinely on blood samples taken from patients referred to them.[169] Haemophilia clinicians tend always to tell the patient if they are testing for HCV and to discuss the condition prior to testing.[170] Professor Nathanson's explanation was that liver specialists would expect that at an earlier stage in the process another clinician would have provided the necessary information. It appears reasonable to suggest, however, that if there had been a specific ethical rule that patients required to be counselled before being tested for HCV, a hepatologist would have had to check that prior counselling had been given. On the evidence of both experts, counselling was and is perfunctory in those situations.

32.176 In the circumstances, Dr Hay's evidence that there has never been any specific advice from either the BMA or the GMC or any other body about consent or counselling for HCV testing is accepted.[171]

32.177 Apart from express guidance, both experts in the end looked to the wider context of growing scientific knowledge and changing perceptions of the doctor/patient relationship in identifying milestones in the development of the requirements of good ethical practice. Professor Nathanson expected that as knowledge of NANB Hepatitis and later HCV developed clinicians would pass on that information to their patients. By 1985 clinicians would have been expected to advise patients clearly of the risk of contracting the disease from the use of factor concentrates. By 1991 a clinician would have been expected to advise patients clearly of the risks associated with any medical intervention, including testing. Dr Hay considered that the years 1991-92 were particularly significant because of the introduction of specific testing for anti-HCV. However, he observed that by then treatment was available and the prognosis for patients infected with HCV was regarded as generally good. Dr Hay said that in most cases HCV testing would be mentioned in passing and formal consent to testing would not have been sought.

32.178 It is not possible to find that up until 1988 there was a well-developed and widely recognised ethical duty, of any degree of specificity, to advise patients about the nature and implications of NANB Hepatitis or (after the isolation of HCV in 1988) of Hepatitis C. Indeed, on detailed discussion, Professor Nathanson's evidence fell short of suggesting that there was.

32.179 As far as testing was concerned, Professor Nathanson considered that the 'gold standard' of care would involve obtaining patients' consent before testing blood samples for HCV, whether they were stored or fresh. However, she acknowledged that haemophilia patients monitored for liver function throughout the 1980s could have expressly consented to a future HCV test when blood was taken or have been held to have implicitly consented on the basis that a specific HCV test was effectively a confirmatory test for a patient who had already been told that it was likely that they had NANB Hepatitis due to persistent irregular liver function tests. However, once results were obtained, as with an AIDS diagnosis, they should have been communicated to the patients.

32.180 There are difficulties with this as a basis for a rule of practice. Professor Nathanson acknowledged that some patients had difficulty processing bad news or complex information during consultations with clinicians and she offered this as an explanation of why some patients may not have retained information that they have been given. The memories of clinicians can be similarly fallible, and, without a record, clinicians in succession would not know what consents their predecessors had obtained.

32.181 In practice, based on general guidance from the late 1980s and influenced by the experience of HIV/AIDS, haematologists and haemophilia specialists in particular have provided information about HCV and about testing for the disease as an aspect of their care and management of their patients. Practice has been variable, reflecting the approaches of individual practitioners, including Dr Hay and Dr Alexander. In adapting general ethical principles to specific circumstances that is inevitable.

32.182 However, broadly speaking, Professor Nathanson and Dr Hay agreed that, as knowledge increased, patients should have been told about the risk of infection with HCV and that patients should have been told about the changing views about the severity of the disease as they developed. They agreed that it was appropriate to obtain consent before proceeding with an HCV test although a failure to do so for a haemophilia patient who had already given consent to have their liver function monitored for the purpose of investigating, amongst other things, NANB Hepatitis was understandable. Both agreed that the extended pre-test counselling that was appropriate before an HIV test in the 1980s is not necessary today with regards to HCV and was not necessary during the earlier period either. This level of common understanding left considerable scope for variation in individual practice.

The current position in general

32.183 It is clear from the evidence that there have continued to be significant developments in the provision of information to patients. As Professor Nathanson saw it, the modern approach to the doctor/patient relationship involves the patient fully in the decision-making process: it sees medical practice as being about sharing. The doctor does not assert that he knows everything but adopts the approach that 'This is how I would interpret the information you are giving me and what I'm learning about you from tests'. There was a radical shift from 'Doctor knows everything and will give orders' to 'We will share information and my role is to help you make a decision'.[172]

32.184 Professor Nathanson explained what would constitute best practice in terms of the provision of information to patients:

[T]he most important thing is about offering information to patients, not pushing information at them. It's about helping patients to come to terms with information, giving them the opportunity to think and to question, and being open to a repeated set of questions, rather than delivering a measured amount of information each time, which is identical for each patient .... It has to be what's right for that patient at that time ... and trying to test, which is where the communication skills also come in ... that they have understood sufficient to be able to make a decision based upon the information that you are offering.[173]

32.185 In modern practice in the UK, in contrast to much of the reference period, this extends to providing the patient with sufficient information to allow the patient both to understand the choice they are making and to enable the patient to make that choice freely. What is 'sufficient' will vary from patient to patient and will depend on what the patient wants to know as well as what the major risks, benefits and alternatives are. In the modern situation, a doctor is trying to make sure that the patient understands enough to make an informed decision: it is more complicated than under the regime that obtained until the late 1980s and early 1990s. In addition there are many more treatment choices available. In modern practice, ethics is considered to be far more complex and nuanced than in the past and the right thing to do is not always clear.

32.186 The aim of the GMC publication Good Medical Practice (see paragraph 32.191 below) is to give advice, supplemented by the BMA, the Medical Defence Union and other medical defence bodies, which will help doctors to be better at their job and to follow best practice. The general direction of movement in medicine after the 1970s, away from paternalism and towards patient-centred medicine, had taken a long time, however, and according to Professor Nathanson it is still ongoing.

32.187 There was broad agreement that there had been significant change over the reference period. As with any progressive, but relatively unstructured, development in patterns of behaviour, it can be difficult to define with any precision the point reached in general understanding of the evolving scene at any given time, in the absence of specific regulation or guidance providing a reference date. It can be particularly difficult to relate general understanding to the position of a doctor trying to assess the needs of patients presenting with a particular set of circumstances. This was particularly true in the mid-1980s with the advent of AIDS. Even now, there are still unsettled or unresolved issues.

32.188 Quite what 'patient-centred care' requires of the doctor varies with circumstances. Two patients with the same medical condition may not necessarily want the same solution. Doctors now recognise that different patients may have different views and priorities. One patient with a serious condition might prefer to be pain free and another might prefer to be more alert and aware and able to interact with their family. The underlying concept is that the patient should be comfortable with whatever is done: it is the patient's body or illness that is being treated. The doctor has the responsibility of knowing as much as possible about the patient, of looking at the patient holistically as a person and not as a physiological, anatomical specimen. The complexity in any individual case arises because the doctor is trying to give the patient the power to decide whether they want to make a decision about treatment, but not forcing them to do so. The patient's decision could be that they want the doctor to make the decision for them. The fundamental change from the 'paternalistic' approach is that power has transferred to the patient.

32.189 Professor Nathanson did not think that responsibility had transferred to the patient as well as power. Patients do have the responsibility to tell their doctors the truth about themselves but the patient should not be forced into taking the final decision about their treatment: the patient has to be protected from taking decisions with which they are uncomfortable. It can become very uncomfortable for the doctor where a patient may say that they know that they have a fatal disease and there is a curative treatment but they do not want to accept treatment. The picture painted by Professor Nathanson of the requirements of current ethical practice is very different from that described relative to practice in the period that is of concern to the Inquiry.

32.190 She explained that there has been a dialogue with the public on the principles of medical ethics. Half of the BMA committee are now lay people or non-doctors. The BMA commissions pieces from members of the public and involves them in conferences. For example, with topics such as consent and assisted dying the BMA has taken into account the views of the public. The aim is to produce an ethical framework that is a balance between what doctors and the public expect.[174]

Current guidance on HCV

32.191 In terms of formal guidance, the current approach was set out in the GMC booklet, Good Medical Practice and the supplement from June 2008, Consent: patients and doctors making decisions together.[175] Professor Nathanson noted the GMC's current guidance on the information that should be given to patients in her first report to the Inquiry:

You must give patients the information they want or need about:

(a) The diagnosis and prognosis

(b) Any uncertainties about the diagnosis or prognosis, including options for further investigations

(c) Options for treating or managing the condition, including the option not to treat

(d) The purpose of any proposed investigation or treatment and what it will involve

(e) The potential benefits, risks and burdens, and the likelihood of success, for each option; this should include information, if available, about whether the benefits or risks are affected by which organisation or doctor is chosen to care

(f) Whether a proposed investigation or treatment is part of a research programme or is an innovative treatment designed specifically for their benefit

(g) The people who will be mainly responsible for and involved in their care, what their roles are, and to what extent students may be involved

(h) Their right to refuse to take part in teaching or research

(i) Their right to seek a second opinion

(j) Any bills they will have to pay

(k) Any conflicts of interest that you, or your organisation, may have

(l) Any treatments that you believe have greater potential benefit for the patient than those you or your organisation can offer.[176]

32.192 Professor Nathanson explained that the GMC had been producing versions of Good Medical Practice[177] for some years and it became clear over time that more detail was required on the issues of both 'consent' and 'confidentiality'. The GMC therefore put together a more detailed document on consent:

[T]o help doctors in making decisions about whether or not a patient could give consent, whether it was appropriate for somebody else to consent for that patient and about how to go about the process of giving patients information so that those decisions could be made ... this is about patients and doctors making decisions together. And that's a very deliberate decision by the General Medical Council, to stress that consent is not about a doctor deciding to do something and the patient then agreeing the doctor could do it, it's about that process of decision-making together, and that is very much a change of emphasis from say, the 60s or 70s, when it would be more about a patient agreeing to what a doctor had suggested.[178]

32.193 Professor Nathanson identified what she took to be the key statement on consent in the 2008 guidance:

5(b) The doctor uses specialist knowledge and experience and clinical judgement, and the patient's views and understanding of their condition, to identify which investigations or treatments are likely to result in overall benefit for the patient. The doctor explains the options to the patient, setting out the potential benefits, risks, burdens and side effects of each option, including the option to have no treatment. The doctor may recommend a particular option which they believe to be best for the patient, but they must not put pressure on the patient to accept their advice.[179]

32.194 Professor Nathanson explained that the importance of this paragraph was its emphasis on setting out all medical treatments, or options for treatment, and making it clear that the role of the doctor is to use his or her knowledge, skills and experience to understand what a patient wants and using that to identify what investigations or treatments will result in overall benefit. This section is not specific to a particular condition or type of test but encompasses all conditions and all tests.[180]

32.195 She said that doctors are expected to offer their patients all of the elements of information identified in the guidance. In addition she said:

Many doctors today back up their information sharing with leaflets, or web links, so that patients and relatives are better able to make sure they have all the information they want and can test their recollections of the conversation with the doctor.[181]

32.196 She commented that patients have a basic right to information about themselves. This does not mean that doctors simply hand over the information, including test results, however. Information should be shared with the patient in an appropriate manner:

In practical terms this means telling the patient where this places him/her in terms of a differential diagnosis, and what further tests are necessary, or what treatment now seems to be indicated.[182]

32.197 Professor Nathanson was of the view that the guidance given by the GMC was a 'counsel of perfection' but she did not accept that it was provided by a body that was out of touch with the realities of clinical practice. She stated that it was not necessary for a practitioner to set out 'every single detail of every single option'. The guidance in this paragraph concerned the offering of information, understanding the patient's views and exploring options with them. By understanding the patient's views some options could be discounted and would not need to be explained further. In her view the guidance was that a skilled doctor should prioritise the most important pieces of information for their patient. The process is often somewhat easier in the relationship between a patient and their GP, because GPs often know their patients better than specialists to whom they may be referred and a lot of decision-making is broadly similar for different conditions. She accepted that for some patients and for some tests and procedures it can take a long time to obtain valid consent but, equally, very often it takes a short time. She explained that 'practising doctors on my committee, for example, ten people who are in everyday clinical practice, say, "This doesn't cause a problem"'.[183]

32.198 The family members of competent adult patients have no right to know a diagnosis. Doctors should work with patients to help them understand the benefits of sharing their diagnosis with others but cannot force them to share the information.

32.199 In oral evidence Professor Nathanson expanded on the issue of what, and how much, information a doctor should offer to a patient. She explained that the BMA is aware that the amount of information a patient can take in and accurately recall from one-to-one meetings with their doctor can be very limited. This can be affected by the patient being upset and anxious about what is happening to them. Increasingly, doctors will offer brief information leaflets or links to helpful and specific websites to their patients so they can conduct their own research and find out more themselves.[184] It is hoped that this approach obviates the risk of patients using unreliable or inaccurate websites, which can be unsafe, in their own research. The doctor can try to steer the patient to the sites that are reputable and this should help the patient to ask the right questions of the doctor.[185]

32.200 Professor Nathanson explained that, when seeking agreement to carry out a test, information should be offered to explain why it is being performed, what the test might show and what decisions will be made in respect of the results.[186] In oral evidence she expanded this point by explaining that the contemporary approach to 'seeking agreement to tests' will depend on the circumstances. For example an individual may approach their GP because they have been feeling unwell and this may lead to the GP conducting tests for possible anaemia. The doctor could explore the patient's medical history with them in their discussion and, based on what they found out, decide which tests are appropriate. Some patients will want to know what these are and some will prefer to await the results and then have the test results explained.[187]

32.201 Offering information about testing, and deciding how much information to give, depends on the patient and what the doctor thinks they might discover in the test. The test for anaemia may be routine but there are many causes of anaemia, with some being minor and some very serious, such as leukaemia. It is not necessary that the doctor should tell the patient about the most serious possibilities at the outset: 'How much you offer, how much information really depends upon what you think is likely to come out of that test'.[188] If the patient asks specifically if there could be a serious reason for the anaemia, such as cancer, then the doctor should be honest that it is a possibility, but go on to explain there is a more likely less serious cause.

32.202 The information that a clinician gives to a patient may depend on the suspicions they have about the patient's diagnosis or likely test results; but it also depends on the implications of the test results. If a clinician thinks the result will be negative and the test is one of exclusion, they may not give a detailed explanation of what a positive result would mean. By way of contrast, if the clinician thinks the test result will be positive they should go into more detail about the implications of such a result. Once there is a diagnosis, the amount of information given to the patient will increase and become more detailed.[189] As explained by Professor Nathanson, the provision of information may be a graduated process, depending on what the clinician expects to find from a test and whether it is the initial test of a possible series of tests, at which point a relatively small amount of information may be offered.[190] Generally speaking a clinician should modify every piece of information that is given to the patient depending on their circumstances.

32.203 She also explained that, in the case of ongoing, routine monitoring tests, doctors may require to provide more information than that given at an earlier period as the implications of the test results may change over time. These changes may be due to emerging knowledge about the natural history of the illness or different treatment options becoming available. They may also be due to non-medical factors such as changing public perceptions of a disease:

Another element that is relevant when testing for medical conditions with specific non-medical consequences, such as social stigma, or employment and financial consequences is that these should be part of the discussion. It should again be noted that such stigma or financial consequences emerge over time.[191]

32.204 Testing for HIV has had obvious non-medical consequences, financial and social, from a very early stage. Some people think HCV is also stigmatising and can have social consequences; it can also have employment consequences in some circumstances.[192] In 1992, when a great deal of HCV testing was first carried out, doctors conducting the tests could not have known what the non-medical implications of a positive diagnosis would be. Professor Nathanson added that doctors would also have had limited knowledge of the medical consequences as HCV was a condition that was learned about by tracking infected patients over a long period of time.[193]

32.205 Professor Nathanson was asked to sum up what she considered to be best practice today in testing for Hepatitis C:

It comes back to the consent paragraph that I quoted from the General Medical Council's book. It's about giving the patient enough information to make a decision about having that test. That means a short discussion. It is not the most serious chronic illness. It is a serious chronic illness but it is not the most serious. It is not the worst diagnosis you could be faced with. You do need to give patients some information about it, not least to make sure that they are aware that this is something that, if it's positive, you are going to want to follow them up with, and that you would want, therefore, this to be potentially the beginning of quite long period of follow-up, including potentially some quite complex treatment.[194]

32.206 In light of the discussion of terminology in this chapter, it is appropriate to make a general observation about the use of the word 'counselling'. It was clear from the evidence heard by the Inquiry that this term was used by different people in different ways and at different times. While the guidance given by the GMC and the BMA to doctors is a matter for them, the confusion that entered the evidence, especially of Professor Nathanson and Dr Hay, from the use of a term of uncertain meaning should encourage the responsible bodies to ensure that official guidance and rules are expressed with sufficient clarity to have an obvious meaning or are supported by clear definitions of the scope of significant terms in context, in order to avoid confusion. The written guidance that they produce is and has always been important to practitioners but perhaps increasingly it is also important to patients, who are entitled to look to these official sources as indications of what they are entitled to expect from their medical practitioners.

32.207 In conclusion, this chapter has discussed the medical profession's views on ethical practice relating to consent for testing for HIV and HCV, and in relation to the information provided to patients on these conditions. Although the three experts featured have some differences of opinion and emphasis, they broadly agree that best practice now in relation to informed consent and even in the sharing of information differs from the practices which prevailed during the reference period, or at least up until 1988 when the influence of HIV/AIDS helped to bring about significant changes. Dr Hay and Professor Nathanson agree that there was a qualitative difference between the nature of HIV/AIDS and Hepatitis C which, they concluded, meant the requirements for informed consent and information to patients were less onerous in relation to Hepatitis C. While their evidence is accepted, it must be acknowledged this will not bring consolation to the many patients and relatives troubled by what they see as a lack of informed consent or a lack of information in their own particular circumstances. Those suffering from HCV, especially those who progress to liver cancer, may find views that compare their condition favourably with other infections unpalatable. Some people who struggle with chronic Hepatitis C may also be experiencing repeated failed treatments for the virus. Whilst HCV is perhaps, in Professor Nathanson's words, 'not the worst diagnosis you could be faced with', for such individuals it was and continues to be devastating.

1 Closing submission by NHSScotland on information given about the risk of AIDS [PEN.019.0428] at 0436

2 Ibid [PEN.019.0428] at 0432

3 Ibid [PEN.019.0428] at 0436

4 Submissions on behalf of the Scottish Government [PEN.019.0274] at 0309

5 Professor Nathanson's first report to the Inquiry [PEN.012.0330]

6 Professor Nathanson's supplementary statement [PEN.018.0419]

7 Dr Hay's report on communication to patients about hepatitis [PEN.018.0961]

8 Professor Nathanson - Day 84, pages 1-2

9 The General Medical Council registers doctors to practise in the UK. Its purpose is to protect, promote and maintain the health and safety of the public by ensuring proper standards in the practice of medicine.

10 British Medical Association, Medical Ethics Today: Its Practice and Philosophy, 1993, BMJ Publishing Group, London xxv.

11 Professor Nathanson - Day 37, pages 1-3

12 Quoted in Professor Nathanson's first report to the Inquiry [PEN.012.0330] at 0332

13 British Medical Association, Medical Ethics Today: Its Practice and Philosophy, 1993, BMJ Publishing Group, London, xxv.

14 Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Washington, D.C. (1949): U.S. Government Printing Office. Vol. 2, 181-182. Available online at [last accessed 23/12/2014]

15 Professor Nathanson's first report to the Inquiry [PEN.012.0330] at 0334

16 British Medical Association, Medical Ethics Today: Its Practice and Philosophy 1993, BMJ Publishing Group, London, xxv.

17 Ibid

18 Professor Nathanson's first report to the Inquiry [PEN.012.0330] at 0330. The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed by the World Medical Association and adopted by the WMA General Assembly in June 1964. It has undergone six revisions since then. The current, sixth revision was adopted by the General Assembly in Korea in October 2008. It was addressed primarily to physicians, and emphasised the physician's duty to promote and safeguard the health of patients, including those involved in medical research. It provided that in medical research involving human subjects the well-being of the individual research subject must take precedence over all other interests.

19 Professor Nathanson - Day 37, pages 15-17

20 Barratt, 'Medical ethics today', Triple Helix, Spring 2005; 20-21. Available at [last accessed 8/1/15]

21 Quoted in Professor Nathanson's first report to the Inquiry [PEN.012.0330] at 0330

22 Professor Nathanson's first report to the Inquiry [PEN.012.0330] at 0330

23 Ibid

24 Available at [last accessed 08/01/2015]

25 Dr Norfolk's statement on the use of blood and blood components in clinical medicine [PEN.010.0048] at 0065

26 Ibid [PEN.010.0048] at 0068

27 Ibid [PEN.010.0048] at 0070

28 British Medical Association, Medical Ethics Today: Its Practice and Philosophy, 1993, BMJ Publishing Group, London, xxv.

29 Ibid

30 Professor Nathanson's first report to the Inquiry [PEN.012.0330] at 0331

31 Ibid [PEN.012.0330] at 0334-35

32 Quoted in Professor Nathanson's first report to the Inquiry [PEN.012.0330] at 0335

33 Professor Nathanson's first report to the Inquiry [PEN.012.0330] at 0335

34 The full text of the Declaration of Lisbon is available at [last accessed 08/01/2015]

35 HIV Infection and AIDS: the Ethical Considerations, General Medical Council, May 1988 [PEN.016.1165]

36 Professor Nathanson - Day 37, pages 31-35

37 'Informed consent' had a specific meaning in the USA, where it was a legal requirement. It was not a requirement of UK law, and the use of the expression in this context is 5 questionable.

38 HIV Infection and AIDS: the Ethical Considerations, General Medical Council, May 1988 [PEN.016.1165] at 1168

39 British Medical Association, Philosophy and Practice of Medical Ethics, 1988, London, Chapter 4 : 'Consent to Treatment' [PEN.018.0424]

40 Professor Nathanson - Day 37, pages 24-25

41 Quoted in Professor Nathanson's first report to the Inquiry [PEN.012.0330] at 0335

42 Kessel, 'Book Review: British Medical Association: 1988, Philosophy & Practice of Medical Ethics, BMA, London', Journal of Medicine and Philosophy, 1989; 14/6:709-710 [LIT.001.5839]

43 Professor Nathanson's first report to the Inquiry [PEN.012.0330] at 0337

44 British Medical Association, Medical Ethics Today: Its Practice and Philosophy, 1993, BMJ Publishing Group, London, page 3

45 Ibid at page 1

46 General Medical Council, Serious Communicable Diseases, October 1997 [PEN.018.0494]

47 Ibid at 0495

48 Professor Nathanson - Day 84, pages 27-28

49 General Medical Council, Seeking patients' consent: The ethical considerations, November 1998 [PEN.019.1523]

50 Ibid

51 Department of Health, Reference Guide to Consent for Examination or Treatment, 2001 [PEN.019.1487]

52 Ibid

53 British Medical Association, Medical Ethics Today: Its Practice and Philosophy, 2003, 2nd edition, BMJ Books, London

54 Professor Nathanson - Day 37, page 11

55 Dr Winter - Day 16, pages 147-149; Dr Winter's Submission to the Archer Inquiry [PEN.015.0283] at 0291

56 Leake CD ed, Percival's Medical Ethics, 1927, Williams and Wilkins, Baltimore

57 Professor Nathanson's first report to the Inquiry [PEN.012.0330] at 0339

58 Professor Forbes - Day 33, page 123

59 Professor Nathanson's supplementary statement [PEN.018.0419] at 0419

60 Ibid

61 Professor Nathanson's first report to the Inquiry [PEN.012.0330] at 0339

62 Professor Nathanson's first report to the Inquiry [PEN.012.0330] at 0332

63 British Medical Association, Medical Ethics Today: Its Practice and Philosophy, 1993, BMJ Publishing Group, London, page 3.

64 Bolam v Friern Hospital Management Committee [1957] 2 All ER 118

65 Hunter v Hanley 1955 SC 200

66 Sidaway v Board of Governors of the Bethlehem Royal Hospital [1985] AC 871

67 British Medical Association, Medical Ethics Today: Its Practice and Philosophy, 1993, BMJ Publishing Group, London, pages 10-11

68 Ibid page 11

69 Professor Nathanson - Day 84, pages 25-26

70 Ibid page 25

71 While Professor Nathanson did not say so explicitly, it appears that this advice was sought separately from the advice referred to in paragraph 32.40.

72 Professor Nathanson - Day 84, page 31

73 Dr Hay - Day 83, page 111

74 Ibid page 112

75 Dr Hay's statement on communication to patients [PEN.018.1186] at 1209

76 Ibid [PEN.018.1186] at 1212

77 Dr Winter - Day 16, page 148

78 Professor Nathanson - Day 37, pages 33-35

79 Professor Nathanson's first report to the Inquiry [PEN.012.0330] at 0336

80 Professor Nathanson - Day 37, pages 86-87

81 Ibid page 90

82 Professor Nathanson - Day 37, pages 34-35

83 Professor Nathanson - Day 37, pages 154-55. The observation was made in the context of questions related to testing stored samples, but had general significance.

84 Professor Nathanson - Day 37, pages 87-88

85 Ibid pages 121-127 and 155

86 Ibid page 124

87 Professor Nathanson - Day 37, page 125

88 Ibid pages 126-127

89 HIV Infection and AIDS: the Ethical Considerations, General Medical Council, May 1988 [PEN.016.1165] at 1169

90 Professor Nathanson - Day 37, page 113

91 Professor Nathanson - Day 37, page 114

92 Dr Hay's commentary on Professor Nathanson's first report to the Inquiry [PEN.018.1349]

93 Ibid [PEN.018.1349] at 1353

94 Dr Hay's statement on communication to patients [PEN.018.1186] at 1199. See Chapter 15, Knowledge of Viral Hepatitis 2 - 1975-1985, paragraph 15.122. Dr Craske reported in September 1983 that the risk of contacting NANBH following first exposure to large pool concentrates was 100%.

95 The prevalence of Hepatitis C in the donor population during the 1970s and early 1980s was not known with certainty but was subsequently estimated to have been approximately 0.4-1.0%. Pool volumes of the order mentioned were typical of commercial production. NHS pool volumes were considerably lower but still large enough for the same general conclusion to apply.

96 Dr Hay - Day 83, page 85. Whilst effective in eliminating HIV, early attempts at viral inactivation were not completely effective in eliminating the risk of Hepatitis C transmission.

97 Dr Hay - Day 83, page 86

98 Dr Hay's statement on communication to patients [PEN.018.1186] at 1200; Fletcher ML et al, 'Non-A non-B Hepatitis after transfusion of factor VIII in infrequently treated patients', British Medical Journal, 1983; 287:1754-57 [LIT.001.0239]

99 Dr Hay's statement on communication to patients [PEN.018.1186] at 1200

100 Ibid at 1204

101 Dr Hay - Day 83, pages 88-89

102 Dr Hay's statement on communication to patients [PEN.018.1186] at 1192

103 Dr Hay - Day 83, page 82

104 Dr Hay's evidence reflects his experience, and in particular the Sheffield studies of NANBH. In other areas, such as south east Scotland, until a test for HCV was available, people found to have abnormal liver function test results would not often have a diagnosis of NANBH on that basis alone: see Chapter 16, Knowledge of Viral Hepatitis 3 - 1986 Onwards, paragraph 16.32. Clinical jaundice was a required diagnostic feature.

105 Dr Hay - Day 83, page 104

106 Dr Hay's statement on communication to patients [PEN.018.1186] at 1208

107 Dr Hay went on to comment (Day 83, page 123) that what he did went beyond what a Hepatologist would have done for a patient, then and now.

108 Dr Hay - Day 83, page 121

109 Ibid

110 He referred to the current Guidelines dating from 2008.

111 Dr Hay - Day 83, page 122

112 This would be the case prior to the availability of treatment with Interferon.

113 Dr Hay - Day 83, page 124

114 Ibid page 125

115 Ibid

116 Ibid page 126

117 Minutes of AIDS Group of Haemophilia Center Directors, 12 February 1990 [LOT.003.4450] at 4453. Professor Bloom commented that he did not see why consent was required for a HCV test as it was just another liver function test.

118 Professor Nathanson - Day 84, pages 25-26

119 Ibid page 35

120 Ibid pages 56-57

121 Ibid pages 34-35

122 Dr Hay's statement on communication to patients [PEN.018.1186] at 1208

123 Ibid at 1211

124 Dr Hay explained that a small number of patients, typically those with mild haemophilia who are treated infrequently, may have been tested some time after 1992-93. In general, he felt that 'no harm will have come from this delay in diagnosis, because the rate of progression of hepatitis C is slow' and because early treatment had a low success rate. Dr Hay's statement on communication to patients [PEN.018.1186] at 1199

125 Dr Hay remarked in oral evidence that some of these results could be due to alcohol consumption or obesity as in the general population, but because of the patient profile it was assumed abnormal LFTs were attributable to HCV. Some patients who tested positively for anti-HCV had normal liver function tests.

126 Dr Hay - Day 83, pages 83-84

127 Dr Hay's statement on communication to patients [PEN.018.1186] at 1213

128 Dr Hay - Day 83, page 118

129 Professor Nathanson's supplementary statement [PEN.018.0419] at 0422

130 Ibid [PEN.018.0419] at 0422-23

131 Dr Hay's statement on communication to patients [PEN.018.1186] at 1208

132 Dr Hay - Day 83, page 110

133 Dr Hay's statement on communication to patients [PEN.018.1186] at 1212

134 Ibid [PEN.018.1186] at 1209

135 Ibid

136 Ibid [PEN.018.1186] at 1211

137 Dr Hay - Day 83, page 115

138 Ibid page 116

139 Ibid pages 117-118

140 Dr Hay's commentary on Professor Nathanson's report [PEN.018.1349]

141 The other texts were the GMC Guidance on HIV Infection and AIDS (1988) and the BMA Philosophy and Practice of Medical Ethics (1988).

142 Dr Hay's commentary on Professor Nathanson's report [PEN.018.1349] at 1352

143 Professor Ludlam's commentary on the evidence of Dr Hay and Professor Nathanson [PEN.018.1246] at 1249

144 Dr Hay's commentary on Professor Nathanson's report [PEN.018.1349] at 1353

145 Ibid [PEN.018.1349] at 1354

146 Professor Ludlam was critical of Professor Nathanson's attempt to equate HCV testing with HIV testing from 1990 onwards, as he understood it. In his view this was an inappropriate comparison. He said that there are many potential causes of abnormal liver function, and to explain all of the implications of these many causes would be impossible in the everyday clinical setting. Once the cause of the abnormal liver function has been identified and HCV is the source, then the doctor can concentrate on the specific implications of the HCV infection. Professor Ludlam's commentary on the evidence of Dr Hay and Professor Nathanson [PEN.018.1246] at 1248

147 Dr Hay - Day 83, page 136

148 Dr Hay's commentary on Professor Nathanson's report [PEN.018.1349] at 1355

149 Ibid

150 Ibid

151 Professor Nathanson - Day 84, page 38

152 Ibid pages 38-39

153 Ibid page 39

154 Ibid pages 40-41

155 Ibid page 46

156 Ibid page 44

157 Ibid page 45

158 Ibid page 49

159 Ibid page 48

160 Dr Hay's commentary on Professor Nathanson's report [PEN.018.1349] at 1358

161 Professor Nathanson - Day 84, page 50

162 Letter from Penrose Inquiry to Dr Alexander requesting a report [PEN.018.1241]

163 Dr Alexander's statement on HCV testing [PEN.018.1360] at 1365

164 Ibid [PEN.018.1360] at 1365

165 Ibid [PEN.018.1360] at 1366

166 Ibid

167 Dr Alexander - Day 85, page 143

168 Dr Hay's commentary on Professor Nathanson's report [PEN.018.1349] at 1355

169 Ibid

170 Ibid [PEN.018.1349] at 1354

171 Ibid [PEN.018.1349] at 1352

172 Professor Nathanson - Day 37, pages 11-12

173 Professor Nathanson - Day 84, pages 4-5

174 Professor Nathanson - Day 37, page 27

175 'Guidance for Doctors', Consent: patients and doctors making decisions together; General Medical Council [PEN.018.0430]

176 Ibid [PEN.018.0430] at 0441

177 The GMC's general ethical guidance.

178 Professor Nathanson - Day 84, pages 6-7

179 Guidance for Doctors', Consent: patients and doctors making decisions together, General Medical Council, 2008 [PEN.018.0430] at 0438

180 Professor Nathanson - Day 84, page 7

181 Professor Nathanson's supplementary statement [PEN.018.0419] at 0420

182 Professor Nathanson's first report to the Inquiry [PEN.012.0330] at 0337

183 Professor Nathanson - Day 84, pages 8-9

184 Ibid page 10

185 Ibid page 11

186 Professor Nathanson's supplementary statement [PEN.018.0419] at 0420

187 Professor Nathanson - Day 84, page 12

188 Ibid page 12

189 Ibid page 14

190 Ibid page 15

191 Professor Nathanson's supplementary statement [PEN.018.0419] at 0420

192 Professor Nathanson - Day 84, page 15

193 Ibid page 19

194 Ibid page 20

33. An Investigation into the Systems in Place for Informing the Patients about the Risks - HIV/AIDS >