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FREE BOOK SAMPLE: The Nature of Consent - Lauren Sutherland QC)

23/02/18. This is an excerpt from Chapter One of Lauren Sutherland QC's important new book on consent in clinical negligence.

As far back as 1984 the Handbook of Medical Ethics published by the British Medical Association under the heading “Consent to Treatment” provided a clear and concise summary of the basic principles of consent:

The patient’s trust that his consent to treatment will not be misused is an essential part of his relationship with his doctor. For a doctor even to touch a patient without consent may constitute an assault.… Consent is only valid when freely given by a patient who understands the nature and consequences of what is proposed.… Assumed consent or consent obtained by undue influence is valueless.… It is particularly important that consent should be free of any form of pressure or coercion.… No influence should be exerted through any special relationship between a doctor and the person whose consent is sought.… Doctors offer advice but it is the patient who decides whether or not to accept the advice.… The onus is always on the doctor carrying out the procedure to see that an adequate explanation is given.

Despite this statement, and the fact that the General Medical Council (GMC) has since the 1980s formulated a patient-focused model of consent in its professional guidance, it has taken the courts in the UK some time to bring the law into line with the moral and ethical principles that underpin the obtaining of patient consent.

For many years in the UK the test in information disclosure cases was found in Sidaway v Bethlem Royal Hospital Governors. It was not until the decision in Pearce v United Bristol Healthcare NHS Trust([1999] PIQR P53) that the Court of Appeal considered the question of information disclosure in a patient-focused way.

In Chester v Afshar([2004] UKHL 41) it was accepted that the rationale for the duty to provide information was to enable an adult patient of sound mind to make for themselves decisions intimately affecting their own lives and bodies. The surgeon owed a legal duty to warn a patient of possible serious risks involved in a procedure. The only qualification was said to be the wholly exceptional cases where treatment is objectively in the best interests of the patient that the surgeon may be excused from giving a warning.

Lord Steyn declared that the function of the law is to enable rights to be vindicated and to provide remedies when duties have been breached. In “modern law, medical paternalism no longer rules and a patient has a prima facie right to be informed by a surgeon of a small, but well established, risk of serious injury as a result of surgery”. The patient’s right to an appropriate warning for a surgery “ought normatively to be regar-ded as an important right which must be given effective protection whenever possible”.

Lord Steyn recognised that adequate information disclosure ensures that “due respect is given to the autonomy and dignity of each patient”. The departure from traditional causation principles in Chester v Afshar was directly linked to the court’s appreciation of the fact that the patient’s right to autonomy and dignity needed to be protected.

In 2015 the United Kingdom Supreme Court at last focused the law on information disclosure in Montgomery v Lanarkshire Health Board.Margaret Brazier commented on the decision and said that it has “swept away the last vestiges of legal endorsement of medical paternalism.… No longer are patients only entitled to be told what doctors think it is appropriate to tell them. The much criticised decision of the House of Lords in Sidaway v Royal Bethlem Hospital is consigned to history.”It is said that the death of Sidaway will attract few mourners (Medicine, Patients and the Law, Margaret Brazier & Emma Cave, 6th Edition). The UK law on consent is now in line with other common-law jurisdictions and with the professional guidance formulated by the GMC.

The word “consent” derives from the Latin conjunction of con and sentire, which mean joint agreement. The GMC uses the term “shared decision making”.

In Philosophical Medical Ethics, Gillon defined consent as follows:

[C]onsent means a voluntary, uncoerced decision, made by a sufficiently competent or autonomous person on the basis of adequate information and deliberation, to accept rather than reject some proposed course of action that will affect him or her.

In the area of information disclosure there are two main ideals. The first principle is that a decision whether to undergo a medical procedure or not is ultimately the decision of the patient and not the doctor. The second is that every person has the right to determine what shall be done to their body. Both stem from the basic human right of self-determination, which in some countries is constitutionally protected and in others is seen as a basic right to be protected by common law.

On this basis, a patient has the right to determine when, how and in what circumstances they shall be treated. If alternative medical or surgical treatments are available, then this right entitles the patient to decide if they would like treatment and if so which option for treatment they would prefer.

Patient consent is widely regarded as fundamental in the doctor–patient relationship. It is a moral and ethical rule as well as a requirement of the law. It is not simply the satisfaction of a legal formality. It is a necessity to justify the medical procedure proposed. It implies that doctor and patient feel that the treatment proposed is the right and proper one.

Information is required to enable a patient to make a decision. The purpose of information is to enable an individual to gain knowledge to allow them to exercise “choice”. In cases of information disclosure, the law tends to focus on the question of alternative procedures, and the risks and benefits of those alternatives. The patient also has the choice to elect for no procedure at all.

Consent must be freely and voluntarily given, on the basis of information (unless rejected) as to the risks and benefits of a proposed treatment. A refusal by a competent adult patient to consent to treatment or a procedure should normally be considered conclusive. The power to exercise a choice in treatment options should also include the power to refuse treatment. To give valid consent, the patient should appreciate the implications of their decision. Consent may be either express or implied from conduct.

The role of the doctor is not confined to diagnosis and treatment. Patient consent is an essential prerequisite of all medical treatment, and not simply the satisfaction of a legal formality. It is a necessity to justify the medical procedure proposed.

Peter Jackson J in Heart of England NHS Trust v JB([2014] EWHC 342 (COP)) held:

anyone capable of making decisions has an absolute right to accept or refuse medical treatment, regardless of the wisdom or consequences of the decision. The decision does not have to be justified to anyone. In the absence of consent any invasion of the body will be a criminal assault. The fact that the intervention is well-meaning or therapeutic makes no difference.

In Montgomery, the issue before the Supreme Court was whether Mrs Montgomery should have been advised of the options for delivery of the fetus, and the risks and benefits of each option to enable her to exercise “choice” on which method of delivery she wished.

Her position was that had she been advised of the risks and benefits of elective caesarean section, and had she compared the risks and benefits of that procedure with the risks and benefits of proceeding with vaginal delivery, she would have opted for elective caesarean section.

The Supreme Court was also asked to define the duty of the doctor in circumstances where a patient asked questions or expressed concerns. The arguments advanced in Montgomery in the Court of Session and Supreme Court are considered in detail in Chapter 4.

When considering the important changes introduced by the decision of the Supreme Court in Montgomery it is necessary to understand the underlying concepts that formed the basis for that decision. It is suggested that the decision was important in a number of respects:

  1. The recognition of the importance of patient autonomy or self-determination in the area of information disclosure to patients.

  2. The recognition that the issue of information disclosure to patients can and should be separated from the question of diagnosis and treatment.

  3. Flowing from (a) and (b) above, the recognition that the Bolam or Hunter v Hanley (professional practice) tests are inappropriate in the area of information disclosure to patients.

  4. The introduction of a particular patient-focused test in the area of information disclosure in line with the test as formulated in Rogers v Whitaker.

  5. The focus on the professional guidance issued by the GMC.

  6. The confirmation that where a patient does ask questions of express concern this comes within the second limb of the test formulated in Rogers v Whitaker, imposing a specific duty on the doctor to consider the needs of the particular patient.

Each of the above is analysed below. However, following the decision in Montgomery certain basic principles can be said to apply to consent in the context of the legally competent patient:

  • A doctor requires the consent of a patient to treat the patient.

  • A competent patient has the right to accept or refuse treatment, even treatment that the doctor considers is in the best interests of the patient.

  • A doctor cannot impose treatment on the competent patient against the will of the patient no matter how beneficial or necessary the doctor considers the treatment to be.

  • A patient’s valid consent cannot be substituted by a medical judgement that a treatment is in the patient’s best interests.

  • A patient’s consent is required for any diagnostic, preventative or curative treatment.

  • The right to know is not confined to the choice of treatment once a disease is present and has been conclusively diagnosed. Information should be given in respect of procedures that may lead to a diagnosis.

  • A patient’s consent to a particular procedure is limited to that procedure alone and does not entitle the doctor to extend the procedure because it is medically convenient to do so, or perform a different procedure because the doctor chooses to do so.

  • The patient’s right to receive information is not dependent on making a request for information.

  • Where a patient asks questions, the doctor must answer those questions truthfully.

  • The patient must receive information on alternative methods of treatment and the risks and benefits of those options.

  • The disclosure of information on alternative treatments and the risks and benefits of those alternatives is not filtered by the use of the professional practice test.

  • A doctor does not have to provide a patient with every hypothetical option.

  • The principle of autonomy or self-determination does not permit a patient to force a doctor to proceed with treatment or a procedure that the doctor does not consider to be in the patient’s best interests.

  • The information given to the patient on the risks/benefits of treatment should be accurate.

  • A patient may place limits on consent and a doctor should respect those limits.

  • A patient may withdraw consent validly given, although the determination of this question may be a matter of fact.


2. The term “informed consent”

In this book the use of the oft-used term “informed consent” is avoided where possible. As long ago as 1988, in her book A Patient’s Right to Know: Information Disclosure, the Doctor and the Law Professor Sheila McLean argued that this is an inappropriate term to use in this area of the law. She noted that “informed” consent is a doctrine developed in US jurisprudence and was actually specifically designed to expand the liability of doctors.

In the USA, the first hint of the use of the term is found in Salgo v Leland Stanford Junior University Board of Trustees (317 P 2d 170 (Cal, 1957)). It was initially held that a doctor had a duty to disclose any facts necessary to form the basis of an “intelligent” consent to the proposed treatment. The court then talked about full disclosure of facts necessary to an “informed” consent.

In the UK, the first mention of “informed consent” was in Chatterton v Gerson([1981] Q.B. 432). In Sidaway v Bethlem Royal Hospital Governors Lord Scarman recognised that strictly speaking it is a misnomer to use the term “informed consent”. To obtain real or valid consent the patient has to be “informed”. There is no concept of uninformed consent. In those circumstances, there simply would be no consent.

The High Court in Rogers v Whitaker rejected what the court described as the oft-used and “somewhat amorphous phrase ‘informed consent’”, as had Lord Scarman in Sidaway. It was noted that the Supreme Court of Canada had been cautious in its use of the term “informed consent”.

The adoption of the term “informed consent” has led a flawed interpretation of information disclosure. The quality of disclosure is implied from the quality of the decision. When thinking about consent to treatment, it is important to remember that the main focus of self-determination is choice rather than consent as would be implied by the term “informed consent”.

It has been suggested by some writers that the term “informed consent” should be jettisoned from the discourse in this area of law. The phrase “informed consent” detracts from the aims of autonomy in three main ways. First, it incorrectly focuses on obtaining a patient’s consent while in fact a refusal ought to be respected equally; secondly, it also suggests that a refusal must be measured according to a different standard – one that requires more or less disclosure; and, thirdly, it assumes that the doctor’s role is to provide the information and the patient’s role is to consent.

The preference is to allow patients to make “informed decisions” about the options available to them in which situation consent is obtained. It is suggested that the use of the term “real” or “valid” consent is a more appropriate term to be applied.

In Law & Medical Ethics (Mason and McCall Smith’s 10th Edition), the writers suggest that the phrase “informed consent” is dropped from use in favour of the term “valid” consent. A term is required which pays due deference to patient autonomy and at the same time provides the doctor with a yardstick for what is expected. The writers recognise that there is a need to ensure that any spirit of confrontation between the medical profession and the public is halted. They favour the therapeutic relationship between doctor and patient described by Teff many years previously. The GMC refer to a “partnership” in medical decision-making.

3. Patient autonomy

InMontgomery, the Supreme Court recognised that the concept of patient autonomy or self-determination was central to the issue of patient consent. The word autonomy derives from the Greek, auto meaning “self” and nomos meaning “custom” or “law”. This principle is regarded by many eminent medical ethicists as an important or premier principle in medical ethics. To respect patient autonomy is to accept that the individual patient has a right to their own opinion, to make their own choices, and to make decisions based on their own personal values and beliefs.

It is generally accepted that human beings are entitled to respect and this is so even when the person is sick. This right is neither lost or suspended simply because they are ill, to be restored at some later point in time when they are well. The rights of the individual patient to information go beyond the nature of their illness and whether there is a cure.

Patient autonomy can only be protected where a patient is able to make a meaningful choice, on the basis of adequate information on the available treatments or therapies and the risks and benefits of each. The patient should have information about alternative procedures or treatments, the risks of those alternatives and also the potential benefits of any treatment or therapy.

The recognition of the right to appropriate disclosure of information and the patient’s right to accept or reject therapy is the only way to achieve meaningful consent to treatment, or to validate the withholding of treatment. The doctor is the person who holds the information by nature of his/her education and experience. The patient does not have that information but should be the person who makes the ultimate decision about their own body. As the GMC emphasises, the patient should be an active participant in the decisions made about their own health care.

The principle when properly applied envisages a relationship that is more than one where it is accepted that “doctor knows best”. On a proper application of the principle it cannot be said that disclosure of relevant information to patients about their condition of treatment is not required because they may not understand the issues. A patient may be in a vulnerable position and this should not be used as an excuse for eliminating their autonomy.

In 2009, Beauchamp and Childress explained:

To respect autonomous agents is to acknowledge their right to hold views, to make choices, and to take actions based on personal values and beliefs. Such respect involves respectful action, not merely a respectful attitude.… Respect, in this account, involves acknowledging the value and decision-making rights of persons and enabling then to act autonomously, whereas disrespect for autonomy involves attitudes and actions that ignore, insult, demean, or are inattentive to others’ rights of autonomous action.

The law has always recognised that the concept of autonomy of the patient is universally important. This was set out clearly by Cardozo J in Schloendorff v Society of New York Hospital((1914) 211 N.Y. 125), where he said:

every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault.

In Schloendorff it was said that individuality and autonomy have long been central values in Anglo-American society and law. In general, the more intense and personal the consequences of the choice and the less direct or significant the impact of that choice upon others, the more compelling the claim to autonomy in the making of a given decision. Under this criterion, the case for respecting patient autonomy and decisions about health and bodily fate is very strong.

In St. George’s Healthcare NHS Trust v S (Guidelines); R v Collins Ex p. S (No.2) ([1999] Fam.26),a woman who was in labour was advised by medical staff that she required a caesarean section and if she did not agree to this she would die, as would her baby. She refused to consent but despite this the caesarean section was performed and the Court of Appeal held that this was unlawful. The court held that the competent adult patient has the right to refuse treatment even at the risk of death. This right of choice is not limited to decisions which others may regard as sensible. It exists notwithstanding that the reasons for making the choice are rational, irrational, unknown or even non-existent (see also Re S (Adult: Refusal of Medical Treatment) [1993] Fam.123; Re MB (Medical Treatment) [1997] 8 Med. L.R. 217; Re T [1992] 3 W.L.R. 782).

In Airedale NHS Trust v Bland ([1993] A.C. 789) the court emphasised that any treatment given by a doctor to a competent patient which involves an interference with the physical integrity of the patient requires consent. Respect must be given to the wishes of the patient even if the doctor does not consider that it is in their best interest.

The principle of beneficence is closely linked with medical practice. It has been recognised as a key ethical norm (Tom L. Beauchamp and James F. Childress, Principles of Biomedical Ethics, Oxford University Press, 5th Edition, 2001, p12). This concept is recognised in the Hippocratic Oath and by professional bodies. The basic premise is that doctors are trained to act in a positive way that benefits the patient. This is applicable to the patient’s right of autonomy or self-determination. Previously the focus has been on the benefits as determined by the medical profession, and for many years the principle was hijacked as a justification for paternalism. However, properly applied, this duty requires respect for the individual patient’s autonomy. The GMC promulgation of “shared decision-making” could be seen as a method of striking a balance between the concept of patient autonomy and the doctor’s role as a beneficent practitioner.

The principle of autonomy is a legal rule but is also an ethical principle based on the patient’s right to “self-determination”. The right to autonomy strictly construed would mean that the patient would be entitled to decide and demand what treatments they should have. However, the law does not permit a patient to dictate to the doctor what treatments they will receive.

A doctor is permitted in law to refuse to perform a procedure requested by a patient where the doctor is of the view that this procedure would not be in the best interests of the patient or could be harmful to the patient. In practice, it is recognised that in this area there is a legitimate restriction on patient choice.

InR (Burke) v GMC([2005] EWCA Civ 1003 [2006] Q.B. 273) the Court of Appeal held that where a competent patient makes it clear that they do not wish to receive treatment which is, objectively, in their best medical interests, it is unlawful for doctors to administer that treatment. Personal autonomy or the right to self-determination prevails. However, it was held that autonomy and the right to self-determination did not entitle a patient to insist on receiving a particular medical treatment regardless of the nature of the treatment. Insofar as a doctor has a legal obligation to provide treatment, this cannot be founded simply on the fact that the patient demands it.

InR (Burke) the GMC was concerned that a doctor could be required to provide treatment to a patient, or procure another doctor to provide such treatment, even though the doctor believed the treatment was not clinically indicated. The court endorsed the following propositions advanced by the GMC:

  1. The doctor, exercising their professional clinical judgement, decides what treatment options are clinically indicated for their patient.

  2. The doctor then offers those treatment options to the patient, in the course of which they explain to the patient the risks, benefits, side effects etc. involved in each of the treatment options.

  3. The patient then decides whether they wish to accept any of those treatment options and, if so, which one. In the vast majority of cases they will, of course, decide which treatment option they consider to be in their best interests and, in doing so, they will or may take into account other, non-clinical, factors. However, they can, if they wish, decide to accept (or refuse) the treatment option on the basis of reasons which are irrational of for no reasons at all.

  4. If the patient chooses one of the treatment options offered to him, the doctor will proceed to provide it.

  5. If, however, they refuse all of the treatment options offered to them and instead inform the doctor that they want some form of treatment which the doctor has not offered, the doctor will no doubt discuss that form of treatment with the patient (assuming that it is a form of treatment known to the doctor) but if the doctor concludes that this treatment is not clinically indicated he is not required (i.e. he is under no legal obligation) to provide it to the patient, although he should offer to arrange a second opinion.

In Consent: Patients and Doctors Making Decisions Together (2nd June 2008),the GMC provides:

If the patient asks for a treatment that the doctor considers would not be of overall benefit to them, the doctor should discuss the issues with the patient and explore the reasons for their request. If, after discussion, the doctor still considers that the treatment would not be of overall benefit to the patient, they do not have to provide the treatment. But they should explain their reasons to the patient, and explain any other options that are available, including the option to seek a second opinion. (5 d)

This issue was considered recently in the case of an 11-month-old baby called Charlie Gard who suffered from encephalomyopathic mitochondrial DNA depletion syndrome, an extremely rare genetic condition. His parents wanted him to have what was said to be an experimental treatment that was only available in the USA. The doctors at Great Ormond Street Hospital disagreed with the views of the parents as to the suitability of this treatment. They did not consider that any treatment could reverse the brain damage that Charlie had suffered and that his best interests would be served by withdrawing treatment.

The case went first to the High Court, then to the Court of Appeal, then to the Supreme Court and finally to the European Court of Human Rights (Gard v United Kingdom (Admissibility) (39793/17) [2017] 2 F.L.R. 773)) The judge in the High Court found on the evidence that it was not in the child’s best interests to have further treatment and ultimately this decision was upheld.

However, the patient does have the absolute right to refuse treatment and that is more consistent with a right to bodily integrity. This is dealt with below. The concepts inherent in this right were stated to be the bedrock upon which the principles of self-determination and individual autonomy are based. It has also been suggested that involving the patient as an active participant in the process does assist in the treatment of the patient.

Other jurisdictions have recognised the principle of autonomy as being fundamental to the question of information disclosure to patients.
In Canada, in
Ciarlariello Estate v Schacter([1993] 2 S.C.R. 119, 100 D.L.R. (4th ) 609 at 618) Cory J said:

It should not be forgotten that every patient has a right to bodily integrity. This encompasses the right to determine what medical procedures will be accepted and the extent to which they will be accepted.… This concept of individual autonomy is fundamental to the common law and is the basis for the requirement that disclosure be made to a patient.

In determining the test to be applied in consent cases in the UK, the Supreme Court recognised the fundamental importance of patient autonomy and the patient’s right to make choices about his/her own life. The assessment of a person as legally competent implies that the person is autonomous and as such their decisions should be respected. There has been a clear shift in focus from medical paternalism to respect for patient autonomy.

In Montgomery, Lords Kerr and Reed held:

patients are now widely regarded as persons holding rights, rather than as the passive recipients of the care of the medical profession. They are also widely regarded as consumers exercising choices.… It would therefore be a mistake to view patients as uninformed, incapable of understanding medical matters, or wholly dependent upon a flow of information from doctors. (para 75)

The social and legal developments which we have mentioned point away from a model of the relationship between the doctor and the patient based upon medical paternalism. (para 81)

Lady Hale held:

It is now well recognised that the interest which the law of negligence protects is a person’s interest in their own physical and psychiatric integrity, an important feature of which is their autonomy, their freedom to decide what shall and shall not be done with their body. (para 108)

It was noted that under the stimulus of the Human Rights Act 1998 the courts have become increasingly conscious of the extent to which the common law reflects fundamental values. The right to respect for private life is protected by Article 8 of the European Convention on Human Rights. The resulting duty to involve the patient in decisions relating to their treatment has been recognised in judgments of the European Convention on Human Rights, such as Glass v United Kingdom((2004) EHRR 341) and Tysiac v Poland((2007) 45 EHRR 947 at 80).

The GMC was represented at the hearing in the Supreme Court, although it had not been represented at any of the previous hearings. It came into the action as an intervener shortly before the Supreme Court hearing and was able to provide the court with a summary of the position of the GMC on the issue of patient consent. The GMC documentation on Good Medical Practice and the documentation on patient consent were provided to the court.

Consent: Patients and Doctors Making Decisions Together provides:

For a relationship between doctor and patient to be effective, it should be a partnership based on openness, trust and good communication. Each person has a role to play in making decisions about or care. (para 3 2008 Guidance)

It is clear that the Supreme Court took account of the view of the professional body in coming to its conclusion:

The submission on behalf of the General Medical Council acknowledged, in relation to these documents, that an approach based upon the informed involvement of patients in their treatment, rather than their being passive and potentially reluctant recipients, can have therapeutic benefits, and is regarded as an integral aspect of professionalism in treatment. (para 78)

The prioritisation of the individual right of autonomy or self-determination by the Supreme Court was the first important change made in Montgomery. Patients are now recognised in law as having the right to make choices about their own health. The court understood that the right of the individual patient is distinct from the hypothetical reasonable patient and that an individual patient might legitimately make choices that a hypothetical reasonable patient might not do.

Lord Scarman in Sidaway had not gone so far as to focus on the individual patient, and intentionally did not do so. Pearce could not in law introduce a specific patient-focused test since the test in Sidaway was binding upon the court. Pearce did however focus on a “reasonable patient” but did not assume a “reasonable patient in the patient’s position”. In Montgomery, the test now becomes a specific test that recognises the right of the individual patient to receive information and participate in decisions about their own health care. Respect for the patient’s right to self-determination demands no less an approach.

4. The separation of information disclosure

A second important factor in the Supreme Court decision in Montgomery was the separation of the disclosure of information to patients from the duty of the doctor in areas of diagnosis and treatment. For many years, writers in ethics had suggested that it was essential to make this distinction in the area of information disclosure cases but the courts had failed either to understand or grapple with this issue.

InLaw, Ethics and Medicine (1984) P.D.G. Skegg said that there is nothing “medical” about the requirement that a doctor must obtain a patient’s consent. The requirement to obtain the patient’s consent is imposed not in the interests of the patient’s health but in the interests of individual liberty.

In Canterbury v Spence(464 F 2d 772 (1972) (U.S.C.A., District of Colum-bia)) the court distinguished between those aspects of a doctor’s duty that are technical and those that are not:

The context in which the duty of risk disclosure arises is invariably the occasion for the decision as to whether a particular treatment procedure is to be undertaken. To the physician, whose training enables a self-satisfying evaluation, the answer may seem clear, but it is the prerogative of the patient, not the physician, to determine for himself the direction in which his interests seem to lie. To enable the patient to chart his course understandably, some familiarity with the therapeutic alternatives and their hazards becomes essential.

The Canterbury test was not accepted in a significant number of US states but it is regarded as a highly influential decision. The court saw formidable obstacles to the acceptance of the notion that the doctor’s obligation to disclose is either germinated or limited by medical practice. Patients do require access to medical information to enable them to make a decision but the ultimate decision is often based on more than clinical matters. The doctor is unable to properly evaluate the “patient factors” in a decision-making process.

InSidaway, Lord Scarman understood that there were often non-medi-cal factors which influenced a patient’s decision-making and recognised the duty of a doctor to:

provide his patient with the information needed to enable the patient to consider and balance the medical advantages and risks alongside other relevant matters, such as, for example, his family, business or social responsibilities of which the doctor may be only partially, if at all, informed.

The doctor’s concern is with health and relief of pain. These are medical objectives. But a patient may well have in mind circumstances, objectives, and values which he may reasonably not make known to the doctor which may lead him to a different decision from that suggested by purely medical opinion. (paras 885–886)

He recognised the different nature of the doctor’s duty and the fact that the ultimate decision should be legal not medical:

In a medical negligence case where the issue is as to the advice and information given to the patient as to the treatment proposed, the available options and the risk, the court is concerned primarily with the patient’s rights. The doctor’s duty arises from the patient’s right. If one considers the scope of the doctor’s duty by beginning with the right of the patient to make his own decision whether he will or will not undergo the treatment proposed, the right to be informed of significant risks and the doctor’s corresponding duty are easy to understand, for the proper implementation of the right requires that the doctor be under a duty to inform his patient of the material risks inherent in the treatment.

In their research, Faden and Beuchamp suggested that 88% of subjects in their study made decisions based on factors external to the information given (Decision-Making and Informed Consent: A study of the Impact of Disclosed Information, Social Indicators Research, 7, 1980).

In Australia, the courts have held that there is a fundamental difference between diagnosis and treatment and the provision of advice and information to a patient. It has long been recognised that, in diagnosis and treatment, the patient’s contribution is limited to the narration of symptoms and relevant history. In this scenario, the medical practitioner provides the diagnosis and treatment according to their level of skill. However, with the exception of cases of emergency and necessity, all medical treatment is preceded by the patient’s choice to undergo it.

In the information disclosure case, choice is meaningless unless it is made on the basis of relevant information and advice. It has been held in Australia that, because the choice to be made calls for a decision by the patient on information known to the medical practitioner but not to the patient, it would be illogical to hold that the amount of information provided can be determined from the perspective of the practitioner alone, or for that matter the medical profession. It was concluded that whether a patient has been given all the relevant information is not a question to which the answer depends upon medical standards or practices.

In Canada, in Reibl v Hughes there was also a recognition of the distinction:

Expert medical evidence is, of course, relevant to findings as to the risks that reside in or are a result of recommended surgery or other treatment.… The issue under consideration is a different issue from that involved where the question is whether the doctor carried out his professional activities by applicable professional standards. What is under consideration here is the patient’s right to know what risks are involved in undergoing or foregoing certain surgery or other treatment. (paras 894–895)

In Montgomery, it was argued by the claimant that there is an important and crucial distinction between the types of duties owed to patients by treating doctors. The doctor has a duty of care in the performance of treatment, and in making a diagnosis. There is a separate duty to the moral or ethical duty which relates to information disclosure. The provision of information permits patients to make choices about what risks they are prepared to run. Medical choice depends on factors that transcend professional training and knowledge.

The Supreme Court accepted that the doctor’s duty in relation to information disclosure is separate and distinct from the duty of the doctor in the area of diagnosis and treatment. They recognised as important the fact that patient choice in this context did not depend exclusively on medical considerations.

They noted the fundamental difference between the doctor’s role in diagnosis and treatment and their role in discussing with the patient any recommended treatment and the risks and benefits of the alternatives to treatment. The court held:

it is a non sequitur to conclude that the question whether a risk of injury, or the availability of an alternative form of treatment, ought to be discussed with the patient is also a matter of purely professional judgement. The doctor’s advisory role cannot be regarded as solely an exercise of medical skill without leaving out of account the patient’s entitlement to decide on the risks to her health which she is willing to run (a decision which may be influenced by non-medical considerations). Responsibility for determining the nature and extent of a person’s rights rests with the courts, not with the medical profession. (para 83)

The “informed choice” qualification rests on a fundamentally diff-erent premise: it is predicated on the view that the patient is entitled to be told of risks where that is necessary for her to make an informed decision whether to incur them. (para 61)

It is clear from reading the decision in Montgomery that the Supreme Court not only highlighted the fundamental principle of patient aut-onomy or self-determination but also identified that questions of disclosure of information to patients must therefore logically be separated from questions related to the duty of the doctor in diagnosis and treatment. In law, issues of information disclosure are now considered a separate and distinct ground of fault to be dealt with by the courts in a different way from traditional professional negligence. This brings the UK into line with other common-law jurisdictions.

5. The use of the professional practice test

Having identified that the key underlying principle was respect for patient autonomy and self-determination, and consequently that the question of information disclosure must be separated from other aspects of the duty of the doctor, the inevitable result must be that the Bolam or Hunter v Hanley tests are not applicable to this area of the law. The application of such tests is fundamentally inconsistent with these principles.

Prior to Montgomery UK law on patient consent was found in the deci-sion of the House of Lords in Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital.A full analysis of this decision is found in Chapter 2. Kennedy and Grubb argued that Lord Diplock was in the minority in Sidaway and that the majority rejected the Bolam test in information disclosure cases. Margaret Brazier argued that Sidaway simply reaffirmed professional standards. Others con-cluded that Bolam had been retained but modified.

In Bolam, the issue of information disclosure was one aspect of the case.In the speech to the jury there was no attempt to distinguish the provision of information from any other aspect of the doctor’s duty of care to their patient. It was suggested to the jury that it was acceptable for a doctor to not advise of the risks of a therapy if the doctor felt that it was in the patient’s best interests and that the patient would be put off if advised of the risks.

The obligation to make disclosure was not defined in terms of the patient’s rights. The effect of the Bolam test, pre-Bolitho, was that the medical profession was permitted to determine what was acceptable practice in terms of the communication of information to patients without any check.

The problem with using the Bolam test in the area of information disclosure is that this this test is more concerned with professional consensus and standards than with the rights of the patient. The peculiarities of the particular patient are not considered and non-medical considerations are irrelevant.

The existence of a discernible custom or practice reflecting a respectable medical consensus must be seriously in doubt. Professor Kennedy (The Patient on the Clapham Omnibus, 1984 47 MLR 454) has described it as “an obvious fiction” and “something of a nonsense”. The professional standard of disclosure has been said to unreasonably subordinate the interest of the patient to the whim of the medical community. Professor Kennedy identifies the basic moral principle to tell the truth and notes that any exceptions to that principle should not rest on the unarticulated say-so of the doctor.

Sir John Donaldson in the Court of Appeal judgment in Sidaway and Lord Scarman in the House of Lords recognised the importance of patient autonomy in the information disclosure case. Lord Scarman praised the Canterbury test and was not prepare to accept that professional practice should be determinative in the information case. He focused on the issue of patients’ rights. If the professional test were deemed appropriate, then:

The implications of this view of the law are disturbing. It leaves the determination of a legal duty to the judgement of doctors.… It would be a strange conclusion if courts should be led to conclude that our law, which undoubtedly recognises the right of the patient to decide whether he will accept or reject the treatment proposed, should permit the doctors to determine whether and in what circumstances a duty arises, requiring the doctor to warn his patient of the risks inherent in the treatment which he proposes.

Prior to Bolitho, decisions following Sidaway were inconsistent. The Court of Appeal interpreted Sidaway in both Blyth v Bloomsbury Health Authority([1993] 4 Med. L.R. 151 C.A.) and Gold v Haringey Health Authority([1988] Q.B. 481). Both judgments have been heavily criticised by writers.

InMcAllister v Lewisham and North Southwark Health Authority([1994] 5 Med. L.R. 343, QBD), whilst endorsing the Bolam test Rougier J concluded that there were certain risks that did have to be disclosed irrespective of professional practice. It was held that patients were entitled to be given sufficient information on the risks of an operation to enable them to exercise a balanced judgement. (See also Smith v Tunbridge Wells Health Authority([1994] 5 Med. L.R. 334); Gascoine v Sheridan([1994] 5 Med. L.R. 437);Doughty v North Staffordshire Health Authority([1992] 3 Med. L.R. 81);Newell and Newell v Goldenberg([1995] 6 Med. L.R. 371)).

InBolitho v City and Hackney Health Authority ([1998] A.C. 232) the Bolam test was considered, although not in the context of information disclosure. It was recognised that in the vast majority of cases the fact that distinguished experts in the field are of a particular opinion will demonstrate the reasonableness of that opinion. Lord Browne-Wilkinson held that only rarely would the courts conclude that an expert’s opinion is not logically defensible. Academic reaction to the decision was mixed.

InPearce v United Bristol Healthcare NHS Trust([1999] P.I.Q.R P53; (1999) 48 BMLR 118) the Court of Appeal was asked to consider the question of information disclosure. It was submitted on behalf of the claimant that when looking at the question of the adequacy of advice given by a doctor the courts are not confined to follow the test in Bolam. The claimant lost her case but Lord Woolf MR held:

In a case where it is being alleged that a plaintiff has been deprived of the opportunity to make a proper decision as to what course he or she should take in relation to treatment, it seems to me to be the law … thatif there is a significant risk which would affect the judgement of a reasonable patient, then in the normal course it is the responsibility of a doctor to inform the patient of that significant risk, if the information is needed so that the patient can determine for him or herself as to what course he or she should adopt.

Pearce was a case where the claimant had a choice between intervention or not in terms of delivery of her baby. The duty to disclose in this statement is restricted to a “significant” risk that would affect the judgement of “a reasonable patient”. Although reluctant to define “sig-nificant”, Lord Woolf MR then focused on a 10% risk, which one of the experts had suggested was the level of risk that would trigger a duty to disclose. He held that the 0.1–0.2 % risk in this case was not significant.

In this decision, there was focus on statistical probability alone in assess-ing the significance of the risk. The question of the significance of the risk appears to be the first question to address. He appeared to accept the decision of the medical experts on what would be classified as “significant”. He permitted the medical profession to filter what risks were included for consideration. There was no consideration of “individual patient factors”, nor was there any consideration of the potentially serious consequences should the risk materialise.

More problematically for those who advance a concept of information disclosure based on the principles of autonomy and self-determination of the patient, the relevance of the risk in Pearce was to an objectively reasonable patient. There was no suggestion of that the subjective position of the particular patient should be a factor taken into account when assessing risk. The difficulty with the objective patient approach is that this does not comply with the patient’s right to autonomy or self-determination, which is the foundation for information disclosure. The Australian courts have emphasised that it is the individual patient who matters and not the hypothetical or imaginary reasonable patient.

In Maclean, Beyond Bolam and Bolitho, it was said of the decision in Pearce...

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