37. The common law already emphasises the importance of informed decision-making by patients. It does not provide, however, specific and detailed guidance to doctors and patients on the nature and amount of information that should be given in particular cases. For this reason, other means should be considered to deal with the communication problems described earlier. Legislative and non-legislative measures are now considered.

Legislation

38. In some jurisdictions, legislation has been enacted stating the type of information that doctors are required to give to patients. In South Australia, for example, there is legislation¹ in general terms on the provision of information to patients. In Victoria and New South Wales there is legislation² on the provision of information to mentally-ill patients undertaking certain medical procedures.

39. Legislation can take three forms:

• a statute;
• subordinate legislation, made by a person such as the Minister for Health (Federal or State), or a body such as the National Health and Medical Research Council; or
• guidelines under a statute or under regulations, prepared by a similar person or body.

40. Legislation requiring doctors to give certain information to patients may be thought to have the advantage of providing a clear and precise statement of the requirements concerning information-giving and the consequences of failing to meet those requirements. There are, however, several reasons for not attempting comprehensive legislation.

41. First, the common law already provides a satisfactory general standard and legislation is not necessary for this purpose, other than to extend the consequences of non-compliance with the common law requirements (see below).

42. Secondly, while more specific and practical guidance to doctors on the provision of information might be desirable, legislation is not a suitable vehicle for providing it. A legislative model, particularly one providing for sanctions for non-compliance, would have to retain sufficient flexibility to deal fairly with all cases that might arise. The South Australian, Victorian and New South Wales legislation mentioned above, like the common law on which it is based, gives only general guidance on the nature and amount of information that should be given to patients. For example, the South Australian Act requires ‘proper and sufficient explanation of the nature and likely consequences of the procedure’ but that leaves open to interpretation what ‘proper and sufficient explanation’ is. As the Working Party whose report led to the South Australian legislation acknowledged, the formulation offers little practical guidance to doctors on the precise content of the information to be given. The Working Party suggested that the legislation should be supplemented by guidelines detailing this information.³ The Victorian provisions on psychosurgery and electro-convulsive therapy offer little more guidance. They require ‘a clear explanation containing sufficient information to enable him or her to make a balanced judgment; and ... an adequate description of benefits, discomforts and risks without exaggeration or concealment; and ... [advice] of any beneficial treatments; and ... [that] any questions relating to the techniques or procedures to be used asked by the person have been answered and the answers have been understood by that person . . . ‘.⁴

43. Thirdly, legislation is rigid. Amendment to statutory standards may be required due to advances in medical knowledge and changes in practice. It is sometimes a complex matter to amend legislation, and it always takes some time. It is dependent on the Government’s priorities, and on the legislative and parliamentary timetable. Although regulations and legislative guidelines are much more easily and speedily amended, they too may be relatively rigid and difficult to amend.

Recommendation 1

The common law standard of reasonable care which now applies to the provision of information to patients concerning a proposed treatment or medical procedure should not be replaced by a statutory standard.

Non-legislative guidelines

44. Non-legislative guidelines, stating doctors’ obligations in general and in particular cases, would be a more effective means of improving communication between doctors and patients. If doctors are involved in drafting the guidelines, they are likely to enjoy a high level of support within the medical profession. There is already recognition of the value of guidelines within the medical profession. Guidelines are more flexible than legislation and need not be limited to a statement of general principles. They may include examples to assist understanding and to explain general statements. They can also be altered relatively easily in the light of changing circumstances. Guidelines can be given recognition in the legal process (see below, para 53 in relation to court proceedings and para 55 in relation to disciplinary proceedings). The Royal Australian College of Physicians has already taken steps in this direction by publishing Guidelines for the Medical Profession on Informed Consent.⁵

Possible objections to guidelines and response

45. The Commissions acknowledge that some doctors may oppose the preparation of guidelines outlining the information that they should give patients. Possible grounds of objection are considered below:

• doctor-patient relationships are so varied that it is not useful to state general rules concerning the information to be given to patients. While difficulties may arise in preparing the suggested guidelines, they can be overcome. First, the guidelines could be made more specific and useful if examples were given to explain how they would operate in practice. Second, if the guidelines did no more than focus attention on the importance of giving patients an opportunity to decide for themselves about their treatment and giving them sufficient information to make that decision, they will serve a useful purpose. And third, if doctors are involved in preparing the guidelines, doctors can be expected to be sympathetic to the problems arising in everyday medical practice and to take them into account in the guidelines.
• it will not be possible to make adequate provision in general guidelines for doctors to exercise their discretion to withhold information that they believe might seriously harm a patient’s health or welfare. This matter would require careful drafting and a range of examples would, it is suggested, need to accompany the guidelines. It is essential that a doctor’s discretion should be retained in some cases, for example, where he or she believes on reasonable grounds that the patient’s health would be seriously harmed by the information. On the other hand, if the discretion is too broad, it may overwhelm the requirement that patients should generally be given sufficient information to make their own decisions. The discretion to withhold information should not be exercised lightly. A balance could be achieved by a provision that doctors may withhold information that would otherwise be required to be given only if they believe on reasonable grounds that the patient’s health or welfare might be seriously harmed by that information being given.
• if the guidelines require that additional information should be given to patients, that will unduly increase the cost of medical consultations. There is no evidence to support a conclusion that the overall cost of medical treatment would be increased by giving adequate information to patients.⁶ It may even be decreased by improvements in the efficiency of treatment following better communication between doctor and patient. Inadequate information about prospective treatment may also have a social cost, in the form of stress and anxiety for the patient and damage to the doctor-patient relationship.

Guidelines

46. The Commissions do not have either the medical expertise or the consumer input to draw general guidelines or the more detailed ones that will be required for particular specialties. The National Health and Medical Research Council (NHMRC) would be a more appropriate body because:

• it has the necessary expertise and experience in drawing guidelines in relation to medical matters;
• it has the respect and trust of doctors;
• it is a federal body and its guidelines will apply throughout Australia. This is an ideal method of ensuring there is one code of practice throughout the country;
• it reports annually to the Commonwealth Minister for Health and has direct links with State Ministers for Health.

47. Discussions have been held between representatives of the Australian, New South Wales and Victorian Commissions and Dr Diana Horvath, Chairman of the Health Care Committee of the National Health and Medical Research Council. Dr Horvath also discussed the matter with Professor John Chalmers, Chairman of the National Health and Medical Research Council. As a result of these discussions, the National Health and Medical Research Council will establish a sub-committee to prepare guidelines concerning the information that doctors should give patients in relation to particular medical procedures. The Commissions will be invited to be represented on the sub-committee which, in accordance with the Health Care Committee’s normal practice, will include wide representation from the general community as well as the medical profession.

Content of guidelines

48. Guidelines on the provision of information to patients could emphasise not only that doctors should give information to patients but that doctors should focus on patients’ needs in deciding what information should be given. The guidelines could state general requirements for information-giving and be extensively illustrated by reference to specific procedures. For example, the first guideline could state that doctors should generally give patients sufficient information to enable them to make an informed decision about what diagnostic tests or treatment they will undertake. This guideline could be followed by a ‘checklist’ of matters on which information should be given, including, for example, diagnosis, prognosis related to options for treatment, and possible risks and complications. Examples could be given of information that would be appropriate in particular cases. For instance, the guidelines dealing with a particular condition might set out the options for treatment of that condition, together with their likelihood of success and associated risks, and direct the doctor to discuss these matters and the general nature of each treatment with the patient.

49. The guidelines could recognise that, in exceptional cases, doctors may be justified in giving less information than would usually be required. The guidelines could make it clear that this is only allowable where the doctor is clearly satisfied on reasonable grounds and after reasonably careful investigation that the patient understands the general nature of the proposed procedure and agrees to undertake it but:

• the patient does not want any further information about the potential success, risks, complications or side-effects of the proposed procedure or any alternative procedure; or
• the patient’s health or welfare might be seriously harmed if he or she were informed of those matters; or
• an emergency exists in which it is not possible to give the information.

The guidelines could also require that doctors give more information if it is specifically requested by a patient.

50. In order to have an impact on professional practice and public attitudes, it is important that the guidelines be disseminated widely. The ways in which this might be achieved include the following:

• by professional education programs in medical undergraduate courses and post-graduate courses, and continuing education such as that already being developed by some faculties.⁷ Matters to be considered could include communication skills - listening, feedback techniques and the use of non-technical language; the nature of negotiation, decision-making, and behavioural processes, and an understanding of the needs of minority groups. Some instructors in these courses could come from outside the medical profession. If and when attitudinal change occurs, it may be that communication skills could be one of the criteria for the selection of clinical teachers.⁸
• by health caregivers looking at standards for giving information in quality assurance and peer review programs. However, unless used carefully, these techniques may be criticised for maintaining the status quo.⁹
• by major teaching and private hospitals developing protocols for giving information to patients. The development of administrative procedures (which many hospitals have already undertaken) to ensure that adequate information is given could be a requirement of accreditation of hospitals. Hospitals could also assist patients by providing them with written information and by supporting the preparation of such material within departments.^10,11
• by health complaints and medical disciplinary bodies reporting regularly on doctor/patient communication issues raised before them and their decisions on those issues.
• by continuing emphasis in clinical education on the importance of using an accredited interpreter whenever there are language difficulties.
• by patient education. Research indicates that many patients have little knowledge of health, health services and medical procedures. Both education and easier access to information through appropriate community groups and medical institutions would apprise patients of the role they could take in obtaining information and participating in decision- making.¹² Patients need information about health in general and their specific illness to enable them to select an appropriate service for their needs,¹³ to take responsibility for their health, and to help them make decisions.¹⁴ Patients can be helped to understand the procedural steps of a medical interview, to think precisely about their symptoms and the degree of discomfort, and to be able to list them. They could also learn to give relevant information about their circumstances, write reminders for themselves about questions they need to ask, and learn to indicate whether they have understood. It is recognised that education of patients will only assist, not solve, all the problems of information exchange in the medical interview. But an ‘educated’ patient would act as a catalyst for change.
• by self-help groups such as the Australian Cancer Patients Foundation, the Australian Huntington’s Disease Association and the Victorian Back Pain and Chronic Back Pain Associations Patient education is also being undertaken by Community Health Centres and some hospitals. This should be encouraged.
• by other health caregivers providing information. This already occurs in practice¹⁵ and greater use could be made of it, provided that doctors retain the ultimate responsibility for ensuring their patients are informed about particular procedures. Other health care professionals are concerned about their role and responsibilities in giving information.¹⁶

Recommendation 2

Guidelines for the provision of information to patients concerning a proposed treatment or procedure should be formulated by the National Health and Medical Research Council.

(a) In considering the guidelines, the Council should take account of the following matters:


(i) the need in each case for doctors to pay attention to the patient’s circumstances;

(ii) the fact that less information may be necessary if the doctor is clearly satisfied on reasonable grounds, and after reasonably careful investigation, that the patient understands and agrees to the proposed procedure, but does not want more information; or that the patient’s health or welfare might be seriously harmed if the patient were more fully informed about the procedure; or that an emergency exists in which it is not possible to give the information;


(b) the appropriate authorities should consider including discussion of the guidelines in medical courses as a means of educating medical students in relation to giving patients appropriate information. The guidelines might also be referred to in quality assurance and peer review programs, hospital protocols and hospital accreditation reviews. Patient education and self-help programs might also inform patients about the guidelines to help patients communicate with their doctors.

Evidentiary status of the guidelines

51. The Commissions recommend that legislation should be enacted giving the proposed guidelines a specified status in relation to the law of negligence. This could be done in two ways. First, the guidelines could be made conclusive evidence of the standard of reasonable care in relation to the provision of information about proposed treatment, or of what constitutes ‘approved professional practice’ as that term was used by Chief Justice King in F v R (see para 26). And secondly, the guidelines could be made admissible evidence of the standard of reasonable care or approved professional conduct, leaving it open to the courts to admit other evidence as well on the topic.

52. There are several problems with the first approach. Those who formulate the guidelines would be required to prepare guidelines of universal application. It would be extremely difficult to draft guidelines that were sufficiently precise to define a standard for legal purposes yet which would operate fairly in all cases. There may be, for example, circumstances in which a doctor might contravene a relevant guideline yet be found to have acted reasonably, particularly if there is evidence that many doctors disagreed with or disregarded the guideline. Conversely, in the circumstances of a particular case, the failure to provide certain information to a patient might be unreasonable notwithstanding that the relevant guideline did not require that such information be generally given. A conclusive evidence model would not have the flexibility to take account of such cases. Moreover, it would hand over to a non-judicial and largely professional body the task of deciding the standard of disclosure required of doctors. The Commissions believe that the Courts should continue to perform their traditional role, common to all areas of negligence law, as the final arbiter of reasonable conduct.

53. The Commissions therefore recommend the second option: that legislation should be enacted requiring that, in an action for damages for professional negligence, the guidelines are admissible evidence and that the courts will consider them in deciding whether a doctor has acted reasonably in relation to the provision of information. Evidence could, however, also be adduced that compliance with the relevant guidelines in a particular case was impracticable, or that many doctors did not follow the guideline or would not have done so in the particular circumstances. It is expected, however, that the courts would give considerable weight to the guidelines and that, as a practical matter, it would be for a doctor to show why it was reasonable not to have observed them in a particular case.

Recommendation 3

Legislation should be enacted requiring that, in an action for damages for professional negligence, the courts will consider the guidelines in deciding whether a doctor has acted reasonably in relation to the provision of information.

Disciplinary proceedings against doctors

54. Failure to provide adequate information of sufficient degree to attract the disapproval of the doctor’s peers would probably already constitute ‘professional misconduct’ under the Medical Practitioners Act 1970 (Vic), the Medical Practitioners Act 1938 (NSW)¹⁷ and the Medical Practitioners Registration Act 1930 (ACT) as they now stand. However, the obligation of doctors in this regard should be emphasised. This should be done by an amendment to the legislation to make it clear that professional misconduct includes failure to give adequate information and that, in deciding whether adequate information has been given a court, board or tribunal should take into account any applicable standard or guideline published by the NHMRC.

55. What amounts to a failure to provide ‘adequate information’ would be a matter for the disciplinary tribunals and would be determined in accordance with the standards of the profession. As with a negligence claim, failure to give information as required by the guidelines would, as a practical matter, place an onus on the doctor to justify non-compliance with the guidelines in a serious case. The usual range of sanctions described in paras 35-37 would apply, including the ultimate sanction of deregistration in an extreme case.

Recommendation 4

The Medical Practitioners Act 1970 (Vic), the Medical Practitioners Act 1938 (NSW) and the Medical Practitioners Registration Act 1930 (ACT) should each be amended to provide specifically that professional misconduct includes a failure to provide adequate information to a patient concerning a proposed treatment or medical procedure.

FOOTNOTES

1 . Consent to Medical and Dental Procedures Act 1985 (SA). This Act protects medical practitioners from criminal and civil liability in respect of a medical procedure if -

• the procedure is reasonably appropriate in the circumstances having regard to medical... standards;
• the procedure is carried out in good faith and without negligence; and
• the patient, being a competent adult or a minor covered by the Act, consents. ‘Consent’ is defined to mean ‘an informed consent given after proper and sufficient explanation of the nature and likely consequences of the procedure’.

3. Report of the Working Party on Consent to Treatment, South Australia, December 1983, 49.

4. Section 55 (psychosurgery) and Section 72 (electro-convulsive therapy). Other requirements are that the medical practitioner should not have an undisclosed financial interest in the hospital where the treatment is to be performed; that the patient has the right to obtain legal and medical advice and to be represented before consenting; that the patient may withdraw from treatment at any time, and that the patient has been given a statement in the prescribed form of the patient’s rights.

5. Fellowship Affairs,October 1988, 5.

6. Mr Peter Read, former adviser on Medicare to the Commonwealth Minister for Health, told the Victorian Commission that under the present fee for service arrangements the standard rebate pays for 5 to 25 minutes of general practitioners’ time which allows sufficient time for patients with minor ailments to be given information. If more time is necessary with a patient who needs more discussion, that time can be averaged against shorter consultations. Specialists can claim for either procedures or consultations and rebates should be sufficient to cover the giving of advice. Under the proposed arrangements between the government and the College of General Practitioners, the content based descriptors specifically include the provision of advice to the patient and/or relatives.

7. Doveton-Hallam Community Health Centre suggested that doctors will value this education as it will give them increased confidence in their abilities in this area and lessen what doctors tend to perceive as difficult and undesirable aspects of their work.

8. M Somerville, ‘Informed Consent: An Introductory Overview’, Informed Consent, Victorian Law Reform Commission Symposia Papers, Globe Press, Melbourne, 1987, 3.

9. Quality assurance programs in general are supported by the health care professions, hospitals and government. The Victorian Health Minister recently commissioned a Task Force to report on quality assurance: Quality Assurance and Health Care in Victoria, Report to Minister for Health from the Task Force on Quality Assurance, Health Department, June 1987.

10. Much of this work is already being done in hospitals particularly those which are members of the Victorian Hospitals Association.

11. Dr N Hicks has suggested that it is the smaller private hospitals, nursing homes and rural hospitals which might need to consider protocols further: N Hicks, ‘Structural Conditions for Informed Consent’, Informed Consent, Victorian Law Reform Commission, Symposia Papers, 19.

12. N Hicks, n 11, 19.

13. The Health Issues Centre in Victoria has issued a wall chart and a series of publications on these matters.

14. There are numerous developments in this area: pamphlets about specific illnesses and treatments have been developed by some hospitals and Royal Colleges. Some doctors prepare their own information sheets. Consumer groups, information resource collectives, self-help groups and community health centres all produce a range of material. Much of this was developed in response to a lack of verbal information, but it is also very useful as an ancillary to information doctors give to patients.

15. At the Huntington’s Disease Unit at Lidcombe Hospital, New South Wales, a social worker often attends doctor/patient consultations and assists in both ensuring that patients fully understand the information they are given and in helping them to come to terms with it. Similar systems prevail in other hospitals. Nurses are central figures in patient care and patients often see them as more ‘available’ (more empathetic and approachable) for information.

16. Nurses are questioning their legal liability when providing information not provided by the care-giver. (Consultation: Victorian Nursing Council.) The South Australian Health Commission’s Working Party on Consent to Treatment reported that consent was obtained in varied ways, both within and between hospitals. (South Australian Health Commission, Report of the Working Party on Consent to Treatment, SAHC, Adelaide, 1983.) Residents have registered their concern when patients arrive in hospitals for major procedures and do not know why. This is confusing for junior staff who are not in a position to ‘require’ better procedures from their seniors. (Consultations with Victorian Commission).

17. The definition of’ ‘professional misconduct’ in the New South Wales legislation already includes any conduct that demonstrates a lack of adequate knowledge, experience, skill, judgment or care by the practitioner in the practice of medicine.