Biomedical Law and Ethics

• Date: 01 December 2010
• Author: Paul TAN LLB (Hons) (National University of Singapore); Advocate and Solicitor (Singapore).
• Published date: 01 December 2010

Introduction

6.1 The year under review saw the courts hand down two decisions that not only dealt with important procedural issues in relation to the prosecution of medical practitioners, but also clarified the law regarding the ethical obligations of medical practitioners in relation to the extent to which they may apply novel forms of treatment to their patients. Although these decisions were issued in the context of professional disciplinary hearings, there may be some impact on medical negligence litigation in general. A third decision was also delivered bearing on the circumstances in which a medical practitioner may delegate the postoperative care of a patient to a nurse or another medical practitioner.

Ethical obligations in relation to novel treatments

6.2 In Gobinathan Devathasan v Singapore Medical Council [2010] 2 SLR 926 (‘Gobinathan Devathasan’), the medical practitioner was charged with applying two treatments - Repetitive Transcranial Magnetic Stimulation (‘rTMS’) and Therapeutic Ultrasound - to a 77-year-old patient who was suffering from a chronic and complicated neurological syndrome, specifically, a sub-type of chronic stroke. Previous attempts at therapy with other neurologists had been unsuccessful. Although it appears that much of the evidence led at trial related to the safety of the combined used of rTMS and Therapeutic Ultrasound, the Singapore Medical Council (‘the SMC’) preferred two charges, one in relation to each form of treatment, alleging that the therapy was not indicated by the patient“s condition, not generally accepted by the medical profession as a form of treatment for the patient“s condition, and inappropriate for the patient“s condition. Dr Devathasan was eventually convicted by the disciplinary committee of only the allegations relating to the use of Therapeutic Ultrasound, though this was subsequently overturned by the Court of Three Judges. We will revisit the procedural issues relating to the prosecution and focus, presently, on the ethical obligations on medical practitioners in relation to novel treatments.

6.3 As the court explained in its judgment, there are potentially at least two different - though sometimes related - inquiries when a

medical practitioner decides to apply novel treatment in the best interests of the patient. The first relates to the extent to which a medical practitioner may prescribe such treatment when, as a matter of fact, a treatment is novel, and therefore, by definition, has not gained widespread acceptance by the medical community. The second inquiry is the extent to which such treatment, often unapproved and ‘off-label’, should be prescribed, considering the effect that such treatment may have on the patient.

Treatments not generally accepted by the medical profession

6.4 The permissibility of prescribing treatment that is not generally accepted by the medical profession is expressly provided for in Guideline 4.1.4 of the SMC Ethical Code and Ethical Guidelines (‘the SMC Ethical Guidelines’), which states:

A doctor shall treat patients according to generally accepted methods and use only licensed drugs for appropriate indications. A doctor shall not offer to patients, management plans or remedies that are not generally accepted by the profession, except in the context of a formal and approved clinical trial.

…

It is not acceptable to experiment or authorise experiments or research which are not part of a formal clinical trial and which are not primarily part of treatment or in the best interest of the patient, or which could cause undue suffering or threat to the life of a patient.

[emphasis added]

6.5 On a literal reading of this provision, it would appear that any treatment, unless otherwise widely approved or endorsed by one“s peers, should not be prescribed except in the context of a clinical trial. Such a narrow reading of the provision, however, is ultimately counterproductive and may not be in the best interests of patients for whom conventional treatment has proven futile. Moreover, as the disciplinary committee quite rightly pointed out, a zero-tolerance policy against the use of novel treatment may hinder progress and innovation in medicine: see Gobinathan Devathasan at [21].

6.6 As an aside, it may be noted that, in general, the priority of clinical trials is not the interests of the patient but the protocol objectives of the trial. In this sense, there is an uneasy tension inherent in Guideline 4.1.4 of the SMC Ethical Guidelines, which requires treatments not yet generally accepted to be applied only in the context of clinical trials and ‘which are … primarily part of the treatment or in the best interests of the patient’. This suggests that even when applied in the clinical trial context, the novelty of the treatment requires a further

limit - that it is in the best interests of the patient. I am grateful to Asst Prof Tracey Evans Chan for this point.

6.7 Implicit in this discussion as to whether a particular treatment is accepted by the medical community is the question - which medical community? If a treatment is not widely accepted in Singapore but widely practised in other countries, should a medical practitioner be prevented from using such treatment? The disciplinary...