Informed Consent

 Name and Constituency of Member of Parliament
Assoc Prof Daniel Goh Pei Siong
Non-Constituency MP

Question No. 2611
To ask the Minister for Health to what extent should informed consent for minor medical procedures be sought from patients that will be considered reasonably detailed and effective and not lead to the practice of defensive medicine and drive up costs.

Name and Constituency of Member of Parliament
Mr Desmond Choo
MP for Tampines GRC

Question No. 2614
To ask the Minister for Health in respect of the recent imposition of a $100,000 fine on an orthopaedic doctor (a) whether this will result in more instances of "defensive medicine"; (b) whether there will be an impact on medical costs as a result of doctors paying more for litigation insurance; and (c) how will the Ministry work with the Singapore Medical Council to reassure doctors that only egregious cases will attract heavy penalties.

Name and Constituency of Member of Parliament
Dr Lim Wee Kiak
MP for Sembawang GRC

Question No. 2615
To ask the Minister for Health in respect of the recent action against a doctor for not informing his patient on the side effect of a minor medical procedure and the online petition by doctors for a review of the disciplinary action by the Singapore Medical Council (SMC) (a) what is the Ministry's position on the SMC ruling and its response to the petition; (b) what is the impact on clinical practice in Singapore if it is now mandatory for a doctor to outline and get the consent of a patient for every possible side effect and potential complications of a drug or treatment procedure; and (c) what is the impact of this requirement on medical costs and treatment.

Name and Constituency of Member of Parliament
Ms Irene Quay Siew Ching 
Nominated MP

Question No. 2625
To ask the Minister for Health with regard to the fine meted out by the Singapore Medical Council on a surgeon for not informing his patient of the side effect of a medical procedure (a) whether the penalty is commensurate with similar cases in the past, and if there were extenuating circumstances for these cases; (b) whether the penalty meted out will (i) result in a shift of such procedures back to the hospitals and impact patients' accessibility of care and (ii) impact the future practice of medicine and overall healthcare costs in the long run; and (c) how do we define material information that patients need to be informed of under the modified Montgomery test.

Answer

1                    Mr Speaker, members have raised several queries relating to the recent disciplinary action against an Orthopaedic doctor for not informing his patient on the side effect of a minor medical procedure and the potential impact on clinical practice in Singapore.

2                    First, let me briefly set out the background:.

(i)               Dr Lim Lian Arn is an orthopaedic surgeon.  His patient complained  that Dr Lim had failed to advise her on the possible complications arising from an injection of a steroid and local anaesthetic injection (H&L Injection).

(ii)             Dr Lim’s treatment of the patient was found to be appropriate. But he did not advise nor document in the patient’s medical records, possible complications or the patient’s consent.

(iii)          Dr Lim, who was represented by lawyers at the DT Inquiry, pleaded guilty to a charge of professional misconduct under section 53(1)(d) of the Medical Registration Act for failing to obtain informed consent from the patient before administering the H&L Injection.

(iv)           Through his lawyers, Dr Lim asked for the maximum fine of $100,000 in lieu of suspension or if the DT decided that suspension was warranted, a three-month suspension.  The SMC had sought a suspension of 5 months.

(v)             After considering sentencing precedents and the facts and circumstances of the case, the DT agreed with Dr Lim’s counsel that the maximum fine of $100,000 would be an appropriate sentence.

(vi)           Both Dr Lim and the SMC did not appeal the sentence.

3                    Members have asked how this case would affect the future practice of medicine, with regard to informed consent and what constitutes material information.  Members also asked if the penalty was commensurate with similar cases in the past, and how MOH would assure doctors that only egregious cases will attract heavy penalties.  Overall, members were concerned about whether the decision will lead to defensive practices and increasing healthcare costs.

Overall Situation

4                    Let me first set out the overall situation, before discussing the specific matters in this case.  From 2013 to 2018, the SMC convened CCs to investigate over 900 complaints and in about 92% of these cases, the CCs were of the view that no formal inquiry by a DT was necessary.

5                    In those cases referred to the DT, the profession accepted the DTs’ findings and sentences in most of them.  Only in a few cases were questions raised.

6                    Now let me deal with some questions which have arisen in respect of this case.

Informed Consent

7                    First, on the issue of informed consent.  It is wrong to infer, the decision makes it mandatory for a doctor to lay out and get the consent of a patient for every possible side effect and potential complications of a drug or treatment.

8                    Dr Lim admitted that he was guilty of failing to inform the patient of any risks and complications; he was not found guilty for failing to inform the patient of all possible complications that could arise from the H&L Injection.  

Material Information

9                    Second, what is considered material information? Under the SMC Ethical Code and Ethical Guidelines (“ECEG”), doctors are to disclose relevant and material information to their patients, while remote risks with minor consequences will generally be deemed immaterial and need not be disclosed.    What a doctor needs to inform a patient about prior to a treatment or procedure continues to depend on the specific facts of the case, including the particular circumstances of the patient.  However, what is considered material information was not the issue before the DT in Dr Lim’s case, and the DT did not apply the modified Montgomery Test as Dr Lim conceded that he had not informed the patient of any risks or complications at all.

Appropriate Sentencing

10               In determining the sentence, the DT considered cases submitted by both counsel involving similar misconduct, where the sentences had ranged from fines from $5,000 to $10,000, with $10,000 being the maximum penalty allowed before the increase to $100,000 when the Medical Registration Act was last amended in 2010; to suspension orders from 3 to 12 months, or both fines and suspensions. Ultimately, the DT decided that the maximum fine of $100,000 requested by Dr Lim’s lawyer would be the appropriate sentence.

11               There can be questions as to whether this was too high a fine, and why the SMC was asking for a 5 month suspension.  There has been considerable concern in the medical profession about the maximum fine having been imposed, and that at one point suspension was considered. The concerns are understandable, when considering the facts and circumstances of this case.  Many fair minded doctors would think that the penalty imposed was harsh.

12               The appointment of a Sentencing Guidelines Committee on 1^st January 2019 will therefore help in ensuring consistency and fairness in the sentences meted, and improve transparency and rigour in the disciplinary process.

Conclusion

13               Mr Speaker, the Ministry understands and acknowledges the concern that this decision (including the penalty) has caused to the medical profession.  There has been feedback on the considerable confusion amongst medical practitioners on the requirements on informed consent and material information, and how the modified Montgomery Test and the ECEG should apply.  

14               We want to take steps to reassure the profession – and clarify the position, as the MOH does not want the profession to go down the path of defensive medicine.  We acknowledge that the profession needs assurance on what the legal position is, and what the procedures / punishments are when disciplinary proceedings are undertaken. We will need to discuss the issues with the profession, in the context of a broader review of the current rules, processes and legal position, to achieve the above outcome.

15               Our medical disciplinary process is self-regulated. While the SMC administers the disciplinary process, the CCs and DTs comprise substantially of senior doctors and make decisions independently of the SMC.  In arriving at their decisions, the CCs and DTs also obtain the opinions of experts who are peers of the respondent doctor.  This protects both the public and ensures fairness to the doctors.

16               This system works well only with the support of doctors, and only if doctors understand and participate fully in the system. My Ministry will carefully consider what steps are necessary to maintain the trust between patients, doctors, SMC and MOH.