Informed Consent for Medical Procedures Following Recent Case where Orthopaedic Doctor was Fined

21 Assoc Prof Daniel Goh Pei Siong asked 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.

22 Mr Desmond Choo asked 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.

23 Dr Lim Wee Kiak asked 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.

24 Ms Irene Quay Siew Ching asked 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.

The Senior Minister of State for Health (Dr Lam Pin Min) (for the Minister for Health): Mr Speaker, Sir, may I have your permission to take Question Nos 21 to 24 together?

Mr Speaker: Please proceed.

Dr Lam Pin Min: 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. I understand Mr Murali Pillai¹ had also filed a similar question on this issue and I hope that my reply will address the queries raised by the Member.

First, let me briefly set out the background.

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 anesthetic injection, also commonly known as H&L Injection. 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.

Dr Lim, who was represented by lawyers at the Disciplinary Tribunal or DT, 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.

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 five months.

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. Both Dr Lim and the SMC did not appeal the sentence.

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.

Let me first set out the overall situation, before discussing the specific matters in this case. From 2013 to 2018, the SMC convened Complaints Committees or 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.

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.

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

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.

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.

Second, what is considered material information? Under the SMC Ethical Code and Ethical Guidelines or 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.

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 three 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.

There can be questions as to whether this was too high a fine, and why the SMC was asking for a five-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.

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

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.

We want to take steps to reassure the profession – and to 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.

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.

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.

Assoc Prof Daniel Goh Pei Siong (Non-Constituency Member): I thank the Senior Minister of State. The Disciplinary Tribunal says that the doctors do not have to disclose all side effects but we have seen that in this case for the H&L injection, it was listed out from (a) to (g) the side effects that Dr Lim should have informed and noted in the case notes for the patient. So, it seems as though that although the DT says that the doctor does not have to list all the side effects to the patient, yet, at the same time, the charge is precisely that he had failed to list out all the side effects and that he should have done so. I could read out (a) to (g) but it would be very long, and that is precisely the point. Because it is a very long list, and the consultation would drag on for very long for the doctor.

So, the question is for MOH, when it says material information is all that is needed, how? (a) to (f)? (a) to (e)? (c) to (f)? How many side effects would be material information? And if the doctor informs the patient from (a) to (e) and leaves out (f), and if the patient gets (f) as a side effect, would then the doctor be liable?

Dr Lam Pin Min: I would like to thank the Member for the clarification. I would like to reiterate that there is no need to list all the complications for a particular procedure. What is important is that the doctor needs to inform patients complications or side effects that are relevant to the patient.

In the grounds of the decision by the Disciplinary Tribunal in this case, I note that there were six possible complications that were listed from (a) to (f). But I would like to reassure Members of the House as well as the medical profession that these are just examples of some of the possible complications that Dr Lim could have told the patient. However, in this case, it is not a matter of whether sufficient complications or side effects had been counselled; rather, it is the case whereby Dr Lim had failed to even inform the patient of any possible side effects.

Mr Speaker: Dr Lim Wee Kiak.

Dr Lim Wee Kiak (Sembawang): Thank you, Mr Speaker. I would like to declare my interest as a practising ophthalmologist. The medical fraternity currently has rallied, including with the public coming in, to raise a petition against this whole issue. Even for the public, they felt that this $100,000 fine is a little too excessive. Yes, I agree with the Senior Minister of State that it is self-regulatory, but self-regulatory does not mean no regulation at all. MOH should still have an oversight over SMC. My question, then, is what is MOH's position and will this $100,000 fine be reviewed again rather than to leave it as it is. If we leave it as it is, then the medical fraternity will just say that there is no change in everything else; which means that we still could be fined $100,000. If we miss out just one side effect, we could be fined.

Dr Lam Pin Min: I would like to thank Dr Lim for the supplementary question, as well as to highlight the concern of the medical fraternity regarding this case. Particular to this case, we note that Dr Lim's lawyer had actually requested either $100,000 fine in lieu of suspension, or if the DT decided on suspension, a period of three months. Of course, this is based on past precedents, as noted by both SMC and the defendant's counsel. While the DT could have ordered an alternative sentence, it decided to impose the maximum of $100,000 as proposed by Dr Lim's lawyer and not to impose a suspension instead. But we acknowledge the concerns raised by the medical community and together with the Ministry of Law, we have assisted the SMC in appointing a Sentencing Guidelines Committee on 1 January 2019, as I have mentioned in my reply, so that we could assist the DTs and legal counsels in setting appropriate sentences going forward.

Mr Murali Pillai (Bukit Batok): Sir, I thank the hon Senior Minister of State for his comprehensive explanation. My question revolves around the fact that in the recent past, I see that doctors were somehow disquieted by SMC's rulings. Given that the medical profession is meant to be self-regulating, as mentioned by the hon Senior Minister of State, how do we address the gap between what is understood by the medical profession on one hand and the SMC's rulings meted out by senior doctors? In that regard, I note that there are sentencing guidelines that would be issued. What other steps can be taken to address this gap?

Dr Lam Pin Min: I would like to thank the Member for the supplementary questions. Indeed, our medical disciplinary process is self-regulated. While SMC administers the disciplinary process, the CCs and the DTs, comprised substantially of senior doctors, make the decision independently of the SMC. So far, based on the statistics that I have given in my reply, majority of DT findings and sentences were accepted by the medical profession. Only a small number of cases attracted some questions with regard to the decisions. But based on these statistics, we can see that, actually, the self-regulatory processes are working very well. I do understand there are some concerns with regard to informed consent as well as material information, and we will engage the medical community to clarify some of these doubts that they may have.

Mr Speaker: Dr Lim Wee Kiak.

Dr Lim Wee Kiak: Thank you, Mr Speaker, for giving me a chance to seek clarification. I would just like to ask the Senior Minister of State again: in the past, there have been precedents whereby DTs have thrown out certain cases but, in the end, upon appealing to the Ministers, the DT has to reopen the case again. In this case now, it is the direct opposite, which means that the DT has already decided, whether, currently, since there is a petition from both the public as well as from the medical fraternity to the Ministry, will the Minister now consider reopening this case?

Dr Lam Pin Min: I thank the Member for the supplementary question. This case has been decided at the DT and has been accepted by both the defendant as well as the SMC. Therefore, there will be no need to reopen this case. But having said that, we will continue to look at some of the concerns of the medical profession. In fact, we will be engaging the three professional bodies of the medical profession to see how we can address some of these concerns. At the same time, if necessary, we will review the disciplinary processes in the form of amending the Medical Registration Act. And, if necessary, even amending other laws, moving forward.

Mr Desmond Choo (Tampines): I thank the Minister for his clarification. I would like to ask that while we have retained the Bolam test for the diagnosis and treatment, that has provided clarity, but a significant issue is the Modified Montgomery Test, and that has created a lot of confusion on the ground. Would the Ministry then consider having it into the Statutes, so that it makes things a lot clearer? And what is the Senior Minister of State's view on the implications of clinical practice till the day we get clarity on this test?

Dr Lam Pin Min: I would like to thank the Member for the very pertinent clarification. To put things in perspective, the Modified Montgomery Test was introduced in the Court of Appeal decision recently and not by MOH or the SMC. Prior to the Court of Appeal's decision in Hii Chii Kok's case in 2017, it was settled law in Singapore that the assessment of whether a doctor has met the requisite standard of care in all aspects of his interaction with the patient should be made with reference to the practices and opinions of a responsible body of medical practitioners although such practices and opinions must be logically defensible. This test, like what Mr Desmond Choo has mentioned, is also known as the Bolam-Bolitho test.

In May 2017, the Court of Appeal in Hii Chii Kok decided to move towards a somewhat more patient-centric approach when assessing the doctor's duty to advise, as the Court opined that the patient has autonomy over whether to proceed with the treatment and requires full information to make this decision.

I am clearly aware of the concerns of many medical professionals on the Modified Montgomery Test. I have personally received feedback from fellow medical practitioners especially on the requirement on informed consent and material information, and how this new test should be applied. There is also feedback from the medical community that this may lead to defensive medicine and escalation of healthcare cost.

MOH is aware and understands the apprehension and the confusion and uncertainty on the ground. MOH and SMC are studying the ruling and we will consult the profession on what should be the appropriate practice in Singapore, moving forward.

Prof Fatimah Lateef (Marine Parade): Can I ask the Senior Minister of State, with the changeover to the Modified Montgomery Test and also taking the Hii Chii Kok case as an example – which of course has its pros and cons as well – moving forward, because we practise in a restructured hospital where there are lots and lots of junior doctors and personnel in training who are performing procedures almost every day and taking consent, so, perhaps, will MOH be able to come up with some kind of standardised guidelines for doctors in practice as well as for specialists? And also, perhaps, to do some focus group discussions, not only with the senior representatives but also with the junior level of doctors, because they are the ones whom we need to allay their anxieties, and they are the ones running the clinics, whether through direct supervision or indirect supervision by seniors and consultants; they are the ones who are running our clinics and the hospitals in the restructured hospital setting these days.

Dr Lam Pin Min: I would like to thank Prof Fatimah Lateef for the suggestion. Indeed, we need to continue to provide education to medical profession with regard to proper documentation as well as consent-taking. In fact, it is important that the medical professionals properly document the management of patients under their care because properly kept medical records form the basis of good management of the patient and sound communications pertaining to the care of the patient. Anecdotally, it seems that many complaints by patients could have been avoided if their doctors had communicated with them better. One good example is in the Hii Chii Kok case where having proper documentation can actually even protect the doctor against unmeritorious complaints.