Clinical governance and the role of law

CHAPTER ONE: INTRODUCTION At the height of the global financial meltdown, one of the most humbling moments was when the United States‘ economic maestro, former Federal Reserve Chairman Alan Greenspan conceded he had erred in allowing the capitalist free markets to self-correct1, contributing to what is arguably the worst economic hardship since the Great Depression. Perhaps it is inappropriate to compare the medical profession to the financial industry. However, in the wake of events after the sub prime mortgage debacle, the sobering reminder that good governance is essential for the public good cannot be ignored. Looking at the state of affairs in Singapore‘s medical profession and the direction along which medical practice has evolved over the years, perhaps it is time to examine how the medical profession is regulated in Singapore and consider whether any new measures ought to be installed to safeguard clinical governance. Interestingly, the notion of clinical governance was the product of an evolution from the theory of corporate governance, which originated in the 1990s as a means of stemming unacceptably low standards in the world of business. Central to clinical governance is the creation of a regulatory framework, which holds healthcare providers accountable to patients and to the public. Clinical governance was first mooted in the UK government‘s White Paper ‗The New NHS‘2. It was recognized then that variable standards within the NHS were not only detrimental to patients‘ interests, but also eroded public confidence in the healthcare system. Clinical governance was employed to address these problems. Instrumental to the UK‘s concept of clinical governance is taking action to ensure that risks are avoided, adverse events are rapidly detected, openly investigated and lessons learned, good practice is rapidly disseminated and that systems are in place to ensure continuous improvements in clinical care. For instance, in the NHS (National Health Service) structure conceived then, all NHS Trusts will be required to open up their board meetings to the public. They will have new statutory duties on quality and on working in partnership with others. Openness and public involvement form key features of all parts of this new NHS. 1 Greenspan had made this admission during his Congressional testimony about the global financial meltdowninformation taken from The Associated Press. 23rd October 2008. 2 Department of Health.‗The new NHS white paper’, The Stationery Office, London, 1997. 1 In Singapore, clinical governance is largely driven by professional self-regulation. At the heart of this regulatory system, is the community‘s trust that doctors will never fail to put patients‘ interest before personal gains3. Such complete reliance on doctors to police their own brethren or rein in shoddy practices is fundamentally flawed. This thesis aims to highlight the failings of professional self-regulation and explore how ‗law‘ may contribute to clinical governance after the curtailment of professional selfregulation by doctors. The areas of clinical governance examined in this thesis will pertain to the licensing of medical practitioners, clinical audit and disciplinary procedures. When references are made to ‗law‘, I intend to embrace a broad definition of this term and encompass both statutory law as well as the common law. In the following chapter, I will first discuss the implications of clinical governance on the Singapore healthcare system and why it has taken on added importance with time. Chapter three then recounts some of the most recent prolific medical scandals in the United Kingdom (UK) to illustrate how lapses in clinical governance had ultimately cost innocent lives and resulted in unnecessary anguish for patients‘ families. Along the way, I will draw upon some of the main lessons learnt in the aftermath of these scandals to set the stage for advocating stricter clinical governance. Chapter four then discusses how clinical governance is achieved at present in Singapore and its relationship with law. The discussion will touch on three aspects in professional regulation, namely the licensing of medical practitioners, clinical audit, and the disciplining of errant doctors. Related to the disciplining of doctors, is the use of the judicial process to obtain redress for injured patients. Hence, medical tort law will also be included in this discourse. In chapter five, I will flag various incidents involving Singapore‘s medical community to challenge any proposition that the current framework of regulations centered on professional selfregulation is adequate. In particular, this chapter focuses on the capacity of the medical profession to oversee clinical governance as well as certain unsettling trends within the profession that have emerged in 3 In the introductory chapter to the Singapore Medical Council‘s ‗Ethical Code and Ethical Guidelines’, it was acknowledged that ‗In modern medical practice, patients and society at large expect doctors to be responsible both to individual patients‘ needs as well as to the needs of the larger community. Much trust is therefore endowed upon doctors to do their best by both.‘ 2 recent years. Chapter six to nine then analyze the weaknesses in the present approach to clinical governance. During the analysis, possible reforms to the status quo will be propounded. Unlike the patient centric debate on clinical governance in UK, the discourse in this chapter will not be restricted to exploring measures that enhance patients‘ interests, but will also examine ways to strengthen doctors‘ access to justice within the professional regulatory structure. Lastly, chapter ten summarizes the main arguments made in this thesis and briefly dwells on future challenges that lie ahead for clinical governance in Singapore. 3 CHAPTER TWO: THE NEED FOR CLINICAL GOVERNANCE Bearing in mind the changes marching through Singapore‘s healthcare landscape, one cannot possibly over-emphasize the importance of clinical governance. The continual rise of medical technology in healthcare delivery underscores the need to ensure medical innovations are put to good use and only for the right indications. After its introduction by Mouret4 of France in gallbladder surgery, laparoscopic surgery has grown in its usage and fast established itself as the standard surgical approach in Singapore. Doctors have progressed beyond the original application of laparoscopic surgery, which is limited to operations within the capacious abdominal cavities, to operations in virtually any part any part of the body, ranging from the neck, to the chest, and even to bony joints. The frontiers of minimally invasive surgery are challenged further by the advent of Natural Orifice Transluminal Endoscopic Surgery 5 (NOTES). Though in the infancy stages, NOTES has generated widespread excitement within the international medical fraternity by enabling surgery to be scarless. Amidst the medical profession‘s enthusiasm towards embracing advanced medical technology and gadgets, clinical governance is pivotal to ensure patients are not subjected to unnecessary risks in return for marginal benefits during medical procedures. For instance, NOTES has turned out to be a somewhat divisive technique in medicine for NOTES breaches one long held doctrine in surgery, which is to preserve the integrity of normal, healthy organs during operative procedures. In NOTES, the endoscopist deliberately creates a perforation in a healthy hollow organ (usually the stomach or colon) to gain access to the abdominal organs, deploys instruments through the perforation to perform procedures and then repairs this iatrogenic defect in the organ after the procedure is completed. This surgical technique is controversial because the hollow organ perforation induced, can be complicated by serious infection and death. Therefore, the question arises as 4 Litynski, Grzegorz S. Mouret, Dubois, and Perissat: The Laparoscopic Breakthrough in Europe (1987-1988). Journal of the Society of Laparoendoscopic Surgeons. Vol 3. No.2. April/June 1999;163-167 5 This can be likened to a form of hybrid surgery that combines fibreoptic endoscopes with minimally invasive surgical instruments to operate within the body cavity. 4 to what extent doctors should allow patients to undertake risks during procedures, so as to enjoy marginal improvements in cosmetic results 6 compared to other forms of minimally invasive surgical techniques. Conversely, clinical governance must be in place to assure patients that they will not be wrongly deprived of the appropriate medical treatments. The need for patient safeguards is accentuated in the present age as treatment prescribed by doctors may no longer be a purely clinical decision making process. Expectedly, in a society with scarce resources, policies are drafted to allocate resources prudently in order to tame healthcare costs. The foundation of some of these policies, such as ‗means testing‘7 is premised upon the philosophy that patients ought to be distinguished according to their economic class, to allow the diversion of state resources towards the more needy groups in society. Patients in public hospitals are segregated into two distinctive groups according to their financial status: ‗subsidized‘ patients and ‗private‘ patients. Patients in the ‗subsidized‘ category receive significantly more subsidies compared to those in the ‗private‘ group. In return, ‗private‘ patients are given the right to choose their specialists and enjoy better creature comforts during their hospital stay. Under this dichotomous classification of patients, ‗subsidized‘ patients are sometimes not entitled to more costly but possibly better treatment modalities in public hospitals. Amongst several other examples, painless stapler haemorrhoidectomy8 surgery is not routinely offered to ‗subsidized‘ patients in most public hospitals due the extra charges incurred through the usage of the disposable stapler device; it was not too long ago that certain restructured hospitals reserve some minimally invasive surgeries mainly for ‗private‘ patients while ‗subsidized‘ patients are limited to conventional methods that possibly require longer hospital stays and recovery time, because minimally invasive surgical techniques consume a greater quantity of 6 In laparoscopic surgery, there is already minimal scarring of the skin as the procedure is performed via several stab incisions that usually range between 5 –10mm in size- information taken from R.M. Kirk. General Surgical Operations 3rd Edition. Churchill Livingstone, 1994; 337-347 7 A method to calculate the amount of subsidies a patient will get and takes into consideration 1)gross income of the patient/spouse/immediate family members 2)number of family members 3)ownership of private assets- information taken from Singapore Ministry of Health FAQ (accessed 23rd November 2009) (http://www.pqms.moh.gov.sg) 8 Surgery for piles- information taken from R.M. Kirk. General Surgical Operations 3rd Edition. Churchill Livingstone, 1994;300-302 5 expensive non-reusable devices9. Newer generations of drugs that are more efficacious are occasionally dispensed more readily to ‗private‘ patients but prescribed less commonly to ‗subsidized‘ ones; when ‗COX-2‘10 painkillers were first available, it was a common practice that only ‗private‘ patients were entitled to this class of drugs despite evidence confirming their superiority in avoiding stomach ulcers compared to older but far cheaper anti-inflammatories 11. ‗Subsidized‘ patients also encounter more restrictions in their waiting times for an appointment, be it to see a specialist or to undergo nonemergency surgery compared to their ‗private‘ counterparts. Patients in public hospitals have the option of cutting queues or even direct access to specialist outpatient services, as long as they are willing to fork out the extra money to upgrade to become private patients. At certain public hospitals, private patients also have the choice of undergoing selected elective surgeries in the evenings after office hours, as long as they are willing to fork out the necessary premiums 12. The unique nature of the Singapore healthcare model makes clinical governance pivotal to promoting the equitable treatment of patients. Like many other health systems, the Singapore healthcare system is divided broadly into a private sector which operates on a fee-for-service scheme13, and an alternative public sector receiving government funding. However, unlike any other health systems, the Singapore healthcare system is distinguishable by the way in which public hospital resources are used to generate revenue from fee-paying ‗private‘ patients. At the same time, data published by Singapore‘s Ministry of Health (MOH) reveal an imbalance in workload distribution between doctors in the public sector compared to their private sector colleagues 14. According to figures released by the MOH‘s website, Singapore‘s doctor to patient ratio from 2004 to 2006 has remained stable at about 1:650, something which is comparable to the targets attained in Western developed nations. Slightly more than half of these 9 These devices are regarded as ‗non-standard‘ equipment and thus patients usually receive minimal or no subsidies for their usage. 10 ‗COX-2‘(cyclooxygenase 2) inhibitors are a new generation of anti-inflammatory drugs 11 Silverstein FE, Faich G, Goldstein JL et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal antiinflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: A randomized controlled trial. Celecoxib Long-term Arthritis Safety Study. JAMA 2000 Sep 13;284(10):1247-55. 12 Evening Ops at SGH help cut waiting time. The Straits Times (Singapore) 6-1-2005. 13 In essence, this is a ‗user-pays‘ system where the patient makes out of pocket payments for every medical facility or service utilized and does not receive government healthcare subsidies. 14 Information taken from MOH online website at: http://www.moh.gov.sg/mohcorp/statistics. 6 doctors serve in public institutions. However, more than 75% of Singapore‘s patient load is attended by doctors in the public sector. In fact, sub-analysis of the statistics reveals that nearly 80% of the male population seeks medical care in public hospitals. In the pursuit for ‗private‘ patients, one strategy employed by public hospitals is to benchmark specialists‘ remuneration to the ‗private‘ patient workload that he attends to and the number of medical interventions or procedures performed. In the public healthcare system where resources are stretched more thinly, doctors may succumb to the pressure to attract ‗private‘ patients by prioritizing this group of patients over ‗subsidized‘ ones. Clinical governance thus provides a safety net for ‗subsidized‘ patients by ensuring patient care for this group of individuals will not be compromised by financial incentives for doctors. Having a robust regulatory framework reduces the likelihood that doctors will prescribe treatment based on the financial gains they can accumulate by subjecting a medical practitioner‘s professional behavior to greater scrutiny. Thus, clinical governance can guard against the dangers of financial temptations. In a letter published in the Straits Times 15, Professor Lee Wei Ling, director of the National Neuroscience Institute, cited some of the money-spinning tactics that have surfaced within the medical profession. These included: - Charging low fees for medical consultations and instead profit from a doctor‘s right to dispense medicines by making significant mark-up to the prices of medicines sold to patients. - Preying on the desperation of dying cancer patients and their family members, by pushing the usage of costly cancer drugs by such patients despite the absence of certainty in efficacy. - The promotion of non evidence-based therapy and supplements. - Multiple referrals to various specialists within the same group practice, when a patient is admitted for an unrelated condition. Such involvement of different specialists maximizes opportunistic earnings by these professionals at a financial detriment to patients. - The availability of cardiac CT scans encouraging a low threshold in subjecting otherwise well people to such scans. Not surprisingly, the sensitivity of these CT scans demonstrates features of 15 Lee Wei Ling. ―Tighter rein needed on doctors‖. The Straits Times (Singapore). 26 April 2008. 7 degeneration in the arteries of many of these people. Some of these individuals have proceeded to have invasive cardiac angiograms, which carry a small but definite risk including heart attack, stroke and kidney failure. This is despite the fact that a cardiac angiogram would not have made a difference to the patient‘s outcome, because in many instances, such asymptomatic patients do not require invasive intervention. Clinical governance therefore serves as a check on doctors who have discarded their professional calling and make clinical decisions on the basis of monetary rewards as the prescribing behaviour of these doctors will come under scrutiny. Last but not least, clinical governance unplugs the conspiracy of silence16 that may possibly seep into the medical profession over time. The organization of hospital institutional medical practice into structured medical teams and the differentiation of medical practice into subspecialties pose a new challenge to the regulation of medical practice in Singapore. Under the team system, doctors are organized into a hierarchical system with each patient under the overall responsibility of a specialist consultant. Each consultant is aided by doctors of different ranks namely hospital interns, medical officers and specialist registrars. Doctors in each rank are empowered to make independent clinical decisions within demarcated limits and are expected to escalate more complicated clinical problems to involve the higher ranks. One unfortunate consequence of this workplace hierarchy is that the views of senior doctors almost always trump the opinions of the junior ranks. At times, free discussion of clinical issues may be stifled as junior doctors become averse to voicing their personal views for fear of contradicting their senior colleagues 17. With sub-specialization in health care, specialist consultants delineate their fields of clinical practice according to organ systems within the human body. The extent of participation by each specialist in patient care hinges on the discretion as well as clinical capabilities of the primary specialist consultant because each individual consultant has his own threshold in making referrals to other fellow 16 This refers to communal tacit consensus not to acknowledge or discuss matters deemed controversial or shameful. At times, it gives rise to a reluctance by doctors to criticize their peers when clinical errors occur; in chapter three, this was alluded to as a ‗no-blame culture‘ by The Shipman Inquiry. 17 This issue of workplace hierarchy will be explored again in later chapters. 8 colleagues. Therefore, not uncommonly, a patient warded for what appears to be a single illness, will come under the care of a multidisciplinary medical team18. This differentiation of doctors into various sub-specialties heralds a new era in medicine. In a multidisciplinary setting, the virtues of teamwork and collegiality have never been more important as patient care is no longer dependent on decisions made entirely by one or two doctors. Instead, each patient in healthcare institutions is now under the care of a specialist consultant aided by a team of doctors. The importance of having cordial working relationships at the workplace may inadvertently lead to doctors hesitating to criticize their colleagues. Good governance in the medical profession surmounts such obstacles by nurturing a culture of openness conducive for doctors to speak up freely and objectively. 18 For instance, a lady newly diagnosed with breast cancer would be admitted to a hospital by a breast surgeon. This surgeon is in charge of resecting the affected breast along with the tumour. During the surgery, the breast surgeon may enlist the expertise of a plastics surgeon to carry out reconstructive surgery for the patient once the cancerous breast has been removed. Post operatively, the patient will almost certainly come under the review of an oncologist who will make a joint decision with the breast surgeon on whether the patient requires any chemotherapy or hormonal therapy subsequently. 9 CHAPTER THREE: THE UNRAVELLING OF PROFESSIONAL SELF-REGULATION IN THE UK Within the last decade, the uncovering of medical scandals in the UK has triggered public outcry against the medical profession. Responding to public demands for justice, the UK government commissioned a series of inquiries to examine the circumstances that contributed to these atrocities. This chapter will recount three of the reports issued at the conclusion of the their respective inquiries. The reports exposed traits inherent to the UK medical profession‘s culture that impeded the profession‘s capacity to regulate their practices; one of the reports had also critiqued the General Medical Council‘s (GMC) disciplinary process and proffered recommendations for improvements. The selection of cases is intended to drive across one key message: Professional self-regulation in the UK did not just allow a rogue doctor in the form of Harold Shipman to claim hundreds of his patients‘ lives; the lack of stringent external audit had also enabled failure at the institutional level to bring harm to patients and families. The case of Harold Shipman19 Probably the most atrocious misdeed committed by a medical practioner in the UK will be that by a general practioner named Harold Shipman. In October 1999, Harold Shipman was charged with 15 counts of murder committed against patients under his care, as well as one count of forging a patient‘s will. On 31st January 2000, Shipman was convicted on all counts and sentenced to 15 terms of life imprisonment for the killings. Under public pressure, in September 2000, the Secretary of State for Health announced the formation of an independent public inquiry chaired by Dame Janet Smith DBE, a High Court Judge. The Inquiry‘s grisly findings revealed that Shipman was responsible for the deaths of another 200 patients in addition to the 15 patients he murdered. The Inquiry also took the opportunity to proceed with 19 Smith J. The Shipman Inquiry. Chairman: Dame Janet Smith. The Stationery Office, London, 2004. 10 a comprehensive review of clinical governance within the NHS, and revealed pathological weaknesses in the healthcare system. The medical profession‘s failure as custodians of patients‘ welfare was so abysmal that at the Forum on Quality in Healthcare on January 2004, the guest speaker Professor Richard Baker20, commented that ‗all doctors, and not general practitioners alone, share responsibility for creating the circumstances that enabled Shipman to be so successful a killer‘ 21. The Inquiry first exposed a ‗no-blame culture‘ entrenched within the medical profession. In theory, a doctor‘s standard of practice ought to improve as he progresses. Under the ‗no-blame culture‘, after a medical mishap occurred, it was more important to learn from the experience so that similar incidents would be avoided, than to punish the doctor or healthcare professional who caused the mishap; personal factors that contribute to medical mishaps such as the failure by doctors to keep up to date with rapidly evolving medical knowledge were overlooked. In the Inquiry‘s reports, Dame Janet Smith expressed her disquiet over this ‗no-blame culture‘. Her view was that justice required doctors to be held accountable if they had failed in any aspect of their care. When mishaps occur, Dame Janet Smith supported proper investigation and identification of the cause. This was because she believed a systems failure could only be corrected when it was identified and it was essential that steps be taken, in the form of disciplinary action or re-education to protect patients‘ welfare. Dame Janet Smith acknowledged that some may label this ‗a culture of fair blame‘, but she emphasized that it was necessary for ‗justice, learning and protection‘. Dame Janet Smith was not the lone voice in expressing concern at this state of affairs within the medical profession. As early as 1980, Professor Ian Kennedy, Chairman for Healthcare Audit and Inspection22, was already critical23 of the GMC. He questioned the merit of self-regulation by the medical profession and pointed out that although the GMC had a duty to protect the public interest, it did not have a mechanism in place for engaging the public. His other criticisms include the GMC being too ready to 20 Director, Clinical Governance Research and Development Unit, University of Leicester. During Professor Baker‘s Pioneer Lecture at the Forum on Quality in Healthcare on 13th January 2004. 22 Now known as the ‗Healthcare Commission‘. 23 Professor (now Sir) Kennedy delivered his opinions at a public lecture entitled ‗Unmasking Medicine‘ in 1980. 21 11 dismiss complaints about doctors without adequate investigation or public scrutiny, and the fact that the GMC was not held accountable to a higher authority like the Privy Council. Another individual critical of the GMC, was Jean Robinson, one-time Chairman of the Patients Association and a lay member of the GMC. In 1988, she published her comments on the lack of transparency of GMC procedures and their failure to protect patients from the poor clinical performance of incompetent doctors. These criticisms were given more weight by the submissions made by the GMC‘s Leading Counsel, Roger Henderson QC, during the Shipman Inquiry. Mr Henderson concurred that there was insufficient audit of GMC decisions because previous audit had only focused on how many cases had been dealt with by the GMC and not whether they had been properly decided. Therefore, inconsistent and idiosyncratic decisions made by the GMC went unnoticed. This lack of consistency and quality in the decision making process were aggravated by the fact that the GMC or its committees were not obliged to give reasons for their decisions. Mr Henderson acknowledged that greater transparency in GMC procedures was necessary and more in line with the needs of contemporary society. Dame Janet Smith‘s report then proceeded to espouse the virtues of greater transparency in GMC‘s procedures and related how this change will benefit both patients and doctors alike. Doctors would be able to regulate their behaviour more appropriately if they were aware of what type of conduct or deficiency of performance would fall foul of their professional regulatory body. From the public‘s perspective, if patients have a better understanding of what complaints would be dealt with by the GMC, they would know when they could appeal to the GMC to resolve their grievances; if they do not, their complaints would be rejected by the GMC and this would only frustrate aggrieved patients and perpetuate the GMC‘s image as a self protectionist organization. Greater openness within the profession also facilitates the referral of cases to the GMC by NHS organizations, such as doctors‘ employers, as well as other healthcare professionals, because they are more aware of the type of cases they should refer to the GMC. Last but not least, transparency promotes consistency in actions taken by decision makers in the GMC as they have a better knowledge of the required standards. One might summarize these points by 12 saying that transparency within the GMC leads to greater fairness to both the doctors against whom the complaints are made, and to those who made the complaints. The bias towards doctors by the GMC was particularly evident in the GMC‘s screening process when handling complaints against doctors. Under section 13(2) of the Medical Act 1978, the Preliminary Proceedings Committee (PPC) functions to decide whether any case referred to them ought to be referred for inquiry by the Professional Conduct Committee (PCC) or the Health Committee. Preliminary screeners within the GMC serve to facilitate the PPC‘s duties, by filtering out cases that clearly could not give rise to disciplinary action. Unfortunately, what the Shipman Inquiry revealed was failure by both the preliminary screening process and the PPC, to balance patients‘ interests with the competing interests of doctors. The screening process was plagued by screeners who exercised far more discretion than they ought to. Despite aiding medical screeners by defining the categories that fall within Serious Professional Misconduct (SPM), a review conducted in 2002 found that not all cases that should be classified as ‗SPM by definition‘, had been referred to the PPC by medical screeners. For instance, in the ‗dishonesty/criminality‘ category, only 47% of cases that had gone to the medical screeners in 2000 had been referred to the PPC, possibly due to screeners exceeding their discretionary powers. This weakness in the preliminary screening process was attributed to two factors. Traditionally, screeners were nominated by the President of the GMC. It was felt that this close association with the President and the GMC may have empowered screeners into exercising their discretion and making decisions based on their personal views to a far greater extent than the GMC Rules actually permitted. Secondly, being experienced doctors, there was a tendency for medical screeners to ‗slip into‘ the weighing of evidence by reaching into their own experience ‗to see whether there might be an alternative explanation for the conduct complained of‖. Thus, by wanting to ‗add value‘ to the screening process and step beyond a mechanical screening process, these misguided medical screeners very often stepped beyond their boundaries as medical screeners. Similarly, members of the PPC were found to have confused their roles as screeners because the PPC had a tendency to focus on the circumstances of the doctor rather than on the seriousness of the 13 offence. Therefore, it came as no surprise when statistics revealed that a substantial proportion of the more serious conviction cases were not being referred to the PCC for disciplinary consideration. What was rather perturbing was how the GMC contributed to this flawed screening process. The Inquiry panel noted that the GMC did not provide proper criteria to guide screeners and the PPC in the decisionmaking. There was also no internal audit to review the quality of screening decisions; PPC panels were allowed to sit in private, without any monitoring of their outcomes. The only effort at audit took the form of publishing annual statistics relating to the cases dealt with by the GMC. However these figures shed no information on the seriousness of individual allegations and only served to show that the number of complaints referred by medical screeners to the PPC was small. The Shipman Inquiry also articulated reservations about the quality of decisions made by GMC members during disciplinary hearings and identified three factors that contributed to this undesirable scenario. Despite the GMC elucidating criteria and standards in its publication ‗Good Medical Practice‘, it was felt that there was still a lack of clarity on how serious a departure from ‗Good Medical Practice’ has to be, before disciplinary measures would be evoked. Another problem was the absence of proper threshold definitions for what constituted SPM. There were examples provided by the GMC of what might or might not be regarded as SPM, but these were described as ‗more like a miscellaneous collection drawn from a wide variety of different types of conduct‘. This lack of guidance resulted in individuals importing their own personal views on a variety of topics, ranging from the threshold of SPM, to the significance of various evidential proofs provided. Not surprisingly, the Inquiry panel expressed grave concerns about the consistency of decisions arrived at by GMC members. To surmount these weaknesses in the GMC‘s disciplinary hearings, the Inquiry panel spoke favourably of suggestions to engage legally trained individuals in the GMC‘s hearings. For instance, appointing an experienced lawyer as the Chairman of PCC panel would enhance the PCC‘s compliance with principles enshrined in Evidence Law. In view of the fact that the PCC panel would often have to investigate a mixed bag of allegations against doctors, some relating to misconduct, others related to performance and health, a legally trained Chairman could aid the PCC in dissecting out the 14 issues in each case, help sort out the relevant evidence and guide the panel in deciding the standard of proof applicable to each issue. The Chairman could also ensure that the panel does not take irrelevant considerations into account or give excessive weight to hearsay evidence. The Inquiry panel noted that Rule 28 of the Professional Conduct Rules permitted the PCC to factor in ‗the character and previous history of the practitioner‘ during the assessment of alleged SPM by a doctor, and was perturbed by how the PCC might wrongly apply ‗the similar fact rule‘ in Evidence Law when deciding whether a doctor‘s conduct amounts to SPM. The Inquiry panel gave the illustration of the PCC, in finding that a doctor had breached a patient‘s confidentiality, had weighed evidence that the doctor had previously been found guilty by a PCC of misconduct arising from a serious prescribing error. Also, Rule 28 permitted the doctor to put before the PCC panel purely personal mitigation, which might have been quite irrelevant to the issue of SPM. For example, it was very common for the doctor to produce testimonials from patients and colleagues about his/her general abilities and character. The Inquiry panel contended that such matters might be relevant to type of sanction imposed, but were quite irrelevant to the issue of whether the doctor was guilty of SPM. To bolster its point, the panel cited an example in which the PCC panel concluded that over a period of months, a doctor had failed to adequately examine his patient and also failed to heed the complaints of symptoms made by the patient herself and by members of her family. However, notwithstanding that finding, the PCC panel found that the conduct did not amount to SPM partly because the PCC panel considered a number of glowing testimonials about the doctor‘s track record as well as the doctor‘s insight into his failings and the fact that he had taken steps to address his deficiencies. With regard to how mitigating factors ought to be handled in SPM hearings, the Inquiry panel‘s opinion was clearly aligned with the English courts‘ approach. In Preiss v General Dental Council [2001] 1 WLR 1926, the Privy Council, in considering submissions that the plaintiff Preiss, was a man of many years‘ good standing, had applied such evidence of long and impeccable professional service only when determining the sanctions that ought to be imposed; in his judgment, Lord Cooke had very clearly held that such 15 evidence had ‗some force‘ in the context of sanctions to be meted to the guilty party, but did not weigh this evidence when deciding on what constituted SPM. Pertaining to the standard of proof, Dame Janet Smith raised her concern that the PCC applied the criminal standard of proof when reaching conclusions on the facts. The medical community‘s rationale for adopting the criminal standard of proof had been that it would only be justifiable to deprive a doctor of his/her livelihood in the face of evidence that attained this high standard of proof. Dame Janet Smith perceived this approach as allowing the interests of the doctor to override the need for public protection; she questioned the appropriateness of such a high standard of proof if the primary purpose of a tribunal is to protect the public from doctors who are not fit to practise. There is a better strategy, she argued, that could be employed to safeguard the public‘s interests and fairness to doctors. While she held that it would be appropriate to retain the criminal standard of proof where the allegation amounted to a serious criminal offence, she advocated using the civil standard of proof in GMC hearings as being more suitable in a protective jurisdiction. She felt that requiring all members of the PCC to be convinced to the civil standard as to what the defendant doctor has actually done, offered greater protection for the defendant doctor than a system that as opposed to permitting a decision to be made when a simple majority of the panel were satisfied about a set of facts to the criminal standard but the minority might think that the doctor had done nothing wrong at all, would actually have been greater protection for the doctor. In essence, Dame Janet Smith opined that ‗good decision-making should, if possible, be unanimous‘. In the Inquiry‘s fifth report, the GMC‘s procedures on handling questions about a doctor‘s fitness to practise came under scrutiny. These procedures serve two distinct functions; the first function, carried out by medical screeners and the PPC, was to decide whether there was sufficient evidential basis to justify a referral to a committee for a formal hearing. This first function has been likened to the role of a prosecution service and was termed ‗investigation‘ by the GMC. The second function termed ‗adjudication‘ comprised the hearing and determination of cases and was conducted by the PCC. Sometime in 2000, the GMC became convinced that the two functions ought to be separated more clearly. This conclusion came about after the implementation of the Human Rights Act 1998 in October 16 2000 and the GMC was concerned that having the same organization prosecute errant doctors and sit in judgment on these doctors risked undermining both the public‘s as well as doctors‘ belief in the system to be independent and impartial. Subsequently, the GMC embarked on a reorganization of its ‗fitness to practise‘ procedures. Under the new arrangements, the GMC would remain in full control over the ‗investigation‘ phase, by filtering out cases that warranted a full hearing. However, the decision making at these hearings would not be by GMC members. Instead the ‗adjudication‘ phase would be the responsibility of both medically qualified and lay persons appointed by the GMC. These changes put forward by the GMC were criticized for being more of a cosmetic exercise rather than having substantive effects. By having the power to select and appoint and dismiss panelists involved in adjudication, the GMC exercised close control over the adjudication process vicariously. Furthermore, when referring cases to the adjudication committees, the GMC by indicating what outcome it was seeking in the case, revealed its intention to influence the outcome in a particular case. The GMC would also ‗advise‘ a panel chairman when it considered that an adjudication panel had erred, putting into question the independence and impartiality of such panels. Despite these sobering revelations about the failings of the GMC, Dame Janet Smith unequivocally stated that the GMC still has an important role as the keeper of the medical register and in deciding who can practise as a doctor and who cannot. Nevertheless, she did roll out a series of recommendations to reform the GMC and enhance governance within the medical profession, as well as enhancing the public‘s perception of medical organizations. Perhaps Dame Janet Smith‘s most significant input would be her recommendation towards reorganizing the makeup of the GMC. At the time of the Shipman Inquiry, the GMC comprised 35 members of whom 21 were registered medical practitioners and 14 were non-medical or lay members. Among the medical practitioners, 19 were elected members chosen by several different geographical ‗constituencies‘ of doctors, while two were appointed by the collective decision of universities with medical schools and the medical Royal Colleges. Dame Janet Smith‘s view was that the GMC should continue to be dominated by medical members because many tasks, such as the development of policies and medical guidance could not be carried out by lay people. However, she 17 professed her apprehension that the elected medical members may conflate their duties towards the public with their roles as representatives of an electorate and end up furthering the interests of the profession at the expense of the public interest. Therefore, Dame Janet Smith mooted the idea that there should be more appointed medical members, people who are not beholden to an electorate, such that the elected members do not have an overall majority. In this way, the GMC would not lose sight of its primary objective: protecting patients‘ interests. In the area of lay representation on the GMC, Dame Janet Smith emphasized the importance of diversity in the backgrounds among lay members. She cautioned that lay members with a professional background in NHS management or administration, would be influenced by the culture of the medical profession and of NHS management. These individuals might be perceived by the public as ‗members of the same club‘ and their presence would only erode the public‘s faith towards the independence of these lay members. Earlier, it was mentioned that decision-making involving doctors‘ fitness to practise procedures within the GMC was plagued by inconsistencies in the outcome. The Inquiry panel quoted submissions from Sir Donald Irvine, former GMC President, who reported that during GMC hearings, there was often much ‗heat‘ and ‗emotion‘ in the disagreement over whether a particular set of facts amounted to SPM. Thus, Dame Janet Smith urged the GMC to establish standards, criteria and thresholds relevant to decision making at every stage in the GMC‘s disciplinary procedures. She cautioned against ‗a mechanistic assessment which will result in cases being put into a specific pigeonhole‘. Rather, what she had in mind was a framework, drawn up after active consultation with members of the public and patient‘s representatives, to guide decisions so that individual circumstances could be factored in. Besides promulgating clear standards, criteria and thresholds by the GMC to enhance transparency in its proceedings, Dame Janet Smith saw the need to clarify the GMC‘s accountability structure. She noted the GMC‘s submission that even though the GMC‘s powers were vested by Parliament, the GMC was not directly accountable to Parliament for the way in which it exercised its powers. She was in full support of the GMC‘s suggestion that it were to be directly accountable to 18 Parliament and further recommended that it published an annual report of its activities, which could be scrutinized by a Select Committee. Such a report would contain statistical information and specified details, so as to strengthen transparency within the organization. Likewise, the reports by Dame Janet Smith affirmed the importance of revalidation and were critical of how the GMC had gradually departed from the true spirit of a revalidation process. In December 2002, the Medical Act 1983 was amended to impose a duty on the GMC to make the ‗revalidation of a medical practitioner of a prescribed description as a condition of his continuing to hold a licence to practise‘. However, there was much opposition from within the medical profession, particularly hospital consultants, resulting in a change of direction by the GMC. It discarded the notion of evaluation of individual doctors by independent revalidation groups and instead opted to base revalidation for doctors on less stringent criteria of appraisal by their employers without further scrutiny. Linking revalidation to appraisal was inappropriate, the Inquiry panel noted, because the appraisal process was never intended to provide any form of assessment or evaluation of the doctor. Rather, the appraisal was designed to provide for doctors an opportunity to think and discuss their practice and, by means of this process, to improve it. Therefore, appraisers had not been trained to form any judgment about an appraisee‘s fitness to practise, but were there mainly to stimulate self-examination by the appraisee. Secondly, there was a selection bias in the type of information revealed by doctors during the appraisal. There was no list of mandatory documents the doctor had to produce. Instead, the contents of the appraisal folder were selected entirely by the doctor being appraised. The Case at Bristol24 The events at the Bristol Royal Infirmary had concerned babies born with congenital heart disease and their subsequent treatment, in particular open heart surgery. In 1984, the Bristol Royal Infirmary was made one of nine designated centers for paediatric cardiac surgery. This came about as the result of a 24 Kennedy I. The report of the public inquiry into children’s heart surgery at the Bristol Royal Infirmary19841995: learning from Bristol. Chairman: Professor Ian Kennedy. The Stationery Office, London, 2001. 19 larger scheme (called Supra Regional Services or SRS) started by the then Department of Health and Social Security to concentrate very specialized healthcare services into chosen regional centers. The aim of this scheme was to avoid too many units spending too much resources and expertise in doing highly complex but uncommon procedures. Another rationale for this arrangement was the assumption that a unit should manage a certain volume of cases to ensure high standards in precision surgery and encounter the complete repertoire of rare cases. Over the ten years Bristol was a SRS center, it never chalked up the numbers deemed appropriate and was not on par with other units in terms of operations performed. Since the early 1980s, concerns were also raised about the quality of care delivered by Bristol‘s Paediatric Cardiac Surgery (PCS) unit. Statistics from various reviews suggested that Bristol‘s PCS had a mortality rate for infant open heart surgery that was higher than the national average: The Annual Report for 1988 gave a mortality rate for PCS in the under-1s in Bristol for 1988 of 37.9%, and 27% for the period 1984-1987, compared to 22% for the national average covering 1984-1987. The Annual Report of the Unit for 1989/90 gave a mortality rate of 37.5% for PCS on children under one. In contrast, the UK average was 18.8%. When these figures were circulated within the medical fraternity, response within the professional community was muted. Doctors from other units and institutions were generally concerned about the statistics. However, they failed to call for more data collection to verify the numbers, or request their Bristol colleagues to explain their poor patient outcome figures. This process dragged on for several years. Meanwhile, doctors within Bristol‘s PCS unit closed ranks and put up a spirited defence of their track record. They stated that their results were comparable to other centers in UK and the occasional less favorable outcome could be attributed to a small number of complex procedures which prejudiced the statistics. They even decried ‗a campaign of vilification‘ against their unit and banded together in a ‗paediatric cardiac club‘ to endorse one of the surgeons embroiled in the controversies. Around the same time, autopsies of patient mortality at Bristol revealed a disturbingly high rate of unsuspected abnormalities not picked up by the unit. There were also other concerns that patients at Bristol were subjected to longer duration of operations and hence spent more time on machine bypass and 20 were at greater risk of the consequent effects. The anaesthetist who made this observation also happened to be one of the persons who highlighted the discrepancy in operative mortality rates. Unfortunately, this anaesthetist soon found himself in a lonesome crusade; he was rebuked by a fellow doctor for revealing information to outsiders and was ostracized by colleagues after he wrote to higher authorities to raise awareness about Bristol‘s PCS unit. In January 1995, 18 month old Joshua Loveday died while undergoing heart surgery (the ‗Switch‘ operation) at Bristol‘s PCS unit. This finally turned to be the catalyst for establishing an independent external inquiry into Bristol‘s management. The matter was subsequently escalated to the General Medical Council (GMC). Bristol‘s two cardiac surgeons, Mr James Wisheart and Mr Janardan Dhasmana, and the Chief Executive of the Trust, Dr John Roylance were later found guilty of professional misconduct. Unfortunately, the GMC's hearing was limited only to examining the role of these two doctors and focused particularly on the ‗Switch‘ operation performed by these surgeons on 53 children, of whom 29 had died. The following year, a group of parents of children who underwent cardiac surgery at Bristol‘s PCS unit rallied for a Public Inquiry into services at Bristol. A panel chaired by Professor Ian Kennedy carried out a comprehensive review of Bristol‘s track record over the years and delivered its findings in 2001. The main conclusion of this inquiry was that the quality of PCS provided by Bristol was less than adequate. In particular, the panel singled out its finding that performance and outcome of Bristol‘s PCS unit was compromised by poor teamwork within the unit as well as inadequate audit mechanisms within the medical community to ensure that doctors are competent. The Bristol Inquiry pointed out a somewhat disquieting culture entrenched with the medical profession, which inevitably leads to question on whether doctors ought to be given the discretionary power to self-regulate. The panel identified a hierarchical approach within and between the healthcare professions and commented that this approach ‗is a significant cultural weakness‘. For instance, a hospital consultant was regarded as of higher status than a general practitioner. Another observation was the presence of subservience to a perceived superior. This mindset was traced to the setting in which the 21 majority of doctors were educated and trained, a culture in which there was a reluctance to criticize or comment upon the conduct of colleagues, particularly those who were more senior or practiced in the same team or specialty. The panel elaborated how such a hierarchical tradition was detrimental to UK‘s healthcare system- not only would the younger ranks feel pressured to conform to practices for fear of antagonizing those with power or authority, there was a genuine fear within junior doctors that questioning the practices of consultants would jeopardize their career prospects because the junior needed a reference and a recommendation from a consultant in job applications. This pervasive sense of hierarchy determines who gets listened to within the medical community when questions were raised, and breeds an oppressive climate that is not conducive to nurturing a culture of openness between medical staff. In fact, the panel labeled the culture as ‗defensive and secretive‘ and leaning towards ‗old-style attitudes of paternalism and self-protection‘. In short, the current practice, was likened to ‗more of the last century than this‘. Towards the end of its report, the Bristol Inquiry panel mapped out a host of recommendations to reform the UK healthcare system. Of particular relevance to fostering greater openness in medical audit is the panel‘s recommendation to involve the public in medical audit mechanisms. Historically, public views had been articulated indirectly through politicians and healthcare professionals. Elected politicians voice the public opinions in Parliament while healthcare professionals on the ground gather feedback on patients‘ expectations through their daily work. Unfortunately, the Inquiry panel noted, such public involvement by proxy is no longer adequate. Society is evolving and ‗the public are no longer prepared to be passive, trusting and grateful recipients of what is made available‘. In fact, public services had fallen in line with commercial services because the public is now increasingly ready to challenge, question and expect services to be responsive to their needs. Thus, the Inquiry listed ways in which lay persons could participate in medical audit. These ranged from setting the standards in appraisal and revalidation of medical professionals, to involvement in disciplinary proceedings against wayward doctors. The panel emphasized the justifications for public involvement in these activities: doctors are caring for the public as patients and thus it is only natural that the public participates in reviewing admission criteria to the 22 profession. Secondly, public participation ensures that their interests are safeguarded and serves ‗as a reminder that the profession exists for the public‘. At the national level, the panel favoured public participation in health policy formation. Organizations like the National Institute for Clinical Excellence (NICE) were urged to adhere to ‗an unstinting commitment … to engage with the public and patients, to involve them, to listen, to maintain a dialogue and to be responsive to what they have to say‘. By adopting this strategy, the panel opined that not only would the standards of care meet the expectations and needs of the public, it would also nurture public trust in the healthcare system. To actualize this plan, the panel recommended that organizations under the NHS umbrella publish an annual report on how they have involved the public and the effect of the involvement. This enables scrutiny of mechanisms that are effective in engaging the public in healthcare policy. The case of Alder Hey 25 In the course of the Bristol Inquiry, one of the medical experts gave evidence that human hearts were routinely retained for the purpose of study and teaching at various hospitals around the country. The largest collection was identified at Royal Liverpool Children‘s NHS Trust (Alder Hey Children‘s Hospital). As details of Alder Hey‘s organ retention program came to light (through a separate inquiry termed the ‗Redfern Report‘), the public learned that such a practice was widespread in hospitals around the country and dated back many years. At Alder Hey alone, between 1988 and 1995, multiple organs had been retained from approximately 850 post mortem examinations; altogether, there were about 2000 containers holding different organs and tissue fragments held at Alder Hey. Besides using the retained human tissue for education, it emerged that Alder Hey had also given human tissue removed from children to a pharmaceutical company for research in return for financial donations. 25 Redfern M. The Report of the Royal Liverpool Children’s Inquiry. Chairman: Michael Redfern (QC). The Stationery Office, London, 2001. 23 The medical profession had justified the retention of organs as necessary for medical research and education. However, the manner in which the organs were obtained was condemned by the Redfern Report as ‗paternalistic‘. In some cases, consent was not obtained as doctors had believed that families would not want to know that organs were retained and the uses to which they were put. In other cases, the consent forms had been signed but without the relatives understanding fully what that involved. Most shocking was the revelation that organs were removed during unauthorized post-mortems of children as the autopsies were carried out even though the children‘s parents specifically stated that they did not want a full post-mortem. The lessons learnt The evils committed by Harold Shipman thrust the issue of clinical governance to the frontline. As far back as history could reveal, the medical profession in England has always enjoyed much autonomy in its existence even though the basis for allowing self-regulation had never been well elucidated. Medical education traditionally came under the purview of the respective royal colleges and sometime in the mid 19th century, when members of the public rallied for some form of assurance that they were being treated by qualified and competent doctors, the English government responded by establishing the GMC26. The GMC was essentially a professional body constituted predominantly of doctors and assigned the tasks of maintaining a register of doctors and disciplining errant doctors. During the period of the 1960s to 1970s, growing discontent among doctors about the GMC‘s structure, triggered concerns among members of parliament that self-regulation by doctors was disintegrating. A committee of inquiry chaired by Sir Alec Merrison was set up to look into the composition and functions of the GMC. However, this gesture only served to entrench self-regulation by the medical profession, for prior to the Merrison committee setting about its work, then Secretary of State, Sir Keith Joseph, declared in the House of Commons in 197227: 26 27 Richard Smith. Profile of the GMC- 1978 and all that. Br Med J. 1989; 298: 1297-1300. Ibid. 24 ―It is not contemplated that the profession should be regulated otherwise than by a predominantly professional body.‖ With such a shackle around its mandate, it was not surprising that the Merrison committee recommended the GMC continue to be independent and predominantly professional. In all fairness, the committee did view self-regulation by doctors as advantageous to the community. Besides viewing professional independence to be a motivating force for doctors to perform well, Sir Alec Merrison laid out his belief that since a professional skill dealt with matters unfamiliar to the layman, it followed that ‗only those in the profession are in a position to judge many of the matters of standards of professional competence and conduct which will be involved‘ 28. The findings of the Merrison committee found favour with Sir Robert Kilpatrick, former president of the GMC. While Sir Kilpatrick acknowledged self-regulation as ‗one of the greatest privileges we have‘, he opined that this independence was essential for the profession‘s self respect 29. He also held that self-regulation would promote standards of practice and professional behaviour beyond what could be set down in law, although he failed to elaborate on the basis for his belief. Last but not least, Sir Kilpatrick felt that self-imposed discipline was more likely to be accepted by the members of a profession than that imposed from outside the profession30. However, the series of revolting incidents in the UK had shed unprecedented insight on the inner workings of the medical fraternity while exercising its professional autonomy. Patients‘ welfare had given way to self-protectionism and medical chauvinism. These incidents also exposed grave lapses in how the GMC conducted its disciplinary hearings. When entrusted to deal with errant members of the profession, the GMC performed poorly because it departed from basic legal principles that had been established to ensure fairness. Furthermore, the GMC did not adhere to quality control measures intended to maintain competency of doctors. 28 Richard Smith. Profile of the GMC- The day of judgment comes closer. Br Med J 1989; 298: 1241-4. Robert Kilpatrick. Profile of the GMC: portrait or caricature?. Br Med J 1989; 299: 109-12. 30 Ibid. 29 25 Due to close historical ties between Singapore and the UK, doctors in Singapore have much in common with their counterparts in the UK: the training of doctors remains an on-the-job apprenticeship system; the hierarchical consultant-led team is the dominant feature in patient care; during clinical meetings, the final word often rests on the most senior physician present; collegiality is highly valued at the work environment. In all fairness, the horrific incidents in the UK are yet to be paralleled by events in Singapore. However, the scandals in UK should serve as a warning against complacency by Singapore‘s health authorities when regulating the medical profession. The fact that failure at both the individual level and institutional level in the UK health system had gone unnoticed so long, is a reminder to Singapore that any convenience gained through professional self-regulation may not justify the high stakes involved. 26 CHAPTER FOUR: PROFESSIONAL REGULATION IN SINGAPORE Perhaps it is ironic for this thesis to advocate greater legal involvement in clinical governance despite the fact that the route to self-regulation by Singapore‘s medical profession is erected by statutes and at times smoothened by the Singapore courts. The Medical Registration Act (MRA) dictates the scope of practice for doctors in Singapore, whereas the use of any physical facility by doctors to render clinical services is mapped out by the Private Hospitals and Medical Clinics Act (PHMCA). The two statutes are featured again when it comes to scrutinizing the practices of medical practitioners. Clinical audit activities come under the purview of the PHMCA while the Singapore Medical Council‘s authority to rein in errant doctors is enshrined within the MRA. Traditionally, the role of the common law has been to adjudicate disputes between ordinary individuals. However, the last part of this chapter will endeavour to illustrate how by granting anomalous treatment to doctors, the common law in Singapore also perpetuates selfregulation by the medical profession. Licensing of medical practitioners and healthcare facilities The Director of Medical Services (DMS) can be likened to the medical practitioner appointed to the highest-ranking healthcare administrative job in the country. Under s18(1) of the MRA, the Registrar of the Medical Council is automatically appointed to the post of DMS. Hence the DMS by virtue of s18(1) will be a medical professional. Section 19(1) of the MRA describes the main role of the Registrar, which is to maintain ‗The Register of Medical Practitioners‘. The Register in essence contains the names and information, in particular the type of medical registration of individuals under the Register. In this aspect, the DMS is aided by the Credentials Committee established under s29 of the MRA. The Credentials Committee is tasked with reviewing all applications for medical practice and assigning successful applicants into ‗full‘31, ‗conditional‘32, ‗temporary‘33 or ‗provisional‘34 registration. Once a 31 32 s(20) MRA. s(21) MRA. 27 doctor fulfils the necessary criteria for ‗full‘ registration, he is allowed to work throughout his entire professional career without undergoing any further formalized re-accreditation process. Doctors given ‗full‘ registration rights are also in the most optimal position to enjoy the prescribing rights bestowed by another statute, the Medicines Act (MA). The Medicines Act lays out the regulatory provisions relating to the administration and dealing of medicinal products. Section 5 of the MA requires all persons dealing in medicinal products to obtain a product licence while s12(1) enumerates the factors relevant to the determination of application for licence: ―(a) the safety of medicinal products of each description to which the application relates; (b) the efficacy of medicinal products of each such description for the purposes for which the products are proposed to be administered; (c) the quality of medicinal products of each such description, according to the specification and the method or proposed method of manufacture of the products, and the provisions proposed for securing that the products as sold or supplied will be of that quality; and (d) whether the grant of a product licence for the medicinal products to which the application relates will be in the public interest‖. However, s7(4) of the MA unequivocally states that the licensing requirements of s5 [and hence the conditions listed under s12(1)] do not apply to medical practitioners. This exemption provision in the MA together with the MRA translates into a great privilege for doctors with ‗full‘ registration because they can set up independent medical facilities and not be under any statutory duty as opposed to a professional duty to restrict their clinical services to efficacious products. Having obtained ‗full‘ registration rights, doctors can enter the more lucrative private healthcare sector and be independent proprietors of medical facilities. With the increasing popularity of day surgeries and procedures, it is not uncommon for these doctors to integrate minor procedure facilities into their clinics. Hence, the practising rights of many doctors are indirectly impacted upon by the DMS via 33 34 s(23) MRA. s(24) MRA. 28 his work pertaining to the licensing of medical clinics and hospitals. Section 5(1) of the PHMCA bars any premise from being used as a medical facility or healthcare establishment ‗except under the authority and in accordance with the terms and conditions of a licence issued by the Director‘. Section 6 follows by listing the criteria for the successful application and issuance of licences under the PHMCA. Clinical audit In any regulatory process, a proper feedback mechanism will ensure that errors not be repeated and quality measures are at least maintained if not updated. For this purpose, the PHMCA mandates the audit cycle which is pivotal to the upkeep of standards in healthcare services. Under s11(1) of the PHMCA: ―(1) The licensee of a private hospital or a healthcare establishment shall establish one or more quality assurance committees to — (a) monitor and evaluate the quality and appropriateness of the services provided and the practices and procedures carried out at the private hospital or healthcare establishment; (b) identify and resolve problems that may have arisen in connection with any service provided or any practice or procedure carried out at the private hospital or healthcare establishment; (c) make recommendations to improve the quality of the services provided and the practices and procedures carried out at the private hospital or healthcare establishment; and (d) monitor the implementation of the recommendations made under paragraph (c)‖. At times, the licensee must submit these reports compiled by quality assurance committees for inspection by the DMS as part of the DMS‘ legal duty to monitor quality in hospitals and healthcare establishments35. Clinical meetings that can possibly come within the ambit of s11 include regular ‗mortality and morbidity‘ (M & M) meetings and ad hoc hospital inquiries investigating sentinel events in patient care. 35 s11(2) PHMCA. 29 During M & M meetings, clinicians examine lapses in patient care that lead to nosocomial 36 complications or in the most serious of circumstances, contribute to the death of patients. M & M discussions create opportunities for doctors to share their wealth of personal experiences and theorize on how clinical care could have been improved upon and therefore, possibly prevent complications or deaths37. Very often, the M & M meetings deal with isolated incidents which by themselves are not sufficient to trigger medical malpractice suits. What is more probable is that these lapses in doctors‘ vigilance had somehow contributed to patient injury. An example will be the omission by doctors to follow up on tests ordered for patients, resulting in a delay in diagnosis and instituting treatment. Likewise, ad hoc hospital inquiries are internalized institutional activities dominated by the aura of senior clinicians, albeit representing different medical departments and specialties. These panels of clinicians differ from M & M meetings by the severity of the lapses in patient care that they are bound to investigate38. At the conclusion of its inquiry, the panel of clinicians usually submits reports to the hospital administration and recommends changes within the hospital‘s workflow or clinical practice guidelines. Disciplinary proceedings for medical practitioners The Singapore Medical Council is established under the Medical Registration Act and unquestionably, represents the highest professional body governing medical practitioners. Currently, under s4 of the MRA, the SMC comprises exclusively of medical professionals, the majority of whom are appointed (ten doctors), while the remaining nine are elected by medical practitioners in Singapore. Section 5 of the MRA lists the functions of the Medical Council. Of particular interest here is s5(f), which requires the SMC ‗to determine and regulate the conduct and ethics of registered medical practitioners‘. 36 ‗Nosocomial‘ is synonymous with ‗hospital acquired‘. In general, all unexpected patient outcomes will be highlighted and examined, with senior doctors within the department leading the discussion. 38 For instance, cases of how the wrongful administration of treatment to patients had resulted in serious harm or even death are put up for discussion so that measures can be implemented to prevent similar occurrences in future. 37 30 Part VII of the MRA defines the procedures pertaining to disciplinary hearings and confers near absolute control over investigative and adjudicative proceedings on the SMC. Under s38(1), the constitution of both the Complaints Committees and Disciplinary Committees is determined by the Medical Council. Members in either committee are selected by the council from a Complaints Panel consisting: ‗…(a) not less than 10 members of the Medical Council; (b) not less than 10 and not more than 40 registered medical practitioners of at least 10 years standing who are not members of the Medical Council; and (c) not less than 6 and not more than 40 lay persons nominated by the Minister…‘ The Chairman of the Complaints Panel has to be a member of the Medical Council 39 and hence a medical practitioner. When handling complaints against medical professionals, the primary role of the Chairman is to establish Complaints Committees to inquire into these complaints. Not unexpectedly, each Complaints Committee is dominated by the medical profession and comprises one lay person and three medical practitioners40. With this authority by the Chairman to appoint a Complaints Committee, comes the discretionary power to revoke the appointment of the committee or remove any member of a Complaints Committee41. Besides directly taking charge over the appointment of Complaints Committees, the Chairman acts as a screener for complaints raised against medical practitioners. If the Chairman is satisfied that there is adequate information in support of the complaint and that a formal inquiry is necessary to determine the physical or mental fitness of the registered medical practitioner, he will refer the matter to the Health Committee, as required by s39(8)(a). Alternatively, the Chairman might decide that a referral to a Complaints Committee is more appropriate42. 39 s38(4) MRA. s39(5) MRA. 41 s39(9) MRA. 42 s 39(8)(b) MRA. 40 31 The Complaints Committee functions as a second line filter in the handling of complaints against medical practitioners. Under s41(1), a Complaints Committee will assess a ‗complaint or information, or any information or evidence‘ that questions the conduct or fitness to practice of any medical professional, and arrive at a decision. If it is of the view that no formal inquiry is necessary, it may dismiss the matter, send out a warning or issue a letter of advice to the doctor concerned. However, if the committee deems a formal inquiry to be necessary, it would either refer the matter to the Health Committee or order that an inquiry be held by a Disciplinary Committee. The Disciplinary Committee represents the final layer of assessment in the inquiry process and in addition, is empowered by s45(2) to institute action against the registration of medical practitioners; this could either be the revocation of a doctor‘s registration or the suspension of a doctor‘s practicing rights for a period ranging from three months to three years. Under s42(1), the Disciplinary Committee will comprise ‗(a) not less than 3 registered medical practitioners of at least 10 years standing of whom at least 2 shall be members of the Medical Council; and (b) one observer who is a lay person‘. At any point during the inquiry of a complaint, the Chairman of the Complaints Panel, a Complaints Committee, a Disciplinary Committee or the Health Committee may refer the complaint or information to the Interim Orders Committee 43 to ascertain whether it is necessary to suspend a medical practitioner‘s registration temporarily for a period up to 18 months, or to make it subject to conditions the Committee thinks fit to impose44. Under s54(1), the Interim Orders Committee has the discretion to vary, revoke or replace an interim suspension order or order for interim registration upon the recommendation of the referring committee. The Interim Orders Committee is established on an ad hoc basis and comprises entirely of Council members, appointed by the Medical Council itself 45. Thus, it is apparent that the disciplinary process in Singapore parallels that in the UK and can be described as a two-stage procedure contained within the SMC. First, a patient‘s complaint is screened by doctors to ascertain if there is any ground to the charge made. At the second stage, the defendant is hauled 43 s51(3) MRA. s52(1) MRA. 45 s51(1) MRA. 44 32 up in front of a panel comprising his peers to answer the charge made. If deemed culpable by his fellow professionals, the defendant will be subjected to disciplinary measures dictated by the panel of doctors. Medical tort law In Singapore, statutory guarantees of the medical profession‘s right to self governance is complemented by the Singapore courts‘ subscription to English law principles during medical negligence litigation. For decades, the English courts have baulked at the idea of overriding medical expert opinion when adjudicating over medical negligence cases. If anything, the English courts have been on a steady retreat since the seminal case of Bolam v Friern Hospital Management Committee [1957] 2 All ER 118 (‗Bolam‘). In Bolam, Judge McNair expressed his approval that in a situation involving the use of some special skill or competence, a man exercising and professing to have that skill was not negligent if he exercised the ‗skill of an ordinary competent man exercising that particular art‘. To put it in another way, a doctor would not be found guilty of negligence if there were a group of responsible and competent doctors who would have done the same thing, in the same situation 46. Since the articulation by Judge McNair, the English courts had expanded the scope of Bolam on several occasions. In Whitehouse v Jordan [1981] 1 All ER 267, the House of Lords approved the application of the Bolam test to medical treatment and in Maynard v West Midlands Health Authority [1985] 1 All ER 635, the House of Lords held that it was applicable to diagnosis. In Sidaway v Governors of Bethlem Royal Hospital [1985] AC 871, Lord Diplock, representing the majority, extended the Bolam test to cover the issue of advice to the patient: ―My Lords, no convincing reason has in my view been advanced before your lordships that would justify treating the Bolam test as doing anything less than laying down a principle of English law that is comprehensive and applicable to every aspect of the duty of care owed by a doctor to his patient in the exercise of his healing functions as respects that patient.‖ 46 See chapter 8. 33 Later in Bolitho v City and Hackney Health Authority [1998] AC 232 (‗Bolitho‘), the House of Lords clarified that the court was not bound to find for a defendant doctor simply because a body of experts testified in his favour. Lord Browne-Wilkinson observed that: ―[T]he court is not bound to hold that a defendant doctor escapes liability for negligent treatment or diagnosis just because he leads evidence from a number of medical experts who are genuinely of the opinion that the defendant‘s treatment or diagnosis accorded with sound medical practice ... [T]he court has to be satisfied that the exponents of the body of opinion relied upon can demonstrate that such opinion has a logical basis.‖ However, Lord Browne-Wilkinson emphasized that it would be a rare case where expert opinion fails this threshold test of logic: ―I emphasize that in my view it will very seldom be right for a judge to reach the conclusion that views genuinely held by a competent medical expert are unreasonable. The assessment of medical risks and benefits is a matter of clinical judgment which a judge would not normally be able to make without expert evidence.‖ These English cases were followed by the Singapore Court of Appeal in Dr Khoo James v Gunapathy d/o Muniandy [2002] SGCA 25 (‗Gunapathy‘) whereby delivering the judgment on behalf of the court, then Chief Justice Yong Pung How described the Bolam test as ‗the locus classicus for the standard of care required of a medical practitioner in relation to a patient‘, which ‗reigned supreme to confer near-immunity to the medical profession from actions in negligence‘. Applying the Bolam test to the issue of medical advice in Gunapathy, the court decided that the defendant doctors‘ disclosure of the 34 relevant percentage risks of radiosurgery was supported by a respectable body of medical opinion and therefore not negligent. Later in the judgment, CJ Yong touched on Bolitho and held that the ruling in Bolitho supplemented the Bolam test: ―… Bolitho presented a timely addendum to the Bolam test. It gave voice to a commonsense understanding which was hitherto unexpressed – that the Bolam test did not represent immunity from judicial inquiry over the medical process. It was not to be satisfied by the production of a dubious expert whose professional views existed at the fringe of medical consciousness. An expert view, in order to qualify as representative of a ‗responsible‘ body of medical opinion, had to satisfy the threshold test of logic.‖ However, the Court of Appeal differed from the House of Lords in the extent to which judges should intervene in medical adjudication. The House of Lords appears to view medical negligence on equal footing compared to other forms of professional negligence because in Bolitho, Lord BrowneWilkinson cited as support how judges were prepared to adjudicate over the practice of lawyers in the Privy Council case of Edward Wong Finance Co v Johnson Stokes & Master [1984] AC 296. The learned Law Lord stressed the importance of balancing the risks and benefits relating to the matter by medical experts before arriving at a ‗defensible conclusion‘ failing which, the court will intervene. In Gunapathy, CJ Yong cautioned that a liberal interpretation of Bolitho could unwittingly herald invasive inquiry into the merits of medical opinion and curtailed the use of Bolitho by ruling out using a balance of probabilities to determine whether a doctor‘s actions were ‗reasonable‘. Judicial intervention was only warranted, the Chief Justice stated, when either medical opinion contradicts itself or ignores known medical facts or advances in medical knowledge. In unequivocal terms, CJ Yong added that the Bolam principle specifically referred to the medical profession and ‗hence, the willingness of the court to adjudicate over differing opinions in other professions should not be transposed to the medical context‘. 35 Ultimately, it seems the Singapore Court of Appeal is splitting fine hairs by deciding Bolam confers ‗near-immunity‘ to doctors but at the same time ‗did not represent immunity from judicial inquiry‘. By taking a narrow interpretation of Bolitho, what the court has done in reality is allow Singapore doctors to dictate their professional standards. The apprenticeship format of medical training in Singapore, plus the integrated nature of the healthcare delivery system, allows a doctor to quite effortlessly recruit a handful of his brethren who will concur with his clinical decisions and management and therefore satisfy the Bolam test. The Court of Appeal‘s caveat that medical opinion must not fly in the face of known medical facts or advances in medical knowledge gives birth to this paradox: how would the court determine what the medical facts or advances in medical knowledge are, if it consistently adopts a deferential attitude and baulks at active inquiry into the validity of expert medical opinions? Professional regulation in Singapore is not dissimilar to that in the UK. In both jurisdictions, the most recognizable hallmark of the governing process is the overwhelming influence of doctors. The medical profession‘s influence does not end at the licensing of doctors and healthcare institutions; the medical profession‘s hegemony extents even to the administration of justice as the SMC takes on the roles of investigating patients‘ complaints, prosecuting errant doctors, and adjudicating over disciplinary hearings. Aggrieved patients who appeal to the courts for justice through claims in negligence do so under the shadow of the medical profession. The use of the Bolam principle by the Singapore courts swings the balance firmly in favour of the defendant doctor who is exonerated as long as there is a cluster of medical practitioners who are willing to come out in support of his actions. Looking at the extent of autonomy granted to doctors in the area of clinical governance, to describe the medical profession as a highly privileged community is not far from reality. 36 CHAPTER FIVE: CHALLENGING THE RATIONALE FOR PROFESSIONAL SELFREGULATION Professional self-regulation is built upon the community‘s trust that doctors will never hesitate to prioritize the public‘s interests over the profession‘s interests. During a lecture to the Royal College of Physicians in 2004, medical ethicist Dame Onora O‘Neill47 observed that trust has now been widely rejected as being ‗obsolete, intrinsically immature, if not blind‘. She concurred with criticisms that trust was based on a simplistic assumption that ‗others have goodwill towards us‘. Hence, she advocated using robust systems of accountability in a mature society to replace a practice of taking matters on trust. Dame O‘Neill further cautioned that trust could be perverted to mask a ‗club‘ culture in which ‗professional cosiness… flourished‘, and posed a danger in medical practice. This chapter will first document some of the more high profile incidents involving the medical profession in Singapore to dispel any notion that medical practitioners are perched on a higher moral ground and immune from the foibles or temptations of ordinary people. Then the chapter will attempt to show that even if the medical profession has the best of intentions towards the community, doctors are still not suited for self regulation because they are handicapped by their ignorance of what constitutes due process in a justice system. Unmasking the black sheep within the medical profession In recent years, a disturbing trend has emerged within the medical profession. Increasingly, more doctors are hauled up for their indiscriminate prescription of controlled addictive drugs like sleeping pills to boost profit margins. The most appalling of these cases involved the dispensing of the drug ‗Subutex‘ by general practitioners. ‗Subutex‘ was launched on the market as a drug that helps heroin addicts wean themselves off their dependency on heroin. However, consuming ‗Subutex‘ in high doses can itself lead to addiction to the drug. A minority of doctors had exploited patients‘ reliance on ‗Subutex‘ for financial 47 Onora O‘Neill. Accountability, trust and informed consent in medical practice and research. Clinical Medicine. Vol 4. No.3. May/June 2004; 269-276. 37 gains by prescribing the drug without adequate monitoring of its usage. It is estimated that over the last decade, at least nineteen general practitioners have been convicted of offences related to careless prescription48. These errant doctors were subsequently hauled up by the Singapore Medical Council (SMC) for breach of medical ethics. Instead of capitalizing on patients‘ dependency on prescription drugs, the lure of financial rewards and stiff market competition has induced a minority of doctors to make exaggerated claims to boost their public profiles. Since the amendment of the Private Hospitals and Medical Clinics Act to allow advertisements of health services through public media, the Ministry of Health has highlighted how certain doctors have utilized this form of publicity to garner a bigger share of the medical dollar. In particular, several opthalmologists had employed a myriad of strategies to enhance public visibility. Rather than just offering financial incentives like special prices, discounts and free gifts, some eye specialists have resorted to patient testimonials or celebrity personalities to endorse their Lasik procedures. Such tactics to solicit patients were judged by the Ministry of Health to have deviated from ethical guidelines, triggering the issue of warnings against giving the public ‗unrealistic expectations‘ of what Lasik procedures can do49. The Ministry was perturbed by how risks and possible side effects were downplayed while results were overstated by the advertisements: in some cases, the advertisements had staked claim to success rates that were not achieved by the advertising clinics. While the above incidents suggest that medical professionals do not sit on a higher moral ground compared to the ordinary man, disputes between the various medical specialties pertaining the rights to administer certain medical procedures ignite doubts on the profession‘s capacity to self regulate. One such professional jurisdiction issue battled out in the public gallery in recent years was the debate on whether vaginoplasty50 should be performed by gynaecologists or plastic surgeons 51. 48 Salmah Khalik. 2 docs suspended over sleeping pills. The Straits Times (Singapore). 19 January 2009. Salmah Khalik. MOH concerned over misleading LASIK ad claims. The Straits Times (Singapore). 27 November 2007. 50 A surgical procedure to reconstruct the vagina, usually done after childbirth. 51 Cheah Ui-Hoon. Finding the right plastic surgeon. The Business Times (Singapore). 6 January 2007. 49 38 More recently, the Ministry of Health‘s clampdown on shoddy aesthetic medicine procedures had inadvertently unmasked strident disagreements between plastic surgeons and aesthetic medicine general practitioners. Since its inoculation into the medical community, aesthetic medicine has disseminated far and wide within the profession. With an estimated market value of about $200 million, it has been reported that over 1,000 general practitioners and specialists offer aesthetic treatments in their practice52; almost six in ten general practitioners engage in aesthetic procedures while specialists in fields such as anaesthesia, gynaecology and renal medicine were also taking a stab at the aesthetic medicine pie53. The intense competition for a fraction of this lucrative pie became a crucible for the prescription of costly treatment with questionable scientific merit by some aesthetic practitioners. Procedures under scrutiny include purported weight loss procedures like mesotherapy and carboxytherapy, and growth hormone injections for skin treatment. In several instances, disgruntled patients who have suffered adverse effects from aesthetic procedures had lodged formal complaints with the Singapore Medical Council, seeking redress for their suffering54. The situation was deemed serious enough for the Ministry of Health to issue a directive, banning unproven aesthetic treatments, with the warning that recalcitrant doctors face disciplinary action. Doctors who performed such dubious procedures, were labeled by the Ministry as ‗unethical and subjecting patients to unacceptable health risks‘ 55. Such unsubstantiated aesthetic treatments were also likened to ‗snake oil‘ by the Ministry, and these doctors were deemed a ‗greater danger to the public than lay persons selling snake oil because the public trusts doctors more‘ 56. In addition, the aesthetic medicine saga uncovered fault lines within the medical profession. Competition for a slice of the aesthetic medicine market saw general practitioners lined up against their specialist counterparts, namely plastic surgeons. This was evident from public statements issued by general practitioners and plastic surgeons after the Ministry of Health announced its intention to lay out 52 Salmak Khalik. Ministry wants doctors to stop ‗aesthetic treatments‘. The Straits Times (Singapore). 20 March 2008. 53 Salma Khalik. MOH warns docs peddling unproven beauty fixes. The Straits Times (Singapore). 19 March 2008. 54 Judith Tan. GPs quizzed on shoddy cosmetic treatments. The Straits Times (Singapore). 18 February 2008. 55 Salma Khalik. MOH warns docs peddling unproven beauty fixes. The Straits Times (Singapore). 19 March 2008. 56 Ibid. 39 guidelines on aesthetic medicine procedures. First, some general practitioners expressed dismay that the Ministry of Health had acted in reliance on the findings from an advisory panel with no representation by general practitioners57. Secondly, there was a degree of unhappiness pervading the plastic surgeon community that general practitioners were allowed to engage in some cosmetic related medical procedures58. Thirdly, there were plastic surgeons who continued to question the ability of general practitioners to carry out aesthetic procedures; a prominent plastic surgeon had articulated the reason behind his objections to general practitioners performing aesthetic treatments 59: ―when things go wrong, they don‘t know how to correct the mistakes or how to manage the complications. This is where the problem lies.‖ With all due respect to the consultant plastic surgeon, such thinking may be unduly harsh. The reality of modern medicine is such that there will always be a degree of overlap in the nature of work done by the various medical specialties. To expect a practitioner to be able to handle all complications associated with a procedure may be onerous and potentially hinder public access to the tools of modern medicine. For instance, one of the known complications of endoscopy is that of organ perforation during the procedure which would almost certainly require open surgery to repair the site of perforation. However, such complications have not prevented gastroenterologists 60 who are not trained in surgery from carrying out endoscopic procedures on a routine basis. In fact, it is generally accepted that gastroenterologists are among the most competent interventionists and capable of carrying out more intricate endoscopic 57 Jessica Jaganathan. Doctors want say in how new rules are drawn up. The Straits Times (Singapore). 27 March 2008. 58 Salma Khalik. GPs cheer, plastic surgeons fume, over new MOH rules. The Straits Times (Singapore). 28 April 2008. 59 Judith Tan. GPs quizzed on shoddy cosmetic treatments. The Straits Times (Singapore). 18 February 2008. 60 Gastroenterologists are specialists in internal medicine with an interest in digestive problems. 40 procedures compared to many surgeons eg. endoscopic retrograde pancreaticocholangiography 61 (ERCP) and endoscopic submucosal dissection62 (ESD). The above remarks by the plastic surgeon also distract one from the fact that aesthetic procedures carried out by general practitioners are often minimally invasive in nature and often based on the injection therapy of drugs eg. Botox, collagen fillers and body fat dissolution agents. As such, they are technically not too different from other forms of drug injections (eg. pain killers, antibiotics and antipyretics) administered by general practitioners in daily practice which carry the theoretical risk of complications at the injection sites as well63, e.g. abscess formation. If one were to accede to the plastic surgeon‘s remarks, it would mean that general practitioners should also not be administering other forms of medical injections as the complications encountered may require surgical drainage. In July 2008, the Ministry finally published draft regulations aimed at regulating aesthetic medicine procedures 64. Under the new rules, liposuction operations removing more than one liter of fat must be performed in a hospital or surgery center. This is understandable given the fact that removing large quantities of human fat tissue naturally entails higher risks and general anaesthesia; thus patients‘ safety is best served by restricting such invasive procedures to hospitals or surgery centers where medical support and monitoring is more comprehensive. The effect of the Ministry‘s rule is that general practitioners offering aesthetic liposuction in their clinics will be able to continue performing such procedures because these general practitioners operate on body areas that entail removing less than one liter of body fat, in contrast to plastic surgeons who carry out more extensive procedures. Though it is somewhat arbitrary to define the appropriate medical facility according to the quantity of body fat removed, the Ministry‘s laudable attempt to tighten patient‘s safety during aesthetic procedures does have a logical basis. A general guiding principle in medicine has always been that surgical procedures amenable to local anaesthesia can be safely performed in places with minimal 61 An invasive procedure that utilizes fibreoptic devices to remove gallstones causing obstructive problems. A procedure that utilizes fibreoptic endoscopes to excise early cancers of the intestinal tract. 63 Lehnhardt M, Vu P, Kuhnen C et al. Serious complications of injections- retrospective analyses of incidences, complication-management, prophylaxis and economic aspects. Zentralb Chir. 2005 April; 130(2):162-9. 64 MOH. Guidelines on aesthetic practices for doctors. July 2008. 62 41 medical monitoring devices. On the other hand, more extensive surgical operations ought to be restricted to medical centers or hospitals. This is because such procedures can only be done safely and comfortably for patients under general anaesthesia. For instance, a body wall lump such as a lipoma 65, would mandate surgical excision under general anaesthesia if it were of a significant size, because local anaesthetic agents either give ineffective pain relief, or require a dose so large that it risks causing toxicity to the patient. With the clinical indication for general anaesthesia comes the requirement that such patients need to be monitored closely using various support and resuscitation system; devices which only medical centers or hospitals are capable of providing due to the high set up costs involved. In response to the Ministry‘s efforts, The Singapore Association of Plastic Surgeons has labeled them a ‗piecemeal approach‘ that ‗makes a mockery of the comprehensive way that bona fide plastic surgeons are trained‘ 66. This response is untimely, considering public perception that the aesthetic medicine debate was primarily a turf war between two groups of doctors: plastic surgeons had been ‗portrayed as viewing regulation as a way to protect their turf, while GPs were said to prefer minimal oversight so that they could muscle in on the lucrative $200-million-a-year market‘.67 The SMC’s track record That the SMC views its role in clinical governance seriously should never be doubted. In the ‗Introduction‘ chapter to the SMC‘s ‗Ethical Code and Ethical Guidelines‘ (‗Ethical Code‘), the SMC acknowledges its role of ‗promulgating the Ethical Code and Ethical Guidelines on acceptable professional practice and behaviour‘ and that it ‗has the responsibility to exercise its duty to discipline members of the profession who fail to uphold the high standards demanded by society‘. Subsequent chapters in the ‗Ethical Code‘ then outline what the SMC regards as the minimum standards required from all medical practitioners in the discharge of their professional duties and responsibilities. The 65 A benign fatty growth often found just under the skin. Salma Khalik. GPs cheer, plastic surgeons fume, over new MOH rules. The Straits Times (Singapore). 28 April 2008. 67 Jessica Jaganathan. Aesthetic treatments carried out by GPs- new rules‘ impact merely skin deep? The Straits Times (Singapore). 25 July 2008. 66 42 comprehensive range of topics covered, including what constitutes good clinical practice, the nature of the doctor-patient relationship, avoidance of financial conflicts of interest, amongst many others, is testimony of the SMC‘s efforts in defining the relevant benchmarks in clinical governance. Nevertheless, the SMC‘s performance in professional regulation remains far from optimal on several occasions. Perhaps this is not unexpected since medical education does not equip doctors with the necessary skills set to take charge of tribunal proceedings or adjudicative functions. In particular, the legal principles of natural justice and notions of administrative fairness which are fundamental to good governance may be unfamiliar concepts to medical practitioners. According to the MRA, the SMC undertakes a quasi-judicial role in professional regulation. Section 43(7) places a legal obligation on any person giving evidence before a Disciplinary Committee to tell the truth, while s43(8) likens the hearings before a Disciplinary Committee to ‗proceedings in a court of law‘. Similarly, under s40, any registered medical practitioner who ‗without lawful excuse‘ refuses or fails to cooperate with an inquiry by the Complaints Committee when required to do so, shall be guilty of an offence and may face a fine not exceeding $5,000 or possibly imprisonment. On the other hand, a review of Singapore‘s case law reveals some occasional lapses in the administration of the professional disciplinary process. In Tan Boon Chee David v Medical Council of Singapore [1980] 2 MLJ 116, the Singapore High Court expressed its shock at how the SMC had conducted an inquiry ‗in a light-hearted or slipshod manner‘ and chastised the SMC for committing ‗so glaring a breach of natural justice‘. During the inquiry, the appellant was found guilty of ‗infamous conduct‘ in a professional respect and was suspended from medical practice. The inquiry had been held over two days but the record showed that the attendances of members of the Council were erratic and furthermore, members of the Council were walking in and out of the inquiry as and when they liked while evidence of the witnesses was being recorded. In his judgment, the High Court judge articulated reasons for ruling in favour of the appellant: 43 ―… a person who has not seen and heard a witness is as a rule incapable of estimating the value of his evidence. It was therefore improper for members of the Council to walk in and out of the Inquiry while evidence was being recorded or to be absent altogether… such conduct is not only improper and unfair to the practitioner … but it also tends to destroy confidence in the fairness of the Council‘s decision…‖ The case of Lim Teng Ee Joyce v Singapore Medical Council [2005] 3 SLR 709 illustrates how the SMC had unfairly punished the appellant by ordering her to pay all the costs involved in the proceedings. The appellant had been charged with three counts of professional misconduct. She pleaded guilty to the first two charges but was successfully acquitted by the Disciplinary Committee of the third charge. Besides imposing a fine of $ 10,000 and three-month suspension on the appellant in relation to the first two charges, the Disciplinary Committee also ordered the appellant to pay all costs incurred by the inquiry. On appeal to the Singapore High Court, the trial judges held that the Disciplinary Committee had wrongly exercised its power as provided by s45(4) of the MRA to order a medical practitioner to pay ‗such sums as it thinks fit in respect of costs and expenses‘; the Court held that it would be ‗contrary to the notion of fairness‘, for the Disciplinary Committee to punish the appellant with the costs for time spent or work done in relation to the third charge which she was exonerated from. In Chia Yang Pong v Singapore Medical Council [2004] 3 SLR 151, the Singapore High Court ruled that the SMC had overstepped its statutory power under s45(2) of the MRA. The appellant had been convicted by the Disciplinary Committee of eight charges of professional misconduct for improperly prescribing sedatives to patients under his care and had been dealt with a fine of $65,000 and deregistration from the list of medical practitioners. On appeal against the fine, the Court found in favor for the appellant and decided that the fine of $65,000 contravened s45(2)d of the MRA which had capped the limit of any fine imposed at $10,000. The case of Tan Tiang Hin Jerry v Singapore Medical Council [2000] 2 SLR 274 is another example of how the SMC had acted beyond the scope of its authority prescribed by the MRA. The appellant opthalmologist was initially under investigation by the Complaints Committee for potential 44 conflict of interests due to his financial involvement in an optical shop, following a complaint by another medical practitioner. The Complaints Committee then proceeded on its own accord to inquire into the appellant‘s professional conduct in relation to the advertising of his eye clinic as well as the using of the eye clinic to promote the optical shop. The Court of Appeal overturned the High Court‘s decision and held that the respondent Complaints Committee had ventured beyond the scope of the initial complaint against the appellant (for his financial involvement in an optical shop). The court faulted the Complaints Committee for inquiring into extraneous matters which resulted in the SMC framing the two charges against the appellant: the first charge relating to advertising the services offered by the eye clinic, and the second charge relating to the use of the eye clinic in the promotion of the optical shop. Finally, Ho Paul v Singapore Medical Council [2008] SGHC 9 was yet another instance when the High Court stepped in to correct an inequitable outcome. The appellant was found guilty of nineteen charges of professional misconduct relating to the prescription of ‗Subutex‘ and was suspended for eighteen months by the SMC. On review by the High Court, the judicial bench noted that in 2006, another medical practitioner was also found guilty of nineteen charges of professional misconduct for indiscriminate ‗Subutex‘ dispensing and was fined $2,500 but was not suspended from practice. Given that like cases should be treated alike unless there are good reasons to depart from the precedents, the Court ruled that an injustice had been committed, particularly so when unlike the appellant who had an unblemished record, the offender in 2006 already had a previous disciplinary track record with the SMC for prescribing cough mixtures and sleeping pills too freely. Thus, the Court found the suspension order imposed on the appellant to be excessive and ordered it to be set aside. One of the main challenges encountered by a doctor in his daily work lies in having to blend highly specialized theoretical medical knowledge with subjective patients‘ symptoms or signs and then make decisions at the end of this intercourse. Quite often, these decisions wield a direct impact on an individual‘s life. For these reasons, the community has always held the medical profession with high regard. This respect for the profession forms part of the basis for allowing doctors to self-regulate. What this chapter tries to highlight is that such faith in the medical profession could be misplaced. First, it must 45 never be forgotten that doctors are just as fallible as other ordinary people. Secondly, doctors are driven by different motivations at work, not all of which are compatible with the Hippocratic Oath or the SMC‘s Physician Pledge. Many doctors take up their professional vocation in response to a higher calling, but some continue in professional practice because they see opportunities for financial gains; some others wage territorial battles and forget that the distinction between peers should be based on the quality of clinical services delivered rather than historical demarcations of professional duties. Thirdly, the specialized knowledge and abilities of doctors do not extend beyond the realm of clinical medicine so that when adjudicating over professional discipline, very basic errors of law have been committed by the SMC. While such instances when justice is miscarried constitute a minority of cases handled by the SMC, this is no justification for not wanting to improve the current disciplinary proceedings for medical practitioners. These cases involving grave errors of law are not insignificant, for the aggrieved defendant in each case had to go through a legal challenge to right the wrong, resulting in possibly immeasurable damage to the medical profession‘s standing in public. Having put forward the argument that clinical governance is weakened by granting doctors professional autonomy, the second half of this thesis will explore how law might play a role in securing patients‘ and doctors‘ interests. When seeking an alternative to professional self-regulation, the use of legal measures comes naturally to mind for two reasons. First, law represents society‘s higher aspiration towards justice. The notions of transparency, accountability and fairness are enshrined by law, making law the ideal foundation to erect a framework of checks and balances for the healthcare system. Secondly, professional self-regulation is implicitly sanctioned by statutory provisions and common law rulings 68. Any effort at strengthening clinical governance is unlikely to bear fruit if the current legal rules continue to buffer the medical profession from external scrutiny. In the subsequent chapters, the discussion will examine various legal measures that can improve how medical practice is regulated in Singapore. 68 See chapter 4. 46 CHAPTER SIX: REFORMS TO LICENSING PROCEDURES FOR DOCTORS In Singapore, the professional careers of doctors are determined by a small cohort of influential medical professionals (such as the SMC and DMS) who oversee a set of rules that contribute to contrasting practice boundaries between fully fledged doctors and doctors enrolled in training programs: Until a doctor obtains his ‗full‘ registration rights or completes his specialist training programme, he is subject to stringent checks and restrictions. If he is a trainee in a specialized medical field, he has to keep track of the number of procedures he has done and possibly take part in regular performance assessments tailored to the demands of his medical specialty69. Not only that, until he acquires ‗full‘ registration rights, conditions will be imposed to limit the conditions of his employment 70. However, once a doctor has attained the ‗full‘ registration rights of a family practitioner or medical specialist, he is given the freedom to practise medicine with few formal checks beyond fulfilling the requirements of a loosely structured CME (continuing Medical Education) program71. Not only is he able to practise independently in virtually any part of the country, he can choose to blur the boundaries of clinical medicine by marketing nonmedical therapies. A common example will be the sale of over-the-counter skin care products by general practitioners as remedies for skin ailments. This chapter will explore how the licensing procedures for doctors can be changed to protect the interests of doctors, before approaching the topic from a patient‘s perspective. The problem of unfettered discretionary powers Under the PHMCA, the DMS is vested with broad discretionary powers to determine how doctors will be allowed to practise their trade. When considering license applications for healthcare facilities, the DMS is given a mandate to impose terms and conditions as he thinks fit 72. At the same time, these terms 69 Joint Committee on Specialist Training. General information for advanced specialty training. June 2003. s21(5) MRA. 71 See page 60 on how a compulsory CME program has been somewhat diluted by its flexible framework. 72 s6(2) PHMCA. 70 47 and conditions are subject to the variation or revocation at any time by the Director73. The authority wielded by the DMS is not just restricted to the licensing arena, but extends to supervising quality assurance in hospitals and healthcare establishments. Section 11(2) of the PHMCA requires a licensee to submit reports complied by each quality assurance committee ‗as and when required by the Director‘. This is followed by s12(1) which empowers the DMS with the untrammeled right (‗…at any time and without warrant…‘) to enter and assess the premises of hospitals and healthcare institutions to enforce regulations under the PHMCA. The DMS can also inspect, make copies and seize virtually any material on these premises if the material is deemed ‗to be the subject-matter of, or to be connected with the commission of, an offence under this Act or any regulations made thereunder‘ 74. While ascertaining whether the Act is being complied with or evaluating the standard of the facilities and services provided at hospitals or healthcare establishments, the DMS may evoke the authority vested under s12(3), to compel the licensee or person involved in the management of such places to furnish information as the DMS may require during the assessment. Of note, for the purposes of s12(2) and 12(3), the DMS does not require the consent of patients prior to accessing their medical records. The weight attached to the administrative duties of the DMS is reflected in the penalties imposed by the PHMCA on any person who obstructs the work of the DMS. Thus under s12(4), any person who ‗refuses or fails, without reasonable excuse, to furnish any information to the Director in contravention of subsection, or gives any false or misleading information‘ will be liable to a fine not exceeding $10,000. Even more severe, are the punishments incurred under s17, whereby anyone guilty of the offence of impeding the DMS or any authorized officer in the performance of his duty under the Act risks conviction to a fine not exceeding $5,000 or to imprisonment for a term not exceeding 12 months or to both. Considering the breadth of the powers vested upon the DMS and the repercussions on individuals targeted by the DMS, one would expect the DMS to exercise these powers under political or judicial scrutiny. At present, the DMS is privileged by minimal accountability while executing the duties stated by 73 74 s6(5) PHMCA. s12(2) PHMCA. 48 the Act and is answerable only to the Minister. Section 3(1) of the PHMCA subjects the DMS to the ‗general or special directions of the Minister‘ and is a far cry from being a review of the DMS‘ performance record. Admittedly, it is not possible to comprehensively define the standards to be imposed upon the DMS without paralyzing the administrative duties of the DMS into a state of catatonia. Nevertheless, the status quo of not spelling out details on ‗general or special directions of the Minister‘ to the public is untenable. The exclusion of judicial review over the DMS decisions is made more explicit by s10 of the Act. According to this provision, the recourse available to any person aggrieved by the decision of the DMS to revoke a licence or not issue a licence is to ‗appeal in writing to the Minister whose decision shall be final‘. Thus, it appears that a literal reading of s10 ousts judicial control over the appeal process initiated by these aggrieved individuals. In Council of Civil Service Union v Minister for the Civil Service (“GCHQ Case”) [1985] AC 374, Lord Diplock reiterated the boundaries of the court‘s jurisdiction: ―To qualify as a subject for judicial review the decision must have consequences which affect some person (or body of persons) other than the decision-maker, although it may affect him too. It must affect such other person either: (i) by altering rights or obligations of the person which are enforceable by or against him in private law, or (ii) by depriving him of some benefit or advantage which either (a) he had in the past been permitted to by the decision maker to enjoy and which he can legitimately expect to be permitted to continue… (b) he has received assurance from the decision maker that it will not be withdrawn without giving him first an opportunity of advancing reasons for contending that they should not be withdrawn.‖ 49 Clearly, a decision to revoke the licence or not renew the licence of a healthcare provider has grave repercussions on the livelihood of possibly many individuals and comes within the boundaries demarcated by His Lordship. Consequently, by limiting the ultimate control in the issuing and revoking of licences to the DMS and the Minister, s10 of the PHMRC appears inconsistent with the dicta pertaining to administrative law espoused by Lord Diplock in GCHQ Case. At the heart of administrative law lies the axiom of accountability as a form of control over discretionary power. On a related note, fundamental principles in administrative law dictate that the legislature imposes control on various branches of the administration by exercising its political power, whereas the judiciary is concerned with control by the use of law. These principles have been well articulated in various forms by both legal theorists and the courts alike. In Montesquieu‘s 75 theory on the separation of power, the state is divided into three arms, namely the legislature, the administration and the judiciary. The vesting of power in each of these components is quintessential to the notion of how the checks and balances in a state should serve to guard against abuse of power, in particular, discretionary power by either arms of the state. Likewise, the two cornerstones in Dicey‘s theory on the state 76 are that first, discretionary statutory power should be subjected to legal control; secondly, such control ought to be exercised by the courts of law. Such administrative law concepts were echoed by the late Chief Justice Wee Chong Jin‘s when he deliberated over Chng Suan Tze v Minister for Home Affairs [1988] SGCA 16. There, CJ Wee stated: ―The notion of an unfettered discretion is contrary to the rule of law. All power has legal limits and the rule of law demands that the courts should be able to examine the exercise of discretionary power.‖ 75 76 Baron de Montesquieu, French Enlightenment political philosopher. Albert Dicey laid out his principles in his 1885 book ‗An Introduction to the Study of the Law of the Constitution‘. 50 In light of the late Chief Justice‘s words, it is astonishing that the DMS operates in a legal vacuum untouched by judicial review on the decisions taken. Besides reinstating judicial review over the DMS‘ actions by abolishing s10 of the Act, a more thorough governance overhaul also necessitates the establishment of some degree of political control over the DMS. Given that the DMS‘ authority is conferred by Parliament, there ought to be a duty on the DMS to table regular reports to Parliament to disclose the work carried out under the relevant statutory provisions. In particular, such reports will unveil details on: 1) measures implemented by the DMS in response to directions given by the Minister 2) occasions when the DMS exercised his discretionary powers and the bases behind the use of these powers 3) the outcome of any appeal initiated by healthcare providers or medical practitioners against unsuccessful license applications. The need for the DMS to articulate to Parliament the reasons underlying any action taken not only promotes political responsibility on the part of the DMS, but also reassures patients and medical professionals that provisions in the PHMCA are administered in a reasoned and just manner. When maintaining the register of medical practitioners, the DMS is aided by the Credentials Committee established under s29 of the MRA. Whilst the identities of council members are revealed as part of the public information published in the SMC‘s annual reports, the make up of these working committees are not revealed to the public nor medical professionals. The criteria and standards the committee adheres to when assigning a registration status to doctors are also not disclosed. Bearing in mind the impact of decisions made by these committees on the career paths, livelihood (the type of registration conferred determines the practising rights of a doctor) and professional reputation of medical practitioners, it is only fair for doctors and members of the public alike to be informed about the individuals who sit on these committees. The information is made more pressing by the fact that Singapore‘s medical fraternity is a relatively small and closely knit community; public confidence in the work done by the committee is best served by greater insight into the make up of this body. 51 Improving patient safety: revalidation The notion of revalidation has been endorsed by the UK government‘s White Paper on GMC reforms77. Prior its articulation by the White Paper, revalidation was first mooted nearly three decades ago by the Merrison Committee78. Then, the committee noted a growing public interest in linking continued registration with periodic tests of competence. This observation was met with agreement by a report titled ‗Competence to Practise‘ published by the Alment Committee in 1976. In the report, an inquiry 79 chaired by Sir Anthony Alment 80, examined education and the responsibilities of individual doctors to their patients and to the community at large. It stressed the importance of doctors keeping their practice up to date and recommended doctors to be encouraged to do so voluntarily, but fell short of calling for a system of compulsory re-licensure. The momentum for change abated somewhat until the recent spate of horrific medical scandals in the UK, and the publishing of the Chief Medical Officer‘s review 81 on professional medical regulation re-ignited interest in this area. Revalidation can be described as a regulatory measure designed to check a doctor‘s clinical competence during his/her professional career to ensure that doctors are up to date in their practices. Under the framework outlined by the UK government‘s White Paper, revalidation has two core components: relicensure and specialist recertification. At the first stage of relicensure, doctors who intend to renew their practicing licence must meet agreed generic standards of practice set by the GMC. This involves the completion of a 360-degree feedback appraisal exercise at the workplace, together with the resolution of any issues concerning the doctor‘s conduct or practice to the satisfaction of the institution‘s Medical Director or the GMC. The second stage of revalidation is recertification, which requires doctors to demonstrate to the relevant medical Royal College that they continue to meet the particular standards 77 Chapter two. Trust, Assurance and Safety- The Regulation of Health Professionals in the 21st Century. The Stationery Office, London. February 2007 78 Dr A. W. Merrison, vice-chancellor of Bristol University, chaired a committee looking at reforms into the structure and function of the GMC in 1972 and published its report in April 1975 79 This was titled ‗Inquiry into Competence to Practice‘. 80 Then honorary secretary of the Royal College of Obstetricians. 81 The report ‗Good Doctors, Safer Patients‘ by the Chief Medical Officer was released in July 2006. 52 that apply to their medical practice, including general practice. Besides looking at feedback from a range of sources such as employers and patients, the Royal Colleges will assess doctors using simulator tests, knowledge tests and according to a doctor‘s effort to continue professional development. The new system of revalidation is a significant departure from the UK‘s present system of appraisal because it is based on a positive affirmation of the doctor‘s entitlement to practise, not simply on the absence of concerns. Unlike in the medical profession, independent competency checks are a well-entrenched practice in the aviation industry. Just like the medical sector, the aviation industry is a high-risk vocation demanding highly technical skills and employees (commercial pilots) who are responsible for the safety of other individuals 82. Commercial pilots are subjected to a battery of regular proficiency checks that include skills evaluation in high fidelity simulators, review of flight hours log books, and analysis of flight recorder data and incidents relevant to the pilot. A pilot who fails a check, risks suspension from flying and will be referred for retraining before undergoing a repeat round of checks. This culture of rigorous checks has certainly contributed to the high level of safety in the aviation industry. In fact, it was reported that in 2004, 428 lives were lost from 1.8 billion flights completed throughout the year 83. This compares to an estimate that during that year, for one patient in every 300 admitted to hospitals in the developed world, medical error results in, or contributes to, patient mortality. Data retrieved from Singapore‘s Ministry of Health national reporting system reveals a figure of about fifty serious incidents affecting patients each year- in 2007 there were 58 major mishaps reported out of a total of 429,744 hospital admissions- some of whom die, while others suffer permanent disabilities 84. Singapore appears to have performed better than its counterparts in other developed countries 85; nevertheless, the local situation is still a far cry from the standards attained by the aviation industry. The notion of revalidation remains an underdeveloped theme in Singapore‘s medical fraternityonce a doctor attains independent practice (for example, as a consultant specialist or general practitioner), 82 Department of Health. Good Doctors, Safer Patients: chapter seven; regulation in other high-risk industries. Department of Health, London, 2006. 83 Data announced by Giovanni Bisignani, CEO, International Air Transport Association, 2005. 84 Lee Hui Chieh. 50 serious mishaps a year in hospitals. The Straits Times (Sunday). 4 October 2008. 85 Ibid. 53 he is no longer subjected to a formal assessment of his knowledge, competency, clinical skills or performance until he chooses to retire. This unquestioned faith in the doctor‘s competence seems to rest upon some rebuttable presumptions. First, it is probably accepted that knowledge acquired during the training years remains generally true and applicable throughout a doctor‘s professional career. However, as technology marches on and the seemingly impossible becomes possible, long established clinical dogmas are increasingly challenged and on the retreat. For instance, the traditional curative treatment of breast cancer has always been surgical removal of the entire breast and surrounding lymph nodes followed by possible adjuvant chemotherapy and/or hormonal therapy. Yet in the last eight years, advances in chemotherapy regimes have redefined the role of ablative breast cancer surgery, towards a less radical approach centered on breast conservation surgery 86. Similarly, the availability of radioisotope and chemical tracers has narrowed the selection of patients for regional lymph node clearances and given patients the choice of undergoing targeted lymph node biopsies instead 87. Secondly, there is an assumption that a doctor will continue to be familiar with the skills learnt during the training years even if he does not use these skills on a regular basis at work. Many of these skills actually require a high level of dexterity control, especially if they are utilized in the field of surgery. Without regular usage, it is not unexpected if a medical practitioner starts to lose touch with the finer aspects of his skills or lags behind the technological developments in medical appliances employed during the procedures. Thirdly, it is assumed that the performance of doctors in highly technical areas of medicine remains unblemished by the passage of time. Unlike the NHS in the UK, whereby doctors have to abide by a mandatory retirement age in clinical practice, the Singapore health system neither imposes any limit on the professional shelf life of doctors, nor requires doctors to restrict the intensity of their clinical practice as age creeps in. Yet there is data to suggest that with time, the skills and knowledge of medical professionals can erode, with potentially serious consequences for quality of care. In a systematic 86 This includes the use of pre operative use of chemotherapy to shrink existing cancers so that the surgery can be less radical. 87 This technique is also known as ‗sentinel lymph node‘ biopsy and is rapidly replacing the role of routine excision of breast lymph nodes for disease prognostication. 54 review conducted by Choudhry NK et al, the authors found that older doctors and those who have been practising for many years may be at risk for providing lower quality care and may need quality improvement interventions 88. The reasons behind these findings are not clearly explained but one can postulate that this could be contributed by the physiological changes of aging. Some of these changes include decline in sensory acuity in particular, vision; decreased cardiovascular performance which translates into poorer stamina and endurance. Also, medicine can involve highly technical surgical procedures that one would expect a practitioner to get better, as he does more of it. Conversely, medical practitioners who do not regularly perform the complex interventions that they were trained in, risk losing familiarity with these procedures. Such skills attrition may be commoner amongst medical practitioners in healthcare institutions where the caseload is lighter. At the same time, the push for the sub-specialization89 of doctors will exacerbate this phenomenon because specialist consultants are now limited by exposure to a narrower spectrum of clinical conditions. In the Bristol report, Sir Kennedy revealed the panelists‘ surprise at learning that hospital consultants were not subjected to the rigours of revalidation, unlike other healthcare professionals like nurses. For hospital consultants, once they had acquired the necessary qualifications, they could practice for life without any formal requirement to undergo further professional training as condition of continued practice. This state of affairs not only was perceived to be a weakness in the healthcare system, because patients lack the assurance that their doctors remained competent, it also ran contrary to public expectations that medical regulation should include measures to demonstrate that consultants and general practitioners continue to perform effectively throughout their working lives. The panel described the triad of revalidation, periodic appraisal and continuing professional development as ‗…three separate but 88 Choudhry NK, Fletcher RH, Soumerai SB. Systematic review: the relationship between clinical experience and quality of care. Ann Intern Med. 2005 Feb 15;142(4):260-73. 89 When a consultant specialist sub-specializes, he focuses on a particular region of the human body. For instance, an orthopaedic surgeon is already a specialist in bone surgery, but may sub-specialize by channeling most of his time on patients with spinal disorders. 55 interconnected practices…‘ which demonstrate that healthcare professionals ‗…are willing to keep themselves professionally fit on behalf of patients, and that they are accountable for doing so‘. Besides providing reassurance to patients that medical practitioners are of minimally acceptable standards and deserving of trust, revalidation has a more important purpose in fostering improvements in a practitioner‘s performance through regular measurement and feedback. It will be inaccurate to suggest that the Singapore health system does not have a program aimed at ensuring doctors stay up to date; the SMC administers a Continuing Medical Education (CME) program that is compulsory for all doctors in Singapore. Since 2005, all fully and conditionally registered doctors renewing their practicing certificates are required to accumulate the minimum total of CME points within their CME qualifying period(s) before their practicing certificates are renewed90. Unfortunately, the effectiveness of the CME system is compromised by the absence of a definite appraisal component. Essentially, all that a medical practitioner is required to fulfill is to participate in some CME activities of his/her choice within the CME period. These CME events comprise a mixed bag of activities which range from hospital organized lectures, to dinner talks organized by pharmaceutical companies in conjunction with medical organizations, to online self assessment quizzes that a doctor can do in the comforts of home. The weaknesses in the current CME format are not hard to identify: the CME system lacks bite due to the absence of a formal assessment component. As such, a doctor can easily sign up for a CME activity just for the sake of chalking up points and not gain any knowledge through the activity; the CME program‘s ability to promote up to date clinical practice is suspect because there is no compulsion on medical practitioners to participate in educational activities related to their field of practice; for instance, a surgeon may well have chosen to attend seminars on molecular markers of genetic diseases and still qualify for CME points. Compared to the CME program, formal revalidation is a more rigorous scheme that fulfills four objectives. Revalidation requires the positive demonstration of competence by doctors and abolishes the traditional ‗competent unless proven otherwise‘ system; this confers a constant reassurance to the public that doctors will always be of a minimum standard. The regular assessment of medical practitioners 90 Taken from Singapore Medical Council website: www.smc.gov.sg. 56 fosters a culture of self-improvement as practitioners strive to keep abreast of developments in medical science and prescribe only up to date treatments. For a small minority of doctors, revalidation facilitates the identification of problems and fosters opportunities to rectify these issues before any injury is caused to patients. To reiterate the words of Sir Kennedy in the Bristol report, revalidation serves as a filtering device to sieve out medical professionals who fall short of the appropriate competence, before matters deteriorate into a downward spiral for both patients as well as doctors. Such a safety net is critical as for some doctors: ―… competence did (and does) not grow with experience. Others did (and do) not pay much attention to continuing professional development. And others tried their best but their competence diminished with time…‖ Last but not least, in the private healthcare sector where health services are funded by a fee-for-service scheme, revalidation takes on added importance. Unlike public hospitals, the culture of peer review maybe less developed in private institutions because private medical practitioners operate as independent proprietors of their respective practices. Faced with a combination of operating costs, competition from fellow doctors, and possibly less formalized clinical audit activities, a wayward private practitioner may find himself under pressure to perform procedures that he is not entirely familiar with, so as not to lose his patient clientele. Revalidation ameliorates the potential corrupting influence financial incentives have on clinical judgment as revalidation limits medical practitioners only to current therapies that they are competent in. At the core of revalidation lies the objective assessment of medical practitioners according to predetermined benchmarks. The question that follows naturally is to what extent revalidation strengthens professional regulation. This issue can be addressed by referring to published data supporting specialist recertification in the United States of America. Since 2000, the American Board of Medical Specialties 57 has ratified a process of recertification that is similar in its intention to the UK‘s revalidation scheme91. The certification of medical specialists has been ‗time limited‘ to six to ten years and to renew their certified status, specialists in the US must demonstrate evidence of 92: ―- Professional standing - Commitment to lifelong learning and involvement in periodic assessment - Cognitive expertise (using results from a standardized examination) - Standards based evaluation of performance in clinical practice.‖ Sharp LK et al conducted a systematic review of studies published between 1966 and 1999 and found that over half (16 of 29 analyses reported in 11 articles) showed positive and statistically significant associations between certification and superior outcomes 93. After 1999, four other studies also showed that board certification is associated with a higher standard of care across a range of specialties. The first study by Norcini JJ et al examined data from 16, 629 stays in hospital in 1993 in Pennsylvania and concluded that certification in internal medicine or cardiology was associated with a 19% reduction in mortality (after adjusting for hospital resources, co morbidities, and other variables) 94. The second study by Chen J et al used data from 101, 251 patients admitted to US hospitals between January 1994 and February 1996. The authors found that board certified doctors adhered more closely to clinical guideline recommended therapies for acute myocardial infarction than non-certified ones although this did not translate to a statistically significant difference in mortality rates at 30 days 95. In another retrospective study involving 15, 427 patients who underwent segmental colon resections by 514 surgeons, the authors 91 Kim Sutherland, Sheila Leatherman. Professional regulation- Does certification improve medical standards? BMJ 2006; 333:439-41. 92 Ibid. 93 Sharp LK, Bashook PG, Lipsky MS, Horowitz SD, Miller SH. Specialty board certification and clinical outcomes: the missing link. Acad Med 2002; 77: 534-42. 94 Norcini JJ, Lipner RS, Kimball HR. Certifying examination performance and patient outcomes following acute myocardial infarction. Med Educ 2002; 36: 853-9. 95 Chen J, Rathore SS,Wang Y, Radford MJ, Krumholz HM. Physician board certification and the care and outcomes of elderly patients with acute myocardial infarction. J Gen Intern Med 2006; 21:238-44. 58 found that certification by the American Board of Surgery was associated with reduced mortality and complication rates 96. The fourth study looked at the relationship between anaesthesiology board certification and two outcome measures: mortality within 30 days of hospital admission and the failure-torescue rate (defined as the rate of death after an in hospital complication). The results of this analysis suggested that non-certified mid-career anaesthesiologists had higher rates of patient mortality and failure to rescue rates than other anaesthesiologists97. Besides a correlation between certification and clinical outcome, there is evidence to suggest that a lack of certification is associated with errant professional behaviour. In a case-control study of 890 physicians disciplined by the Medical Board of California compared with 2981 randomly selected non disciplined controls, Kohatsu ND et al identified a lack of certification as one of the risk factors for disciplinary action; the offences that led to disciplinary action included negligence, unprofessional conduct, substance misuse, and inappropriate prescribing98. Likewise, another study in Ohio compared 340 disciplined doctors with a matched control group and found that offenders were significantly less likely to be board certified99. A study conducted by Khaliq AA et al drew a similar conclusion and noted that being non-certified was a surrogate marker for disciplinary problems 100. There is evidence to support revalidation as one of the pillars in clinical governance. Regardless of how revalidation can strengthen patient care, it will not translate into practical benefit if it is not integrated into the regulatory process. Under s36 of the MRA, a doctor‘s practicing certificate is valid only for two years from the date of issue and renewal is subject to conditions prescribed by the SMC. However, no mention is made about the nature of conditions that have to be imposed by the SMC. Similarly, the MRA empowers the Specialists Accreditation Board of the SMC to take charge of all 96 Prystowsky JB, Bordage G, Feinglass JM. Patient outcomes for segmental colon resection according to surgeon‘s training, certification, and experience. Surgery 2002; 132:663-70. 97 Silber JH, Kennedy SK, Even-Shoshan O, Chen W, Mosher RE, Showan AM, et al. Anesthesiologist board certification and patient outcomes. Anesthesiology 2002; 96:1044-52. 98 Kohatsu ND, Gould D, Ross LK, Fox PJ. Characteristics associated with physician discipline: a case-control study. Arch Intern Med 2004; 164:653-8. 99 Clay SW, Conatser RR. Characteristics of physicians disciplined by the state medical board of Ohio. J Am Osteopath Assoc 2003; 103:81-8. 100 Khaliq AA, Dimassi H, Huang CY, Narine L, Smego RA, Jr. Disciplinary action against physicians: who is likely to get disciplined? Am J Med 2005;118:773-7. 59 matters pertaining to the registration of specialists and recommend to the SMC programs for the continuing education of specialists 101. Devolving the task of professional licensing to a group of representatives drawn from the medical community may not be prudent; left to its own discretion, the SMC had put in place an informal CME process for the renewal of professional licenses of doctors. There is also no established mechanism to re accredit specialists to ensure they remain competent in highly complex procedures or up to date with medical developments relevant to their specialties. The MRA should spell out the terms on which professional licences are renewed for doctors by setting some guidelines for the SMC. It is proposed that revalidation in Singapore will take on a slightly different format from that in the UK. Peer review should be avoided to minimize subjectivity in the revalidation process, especially since the small size of the tightly knitted medical community in Singapore may predispose to a ‗club culture‘102 taking root. The assessment of one‘s performance according to generic standards will also be omitted to avoid unnecessary administrative work, as such evaluations are already routine during a promotion exercise or contract renewal for the bulk of medical practitioners. Rather, it is envisaged that revalidation in Singapore will be based predominantly on a targeted, objective assessment of a medical practitioner‘s track record. The revalidation process will comprise two components: the use of written tests to determine whether a practitioner‘s knowledge is compliant with current medical therapies and guidelines, and the requirement that doctors who perform complex, invasive procedures submit logbooks for regular scrutiny by appointed independent assessors. The logbook of such a doctor should clearly document the extent of his involvement in the procedure, in particular whether he is the main practitoner carrying out the procedure, or the assistant. The logbook should also state the patient‘s outcome after the procedure and detail any complications encountered during and after the procedure. This logbook may be likened to the logbook kept by commercial aircraft pilots documenting their flight hours and experience. Through this procedure logbook, independent assessors can profile the volume of cases and clinical 101 s35 MRA. This phrase was used in the Bristol inquiry to describe how doctors closed ranks to protect their professional interests when under external scrutiny. 102 60 outcome a medical practitioner has accumulated over the years and make recommendations towards further training if necessary. In the settlement of medico-legal disputes, or investigating allegations of mismanagement by doctors, a procedure logbook provides an objective snapshot of the technical expertise and capabilities of a medical practitioner and is hence useful to helping the relevant authorities resolve issues of contention. Nowadays, simulation devices are increasingly integrated into medical training. Some medical schools have abolished the traditional method of teaching anatomy via cadaveric dissections in favour of three dimensional digital computer imaging to display human anatomy. In surgical training, simulation devices have also gradually positioned themselves as basic hurdles trainees must clear, before they are allowed to carry out procedures on human patients. The inauguration of National University Hospital‘s million-dollar Advanced Surgical Training Center 103 last year gave a glimpse of how simulation devices have carved out a niche in medical education. It is foreseeable that as state of the art simulators become more available, the use of these machines in the revalidation process will become routine. During the revalidation process, the standards of assessment should be set by the SMC‘s accreditation committees in consultation with local medical colleges such as the Academy of Medicine and Singapore‘s College of General Practitioners. For added public trust and confidence, the SMC can also consider recruiting input from international experts or reputable medical colleges. Doing so confers several benefits. First, the endorsement from these external experts or internationally renowned colleges enhances the credibility of the revalidation process. Secondly, Singapore‘s aspiration to be a regional biomedical hub can be given an added boost. Part of the local hospitals‘ strategy to capitalize on medical tourism and attract international fee paying patients includes earning the accreditation from the US based healthcare quality surveyor, Joint Commissions International (JCI). Implementing a re-certification program that enlists the participation of international experts or prestigious medical colleges sends a clear message to local and foreign patients alike, that medical practitioners are subjected to stringent quality checks that match those in the modern western world. Thirdly, being the small community that the 103 http://www.astc.sg/ 61 medical profession is, some specialty fields (for example, organ transplant) comprise only a very small number of consultant specialists. The participation of international experts in revalidation for highly niche specialties gives a more balanced perspective of the standards expected. Licensing medical procedures The spate of controversies swirling around aesthetic medicine last year exposed the potential weaknesses of a regulatory system that tends towards reliance on professional self regulation. Many aesthetic medicine practitioners were offering an array of aesthetic procedures- such as mesotherapy, microneedling dermaroller, skin whitening injections, growth hormone micro-injections - which are not only invasive in nature, but are also of questionable merit. Although the Ministry of Health has since clamped down on the bulk of these dubious remedies, this does not ensure that future recurrences of similar incidents, be it in the field of aesthetic medicine or other medical specialties, do not take place. The Medicines Act (MA) lays out regulatory provisions that relate to the administration and dealing of medicinal products. Section 5 of the MA requires all persons dealing in medicinal products to obtain a product licence. Section 12(1) enumerates the factors relevant to the determination of application for licence104. However, one key exemption provision in the Act firmly positions medical practitioners beyond the policing of this statute. The wording of s7(4) of the MA unequivocally states that the licensing requirements of s5 [and hence the conditions listed under s12(1)] do not apply to medical practitioners. This statutory blank cheque presented to the profession is also reiterated by the MRA for despite being the core legislation on medical practice in Singapore, the MRA fails to spell out the SMC‘s role in overseeing the use of various treatment modalities, in particular the application of new medical therapies. 104 These factors comprise:(a) the safety of medicinal products of each description to which the application relates; (b) the efficacy of medicinal products of each such description for the purposes for which the products are proposed to be administered; (c) the quality of medicinal products of each such description, according to the specification and the method or proposed method of manufacture of the products, and the provisions proposed for securing that the products as sold or supplied will be of that quality; and (d) whether the grant of a product licence for the medicinal products to which the application relates will be in the public interest. 62 Without statutory hurdles in both the MRA and the MA on the importation of new medical devices or pharmaceutical agents by doctors, the protection afforded to patients at the receiving end of medical procedures takes the form of ethical guidelines entrenched within the medical profession. In the SMC‘s Ethical Code, Section 4.1.3 (‗Prescription of medicine‘) exhorts doctors to ‗prescribe, dispense or supply medicines only on clear medical grounds‘. Then there is the immutable precept, which reminds all doctors to remember their first obligation to ensure no patient is harmed by medical treatment 105. However, it is likely that relying on such indirect measures to check a doctor‘s clinical practice will prove inadequate. The effectiveness of the SMC‘s Ethical Code is diminished because neither the SMC nor the Ministry of Health continually monitors compliance with the professional standards enunciated within the Code. At present, enforcement of the Code is largely dependent on a system of peer critique in healthcare institutions. As observed in the earlier sections, many doctors operate as independent agents who are neither answerable to the hospitals‘ authorities nor subject to regular clinical audit by peer review meetings. Therefore, the purported benefits of voodoo medical therapies marketed by an errant medical practitioner may only be discredited in situations where complications surface and trigger patients to lodge complaints with the health authorities 106. In the event that patients do not suffer any serious adverse effects through these dubious treatments, such practices can be perpetuated indefinitely despite the fact that they lack scientific efficacy. Relying on the notion of primum non nocere presents another set of problems. Using this selfimposed restraint as a yardstick to evaluate medical treatment will be setting a professional standard that is unacceptably low107. During the era of Hippocrates when medicine was regarded more of an art108 and the empirical testing of treatment methods was nonexistent, perhaps it would be appropriate to engage this ‗first, do no harm‘ approach. In the modern century, the availabilty of scientific research methodology should limit the adoption of this principle to instances when standard proven medical treatment has been 105 This is commonly known as the ‗first, do no harm‘ principle, or primum non nocere. This was what led to the MOH‘s action against dubious aesthetic medicine procedures; disgruntled patients had lodged complaints with the Ministry after suffering poor outcomes. 107 Hippocrates had emphasized the prescription of regimens must never do harm to patients. 108 Hippocrates had described in Greek, medicine as an ‗art‘. 106 63 exhausted or when a terminally ill patient is to be offered experimental therapies. Furthermore, the innovations in medical technology have not only accentuated the information asymmetry between medical practioners and patients, but translated into spiralling healthcare costs for consumers. Surely, patients who are forking out large sums to finance costly medical treatment deserve a higher standard of clinical decision making than the reassurance that they will not be harmed by the medical treatment they receive? Remembering the personal inconveniences, financial costs, possible physical discomfort and even pain during medical treatment, patients should only be offered treatments with proven benefits. Perhaps the way forward is to extend the licensing requirements of s5 of the MA to include the use of medical devices by doctors or healthcare institutions. By excising section7(4) from the MA, medical practitioners will now have to be mindful that they promote the use of medical equipment with a proven track record in order to fulfil the licensing requirements under s12(1) of the MA. Doctors have always enjoyed a certain degree of unquestioned faith from the community; the undiscerning regard members of the public have for the medical profession is such that any form of therapy associated with a medical practitioner is readily accepted to be of proven benefit and not merely exerting placebo effects. Hence a closer watch over how the medical profession prescribes treatment is needed to prevent the abuse of its prescribing rights by a minority of wayward opportunistic practitioners. With the tightening of control over doctors‘ dispensing privileges, the SMC needs to take on the additional role of assisting the health authorities regulate the use of medical devices by doctors. Under s4 of the MA, the Chief Executive of the Health Sciences Authority (HSA) is responsible for the granting, suspension and revocation of licences pertaining to the administration and dealing of medical products. To facilitate the HSA‘s regulatory duties, it would be ideal if the SMC work together with the HSA to appraise clinical data relevant to the new medical devices submitted by doctors. If necessary, the SMC could also play the part of a coordinator of sorts by gathering feedback from the local specialist colleges. This bench and bedside cooperation integrates laboratory knowledge with clinical observations, thus taking into account the fact that variations occur within a patient population and that a select number of 64 patients at either ends of the normal distribution curve can sometimes benefit from a tailored treatment regime. Summarizing this chapter, it is clear that the majority of doctors carry out their duties in accordance to high professional standards and are unlikely to face any tribunal or disciplinary inquiries throughout their careers. Thus, the laws delineating the practising boundaries of doctors are arguably the most important component in professional regulation compared to disciplinary procedures, since they influence the professional activities of each and every medical practitioner. Rather than devolving all aspects of professional licensing to the purview of the SMC and the DMS, it could be better for statutory provisions to lay out guidelines pertaining to how medical practitioners obtain their professional licences. For a start, there should be some form of audit mechanism in place on decisions taken by the licensing bodies (the SMC or DMS). Such audit could take the form of regular reports on the work done in professional re-licensing. Secondly, the criteria for medical licence renewal could be tightened to include a more formal assessment system that requires doctors to positively demonstrate competence in skills and procedures they choose to perform in their daily work. Lastly, there ought to be greater scrutiny of how private medical practitioners prescribe treatment to their patients so that only clinically proven therapies are used in healthcare facilities. 65 CHAPTER SEVEN: CLINICAL AUDIT The purported value of peer review in professional regulation is tantalizing; medicine is a highly specialized field and it would understandably be more effective for doctors to meet and scrutinize each other‘s practices since they are familiar with the multitude of medical jargon and treatment regimes. The SMC‘s Ethical Code alluded to this point by stating that ‗society at large does not have the necessary knowledge or the experience of medical practice to make determinations on professional matters‘ 109. Yet, a closer look at the composition and proceedings of clinical audit meetings begs the question- to what extent these meetings contribute to the regulation of clinical practice by the medical profession. This chapter explores how the current practice of closed audit meetings risks propagating the ‗conspiracy of silence‘ within the medical profession. Potential drawbacks in clinical audit The pathognomonic feature of clinical audit meetings is how it is exclusively an internal affair. Participation at such meetings is almost always by doctors within the same department or hospital. This exclusive participation by doctors at audit meetings only undermines the credibility and independence of such meetings because the profession‘s hierarchical culture110 is likely to stifle the open review of practices of senior colleagues. The apprenticeship training system in medicine makes it even more daunting for juniors to speak up openly as their promotions and training opportunities are frequently dependent on the reports written by senior colleagues. Another limitation to utilizing peer driven clinical audit meetings as a mode of professional selfregulation can be traced to the differing work ethos between public (restructured) and private healthcare establishments. Doctors in public hospitals shoulder duties that go beyond routine patient care; doctors in public hospitals often involve themselves in the teaching and training of junior doctors. Therefore, clinical 109 Singapore Medical Council. Ethical Code and Ethical Guidelines. The Bristol Inquiry had also identified a hierarchical culture within the profession as a hurdle to professional selfregulation. 110 66 audit sessions are generally well received by doctors in public hospitals because they provide opportunities for junior doctors to be educated about the pitfalls in medicine. For senior doctors who shoulder administrative duties, these meetings are also avenues for peer feedback on the quality of clinical services rendered. On the other hand, medical practitioners in the private sector are likened to free agents who are sole proprietors of their own respective clinics. This differs from the employment hierarchy in restructured hospitals whereby doctors are segregated to various ranks and are answerable to the unit or divisional heads. Invariably, medical practitioners in the private sector do not meet on a regular basis to scrutinize the choice and outcome of treatment fellow doctors have prescribed to their patients. Furthermore, the relevant statutory provisions foster professional malaise towards clinical audit. While quality checks imposed by s11(1) of the PHMCA on hospital assurance committees should include the assessment of the quality and appropriateness of the practices and procedures carried out at hospitals, the thrust of s11(1) is somewhat blunted by the feeble policing of this requirement under s11(2): ‗The licensee of a private hospital or a healthcare establishment shall report to the Director the activities, findings and recommendations of each quality assurance committee of the private hospital or healthcare establishment as and when required by the Director.‘ Without regular monitoring of compliance with s11(1) by hospitals, there is little impetus on medical practitioners to organize themselves into peer review groups to critique the quality of health care delivered. By failing to take into account the workplace dynamics at healthcare institutions, s11(2) has turned out to be a toothless piece of statutory legislation. Earlier, it was brought out how clinical medicine has increasingly become a team effort as doctors are mutually reliant on each other‘s expertise and referrals in patient care. In this setting, the culture of collegiality risks undermining the effectiveness of peer review. Doctors may succumb to temptation and adopt a ‗you scratch my back and I will scratch yours‘ mindset for the sake of good working relationships within the hospital. In its more extreme form, this sense of collegiality may even nurture a siege mentality 67 amongst doctors as they close ranks and rally around an embattled colleague for fear of themselves encountering a similar fate one day, and be without the support of other colleagues. Perhaps this is why in the Bristol Inquiry, the panel had observed that the anaesthetist who first reported Bristol‘s PCS unit‘s exceptional operative mortality rates, incurred the wrath of his medical colleagues who frowned upon his revealing such sensitive information to individuals outside the hospital. The perennial debate on whether medicine is a science or an art is best resolved by submitting that medicine is an imprecise science in many instances because clinical outcome is governed by a multi factorial process rather than a simplistic cause and effect relationship. This, together with a sense of professional solidarity endemic within the profession, forms the ideal matrix for doctors to rationalize and come to terms with medical mishaps during their closed door discussions. One much beloved axiom indoctrinated within the medical profession since the start of medical school education, is to analyze contributory factors to medical complications along the line of ‗patient factors‘, ‗disease factors‘, and ‗doctor factors‘. Through this broad based conceptualization, it becomes apparent that the intercourse between the three clusters of contributory factors often renders causation of medical mishaps indeterminate: a doctor‘s clinical error or even worse, failure, could sometimes be draped over with either a patient‘s frail pre morbid status predisposed to complications, or buffered by attributing poor clinical outcome to an aggressive disease process. Thus, in a discourse driven entirely by clinical input from doctors trained in rationalizing medical complications, there lies the chance that audit findings are unintentionally sanitized by the doctors‘ capacity to rationalize clinical mishaps. It is regrettable that the intended benefits of clinical audit meetings are further ablated by the milieu in which these activities are conducted. Earlier, chapter four noted how clinical audit in healthcare institutions occurs mostly during meetings (termed ‗Morbidity and Mortality meetings‘ or ‗M & M‘) conducted at the departmental level. Traditionally, criticisms made and issues discussed during M & M meetings are rarely recorded in the meetings‘ minutes. Rather, M & M meetings are distinguished by how the scrutiny of clinical mishaps is confined to within the four walls of the meeting room. While this format may encourage doctors to speak up freely without worrying about their mistakes being recorded to 68 their detriment, the role of M & M meetings in clinical governance is diminished because the lessons learnt from these meetings will only benefit the group of doctors who attend these meetings. Even worse, the lack of formal records means that the lessons learnt may be forgotten with time and the exact same mistakes repeated at the expense of patients‘ lives. Hospital inquiries 111 on the other hand, are conducted in a more formalized environment with official appointments given to doctors sitting on the inquiry board, and written reports submitted to the hospital administration at the conclusion of such inquiries. However, hospital inquiry meetings retain an impregnable aura that parallel the closed door practice shrouding M & M meetings: the findings are not automatically disclosed to aggrieved patients and their relatives, despite the fact that such inquiries are established in response to lapses in medical care. Furthermore, Sections 11(3) and 11(5) of the PHMCA impose an additional stenosing effect on the flow of information from hospital inquiries. Section 11(3) is akin to a confidentiality clause that shields doctors in quality assurance committees from the inquisitorial powers of ‗any court, tribunal, board or person‘112. While this shield insulates doctors from obligations beyond that of a quality assurance committee, it also has the effect of enshrining the findings of such committees, within a vault of secrecy inaccessible to external inquiries. Section 11(5) has the features of an immunity provision for doctors under probe as under this section, the findings or recommendations by a quality assurance committee are not admissible in ‗any proceedings as evidence that the service, practice or procedure is or was inappropriate or inadequate‘. Understandably, the exclusive nature of institutional peer review activities and legislation such as Sections 11(3) and 11(5) of the PHMCA, placate the medical profession‘s concern that participation in clinical audit imbibes unforeseeable liabilities and therefore inhibit frank and open disclosure by doctors during clinical audit. However, the flipside is that such appeasement of the medical profession may be inconsistent with the patient‘s best interests. In an 111 These meetings are convened on a ad hoc basis; see chapter four. Under s11(3): A person who is or was a member of a quality assurance committee is neither competent nor compellable — ―(a) to produce before any court, tribunal, board or person any document in his possession or under his control that was created by, at the request of or solely for the purpose of the quality assurance committee; or (b) to disclose to any court, tribunal, board or person any information that has come to his knowledge as a member of the quality assurance committee.‖ 112 69 environment whereby statutory provisions permit a hospital inquiry to withhold factual findings from external person(s), it is difficult to imagine how affected patients can attain closure of their grievances. Legal reinforcements to clinical audit The need for healthcare institutions to ‗come clean‘ with medical errors is supported by research conducted by UK‘s Department of Health. It was revealed that even after claimants had received compensation for medical injuries sustained, these individuals still desired an explanation and an apology; monetary compensation did not fully erase the mental anguish they went through during the course of the injury113. Feedback procured from patients‘ groups by the Department of Health also confirmed patients wanted reassurance that steps were being taken to prevent the same medical injury happening to someone else and there were concerns that there was little systematic learning from patients‘ complaints, either at local or national level114. In his proposal for reforms to the NHS 115, the UK‘s chief medical officer, Sir Liam Donaldson emphasized the provision of an explanation to the patient of the incident as one of four main elements in his new NHS Redress Scheme. Such an explanation would be given after an investigation of the incident has been completed. He even advocated the introduction of legislation that encompassed a duty of candour requiring clinicians to inform patients about actions which had resulted in harm. This measure will concretize a doctor‘s professional obligation under the common law articulated by Sir John Donaldson, Master of the Rolls: "I personally think that in professional negligence cases, and in particular in medical negligence cases, there is a duty of candour resting on the professional man . . . It is but one aspect of the general 113 Department of Health. Making Amends- a report by the Chief Medical Officer. Department of Health, London, 2003. 114 Department of Health. Call for Ideas. Department of Health, London, 2001. 115 Department of Health. Making Amends- a report by the Chief Medical Officer. Department of Health, London, June 2003. 70 duty of care, arising out of the patient/medical practitioner or hospital authority relationship. . . ." (Naylor v Preston Area Health Authority [1987] 2 All ER 353) Sir Liam Donaldson‘s call for legislative intervention might seem draconian and superfluous, given the common law‘s unequivocal stand on the extent of frankness expected in the doctor-patient relationship. On the other hand, his recommendation may not be excessive in Singapore‘s context due to certain ambiguities over professional guidelines for doctors. The fiduciary nature of the doctor-patient relationship and the highly sensitive information transpiring between both parties naturally leads one to assume that the virtue of openness during communication forms the bedrock in this relationship. However, a reading of the SMC‘s Ethical Code suggests a narrow interpretation of the professional duties of doctors during the exchange of information with patients. Section 4.2.4.1 of the Code enshrines the patient‘s right to information which occurs only within the context of making ‗informed choices about his further medical management‘; nowhere within the Code is there any mention of a professional obligation to reveal to patients all information when clinical care spirals into complications or errors. In addition, the legal protection of information uncovered during these meetings- conferred by s11(3) and s11(5) of the PHMCA- stymies information flow from audit activities to patients who seek explanations for medical injuries sustained and only further isolates patients from the truth. In fact, to legislate for a duty of openness by merely transplanting Sir Donaldson‘s recommendation is likely inadequate. What is required to offset the excessive protectionist effect of s11(3) and s11(5) will be legislative provisions to empower patients and improve their access to information uncovered by audit meetings. Health care matters can be issues that hover along the fringe between life and death, thus evoking strong emotional responses from individuals involved. A legal system totally reliant upon legislating a duty of candour by medical professionals may be doomed to failure because it underestimates the possible inherent fear within some doctors that open and frank disclosure risks attracting a host of legal liabilities and bad publicity. Therefore it will not come as a surprise if an aberrant doctor decides to bear the risk of not complying with a legal obligation to disclose 71 the truth to his patient, and downplays or worse still, conceals salient facts surrounding the medical incident from the affected patient. In addition, such legal provisions are hard to police since the closed nature of clinical audit activities with scant documentation of most discussions, makes it difficult to monitor what ought to be told to injured patients. One strategy to smoothen an aggrieved patient‘s retrieval of relevant medical information is to create statutory rights for a patient to request for a formal report after the completion of the audit meeting discussing his medical injury. Such rights should also include granting patients the prerogative to pose specific queries pertaining to clinical care for audit committees to investigate and address. Presently, patients who want to uncover details that cumulated in their injuries can do so via either one of two routes: they can request a meeting with the attending physician to iron out issues, or embark on the extreme measure of litigation to compel aberrant doctors to make submissions under oath. The former method is over-reliant on the willingness of individual doctors to divulge sensitive information and is susceptible to manipulation by a deviant doctor, as alluded to earlier. The latter route is not only costly, but the acrimonious nature of lawsuits can irrevocably scuttle the doctor-patient relationship. This binary system could be bridged by a patient‘s statutory right to request for a formal explanation at the conclusion of audit meetings. In my view, the benefits of this option are several: 1) Bruising legal confrontations are potentially avoided since disgruntled patients need not resort to litigation for answers. A survey commissioned in UK had revealed that patients affected by medical injuries most frequently wanted an explanation or apology (34%); 23% of these patients want an enquiry into the causes 116. These expectations can easily be met by granting patients reports from audit committees, without having to use legal means. 2) The collective opinion by a panel of medical professionals gives additional weight to the explanation issued to a patient who had sustained a medical injury. This gives assurance to 116 Department of Health. Making Amends- a report by the Chief Medical Officer. Department of Health, London, 2003. 72 patients that the medical information they obtain is objective and unlikely to be coloured by the doctor(s) directly involved in the medical injury, which may be the case if the patient were to receive information only from the doctor directly embroiled in the incident. 3) The legal responsibility of having to issue formal explanations to patients serves as an impetus for detailed transcripts of audit meetings to be kept. This translates into an additional wealth of knowledge in the medical archives that can be tapped for educational purposes in future, to ensure that similar errors are unlikely to happen to other patients. Furthermore, the law ought to engage patients and their families in clinical audit processes. Preserving the status quo of limiting participation in clinical audit exclusively to medical practitioners only addresses hospital mortality and morbidity cases from a purely medical perspective; this methodology assumes a meeting of the minds by doctors and patients in identifying issues of importance when a mortality or medical complication occurs. Clinical activities should be primarily a patient focused event and prior to the commencement of audit discussions, patients could be invited to make submissions on any particular area of concern they would like to be examined. This avoids a situation whereby despite informing the relevant patients the findings of audit discussions, such patients continue to habour a lingering sense of insatiety as they feel that their concerns and questions have not been adequately resolved. In short, the current legislation as exemplified by the PHMCA supports local governance within the Singapore healthcare system. Within hospitals and medical institutions, doctors participate in audit meetings as part of their clinical activities. The effectiveness of these local control structures is hampered by transparency issues because medical professionals are bound neither by statutory nor professional duty to reveal to patients all details surrounding medical complications or injuries the patients had sustained. It would benefit patients‘ interests if this legal black hole is plugged by statutory provisions which concretize patients‘ rights to medical information as well as impose on the doctors a duty of candour. 73 CHAPTER EIGHT: DISCIPLINARY PROCEEDINGS BY THE SINGAPORE MEDICAL COUNCIL Singapore‘s medical profession has always maintained close professional ties with its counterparts in the UK, North America, Australia and New Zealand. Many doctors in Singapore receive their specialist qualifications through postgraduate training or exams conducted by professional colleges in these countries. Some other doctors in Singapore had an even earlier association through their undergraduate training in the medical schools there. Not uncommonly, medical experts from the above mentioned countries are invited to visit Singapore‘s healthcare institutions to lecture and share their wealth of clinical experiences. In this chapter, disciplinary proceedings in the UK, US, Australia and New Zealand will be examined to varying degrees of detail for comparative purposes. This is then followed by using legal principles to assess the work done by the SMC in the area of professional regulation. The United Kingdom Since 2001, the GMC has itself become answerable to the Council for Healthcare Regulatory Excellence (CHRE). This statutory body has an overarching responsibilty over professional organisations regulating healthcare providers, including the GMC. The powers of the CHRE include: 1) investigating and reporting on the performance by healthcare regulators of their functions, and to make recommendations for change 2) directing a regulatory body to make specified rules that it considers desirable for the protection of members of the public 3) investigating complaints from individuals about the way in which a regulatory body has carried out its functions 74 4) to appeal to the High Court, against certain decisions of regulatory bodies that appear unduly lenient and compromise public safety; this is a wholly new new concept in professional regulation because previously, only an individual aggrieved at the GMC‘s verdict had the right to mount a legal challenge, whereas now, the CHRE can lodge an appeal on behalf of the public interest. The CHRE comprises nineteen members: nine members from each of the regulatory bodies and ten ‗public‘ members who are not affliated with any of the regulated healthcare professions. Presently, there are plans by the UK Parliament to streamline the CHRE through abolishing representation by the regulatory bodies 117. This amendment will further strengthen independence within the CHRE and foster a more objective assessement of regulatory bodies. In ‗Trust, Assurance and Safety- The Regulation of Health Professionals in the 21st Century‘, the UK government set out and explained the rationale behind reforms to raise the standards of healthcare regulation. The UK government was concerned that doubts harboured by the public and professionals alike on perceived partiality of professional organizations undermines trust in these regulatory bodies. The UK government emphasized the need to dispel patients‘ and the public perception that professional bodies are ‗looking after their own‘, and counter some professionals‘ suspicion that they are treated harshly by regulators pandering to public and media pressure. To ensure regulators are not only independent in their actions, but are ‗seen to be independent in their actions‘ the white paper posits the following measures needed: - all councils should be constituted to disbar professionals from forming a majority to lend greater objectivity to council opinions - as a minimum, there should be parity of council membership between professional and lay members; in such circumstances, councils have to specify additional measures to provide a clear 117 ‗Trust, Assurance and Safety- The Regulation of Health Professionals in the 21st Century‘. Department of Health, 2007. 75 assurance about their commitment to patient interest and fend off professional introspection that is incompatible with social and cultural changes - recruiting lay members from groups that might be sympathetic to professional interests, scuh as retired members of the profession, is discouraged - all members of all councils will be independently appointed by an Appointments Commision according to specfied criteria and competencies; this departure from the traditional method of electing council members by registrants serves to erase public notions that their own interests will be sacrificed because they are excluded from the electoral process. The white paper also announced the government‘s intention to improve accountability by professional regulatory bodies to the UK Parliament. Since Parliament represents the balance of interests and opinion across society, the government held that regulators must report periodically to Parliament. This system of regular checks ensures the independence of regulators remains unblemished even though patients and the electorate are unable to participate in the appointment or election of council members. Chapter four in the white paper lays out the government‘s strategy to improve the investigation of concerns about medical professionals. In this section, the government voices its concurrence with the Chief Medical Officer‘s suggestion that when adjudicating on matters pertaining to a healthcare professional‘s fitness to practice, tribunals should adopt the civil stand of proof and depart from the current criminal standard of proof. This paradigm shift is the result of the government‘s belief that a criminal standard of proof utilized by the GMC during fitness to practice proceedings impedes the referral of complaints to the GMC. Having this high burden of proof nurtures a culture of hesitancy and reluctance to refer cases to the GMC due to perceived difficulties in proving claims to this standard of proof. Ultimately, the government feels that such pervasive inertia compromises patient safety and undermines public confidence. The civil standard of proof advocated by the UK government is a flexible sliding civil scale already widely used by the substantial of health regulators in the UK (eg. General Dental Council, Royal 76 Pharmaceutical Society of Great Britain, General Chiropractic Council). The hallmark of this sliding scale is its ability to factor in the circumstances and gravity of individual cases, with more serious matters requiring a greater degree of probability of the evidence being true; in cases of sufficient gravity, the flexibly applied civil standard is virtually indistinguishable from the criminal standard118. This tailored adjudicative process ensures that appropriate weight can be given to serious allegations against health professionals which if found culpable of could result in erasure from a professional register and consequent loss of livelihood in that area of employment. The government also took the opportunity to dismiss claims that this new civil standard of proof fosters defensive medicine because medical practitioners would rather err on the side of caution when managing difficult cases if the threat of being unfairly struck off the professional register looms over them constantly. The government opined that this flawed argument rested on the presumption that under the criminal standard, professionals might choose riskier but potentially more effective, clinical interventions. This style of medical practice does not happen in reality due to strong fundamentals entrenched within the majority of healthcare professionals: - the presence of high professional standards and commitment to patient welfare - a teamwork culture which promotes mutual peer consultations to arrive at a consensus of expert opinion, whenever there is doubt or uncertainty in clinical management - a professional obligation to obtain informed consent from patients by elaborating on potential risks, benefits and uncertainty about a particular procedure or intervention. The GMC responded positively to the white paper and embarked on a course of reforms in the direction envisioned by the white paper 119. GMC President, Sir Graeme Catto remarked that ‗the white paper provides the basis for a lasting settlement in relation to professional regulation‘ and extolled the 118 Trust, Assurance and Safety- The Regulation of Health Professionals in the 21st Century. The Stationery Office, London, 2007. 119 The GMC issued a press release on 16th November 2007. 77 recommendations as ‗designed to ensure a regulatory system that commands the confidence and support of all those who receive and provide healthcare.‘ Some of the significant changes to be implemented by the GMC include changing the composition of the council to ensure a balanced membership with equal proportions of medical and lay members and working closely with the medical Royal Colleges to set up a system of revalidation. The GMC also paved the way to implement a flexible civil standard of proof once the appropriate legislation is enacted by Parliament. Last but not least, the GMC was exploring how its prosecutor role could be separated from adjudicative function to strengthen impartiality. Other case studies120 In New South Wales, Australia, the state government takes an active role in regulating the medical profession, via a Medical Board which comprises members appointed by the State Governor. There are fifteen professionals and five lay members on the board and the board has to submit an annual report to Parliament detailing complaints encountered, performance assessments conducted and actions taken. The investigation of complaints is a joint exercise by the Medical Board and another independent statutory body, the Healthcare Complaints Commission. Once deemed appropriate, prosecution of a practitioner takes place before the Medical Tribunal. The Medical Tribunal is a distinct and independent body made up of a legally qualified chair, a lay member and two medical practitioners. The Tribunal has the power to mete out a range of punishment, including the de-registering of a medical practitioner. Likewise, medical regulation in New Zealand is characterized by strong government participation and lay representation. The Medical Council of New Zealand is composed of seven professional and four lay members appointed by the Minister of Health. Similar to the Australian model, there is a separation of performance assessment from the adjudication function. The hearing of charges against practitioners is carried out by professional conduct committees of the Medical Council. These comprise two physicians and a lay member, none of whom are council members. Hearings are usually held in public and the civil standard of proof is applied, not the higher criminal standard. A Health Practitioners Disciplinary 120 Information taken from Good Doctors, Safer Patients: Chapter six; medical regulation around the world 78 Tribunal serves as a separate adjudicator and is empowered to take a range of actions against errant practitioners, ranging from cancellation, suspension or imposition of conditions against the practitioner‘s registration. The Tribunal may also censure a practitioner, impose a fine or make an award of costs. In New York State, the investigation and adjudication process is completely separated from the professional body responsible for the register. The New York State Medical Board consists of members nominated by the Office of the Professions and takes charge of licensure and registration. Disciplinary matters on the other hand, are managed by the State Board of Professional Medical Conduct, part of the State Department of Health. This body is separate from the State Medical Board and is made up of state (the Commissioner for Health) appointed members. Complaints are screened and investigated by an Investigation Committee. This committee may dispose of the complaint or refer to the Disciplinary Committee. The Disciplinary Committee would in turn take a variety of action, ranging from issuing fines and censure to instructing the State Medical Board to act upon a doctor‘s registration. The traditional form of professional regulation in the above mentioned countries which was based on self-regulation and characterized by collegiality, informality and confidentiality has given way to greater transparency, more formal rules and stronger accountability to external auditors. As a result, professional self-regulation is on the retreat in these jurisdictions. In the following paragraphs, the SMC‘s approach in dealing with professional misconduct will be critiqued using a legal perspective to ascertain how the process could be improved. Conflict of interests One of the most striking features one elicits after understanding disciplinary proceedings conducted by the SMC is how the entire process is completely internalized within the same professional body. Of note, the SMC‘s Disciplinary Committee takes on the dual roles of prosecutor and adjudicator as it probes into complaints and initiates disciplinary action once it accumulates sufficient evidence to find the defendant guilty. This practice is markedly different from that in the countries that had been cited in the case studies, which is characterized by a movement towards the separation of duties in the disciplinary 79 process or active involvement by the nation‘s health authorities at various stages during the disciplinary process. Freedom from bias is woven into the fabric of natural justice and the common law‘s jurisprudence has always adhered religiously to this concept by distinguishing the trier of fact from the prosecutor and investigator so as to avoid any undue influence. Moreover, justice may miscarry if those who are assigned to prosecute the offender think the sentence options too harsh and shy away from proving guilt on a graver but truer charge. This separation of duties is well established in criminal law, and resonates especially in the field of administrative law. The administrative law‘s maxim, that a man should not be a judge in his own cause, nemo judex in causa sua, disqualifies an individual from acting as an adjudicator not only to a cause in which he is a party, but equally applies to a cause in which he has an interest. The Singapore High Court‘s ruling in Anwar Siraj v Tang I Fang [1982] 1 MLJ 308 is illuminative of this maxim. The plaintiff had objected to the defendant on adjudicating on charges made against him because it was the defendant who had brought up the charges. Granting an injunction against the defendant, the court held that the defendant had a personal interest in the case and had breached the nemo judex in causa sua rule by participating in the tribunal. In Tan Tiang Hin Jerry v Singapore Medical Council [2000] SGCA 17, the High Court addressed this issue within the context of the medical profession‘s disciplinary proceedings. The plaintiff‘s counsel argued that the SMC was in contravention of the nemo judex in causa sua principle based on the following reasons: - the SMC is effectively the decision maker of the Complaints Committee because two of four members in the committee are members of the SMC and of these two, one is the chairman who has a casting vote - the SMC is the prosecutor in relation to the charges brought against the plaintiff - the majority of the Disciplinary Committee is made up of members of the SMC. 80 The court dismissed the counsel‘s assertions after concluding that Parliament had intended members of the SMC be included in the make-up of the Complaints Committee and the Disciplinary Committee. The court narrated s42(2) of the MRA which specifically bars members of a Complaints Committee inquiring into any matter concerning a registered medical practitioner from sitting in a Disciplinary Committee inquiring into the same matter, as reassurance that Parliament had installed a safeguard against possible transgression of fairness. Certainly, s 42(2) insulates the Disciplinary Committee‘s proceedings from opinions held by members of the Complaints Committee. However, the concern that a conflict of interests will arise remains unabated because s42(2) does not bar members in the Disciplinary Committee from taking on the concurrent roles of prosecutor and adjudicator. The nature of disciplinary proceedings in the SMC is such that the Complaints Committee serves as a screener and once a complaint has been escalated to the Disciplinary Committee, the charge made by a patient will be investigated and adjudicated all over again by members in the Disciplinary Committee. The effectiveness of a prosecutor is gauged by its ability to extract the most damning aspects of a case in order to secure a conviction. On the other hand, the role of adjudicator takes a more moderated tone and involves the setting of standards, determining the threshold for conviction and weighing mitigating factors during the sentencing stage. Without a clear demarcation of roles in the Disciplinary Committee, members in the committee may be confused by what is expected from them when handling disciplinary cases. The separation of prosecutor role from that of adjudicator is already a well-entrenched concept in other jurisdictions. In the Shipman report, Dame Janet Smith expressed support for employing such a measure towards strengthening clinical governance. In Australia and New Zealand, the professional medical bodies are delegated inquiry duties strictly whilst adjudication is assigned to the domain of independent tribunals appointed by the government. To improve compliance with the guiding maxims against bias during a legal hearing, the disciplinary process for medical practitioners in Singapore could be re structured along similar lines by limiting the medical profession‘s watchdog bodies to the role of inquiry and delegating adjudication to government appointed expert panels. Alternatively, the MRA can 81 redefine the duties of the Complaints Committee such that it takes on the role of a quasi prosecutor while restricting the Disciplinary Committee solely to the task of adjudication. Consistency in the disciplinary process On occasions, the SMC had incurred judicial rebuke for failing to comply with the principles of justice during the adjudicative process. Such instances of judicial intervention could be when there is a discrepancy in the treatment of like cases (Ho Paul v Singapore Medical Council), or summary judgment after a hearing (Tan Boon Chee David v Medical Council of Singapore), or the overstepping of discretionary statutory powers (Chia Yang Pong v Singapore Medical Council). Relying on the judicial system to correct aberrations in the SMC‘s adjudication is not ideal due to the high threshold of unreasonableness required to qualify for the court‘s intervention. Under s 46(8) of the MRA: ―in any appeal to the High Court against an order referred to in subsection (6), the High Court shall accept as final and conclusive any finding of the Disciplinary Committee relating to any issue of medical ethics or standards of professional conduct unless such finding is in the opinion of the High Court unsafe, unreasonable or contrary to the evidence‖. Likewise, the common law has also hesitated to interfere in the decisions made by a medical professional body. In Julius Libman v General Medical Council [1972] AC 217, Lord Hailsham of St Marylebone LC voiced the court‘s reluctance to displace a finding or order of a disciplinary committee unless it could be shown that something was clearly wrong either (i) in the conduct of the trial or (ii) in the legal principles applied or (iii) unless it could be shown that the findings of the committee were sufficiently out of tune with the evidence to indicate with reasonable certainty that the evidence had been misread. 82 Given that the Singapore courts will intervene in the Disciplinary Committee‘s finding only under the most exceptional circumstances, the SMC should consolidate safeguards to preserve fairness during disciplinary hearings. For a start, more effort must be devoted towards attaining consistency in disciplinary outcomes. Consistency of decision-making is not only a prerequisite for fairness towards doctors by treating like cases alike, but is also integral to the adequate protection of patients. Unfortunately, the summaries of disciplinary cases in the SMC‘s annual reports do not offer sufficient details for the proper articulation of the reasoning behind decisions made by the Disciplinary Committee. Even when reasons were stated for the verdicts made, they were cursory and brief. At the same time, the bases for sentences delivered by the SMC‘s Disciplinary Committees were not elucidated. This problem of inconsistency in disciplinary outcomes is similarly encountered in the UK. During investigations conducted by the Shipman Inquiry, the GMC‘s legal representative admitted that decisions made by the GMC pertaining to disciplinary matters, had been idiosyncratic and given rise to an unacceptable disparity between the outcomes of cases 121. He suggested that one cause of inconsistency and poor quality in decision-making was the fact that it was not the practice for GMC panels or committees to give reasons for their decisions; he further agreed with the Shipman inquiry panel that having to give reasons would improve the decision-making process. The imperative to deliver cogent reasons at the conclusion of a tribunal hearing forms a core tenet of western jurisprudence and has been repeatedly emphasized by judges presiding over legal appeals against the medical profession‘s regulatory bodies. In Dasrath Rai v General Medical Council 122 , Lord Scarman delivering the judgment of the Board observed that there was no obligation on the GMC‘s committee to give reasons. However, their Lordships suggested that giving reasons could be beneficial and assisted justice: 121 122 See the submissions made by the GMC‘s Leading Counsel, Roger Henderson QC, during the Shipman Inquiry. Privy Council Appeal No. 54 of 1983. 83 -in a complex case to enable the doctor to understand the committee's reasons for finding against him; -where guidance could usefully be provided to the profession, especially in difficult fields of practice such as the treatment of drug addicts; and -because a reasoned finding could improve and strengthen the appeal process. Lord Scarman‘s observations in Dasrath Rai were later endorsed by Lord Brandon of Oakbrook who delivered the judgment of the Board in David Jan Rodgers v General Medical Council 123 . These two English cases were cited by Justice M. Karthigesu in Re Dr Alex Ooi Koon Hean [1991] SGHC 82 when he was considering an appeal from Dr Alex Ooi Koon Hean against the decision of the SMC striking him off the medical register. The learned judge opined: ―For myself I would observe that except in the most straightforward of cases the Medical Council and indeed every professional body entrusted with the statutory duty of maintaining professional standards and conduct should give reasons in support of the findings of fact in respect of each of the essential ingredients of the charges.‖ Justice Karthigesu then proceeded to examine the SMC‘s handling of the charges against Dr Alex Ooi and ruled in favour of the appellant. Substantiating the Disciplinary Committee‘s deliberation with reasons takes on added importance as the committee is excluded from the ambit of the Evidence Act 124. This insulation from quality checks enshrined in Evidence Law has contributed to the committee‘s erroneous assessment during disciplinary inquiries. In Re Dr Alex Ooi Koon Hean, Justice Karthigesu had singled out the SMC‘s reliance on feeble evidence as the basis for quashing the appellant‘s conviction by the disciplinary committee. The trial 123 Privy Council Appeal No. 46 of 1984. Section 43(4) of the MRA states: ‗A Disciplinary Committee shall not be bound to act in any formal manner and shall not be bound by the provisions of the Evidence Act (Cap. 97) or by any other written law relating to evidence but may inform itself on any matter in such manner as it thinks fit.‘ 124 84 judge noted the SMC had depended on a copy of the original diary purportedly kept by the complainant as corroborative evidence of the complainant‘s allegations, despite the fact that in law it was devoid of evidential value. The learned judge cited the English case of Wallace Harold Virgo (1978) Cr. App. R 323 whereby the Court of Criminal Appeal held that the real status of diaries was limited to helping a witness give accurate dates, and diaries did not constitute corroboration of a witness‘ statement. Justice Karthigesu also highlighted another fatal flaw in the SMC‘s verdict: the SMC had relied on a taped telephone conversation when in truth it was a piece of hearsay that was inadmissible. It may be unduly harsh to insist the SMC accurately apply evidence law in its full force during disciplinary hearings, considering the fact that these proceeding are administered by non-lawyers. Against this must be balanced the SMC‘s responsibilities as a custodian of ethics and professional standards for medical practitioners in the country125. The difficulties created by exempting the SMC from the Evidence Act could be ameliorated if the SMC were obligated to articulate reasons in its judgment. This requirement would compel the SMC to clarify the weight attached to the various pieces of evidence and by doing so, improves the validity of the conclusions made during disciplinary hearings. Representation The composition of the SMC and its various working committees is a matter that deserves significant attention not just because it influences the public‘s perception of their independence from professional interests, but also because the existence of professional majorities can sway the council to conduct itself in a way that favours the interests of the profession. At present, professional representation in the SMC is evident in overwhelming proportions: council membership is exclusive to medical practitioners; the Chairman of the Complaints Committee, who is responsible for filtering complaints against medical professionals, has to be a member of the council; both the Complaints and Disciplinary 125 s5(f) MRA. 85 Committees are dominated by medical professionals, with a strong council members‘ presence in the case of the Disciplinary Committee126. The advantage of having doctors manage any disciplinary proceeding for their peers is not hard to fathom. The technicalities in medicine and the clinical matters at stake are better digested by medically trained persons than lay people unfamiliar with medical jargon and theories. Nevertheless, input from lay representatives must not be dismissed because it is a valuable source of information on social and cultural changes and expectations. This ensures that the SMC does not lose touch with sentiments on the ground when performing its statutory duties. Members of the SMC must constantly keep in mind that they discipline errant medical practitioners on behalf of the wider public. The public trust enjoyed by the SMC is conditional upon the SMC acting in the public interest to preserve and maintain the safety and quality of medical services. To consolidate the public‘s confidence and trust, the SMC must engage the public on a wider scale. The saying that justice must not only be done, but must also be seen to be done, still holds true in professional disciplinary matters. The composition of the SMC influences the public‘s perception of the organization‘s detachment from professional interests, and the existence of professional majorities undermines the SMC‘s perceived independence. The imbalance in representation at the Disciplinary Committee is accentuated by the fact that nine out of nineteen members of the SMC are voted in by the medical community. Section 6 of the MRA compels every fully registered medical practitioner in Singapore to vote in the nine members of the SMC on the day of elections. Despite common knowledge that elections are an effective method of ensuring members not lose sight of the interests of the electorate and remain responsive to their particular concerns, the use of the ballot box in the SMC presents the organization with the potential problem of unequal representation. The exclusion of patients and the public from the SMC‘s elections may create the impression that patients‘ interests will be given less weight compared to the profession‘s interests as elected members of the council may perceive the SMC not as a regulator, but as the profession‘s representative body and this is in conflict with the SMC‘s primary role as the custodian of patients‘ 126 See chapter four- disciplinary proceedings for medical practitioners. 86 welfare. In the Shipman Inquiry, Dame Janet Smith had linked an ethos of early closure during the GMC‘s screening process to the appointment of elected GMC members as screeners; she opined that these case examiners feel a subconscious pressure to lean towards the protection of doctors given the fact that they were elected by the medical community. The UK government was convinced that in order to send an unmistakable message about its commitment to patient and public interest, the GMC should be constituted to ensure that professionals do not form a majority127. At the minimum, the UK government believed that there should be parity of membership between professional and lay members in the GMC. It may be somewhat a moot point to dictate a formula on the number of lay representatives in a professional organization. What is perhaps more crucial is to ensure a balance such that public opinions are well echoed at disciplinary hearings. At the moment, the degree of lay representation allowed by s42(1) of the MRA is woefully inadequate. The single lay person allowed on the Complaints Committee only serves to underscore the profession‘s monopoly over disciplinary proceeding while the observer status granted to the lone public representative on the Disciplinary Committee has essentially excluded any form of public input during disciplinary proceedings. By barring the observer from voting on any question or matter to be decided by the Disciplinary Committee and not requiring the observer to be present at every meeting of the Disciplinary Committee, s42(3) has effectively emasculated the public‘s sole representative in the disciplinary process and curtailed his participation. It is proposed that the quorum of any disciplinary hearing include the participation of lay person(s) who are given voting rights. While the details of these appointments need to be further ironed out, as a general rule, these lay representatives could be drawn from individuals actively involved in patient advocate groups or voluntary healthcare organizations. The reason behind this selection is because lay persons who are involved in healthcare related non-governmental organizations are more likely to be informed about the issues that patients have to grapple with in their daily lives. These lay representatives will also probably have an in depth understanding of the considerations that influence the clinical duties delegated to doctors. 127 This stance was made clearly in the White Paper on GMC reforms. 87 At the conclusion of the Shipman Inquiry, Dame Janet Smith recommended the separate appointment of full-time legally qualified panelists to chair the GMC‘s disciplinary hearings. She believed the presence of such individuals would make the GMC‘s hearings more independent and impartial. Another advantage she noted was that a legally qualified chairman would bring greater legal rigour to the hearings than does the presence from a GMC nominated legal assessor. This is because such a chairman could assist in sorting out what evidence is relevant to what issues and ensure that the disciplinary panel does not take irrelevant considerations into account, which may not always be possible by having a GMC nominated legal assessor allowed only to give advice. The use of a legal chair in professional disciplinary hearings is actually a firmly established policy in other jurisdictions. For example, in New Zealand, the Health Practitioners Disciplinary Tribunal is chaired by a legal officer of at least seven year‘s experience128. Likewise, the appointment of an independent legally trained chairman by the health authorities to provide guidance at all SMC‘s disciplinary inquiries, as opposed to discretionary involvement by the council, promotes greater public confidence in disciplinary hearings as it reassures the public that an objective, authoritative voice is present at all times within the SMC. This reassurance is especially invaluable if the SMC‘s disciplinary proceedings continue to be excluded from the public‘s eye and dominated by professional representation. To both complainant and defendant involved in the disciplinary hearing, the directions given by a legal chairman guards against inadmissible evidence or inappropriate evidential procedures; this safeguard is particularly important, considering the fact that s43(4) of the MRA liberates the SMC from the constraints of the Evidence Act and ‗any written law relating to evidence‘. In addition, the presence of a legally trained chairman confers other merits not alluded to by the Shipman Report. The activities of the Disciplinary Committee revolve around what constitutes ‗professional misconduct‘ and whether the appropriate ‗standard of proof‘ has been discharged. These 128 Under section 86(1)a of the Health Practitioners Competence Assurance Act, the Tribunal must contain a chairperson and 1 or more deputy chairpersons, each of whom must be a barrister or solicitor of the High Court of not less than 7 years' practice, whether or not he or she holds or has held judicial office. 88 phrases are couched in legalistic language that a legal officer is probably more familiar with than compared to a medical practitioner. Thus, allowing disciplinary hearings to be monopolized by medical practitioners unschooled in legal knowledge is not only counterintuitive, but may actually compromise the quality of decision-making. Secondly, a more liberal interpretation of Section 61(2) of the MRA will create an expanded role for a legally qualified chairman to serve as a custodian of the principles of natural justice. Such a chairman would supervise the activities at all disciplinary inquiries to ensure that the appropriate procedures are followed accordingly. [TK edit here] Transparency The degree of transparency in the SMC‘s affairs is probably another area that needs to be reviewed. For a start, the identity of individuals sitting on the council‘s various working committees is not disclosed to the public. When reference is made to the working committees in the SMC, one does not just have the Complaints Committee and Disciplinary Committee in mind, but includes the Credentials Committee established by s29 of the MRA. Whilst the identities of council members are revealed as part public information published in the SMC‘s annual reports, the make up of these working committees is not available to the public. The importance of these committees cannot be understated: the career path, livelihood (sine the type of registration conferred determines the practising rights of a doctor) and professional reputation of medical practitioners are directly impacted by decisions handed out by these committees. Hence, it is only fair for doctors and members of the public alike to be informed about the individuals who sit on these committees to bolster individual accountability. The information is made more pressing by the fact that Singapore‘s medical fraternity is a relatively small and closely knit community. Conflicts of interest may arise to compromise the impartiality of the work done by these committees and should never be allowed to erode the public‘s trust in the SMC. Unlike hearings conducted by New Zealand‘s Medical Council or the GMC‘s Professional Conduct Committee, the SMC‘s disciplinary proceedings are shielded from the public‘s view and deliberated behind closed doors, often excluding the complainant in the process as his presence is not 89 mandated at the inquiry. Section 7 of the patient‘s declaration form issued by the SMC explicitly states that ‗it is the prerogative of the Committee to decide whether a complaint should be heard in person and no complainant has the right to be present during the investigation‘. In fact, the passive role expected of the complainant is evident in the opening statement of the said section: ―The Complaints Committee will acknowledge receipt of your complaint and inform you of its decision in due course‖. The reasons for this information blackout are unclear, but one can fathom medical confidentiality as a justification to keep inquiry hearings private. Another possible consideration is that of having to ameliorate the effect of negative publicity on a possibly innocent defendant medical practitioner, and the potential threat that such meetings can degenerate into a media circus. These concerns tread on tenuous foundations and ought to be repudiated. Medical confidentiality is hardly ever an issue since patients‘ identification details can easily be made anonymous during the course of the inquiry if needed. Moreover, the omission of patients from the inquiry process runs counter to the spirit of engagement advocated by the Subordinate Courts in medical dispute resolution. In November 2006, the Chief Justice Chan Sek Keong spelt out a ‗pre-action protocol‘ by the Subordinate Courts that require complainants and doctors to discuss any injury or death arising out of medical treatment before complainants are allowed to seek legal redress 129. Under this new initiative, patients or their families will be afforded the opportunity to seek explanations or receive any appropriate apology at the earliest instance. Not only will public hearings demolish the perception that medical practitioners close ranks when their peers are accosted by dissatisfied patients, the open nature of these hearings may actually encourage the larger community to endow greater trust in doctors as it offers the community an understanding of the professionalism and thoroughness with which the SMC conducts these meetings. The medical profession is privileged by the high regard members of the public bestow, and the unquestioned trust that majority of 129 CJ Chan delivered the ‗15th Subordinate Courts Workplan 2006/7’ on 18th May 2006. 90 patients carry, each time they enter a medical consultation. Conducting disciplinary proceedings entirely within the confines of the SMC and excluding complainants from the process is probably not the most appropriate way to reciprocate the public‘s trust. Doctor‘s reservations that vindictive patients can manipulate the media glare to discredit their professional reputation, are not only unfounded but also unjustifiable. All complaints lodged at the SMC undergo a screening process beginning with the Chairman of the Complaints Panel130. Complaints that pass this filtering process are relayed to the Complaints Committee for a second round of examination. If the Complaints Committee deems that it is warranted, the matter will be escalated to the Disciplinary Committee for a comprehensive inquiry131. By enmeshing layers of stringent checks within the SMC‘s complaints process, medical practitioners can be confident that the frivolous and downright malicious stand no chance of being aired in the public arena. If anything, open hearings grant an opportunity to the defendant medical practitioner for public exoneration if found innocent of the charges made. The notion of transparency surfaces again when the SMC‘s annual reports are visited. Between 1995 and 2006, the SMC received an average of approximately 11 complaints per 1000 doctors. These complaints are further categorized into various subgroups, for example, ‗professional negligence‘, ‗conviction in court‘, and ‗abusive behaviour‘. The data suggests that a majority of these complaints do not make it to the Disciplinary Committee. For instance, in 2006, 106 complaints were received by the SMC. Of these, only 10 were referred to the Disciplinary Committees while 29 were adjourned. Other than the summary figures, there is not a single hint by the council on the circumstances that subsequently led to the filtering off of a majority of the complaints so that only 10 complaints were deemed serious enough to be referred to the Disciplinary Committees. While it may not be feasible for the SMC to dwell upon the specifics of each complaint in its annual reports, it is important for the SMC to at the very least disclose the number and nature of complaints screened off by the Chairman as well as the Complaints Committee. Premature closure of complaint inquiries by case screeners in the GMC was identified in the 130 131 s39(8) MRA. s41(1)b MRA. 91 Shipman Report as a weakness that contributed to Harold Shipman‘s atrocities. Of particular concern is screeners‘ premature dismissal of complaints alleging professional misconduct by medical practitioners, since patient‘s safety could be put at risk unnecessarily. Publishing additional information with regards to the nature and proportion of complaints screened off by each level in the SMC will alert the public to the ethos of premature closure, should it be present in the screening process. At times, the veil over the SMC‘s hearings presents a hurdle to the defence mounted by the practitioner facing prosecution. In ‗The Legal Assessor in a Medical Disciplinary Inquiry’132, Deepak Raja gave an overview of the lawyer‘s involvement in the SMC‘s disciplinary proceedings. Of note, when handling difficult legal issues, the Disciplinary Committee may order a short adjournment to have the question considered with its legal counsel. After reconvening, the committee would state its ruling on the question. However, specifically what legal advice was given would not be revealed to the defendant. At the same time, the Disciplinary Committee is not bound by the legal advice rendered and there have been instances when Disciplinary Committees have rejected advice given by assessors. The information stricture on what transpires between the legal assessor and the Disciplinary Committee deprives medical practitioners the opportunity to fully rebut charges made against them. For example, an assessor could have advised incorrectly on a fundamental point of law which the Disciplinary Committee accepted, to the detriment of the defendant medical practitioner. In Tan Boon Chee David v Medical Council of Singapore [1980] SGHC 15, the legal assessor had failed to advise the SMC that the legitimacy of the inquiry would be vitiated if members of the SMC walked in and out while witnesses were giving testimony. This was subsequently brought to the attention of the High Court by way of appeal. The trial judge held that the proceedings in the SMC were irregular for breach of natural justice. In another appeal case at the Singapore High Court, Re Alex Ooi Koon Hean [1991] SGHC 82, Justice Karthigesu found that the legal assessor had failed to advise the Disciplinary Committee of the evidential value of various items submitted. After coming to the conclusion that the evidence tendered was ‗out of tune‘ with the finding of guilt, the trial judge allowed the appeal by the 132 Published in ‗Law Gazette‘, November 2005. 92 appellant practitioner. What these two cases illustrate is that the work of the legal assessor is not infallible. It is crucial that a defendant medical practitioner and his legal counsel be given the opportunity to scrutinize the advice given by the SMC‘s legal assessor. In this way, should the DC‘s legal advisor repeatedly perform below par, the defendant medical practitioner would have a cause to object to the assessor‘s continual participation in disciplinary proceedings so as to minimize further prejudice. Conversely, members of the Disciplinary Committee are neither schooled in interpreting points of law, nor familiar with what constitutes the rules of natural justice. Therefore, any deviation from the legal advice extended by assessors ought to be fully disclosed to ensure a fair hearing has not been compromised due to the erroneous interpretation of legal principles by the Disciplinary Committee. The promulgation of clear standards One of Natural Law‘s most well known legal scholars, Lon Fuller, contended that there were eight possible routes of failure in a system of governance. Among these eight features, he included: - failure to publicize or make known the rules of law - unclear or obscure legislation that is impossible to understand. Each of these features formed a corresponding principle that should be respected in legislation, in order to avoid deficiencies in government. In an ideal system of governance, all the eight principles would be present. These principles Fuller argued, represented the ‗internal morality of law‘. Certainly, there is no doubt that the SMC‘s statutory duties include the disciplining of errant health professionals 133. Yet the types of behaviour capable of amounting to professional misconduct are sketched with scanty details in the SMC‘s Ethical Code. The code describes professional misconduct as akin to ‗infamous conduct in a professional respect‘ and adopts the definition articulated by Lord Justice Lopes in Allinson v General Council of Medical Education and Registration [1894] AC 750: 133 Section 5(f) of the MRA. 93 ―If a medical man in the pursuit of his profession has done something with regard to it which will be reasonably regarded as disgraceful or dishonourable by his professional brethren of good repute and competency, then it is open to the General Medical Council, if that be shown, to say that he has been guilty of infamous conduct in a professional respect.‖ Any uncertainty over what constitutes professional misconduct under the ‗Ethical Code‘ is certainly not helped by the Singapore High Court‘s reinterpretation of ‗professional misconduct‘ in Low Cze Hong v Singapore Medical Council [2008] SGHC 78. This case arose from an appeal lodged by a consultant opthalmologist who had been found guilty of two charges of professional misconduct under section 45(1)d of the MRA by the SMC. It was argued on behalf of the appellant doctor that the SMC‘s definition of ‗professional misconduct‘ as being akin to ‗infamous conduct‘ and that the expression ‗infamous conduct‘ had been judicially defined as involving some moral turpitude, fraud or dishonesty or such persistent and reckless disregard of duty‘ in Dudley Ernest Lyncoln Wager Felix v General Dental Council [1960] AC 704. However, the High Court rejected this definition of ‗professional misconduct‘ and opined that the SMC by linking the scope of ‗professional misconduct‘ to the concept of ‗infamous conduct‘ was taking an unduly restrictive view of ‗professional misconduct‘. The High Court observed that when the Singapore Parliament amended the MRA in 1998 by dropping the phase ‗infamous conduct in a professional respect‘ in favour of ‗professional misconduct‘, Parliament‘s intention was to embrace a wider scope of improper conduct for which disciplinary action could be taken by the SMC. The court also referred to Lord Clyde‘s dicta in John Roylace v. General Medical Council [2000] AC 311, in which His Lordship applied the Privy Council‘s definition of professional misconduct in Doughty v. General Dental Council [1988] AC 164, 173: 94 ―... conduct connected with his profession in which the dentist concerned has fallen short, by omission or commission, of the standards of conduct expected among dentists and that such falling short as is established should be serious.‖ Lord Clyde then went on to elaborate a broad definition of ‗professional misconduct‘ and cited circumstances which may qualify; besides cases of ‗a serious failure to meet the necessary standards of practice, such as gross neglect of patient, or culpable carelessness in their treatment, or the taking advantage of a professional relationship for personal gratification‘, Lord Clyde included behaviour that ‗does not occur within the actual course of the carrying on of the person‘s professional practice, such as the abuse of a patient‘s confidence or the making of some dishonest financial gain‘, as well as conduct which is ‗quite removed from the practice of medicine, but is of a sufficiently immoral or outrageous or disgraceful character‘. His Lordship further stressed unequivocally that moral turpitude was not an essential element of professional misconduct. After considering cases from other jurisdictions, the Singapore High Court concluded professional misconduct could be made out in at least two situations: first, where there is an intentional, deliberate departure from standards observed or approved by members of the profession of good repute and competency; and second, where there has been such serious negligence that it objectively portrays an abuse of the privileges which accompany registration as a medical practitioner. Regrettably, the High Court did not take a step further to outline the reasonable standards expected from medical practitioners, but instead reverted back to the medical profession to set these standards. The grounds for the SMC to explicitly outline what constitutes professional misconduct are not dissimilar to Dame Janet Smith‘s arguments in the Shipman Report. First, it is only fair that medical practitioners know what type of conduct or deficiency of standards is likely to result in disciplinary action so that they can regulate their behaviour accordingly. While it is hoped that most doctors aspire to higher professional standards than just to avoid disciplinary action, it is only fair that doctors fully appreciate the circumstances in which they might run foul of the SMC. Second, patients and their relatives, who have 95 complaints against doctors must have a clear understanding of whether their complaints fall within the purview of the SMC‘s disciplinary mandate. Otherwise, their complaints will be rejected by the SMC, bringing them disappointment, frustration and perhaps even suspicion that the SMC had covered up for the mistakes made by doctors. Such an outcome would create public misgivings about the role of the SMC and results in tarnishing the SMC‘s reputation. Similarly, it is important that those with responsibility for referring cases to the SMC, such as doctors‘ employers and private healthcare bodies, are familiar with the types of cases that they should refer. If they are not, they will refer the wrong cases and either resources are wasted or unnecessary delay will be created in the resolution of medical incidents. Even worse, patients may be inadequately protected as their problems are not directed to the appropriated regulatory body. Lastly, it is important that both members of the disciplinary committee and screeners in the SMC understand the standards to be applied and apply them consistently. Hopefully, this can strengthen the system‘s handling of complaints against doctors and avoid the inequitable outcomes seen in Ho Paul v Singapore Medical Council. With recent judicial efforts to widen the scope of ‗professional misconduct‘, the SMC needs to respond promptly. The SMC should reformulate its exposition of ‗professional misconduct‘ because what is apparent, is that the SMC‘s narrow perspective of this phrase is neither compatible with the High Court‘s definition, nor in line with the interpretation under English law. In the Privy Council case of McCandless v General Medical Council [1996] 1 WLR 167, Lord Hoffman observed: “... the public has higher expectations of doctors and members of other self-governing professions. Their governing bodies are under a corresponding duty to protect the public against the genially incompetent as well as the deliberate wrongdoers.‖ As the custodian of medical ethics in Singapore, the SMC must go beyond a semantic revision of ‗professional misconduct‘, by demarcating the boundaries in greater detail. Instead of adopting a convoluted and yet nebulous definition like ‗reasonably regarded as disgraceful or dishonourable by his 96 professional brethren of good repute and competency‘ 134 to describe professional misconduct, the SMC‘s Ethical Code can render more guidance to all parties concerned by promulgating categories of behaviour that specifically come within the domain of professional misconduct. At present, the SMC‘s Ethical Code details many aspects of clinical practice, including the standards of good medical practice, advertising guidelines, and the desired relationship between doctors and their patients. In the preamble to the professional guidelines, the Ethical Code states that ‗breaches of these guidelines could lead to doctors being asked to defend their actions and ultimately to face disciplinary proceedings for professional misconduct‘. While it is conceivable that a doctor who deviates from section 4.1.1.1 of the Ethical Code by prescribing treatment without ‗an adequate assessment of a patient‘s condition through good history taking and appropriate clinical examination‘, could be culpable of professional misconduct, it seems somewhat harsh to penalize a medical practitioner who has failed to document medical records adequately ‗so that any other doctor reading them would be able to take over the management of a case‘135 for professional misconduct. To be of practical contribution during disciplinary proceedings, what the Ethical Code can do is map out the criteria that cross the threshold for professional misconduct. It is unlikely the criteria set out by the Ethical Code will prove to be exhaustive or comprehensive. Nevertheless, having articulated the professional standards required for conduct, performance and fitness to practice, the SMC can illustrate these categorizations using the SMC‘s case records. It is hoped that having a publicly- available record of cases on professional misconduct, the Ethical Code can better assist committee members in applying the standards of professional misconduct consistently during disciplinary hearings as the committee members would be guided by a body of precedents. The appropriate standard of proof 134 135 Taken from Allinson v General Council of Medical Education and Registration. Section 4.1.2 of the SMC‘s Ethical Code. 97 In the UK government‘s white paper on health care reforms, using the criminal standard of proof in the GMC‘s disciplinary hearings was identified as a hurdle to better clinical governance. For this reason, the government advocated installing a flexible sliding civil standard of proof into the GMC‘s disciplinary proceedings. Although not explicitly stated in the statutory legislation or clarified by SMC, it can be inferred by examining the contents of the SMC‘s annual reports that the Disciplinary Committee applies the criminal standard of proof when serious allegations are made against doctors. In 2001, the SMC was probing an allegation of outrage of modesty by a medical practitioner 136. The defendant medical practitioner was charged with touching the genitals of a female patient in an unprofessional manner while performing an internal pelvic examination on this patient. The SMC‘s Disciplinary Committee acquitted the defendant medical practitioner because the Committee concluded that the charge had not been proven by the prosecution beyond a reasonable doubt. It is not surprising that the higher criminal standard of proof is favoured by the medical fraternity during disciplinary proceedings. A conviction of professional misconduct by the Disciplinary Committee carries harsh ramifications for the defendant medical practitioner- not only will the defendant‘s professional integrity be impugned by a conviction, the punitive measures that follow this verdict can translate into a loss of livelihood for the culpable defendant when he is struck off the professional registry. However, the truth of the matter is that these disciplinary hearings do not function like criminal courts and the impact of rulings passed down by the Disciplinary Committee does not come anywhere close to that of sentences issued by criminal courts. For a start, the State-led prosecution of the accused in criminal courts is conspicuously absent in the SMC‘s disciplinary hearings. Criminal offences are perceived as public offences that threaten social stability. Consequently, the State mobilizes the weight of its entire machinery to investigate and prosecute criminal offenders not just to restore equity or justice within society, but also to serve a deterrent message to other members of society. In contrast, while professional misconduct may inflict injuries upon the victim, it generally does not endanger the public order and is better regarded as a private conflict between two individuals. Therefore, instead of a 136 Case 4 of the Singapore Medical Council Annual Report, 2001. 98 coordinated effort by the various departments of the State, charges made against doctors are handled entirely within the medical community by its own professional watchdog, the SMC. Furthermore, the severity of the punitive measures available to the SMC‘s disciplinary committee is nowhere comparable to the punishments at the disposal of criminal courts. The assortment of criminal sentences ranges from monetary fines, to a loss of freedom in the form of jail terms, and in extreme circumstances, even the loss of life in capital sentences. The harshness of some of these criminal punishments make the SMC‘s disciplinary measures appear more like a slap on the knuckles at times because punitive actions taken against errant doctors range from warning letters, to monetary fines and only lead to de-registration in the most extreme of circumstances. Even then, it is arguable whether professional de-registration is synonymous with ‗loss of livelihood‘. In this era of medical tourism and biomedical research, the skills set obtained from medical training is applicable to the fore mentioned industries. The fact that some doctors have forsaken clinical practice to etch out a career as research scientists, health administrators and health care industry consultants only show that clinical practice is not the only career route after medical school. Thus, an errant doctor who is struck off the professional register still has the option of making the transition into healthcare related industries by taking up nonclinical related careers. There should not be any question that patients‘ safety and interests must be the paramount concern in medical practice. At the same time, the SMC has to ensure fairness to doctors called up to face disciplinary inquiries. Hence, the SMC should clarify the standard of proof it adopts during disciplinary hearings. Requiring professional misconduct to be established on a balance of probabilities according to the civil standard of proof, as opposed to beyond a reasonable doubt in the criminal standard, does not necessarily expose medical practitioners to a higher risk of wrongful convictions. Unlike judicial hearings in Singapore which are often led by a single judge and involve three members on the bench only in appellate cases, the SMC‘s disciplinary committee comprises at least three members 137. In this setting, a defendant medical practitioner is assured of sufficient protection since a guilty verdict is passed only after 137 s42(1) MRA. 99 a majority of the committee members is satisfied that the standard of proof-on a balance of probabilitieshas been met by the appropriate evidence submitted to the committee. This hurdle of majority consensus serves as a second protective shield for medical practitioners against convictions on questionable grounds. An additional protection for medical practitioners can be rendered by formulating a sliding civil standard of proof during the SMC‘s disciplinary proceedings. Under this sliding scale, the standard of proof required is titrated according to the gravity of the charge made. Serious offences that incur professional deregistration or attract criminal liabilities such as sexual misconduct and the illicit sale of addictive drugs will mandate a criminal standard of proof. On the other end, less serious allegations such as false advertising that can lead to monetary fines or at most temporary suspension in practice will require the SMC to discharge the civil standard of proof. The seeds of this flexible legal mechanism were probably first sowed by the Privy Council in the case of McAllister v General Medical Council [1993] AC 388. In the case, the appellant doctor had dishonestly siphoned away funds donated to his hospital and thus found guilty of serious professional misconduct. Lord Jauncey of Tullichettle who delivered the judgment on behalf of the Privy Council, stated that in many cases, the charges which a doctor had to face before the disciplinary committee could not be the subject of any serious or criminal charge at all. Also the committee is composed of medical professionals and to require that every charge of professional misconduct be proven to them just as though they are a jury of lay men is neither necessary nor desirable. His Lordship stressed that what was of prime importance, was that the charge and the conduct of the proceedings should be fair to the doctor in question. At the extreme of circumstances where the events giving rise to charges against a doctor would also found serious criminal charges, ‗it may be appropriate that the onus and standards of proof should be those applicable to a criminal trial‘. According to the model drawn up by the UK government, the civil standard of proof can be flexibly applied to take into account the circumstances and gravity of individual cases, with more serious matters requiring a greater degree of probability of the evidence being true. By utilizing this measured approach, in cases of sufficient gravity, the flexibly applied civil standard is virtually indistinguishable from the criminal standard. 100 Concerns that under the civil standard of proof, clinicians will practise defensive medicine and err on the side of caution are definitely unfounded. First and foremost, medical practitioners generally have always held high professional standards and displayed unwavering commitment to patient care; such professional ethos guards against irrational and reactive clinical decision making. Secondly, the current day multidisciplinary and team approach to patient care allows doctors to seek the collective expert opinions of their colleagues and arrive at a consensus whenever there is doubt, uncertainty or significant risk in making difficult clinical judgments. Such professional cooperation by doctors makes it difficult for disgruntled patients to contest a doctor‘s clinical judgment in court. Lastly, a doctor‘s professional obligation to obtain informed consent from patients, by explaining the clinical indications, potential risks, benefits and uncertainty about a proposed course of action, serves as additional protection against medical controversies. 101 CHAPTER NINE: MEDICAL TORT LAW REFORMS IN SINGAPORE Understandably, the standard of competency expected from doctors exerts a powerful influence on how the profession regulates its practices. Medical tort law in Singapore could have been a custodian of good clinical governance but for the medical profession‘s hegemony during medical negligence suits. Such professional dominance is actually quite contrary to trends in other jurisdictions that have seen a greater willingness by their courts to overrule professional opinions of doctors. In the final installment of this thesis, the discussion first recaps incremental changes to judicial perceptions in medical tort law since the formulation of Judge McNair‘s ratio in Bolam v Friern Hospital Management Committee. Then, an argument will be made for a repudiation of the Bolam test from the Singapore courts. Any advocacy for change will resonate hollow if no viable alternative is proffered. Hence, the final section of the discourse will hazard suggestions on how the Singapore judiciary may approach medical litigation without adopting Bolam‘s test and in the process contribute to clinical governance. The rise of Bolam in Singapore and its retreat in other jurisdictions The principle guiding medical negligence in English jurisprudence can be found in Judge McNair‘s direction to the jury in Bolam v Friern Hospital Management Committee where he said: ―A doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that art … putting it the other way round, a doctor is not negligent, if he is acting in accordance with such a practice, merely because there is a body of opinion that takes a contrary view.‖ 102 The role of Bolam in English law has since been consistently upheld by the appellate courts138. Any suggestion that the emasculation of the judiciary by the Bolam test was mitigated by the House of Lords‘ ruling in the case of Bolitho v City and Hackney Health Authority139 is misguided, for Lord BrowneWilkinson then qualified that expert opinion would fail the court‘s scrutiny only in extreme circumstances: ―I emphasize that in my view it will very seldom be right for a judge to reach the conclusion that views genuinely held by a competent medical expert are unreasonable. The assessment of medical risks and benefits is a matter of clinical judgment which a judge would not normally be able to make without expert evidence.‖ In essence, what the Bolam test has done is perpetuate professional self-regulation in the courtroom. By granting doctors the privilege to determine the standard of care expected from their profession, judicial checks on the medical profession have been significantly curtailed and opportunities created for doctors to get by with less external scrutiny. The Singapore Court of Appeal has affirmed in Khoo James v Gunapathy d/o Muniandy that the standard of care required of a medical practitioner in Singapore is set out in the Bolam test. Of note, the Court of Appeal applied the Bolam test to the issue of advice and ruled that the defendant doctors‘ disclosure of the relevant percentage risks of radiosurgery was supported by a respectable body of medical opinion and therefore not negligent. This was despite submission by the defendant, Dr James Khoo, that he did not inform the respondent Gunapathy that her previous radiotherapy treatment would increase the risk of radionecrosis from the radiosurgery which she subsequently suffered. The defendant also conceded that when advising Gunapathy on radiosurgery, he did not discuss with her the views of the radiologist who reported on Gunapathy‘s brain lesion- the radiologist had described the brain lesion as 138 See Whitehouse v Jordan [1981] 1 All ER 267, Maynard v West Midlands Health Authority [1985] 1 All ER 635. In Bolitho, the House of Lords tried to rein in doctors‘ professional autonomy by subjecting doctors‘ actions to some form of logical analysis by the judiciary. 139 103 having non specific features on imaging and was not confirmatory of a tumour. In applying the Bolam test, the Court of Appeal had essentially disregarded whether the plaintiff Gunapathy would have decided differently if the defendant Dr James Khoo had not made the omissions. The Singapore courts‘ reluctance towards interfering with medical expert opinion probably stem from two considerations. First, public policy concerns act as a shackle on judicial activism; in particular, apprehension that a willingness by the courts to dismiss medical expert opinion will put doctors on the defensive and eventually impedes advances in medicine. The genesis of such a restraint can be traced back to the words of Lord Denning when he was presiding over Roe v Minister of Health [1954] 2 QB 66 in the Court of Appeal: ―[W]e would be doing a disservice to the community at large if we were to impose liability on hospitals and doctors for everything that happens to go wrong. Doctors would be led to think more of their own safety than of the good of their patients. Initiative would be stifled and confidence shaken. A proper sense of proportion requires us to have regard to the conditions in which hospitals and doctors have to work.‖ In the penultimate paragraph of the grounds of judgment of Gunapathy, CJ Yong Pung How expressed similar sentiments: ― … the lawyer-judge in ―playing doctor‖ at the frontiers of medical science might distort or even hamper its proper development. Excessive judicial interference raises the spectre of defensive medicine, with the attendant evils of higher medical costs and wastage of precious medical resources…‖ Secondly, it is likely that the complexity of medical science imposes a stricture on judicial enthusiasm towards distilling medical facts. Again in Gunapathy, the Chief Justice had alluded to this problem: 104 ―At the heart of the Bolam test is the recognition that judicial wisdom has its limits. A judge, unschooled and unskilled in the art of medicine, has no business adjudicating matters over which medical experts themselves cannot come to agreement. This is especially where, as in this case, the medical dispute is complex and resolvable only by long-term research and empirical observation.‖ These words probably form the backdrop for Kuah Boon Theng‘s commentary ‗The Demise of Bolam- Or a Storm in a Teacup?‘140, where she said: ―… one has a sneaky suspicion that the development of this particular legal principle is due as much, if not more so, to the fact that judges without medical training probably find it a daunting (if not impossible) task to second guess and criticise the opinions and reasoning of the defence experts, who almost invariably are senior and respected practitioners giving expert testimony on a very technical matter.‖ The reformulated Bolam test continues to be endorsed in Singapore‘s jurisprudence for in JU v See Tho Kai Yin [2005] SGHC 140, Justice Lai Siu Chiu echoed the words of McNair J in Bolam and that of Lord Browne-Wilkinson in Bolitho and held the defendant‘s standard of care to be not negligent as it was supported by the opinions of two responsible, respectable and reasonable expert witnesses. This continued adoption of the Bolam test, albeit modified by the Bolitho ruling, seems to run in a counter trajectory from current legal trends in other Commonwealth jurisdictions. Australia ranks as one of the first common law countries to jettison the Bolam test. In Rogers v Whitaker [1992] 175 CLR 479 the Australian High Court held that: ―In Australia, it has been accepted that the standard of care to be observed by a person with some special skill or competence is that of the ordinary skilled person exercising and professing to have that 140 Published in Law Gazette, June 2000(3). 105 special skill. But, that standard is not determined solely or even primarily by reference to the practice followed or supported by a responsible body of opinion in the relevant profession or trade.‖ Thus, the High Court ruled that except in the case of an emergency or where disclosure would prove damaging to the patient, a medical practitioner had a duty to warn the patient of a material risk inherent in proposed treatment. The court considered a risk material if, in the circumstances of the particular case, a reasonable person in the patient's position, if warned of the risk, would be likely to attach significance to it or if the medical practitioner was or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it. The court went on to state in unequivocal terms that the fact that a body of reputable medical practitioners would have given the same advice as the medical practitioner gave does not preclude a finding of negligence; evidence of acceptable medical practice served only as a useful guide for the courts and it was for the courts to adjudicate on what was the appropriate standard of care after giving weight to ‗the paramount consideration that a person is entitled to make his own decisions about his life‘. The Rogers principle was later applied to negligent diagnosis by the Australian High Court in Naxakis v Western General Hospital & Anor [1999] HCA 221. In this case, a schoolboy sued a hospital and a surgeon for negligence. He had been struck on the head by another boy and upon admission to hospital was diagnosed as having suffered a traumatic subarachnoid haemorrhage. Two days after he was discharged he collapsed. He was then found to have suffered a major intracranial bleed from a burst aneurysm. It was contended for him at the trial that an angiogram should have been performed when he was first admitted to hospital, which would have disclosed the aneurysm. In the High Court, evidence given by medical expert witnesses agreed that the failure to order an angiogram was in the circumstances reasonable and not open to criticism. However, the High Court differed from the medical witnesses and ruled that the trial judge had erred by applying the Bolam test. Closer to home, the Malaysian judiciary has also dismantled the protective shield afforded to medical practitioners under the Bolam test. The decision by the Federal Court of Malaysia in Foo Fio Na 106 v Dr Soo Fook Mun [2007] 1 MLJ 593 departed from the Bolam test which has been extensively relied on by the Malaysian courts for more than thirty years. In Foo Fio Na, the appellant suffered two dislocated vertebrae after an accident. The first respondent was the orthopaedic surgeon who treated the appellant and the second respondent was the hospital in which she was warded. The first respondent performed an operation on the dislocated vertebrae, which involved the insertion of a loop wire to stabilize the spinal cord. The appellant became paralyzed the day after the operation. Subsequent consultation with a neurosurgeon found that the wire loop was compressing the spinal cord and was the cause of the total paralysis. The first respondent performed a second operation on the appellant on the same day to remove the wire loop. The second operation did not remedy the paralysis and the appellant remained wheelchair bound. At the Federal Court, the appellant sought leave on the question as to ‗whether the Bolam test … should apply in relation to all aspects of medical negligence‘. The Federal Court allowed the appeal after rejecting the Bolam test. Tan Sri Siti Norma Yaakob, Chief Judge of Malaya, delivered the Federal Court‘s decision and expressed the view that Bolam‘s case would have been decided differently in the current environment. The Chief Judge noted that Bolam‘s test restrained the judiciary from treating medical experts as they would experts from other professionals. The court was of the view that this was an ‗over protective and deferential approach‘ and ruled that: ―A practitioner is duty bound by law to inform his patient who is capable of understanding and appreciating such information of the risks involved in any proposed treatment so as to enable the patient to make an election of whether to proceed with the proposed treatment with knowledge of the risks involved or decline to be subjected to such treatment.‖ The Federal Court also approved the principle laid down by the Australian High Court in Rogers v Whitaker [1992] 175 CLR 479 and cited the case of Naxakis v Western General Hospital, where the Australian High Court applied the Rogers principle to a case involving negligent diagnosis. In essence, it 107 appears that the Federal Court of Malaysia has ejected the Bolam test for a more interventionist approach represented by the Rogers principle when adjudicating over medical negligence cases. A more subtle but no less significant development in English case law over the last five years is the paradigm shift within the English courts when dealing with the issue of medical advice rendered by medical practitioners. In Chester v Afshar [2004] UKHL 41, the House of Lords touched on the matter of patient‘s consent for medical procedures in its deliberation and appeared to favour an objective test of a doctor‘s duty to advise over the Bolam‘s test. Although he did not explicitly reject the Bolam‘s test in his judgment, Lord Hope referred to the dicta by Lord Bridge in Sidaway's: ―It is clearly right to recognise that a conscious adult patient of sound mind is entitled to decide for himself whether or not he will submit to a particular course of treatment proposed by the doctor, most significantly surgical treatment under general anaesthesia. This entitlement is the foundation of the doctrine of 'informed consent' which has led in certain American jurisdictions to decisions, and in the Supreme Court of Canada, to dicta, on which the appellant relies, which would oust the Bolam test and substitute an 'objective' test of a doctor's duty to advise the patient of the advantages and disadvantages of undergoing the treatment proposed and more particularly to advise the patient of the risks involved‖. Likewise, Lord Steyn as part of the majority view in Chester, opined that generally speaking, 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‘. Such incremental attrition of medical negligence legal doctrine is not restricted to the English appellate court, but is also taking root in the intermediate courts in England. In Birch v University College Hospitals NHS Trust [2008] EWHC 2237 (QB) the plaintiff suffered a stroke while undergoing a cerebral angiogram carried out by the defendant. The aim of the angiogram was to exclude the possibility that the plaintiff had a posterior communicating artery aneurysm. The trial judge expressed his uneasiness with Lord Diplock‘s application of the Bolam test to medical advice in Sidaway. He noted the defendant had 108 informed the plaintiff about the risk of stroke during the procedure and that the defendant‘s expert witness concurred that it was not necessary to discuss the comparative strengths and weaknesses of different imaging techniques. Nevertheless, the trial judge decided the defendant ought to go further by informing the plaintiff of comparative risk, and how this risk compared with that associated with other non invasive imaging procedures, in particular MRI141. The rationale for this decision, the judge explained, is respect for patient autonomy and the reality that it is the patient who must bear any consequences if a risk transforms itself into a reality. Manning v King's College Hospital NHS Trust [2008] EWHC 1838 (QB) is yet another case whereby the trial judge disagreed with medical expert opinion and decided in favour of the claimant. The claimant was diagnosed with a rare form of tongue cancer in 1993 and completed her treatment in 1994. In September 2001, the claimant was diagnosed with recurrent tongue cancer. By then, the disease was already in the terminal stages and she died in 2002 despite undergoing treatment. The claimant‘s husband initiated legal proceedings against the defendant hospital, alleging negligence against the defendant in failing to diagnose the recurrent cancer in tongue biopsies performed on the claimant in 1995 and 1996, when her disease was still in the early stages. At the hearing, submissions made by experts for the two parties showed a remarkable degree of divergence. The experts for the claimant were adamant that it was very likely that there was cancer present. For the defendants, the expert witness stated that it was very unlikely that cancer was present. This division of opinions between the pathology specialists was accentuated further by the oral surgery experts and oncology experts who testified in support of either party. In the end, the trial judge singled out the fact that both the claimant‘s and defendant‘s witnesses concurred on three suspicious histopathology features in the biopsy slides to rule against the diagnosis given by the defendant‘s expert witness. Both of these cases agreed that the Bolam test remains the guiding axiom in English medical negligence cases. However, unlike the Singapore Court of Appeal‘s acceptance that ‗Bolam reigned 141 Magnetic Resonance Imaging (MRI) is a non invasive computerized scan that allows highly detailed images of the human body to be constructed. 109 supreme to confer near-immunity to the medical profession from actions in negligence‘ 142, the English judges had displayed a much greater willingness to find in favour of the claimants. In Birch, the trial judge imported Lord Steyn‘s dicta in Chester to justify his decision on what the reasonable, prudent doctor would do in similar circumstances. In Manning, it was especially commendable that the trial judge carried out an overall balancing process by considering all the competing arguments and evidence, before rejecting the defendant‘s expert witness‘ explanation that the appearance of the suspicious cells was the result of a sectioning effect when processing the tissue specimens. The post Bolam era Setting aside the chronic criticisms of medical paternalism and depriving patients the right to selfdetermination, the Bolam test ignores how the practice of medicine has evolved within the last decade and is thus estranged from reality. The Bolam test was formulated during a period when there was no consensus on how a treatment (electroconvulsive therapy, in that instance) should be administered. Such a scenario will be an uncommon occurrence in the twenty first century. Since the notion of ‗evidence based medicine‘ (EBM) was conceived, EBM has steadily entrenched itself as the guiding axiom in medical practice. In 1992, Gordon Guyatt, Professor of Clinical Epidemiology and Biostatistics at McMaster University, Ontario, first introduced this concept into medical literature. According to the Center of Evidence Based Medicine sited at the University of Toronto, EBM is ‗the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients‘. EBM stratifies different types of clinical evidence and ranks them according to the strength of their freedom from various biases. The intention of this ranking exercise is to provide the most objective guidance possible to clinicians in their daily practice. A commonly accepted EBM categorization is as follows 143: - Level 1: Evidence obtained from a well planned randomized controlled trial (RCT) or systemic review of RCT. 142 143 CJYong‘s dicta in Gunpathy. Adapted from the Oxford Center for Evidence based Medicine, 2009. 110 - Level 2: Evidence obtained from low quality RCT or systemic review of cohort studies. - Level 3: Evidence obtained from well-designed cohort or case-control analytic studies. - Level 4: Evidence obtained from a case series of similar clinical problems. - Level 5: Opinions of respected authorities based on clinical experience or descriptive studies. The gist of this classification is that medical evidence should aspire to have the following attributes: prospective in nature, randomization, and observer blinding; conversely the least credible and weakest evidence will be the opinions of medical experts because such evidence is most vulnerable to biases. It follows that if the courts were to continue relying on medical expert opinion to steer the adjudication of medical negligence cases, the courts risk diluting public faith in the justice process. In Birch, what distinguishes the trial judge‘s deliberation from many other English cases is the learned judge‘s endeavour to plough through numerous medical articles relevant to the case in hand. For example, when addressing the key issues on whether the plaintiff was likely to have an aneurysm and whether invasive catheter angiography was indicated, the trial judge considered the findings published by various medical journals to arrive at his conclusion that the claimant was unlikely to have had an aneurysm and thus the angiogram was not warranted. Judicial discomfort with hearing medical evidence may be placated by encouraging the differentiation of judicial duties. The initiation of the specialist judge scheme in Singapore has enabled the import of additional expertise to the legal Bench. Under this scheme, senior practitioners and academics may be appointed to adjudicate over particular cases that are closely linked to their areas of legal specialization. To date, two specialist judges have been appointed under this initiative, namely Senior Counsel Tan Chee Meng and Tan Cheng Han, to hear the Fusionpolis144 case and the Informatics145 case respectively. Should this initiative take root and extend to other fields of law, it becomes possible for legal officers who either have a special interest in biomedical law or who have had 144 145 Public Prosecutor v Chan Heng Chye [2007] SGDC 142. Ong Boon Kheng v Public Prosecutor [2008] SGDC 3. 111 some form of education in the medical sciences to be appointed as specialist judges. It is foreseeable that such specialist judges will be more adept at distilling highly technical medical evidence. This suggestion is in fact comparable to a proposal made by Lord Woolf, Master of the Rolls, on nurturing judges to adjudicate over clinical negligence cases in the UK. In Access to Justice- Final Report, his Lordship devoted a chapter to how medical negligence cases ought to receive special treatment by the courts. His Lordship acknowledged that medical negligence work is significantly different from and in many cases more complex than, ordinary personal injury cases. Hence, he opined that effective case management required a degree of familiarity with standard medical practices and procedures that was unlikely to be acquired by judges who only occasionally dealt with medical negligence cases. To outflank this problem, Lord Woolf recommended the creation of a list of judges focussing on medical negligence cases. He believed this arrangement will foster the appropriate degree of special experience and expertise among the judiciary needed for the efficient and effective disposal of these cases. Lord Woolf was also in support of implementing training for judges appointed to handle medical negligence cases. Through such training, the procedural judge will have a better understanding of the substantive issues in a medical negligence case and be able to manage the case more effectively. Lord Woolf‘s recommendations struck a chord with Sir Liam Donaldson, the UK‘s Chief Medical Officer. In Making Amends, Sir Donaldson put forward his proposals for reform to the UK medical litigation system. He noted clinical negligence cases that reach the courts can be highly complex but infrequent. Thus, Sir Donaldson also supported the provision of specialist training in medical issues for judges hearing medical negligence cases. The specialization of judges will be a timely response to societal metamorphosis in Singapore. The internet corridor has virtually revolutionized the transmission of information and helped to demystify medical science- scientific data and medical knowledge are now easily available to both doctors and members of the public alike. Such information can be accessed either through a variety of patient information websites or academic online publications. As patients become more knowledgeable about their medical conditions, the judiciary risks eroding its authority and the public‘s respect if judges appear 112 to know a great deal less about the subject matter of the litigation than other participants, notably the defendant, the expert witnesses, and the lawyers who are becoming increasingly specialist in this area of litigation. In future, the synergy between judicial training and the current revamp in legal education can further facilitate the specialization of judges or at the very least, focus on a few niche areas of law in their daily work. At present, undergraduate law school has diversified the academic credentials of law graduates by offering double degree courses and complementing it by accepting graduate students from other tertiary courses. It is then forseeable that future judges may be versed in both law and medical sciences and hence, not daunted by having to sieve through medical evidence. Despite the specialization of the judiciary, it is unlikely the courts are able to completely sever their reliance on medical expert evidence. The reasons for this dependency were surmised by Lord Woolf in his report: First, causation is more difficult to establish than in other personal injury case because the effects of the allegedly negligent treatment must be distinguished from those of the patient's underlying condition which gave rise to the need for treatment. Secondly, the assessment of damages- although essentially a similar exercise in all personal injury cases- is often complicated in medical negligence because the court must compare the claimant's actual condition and prognosis with the hypothetical condition and prognosis if the patient had received competent medical treatment to ensure that compensation is only given for the injuries caused by negligent treatment and not for any underlying condition. Moreover, even if the courts depart from the Bolam test in favour of an objective assessment of the standard of care required from a medical practitioner, input from medical experts will still be invaluable towards understanding the complex technicalities of medical evidence. To surmount these challenges, the state can appoint one or more independent medical experts to aid the courts in reviewing medical evidence. These medical experts will be drawn from a panel of state appointed experts specifically established to assist judges in medical negligence cases. Such a schema is not totally unheard of in other jurisdictions; in the Civil Law system, judges regularly enlist the help of state appointed experts in the inquisitorial process. There are definite advantages in having state appointed medical experts compared to importing the analyses from experts recruited by litigant parties. 113 First, one would expect litigation costs to be more affordable because the engagement of fewer experts will translate into lower professional fees billed. Secondly, the presence of state appointed experts confer a more independent professional input to the adjudicative process compared to the polarising opinions forwarded by either parties‘ medical experts. Thirdly, this arrangement ameliorates reluctance on the part of doctors to participate in medical litigation for fear of disrupting collegiality because holding a state appointment allows a medical pracitioner to command a certain level of prestige among his/her peers. To bolster the independence of this state appointed panel, paticipation by international experts can also be solicited since these individuals are likely to be more resilient against pressures for professional solidarity. Involving international experts will also allay concerns that in complex medical cases or one where the treatment given was at the 'cutting edge' of medical science, eliciting feedback from one or two local experts may underrepresent the whole spectrum of professional opinion. It is submitted that a proportion of clinical cases will always exist in the penumbra of medical science, where management regimes are yet to be validated by robust empirical data. Such uncertainty in modern medicine forms the justification for a ‗patient tailored‘ approach by doctors in designing therapy; it also constitutes one key reason why judges at times willingly relinquish the adjudication of medical negligence cases to the subjective Bolam test. In this new millenium, patient autonomy and the integrity of the human body reign supreme over purported therapeutic benefits offered by medical science. Instead of benchmarking the standard of care by a medical practitioner to the practices of his/her fellow colleagues, the law ought to pay more heed to the sanctity of individual choice and take on a more holistic aproach. Thus, in instances when there is a lack of consensus in the diagnosis of a clinical condition, like Gunapathy where the patient‘s radiologist and the patient‘s primary physician differed in opinions with regards to the exact nature of the patient‘s brain lesion on MRI scan, there should be a legal duty on doctors to fully disclose such uncertainty to patients so that patients can make a more informed choice. Likewise, if a medical practitioner chooses to prescribe a particular course of therapy that either remains a ‗progressive science‘ (J McNair in Bolam) or hovers within ‗uncharted territory‘ (CJ Yong in 114 Gunapathy), the courts should impose an obligation on the medical practitoner to ensure patients are well informed that they are undergoing treatment that has yet to fully mature. Apart from self deprecating assertions that digesting medical evidence is beyond the judiciary‘s capacity (―… judical wisdom has its limits. A judge, unschooled and unskilled in the art of medicine, has no business adjudicating matters over which medical experts themselves cannot come to agreement‖ per CJ Yong Pung How in Gunapathy), overarching public policy considerations were cited by the Court of Appeal in Gunapathy to rationalize the court‘s subjugation by medical expert opinion. The Court of Appeal was mindful that judges in ‗playing doctor‘ might impede progress in medicine. This perception is laid with communitarian values at the very least, and at the very worst, exudes a distorted brand of utilitarianism because it advances the notion that possible benefits to a society‘s welfare, triumph over restorative justice for an injured patient. It also invites the notion that the court implicitly condones the prescription of experimental techniques on patients as long as the medical profession touts such treatment under the umbrella of medical development. Legal institutions distinguish themselves by embodying higher principles of justice; the courts function to provide an avenue for the aggrieved ordinary man to seek restitution and ought to center on righting any injustice sustained by individuals. The view that legal institutions are obliged to ease the way for medical advancements risks detracting the courts from their primary functions and is symptomatic of a misguided intellectual frolic. Turning to the Court of Appeal‘s rendition that excessive judicial intervention promotes defensive medicine and leads to higher healthcare costs, it can be objectively demonstrated that this warning stands on shaky grounds. The likely basis for the caution might be traced back to the spiraling health care costs in the United States, which is often cited as the most litigious society in the modern democratic world. However, extrapolating such a correlation into a causal relationship mandates a problematic leap of logic. Claims that more successful litigation by patients will spur doctors to order unnecessary expensive tests and thus raise health care costs, are not just unsupported by research data, but take an overly simplistic view of healthcare cost containment. It is a trite fact that Asian societies are less litigious compared to American society. Yet the expenditure on healthcare varies significantly between Asian societies. Japan 115 and Singapore are amongst the cluster of democratic developed nations with similar socio-demographic profiles. However statistics from the 2005 World Health Report 146 revealed that Japan had allocated 7.8% of its 2001 GDP on healthcare while Singapore spent only half the amount at 3.9%. Clearly, the marked disparity in healthcare expenditure cannot be attributed to medical litigation alone, but is more likely the outcome of an intercourse between several factors such as the availability of state of the art medical technology, healthcare provider payment methods, as well as the moral hazards of not adopting a userpays financing system. In addition, every medical investigation, ranging from a simple blood test to an invasive diagnostic procedure is not without risks to the recipient. The prudent doctor will also be mindful of the false positive caveat attached to every medical investigation which may trigger a cascade of follow up procedures or more extensive tests, only to arrive at a clean bill of health for the patient concerned. Medical practitioners who indiscriminately prescribe tests on patients with the intention of buffering their clinical management from medical negligence suits, may quite ironically subject themselves to greater risks of litigation should complications occur. The case of Birch where the plaintiff won damages from the defendant neurosurgeon is a valuable reminder to doctors how the inappropriate use of a diagnostic procedure incurs legal liabilities instead of providing reassurances. Thus, the Court of Appeal‘s conception of defensive medical practice may not materialize because of these legal disincentives. In the post Bolam era, the standard of care is no longer dictated by the medical profession, but instead will be set by the judiciary, aligning medical negligence law with other areas of tort law. Concerns that judges despite their best efforts are not well positioned to spell out the standard of care expected from medical practitioners, could be allayed by having state appointed independent experts assist judges interpret medical literature whenever necessary. Whilst the use of state appointed experts might not completely obliviate the possibility of professional biases or sympathy towards fellow medical practitioners, this still confers greater objectivity to the evaluation of medical evidence, compared to the current system of allowing a defendant doctor recruit the expert opinions fellow colleagues to sway 146 See www.who.int/whr/2005. 116 judicial thinking. At instances when the medical fraternity is equally divided on the most appropriate management of a clinical problem, it is proposed that the courts adopt a more patient-centric approach via a two stage inquiry: 1) Did the defendant doctor fully inform the patient (and possibly family members) regarding the risks, uncertainties and any controversies surrounding the treatment to be prescribed by the defendant147? 2) Having addressed the above matters with the patient, did the defendant doctor discuss the merits and demerits of other alternative treatment(s) with the patient148? 147 This question can be likened to an extension of the ratio in Chester v. Afshar, in which the House of Lords held that a patient undergoing a surgical procedure has the right to be informed even about a small risk related to that procedure. 148 This approach is akin to the court‘s evaluation of whether an invasive procedure is justified given the clinical context and the availability of a non invasive alternative investigation, in the case of Birch. 117 CHAPTER TEN: CONCLUSION Clinical governance premised upon professional self regulation is no longer tenable. Other than historical reasons, it is difficult to justify why the medical profession is bestowed this privilege. Doctors‘ assertions that the technicalities and complexities of medical science make it inappropriate for nondoctors to participate in professional regulation, disregard the fact that professional regulation is more an administrative task rather than a clinical problem. On the other hand, events both in the UK and Singapore have revealed unflattering traits within the medical profession. When things went wrong for patients in the UK, collegiality and professional solidarity overwhelmed the voices of reason such that the independence of medical audit is diminished. In Singapore, medical practitioners unfamiliar with legal rules of procedure had on several occasions conducted disciplinary inquiries in a way which required judicial correction. The hierarchical culture endogenous to the medical community in both countries also raises doubts on the wisdom behind professional self-governance because the opinions of senior clinicians will usually carry more clout. In Singapore, clinical governance is further challenged by the financial considerations that so often permeate the decision making process by medical practitioners. In some instances, the depth of a patient‘s wallet sways the treatment options available to patients. In others, professional practice turf issues have fueled public spats between medical specialties and between medical specialists and general practitioners as well. Even more disturbing, the lure of quick financial rewards has corrupted a minority of medical practitioners into either breaking the law or adopting unethical practices. This undesirable combination of professional self-regulation, financial incentives and deference to senior members would have been attenuated if the injured patient could appeal to the court‘s conscience for compensation. However, the Singapore judiciary has unequivocally endorsed a doctor-friendly stance by affirming the Bolam test, hence minimizing judicial inquiry in medical tort law. Change has to come because it is foreseeable that an increasingly knowledgeable and sophisticated public will grow wary of entrusting unquestioned faith with the medical profession. Already 118 in the UK, there is evidence to suggest that the public does wish to be empowered with the right to untrammeled information when medical errors or incidents occur. Consultations done by the UK‘s National Patient Safety Agency (NPSA) revealed patients would like: ―- To be told about patient-safety incidents that affected them. - Acknowledgement of the distress that the patient-safety incident caused. - A sincere and compassionate statement of regret and distress that they are experiencing. - A factual explanation of what happened. - A clear statement of what is going to happen from then onwards. - A plan about what can be done medically to repair or redress the harm done.‖ Follow up interviews conducted by the NPSA with patient and public focus groups confirmed that patients and the public wanted all incidents disclosed, irrespective of the severity of the outcome, and inclusive of near misses. They felt that such information rightfully belonged to them and ought to be automatically disclosed freely and fully. A survey called ‗Making Amends‘ spearheaded by the UK Department of Health in 2003 shed similar findings. Out of 8,000 people, approximately 400 respondents revealed that they had suffered from a medical error. More importantly, these respondents wanted an apology, an explanation of what happened and an in-depth incident investigation. Reforms to the regulatory framework for Singapore‘s medical fraternity take on an added urgency because to date, Singapore is fortunate enough to remain unscathed by the type of medical atrocities that had occurred in the UK. The public indictment of deviant medical practitioners in the UK did not just reveal how precious lives were lost as a result of acts committed by wayward medical practitioners; the abominable misdeeds of this handful of medical practitioners also inflicted irreparable damage to the profession‘s public standing in the UK. The Singapore medical profession‘s reputation that has been so painstakingly built up by generations of doctors could be wiped out in the twinkling of an eye, should a scandal comparable to those in the UK occur in Singapore. Certainly, more resilient measures have to be put in place to demonstrate that doctors are subject to principles of good governance like any other profession. 119 Given the fact that doctors‘ professional autonomy is sanctioned by law, the overhaul of professional regulation should center on legal reforms. For a start, changes to the profession‘s regulatory bodies must be instituted. These changes would include 1) imposing constraints on discretionary power; 2) promoting the accountability of regulators; 3) increasing transparency by the promulgation of clear regulatory standards and engaging external participation. Greater external participation will not just be limited to involving lay representatives in clinical audit and disciplinary hearings, but should also include having legal input on matters pertaining to law and tribunal procedures. It is envisaged that these reforms will consolidate the public‘s trust in the medical profession and at the same time, doctors whose professional conduct are under probe can benefit from these changes since these practitioners can be assured of fair hearings and the application of uniform standards. Legal amendments do not just strengthen clinical governance, but can also be pivotal to enhancing patient safety. The role of competency checks on fully-fledged medical practitioners has been a somewhat neglected area of professional regulation. Instead of presuming all registered doctors will stay competent throughout their professional careers, revalidation procedures for medical practitioners ought to be installed to ensure that there is no compromise in the quality of clinical care delivered. The Ministry of Health‘s clampdown on sham aesthetic medicine procedures highlights the need for continual vigilance towards patient safety issues and to not overly rely on the conscience of the medical profession. Thus, it may be worthwhile to create legal obligations on doctors to prescribe only medical devices or treatments with proven benefits. In the area of medical tort law, the medical profession‘s imperialism over the court‘s adjudication must be addressed. In the 21 st century, the long held belief that medicine is a highly specialized complex field and beyond the comprehension of those unschooled in medicine is no longer valid. Although technological advancements make medical science more complex, these developments have also greatly demystified medicine by facilitating empirical research to improve understanding of medical conditions and treatments. In addition, technological developments have enabled the lay person to easily access such information through the internet or other tools of the public media. These new changes necessitate a 120 revision of medical negligence principles, in particular, extirpating the Bolam test which forms the jugular of medical negligence jurisprudence. Under the new template for medical negligence law contemplated by this thesis, the medical profession‘s hegemony is abolished. Instead, judges will receive the appropriate training and adjudicate over medical litigation using evidence based analysis and aided by input from independent medical experts. Having been cushioned by a sympathetic body of law and legislative minimalism for many generations, it is anticipated that the medical profession will vehemently resist any attempt to alter the status quo. Support for the resistance to change may even be lent by segments of the legal community that are uneasy with having to handle medical concepts should there be a shift towards greater legal intervention. This year, Singapore‘s Ministry of Health announced plans to amend the MRA. Of note, the SMC‘s Disciplinary Tribunals may now be chaired by a lawyer of adequate experience 149. Preliminary surveys done showed that up to 80% of members of the public support this change 150. In contrast, the medical community has reacted negatively to this proposal. The Singapore Medical Association, representing five thousand doctors, said the MOH had not given due weight to its views and that the new statutory provisions were against the spirit of self-regulation151. What this thesis hopes to achieve, is to dissect the merits of professional self-regulation through a legal scalpel and therefore stimulate a re-think on whether the proposed legal amendments by the MOH have gone far enough. By mooting more extensive law reforms that will also affect professional licensing and clinical audit, instead of just streamlining the medical profession‘s privilege to regulatory autonomy, it is hoped that clinical governance in Singapore can be made robust. At this juncture, it is apt to wrap up the discussion by reiterating the words of Professor Sir Ian Kennedy, Chairman of the UK Healthcare Commission, 2005: 149 Under the proposed s49(1)a, the Chairman of Disciplinary Tribunals could be a Judge or Judicial. Commissioner of the Supreme Court; an advocate or solicitor of not less than 15 years‘ experience; a legal officer in the Singapore Legal Service who has not less than 15 years‘ experience. 150 'Medical Act change: 80% backing for non-doctor to chair discipline panel'. The Straits Times(Singapore), 29 May 2009. 151 Jessica Jaganathan. Plan for non-docs in tribunal delayed. The Straits Times (Singapore). July 29 2009. 121 ―professionals only have duties- they do not have privileges. They have duties over and above the duties of being a citizen.‖ 122 [...]... in the country Under s18(1) of the MRA, the Registrar of the Medical Council is automatically appointed to the post of DMS Hence the DMS by virtue of s18(1) will be a medical professional Section 19(1) of the MRA describes the main role of the Registrar, which is to maintain The Register of Medical Practitioners‘ The Register in essence contains the names and information, in particular the type of. .. independence and impartiality of such panels Despite these sobering revelations about the failings of the GMC, Dame Janet Smith unequivocally stated that the GMC still has an important role as the keeper of the medical register and in deciding who can practise as a doctor and who cannot Nevertheless, she did roll out a series of recommendations to reform the GMC and enhance governance within the medical profession,... proposed method of manufacture of the products, and the provisions proposed for securing that the products as sold or supplied will be of that quality; and (d) whether the grant of a product licence for the medicinal products to which the application relates will be in the public interest‖ However, s7(4) of the MA unequivocally states that the licensing requirements of s5 [and hence the conditions listed... fact that the GMC was not held accountable to a higher authority like the Privy Council Another individual critical of the GMC, was Jean Robinson, one-time Chairman of the Patients Association and a lay member of the GMC In 1988, she published her comments on the lack of transparency of GMC procedures and their failure to protect patients from the poor clinical performance of incompetent doctors These... conflate their duties towards the public with their roles as representatives of an electorate and end up furthering the interests of the profession at the expense of the public interest Therefore, Dame Janet Smith mooted the idea that there should be more appointed medical members, people who are not beholden to an electorate, such that the elected members do not have an overall majority In this way, the. .. noted that Rule 28 of the Professional Conduct Rules permitted the PCC to factor in the character and previous history of the practitioner‘ during the assessment of alleged SPM by a doctor, and was perturbed by how the PCC might wrongly apply the similar fact rule‘ in Evidence Law when deciding whether a doctor‘s conduct amounts to SPM The Inquiry panel gave the illustration of the PCC, in finding... a doctor of his/her livelihood in the face of evidence that attained this high standard of proof Dame Janet Smith perceived this approach as allowing the interests of the doctor to override the need for public protection; she questioned the appropriateness of such a high standard of proof if the primary purpose of a tribunal is to protect the public from doctors who are not fit to practise There is... purpose, the PHMCA mandates the audit cycle which is pivotal to the upkeep of standards in healthcare services Under s11(1) of the PHMCA: ―(1) The licensee of a private hospital or a healthcare establishment shall establish one or more quality assurance committees to — (a) monitor and evaluate the quality and appropriateness of the services provided and the practices and procedures carried out at the private... is not dissimilar to that in the UK In both jurisdictions, the most recognizable hallmark of the governing process is the overwhelming influence of doctors The medical profession‘s influence does not end at the licensing of doctors and healthcare institutions; the medical profession‘s hegemony extents even to the administration of justice as the SMC takes on the roles of investigating patients‘ complaints,... in the mid 19th century, when members of the public rallied for some form of assurance that they were being treated by qualified and competent doctors, the English government responded by establishing the GMC26 The GMC was essentially a professional body constituted predominantly of doctors and assigned the tasks of maintaining a register of doctors and disciplining errant doctors During the period of ... members of the PPC were found to have confused their roles as screeners because the PPC had a tendency to focus on the circumstances of the doctor rather than on the seriousness of the 13 offence Therefore,... their duties towards the public with their roles as representatives of an electorate and end up furthering the interests of the profession at the expense of the public interest Therefore, Dame Janet... appointed to the post of DMS Hence the DMS by virtue of s18(1) will be a medical professional Section 19(1) of the MRA describes the main role of the Registrar, which is to maintain The Register of Medical