Lam Pin Min
Singapore
“Mr Speaker, on behalf of the Minister for Transport, I beg to move, "That the Bill be now read a Second Time". This Bill, together with the Active Mobility (Amendment No.”
“It is timely for us to put in place a regulatory framework to ensure that active mobility devices being brought into and used in Singapore are safe. This is a key step in helping us put in place a safe and sustainable active mobility landscape in Singapore. Mr Speaker, I beg to move. [(proc text) Question proposed. (proc text)] 1.55 pm”
“Clause 6 facilitates the transfer to and vesting in the financial security provider of a seafarer's rights against a shipowner as a result of any liability arising from the shipowner's obligation to repatriate the seafarer. For example, the liability to pay the seafarer's wages and entitlements.”
“Mr Speaker, to ensure a safe and high-quality blood supply for our patients in Singapore, pre-donation interviews are conducted to screen blood donors for risk factors and blood donations are also tested for blood-borne infections. However, infections can only be detected some time after the blood donors have been infected.”
“I thank the Member for that clarification. As far as I know, not all mental conditions will be excluded from blood donation. In fact, we have checked with HSA. There is a wide spectrum of mental illnesses – from very mild mental conditions to very severe conditions.”
“I think we must be cognisant that the reason why they are inmates is because of certain things that have happened, prior to that. That actually pre-disposes them to some high-risk behaviours.”
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“We have adopted a three-pronged approach to external public health threats, namely, reducing the risk of importation, early detection and containment. We perform local and global surveillance to ensure situational awareness for endemic diseases, such as tuberculosis and influenza, and emerging diseases overseas, such as MERS and Zika. We also fund research to evaluate the effectiveness of surveillance and response plans to infectious diseases. These include looking at potential areas for collaboration with the relevant institutions on Zika virus diagnostics, transmission and its association with microcephaly and Guillain-Barre Syndrome. We conduct regular preparedness exercises to practise our responses and identify potential areas for improvements. We also maintain a surge capacity for isolation beds and a national stockpile of personal protective equipment. In the community, we work with about 640 GP clinics which have volunteered as Public Health Preparedness Clinics, or PHPCs, to help manage public health emergencies, such as haze and influenza pandemics. While all GPs play important roles to provide care in such situations, PHPCs take on additional roles, such as providing subsidised care for conditions related to the public health emergencies. Coordinated efforts across multiple Government agencies, as well as with other countries and international organisations, are also vital in protecting Singapore against external public health threats. In relation to Ms Tin Pei Ling's query regarding dengue vaccination, HSA has received the regulatory filing for Sanofi's dengue vaccine in March 2016 and is expediting the review, given the dengue situation in Singapore and recognising that this is the first dengue vaccine available.”
“We will review CHAS regularly and enhance the scheme where needed to ensure that care remains affordable. Dr Chia Shi-Lu asked for measures to improve transparency in the charging of healthcare services. We have implemented various measures to this end. Hospitals are required to provide financial counselling to patients to ensure that they are informed of the charges likely to be incurred for their treatment. For outpatient care, patients are also provided with information on estimated charges for consultation. Since 2013, hospital bill sizes for common conditions and procedures at both public and private hospitals have been progressively published on the MOH website. In 2014, the publication of "Total Operation Fees" for common procedures in public hospitals was introduced. I am pleased to announce that the publication will be expanded to cover "Total Operation Fees" for private hospitals later this year. There will be further breakdown of the "Total Operation Fees" into "Surgeon Fees", "Anaesthetist Fees" as well as "Facility Fees". The expanded publication will provide added transparency on the private hospital bill components attributed to performing the procedure and serve as a point of reference for both healthcare professionals and the general public. Safeguarding public health is another fundamental aspect of maintaining population health. Even as we tackle the increasing prevalence of chronic diseases, we need to remain cognisant of our external environment. In line with the Minister's call for us to remain vigilant, we need to constantly improve our public health system to promote health, prevent diseases and prolong life among our population. Dr Chia Shi-Lu asked about the measures that we are taking to protect Singapore against emerging diseases.”
“We will continue to review the regional primary care needs of our population and work closely with the Urban Redevelopment Authority (URA) and HDB to review and ensure the adequacy of the space needed for primary care facilities in HDB estates. A good primary care system can help to reduce costly interventions in the hospital setting. To keep primary care affordable, CHAS and PG cardholders at the FMCs and CHAS clinics receive Government subsidies for their care. Dr Tan Wu Meng and Assoc Prof Daniel Goh commented on enhancing subsidies for primary care. Since 2012, we have significantly enhanced CHAS so that more Singaporeans can benefit. In 2013, we raised the income criterion from per capita monthly household income of $1,500 to $1,800. In 2014, the age floor of 40 years was also removed. These changes have helped more Singaporean households to benefit from CHAS. 2.30 pm I thank Assoc Prof Daniel Goh for his suggestion to change the qualifying criteria for CHAS. Assoc Prof Goh suggested that we change the per capita household income criterion of $1,800 to an individual's prevailing median monthly income of $3,900. The current CHAS income criterion of $1,800 ensures that lower- to middle-income Singaporeans, or Singaporeans in about half of all resident households, can qualify. This means that a household of four, with the breadwinner earning $7,200, is eligible. A household-based approach ensures that subsidies are equitably distributed to extend more benefits to individuals with more dependants. In determining our income criterion, we will need to strike a balance, bearing in mind the need to target subsidies at those who need it most and Government budget availability.”
“Today, the CHAS provides lower- to middle-income Singaporeans and all Pioneers access to subsidised care at private GP and dental clinics, and 900 GP clinics and 650 dental clinics islandwide have signed up for CHAS. We value their partnership. We have also developed new models of primary care, such as the Family Medicine Clinics or FMCs, since 2013. The FMCs are multi-doctor practices, with onsite nurses and other allied health professionals, delivering comprehensive team-based care, especially for chronic disease management. As part of our continual efforts to better serve our residents, we have been redeveloping existing polyclinics. The new polyclinics in Punggol and Jurong West will open in 2017. I am pleased to announce that we will build another polyclinic in Eunos, in response to Assoc Prof Fatimah Lateef's query on new primary care facilities. The new polyclinic is expected to be operational by 2020 and will be designed to cater for future primary care needs. Today, there are seven FMCs in operation. By early 2017, we will develop two more FMCs: one in Tampines and another one in Keat Hong. We will continue to review and evaluate FMC development as part of our efforts to strengthen and improve primary care. With these range of developments, we have tried to support the growing needs in primary care. To address Dr Tan Wu Meng's concerns, residents in the West can look forward to three new facilities – the new polyclinics in Jurong West and Bukit Panjang, as well as a new FMC in Keat Hong. These will help to relieve the load in existing polyclinics in the West, such as Clementi Polyclinic.”
“With deeper understanding of the family, Dr Leong has recommended suitable health screening for Mr Tan's wife, who has a strong family history of diabetes. Mrs Tan was found to be borderline diabetic and Dr Leong was able to intervene early through advice on lifestyle modifications, to prevent the progression of diabetes. Currently, Dr Leong manages the chronic conditions of Mr Tan, his wife and his son. And I am happy to hear that both Mr Tan and his son have also successfully quit smoking, with encouragement from their family members and Dr Leong. I believe that there are many such positive stories to illustrate the benefits of having a regular family doctor. However, only two in five Singapore residents aged 18 to 69 have a regular family doctor today. We want to call on Singaporeans, especially those with chronic conditions, to take the first step in identifying and sticking with a regular family doctor. To facilitate this, we will review our policies to help strengthen doctor-patient relationships in primary care. As we progress on the journey to realise our vision of "One Singaporean, One Family Doctor", we will continue to engage our GP and polyclinic colleagues to co-create the future primary care landscape, in particular, to achieve better chronic disease management in the community. We are mindful to ensure sufficient primary care capacity with the ageing of the population and a growing chronic disease burden. Our polyclinics will continue to play a key role, especially in the management of complex chronic diseases. In recent years, we have announced the development of new polyclinics and redevelopment of existing ones. Since 2012, we have also strengthened partnerships with private GPs to provide subsidised care to Singaporeans.”
“My response is encapsulated in our vision "One Singaporean, One Family Doctor". Overseas studies have shown that care continuity by a regular family doctor results in better care outcomes for patients. These include decreased hospitalisations and emergency department visits. Our family doctor can be our partner in helping us stay healthy and in providing us with good and affordable care close to us. Many Singaporeans see a doctor when we come down with an illness, such as a bad cold. With a regular family doctor, such visits can develop into a strong doctor-patient relationship over time. As our family doctor develops a holistic understanding of our family's medical profile and health needs, they will become our health advocate in identifying risk factors and can offer more targeted, timely and individualised advice and plans to manage our health. For those with chronic diseases, we can manage our condition better by having a family doctor who understands our condition well and supports us with quality management and treatment. Our family doctor must also have some understanding of our family, social and work situation to advise us on making lifestyle changes and adhering to treatment. They can also refer us appropriately if we require more specialised medical attention and help coordinate our care with other providers. I would like to share a story of a family doctor being one's trusted health partner. Mr Tan Heok Lim has been seeing his family doctor, Dr Leong Choon Kit, for the past 14 years. He feels comfortable with Dr Leong's care and has continued seeing him for his medical needs. This enables Dr Leong to care for Mr Tan holistically – from health screening to diagnosis and management of chronic conditions, such as hypertension.”
“Last but not least, we aim to bring health promotion for the young beyond the school and into their families and the community. We will launch a public consultation later this month to seek ideas on how we can encourage and enable our young to adopt and maintain healthy lifestyles. In particular, we will engage students, educators, parents, caregivers and even the private sector, such as food establishments, to create a healthier environment for our children. To Miss Cheng Li Hui's comments, children are referred to the hospitals for both developmental and mental health conditions by polyclinics, GPs, paediatricians, primary schools and REACH, which stands for Response, Early Assessment and intervention in Community mental Health teams. Besides the Child Guidance clinics at Buangkok View and Outram Road, mental health services for children and youths are also available in other hospitals, such as NUH, Singapore General Hospital (SGH) and KK Hospital. These services typically include assessment, diagnosis and multidisciplinary management of patients up to the age of 18, but may continue to follow up with them beyond this, where appropriate. The subsidies for these services are in line with existing SOC subsidies. From 2013 to 2015, there were about 50,000 psychiatric SOC attendances for patients up to 18 years old, of which two-thirds were seen in IMH. Empowering and teaching our young to lead healthier lives are only one part of the equation. As our population ages and healthcare needs continue to rise, we must reshape the way we approach healthcare. Primary care is the foundation of any healthcare system. We aim to strengthen its place in our healthcare system, to be the first and continuous line of care. Dr Tan Wu Meng asked about the role of the family doctor.”
“MOE and HPB have introduced programmes to provide educators with basic knowledge on common issues faced by our youths. Educators are also equipped with the ability to detect early warning signs and skills to provide appropriate support and referrals to services and resources in the school setting. These programmes have also groomed youth opinion leaders on health, by arming them with knowledge on health and well-being, mental health concerns and youth advocacy. Mr Darryl David also suggested having community-based mental wellness facilities. As Senior Minister of State Amy Khor mentioned earlier, we are steadily building up our mental health services and support networks within the community to identify and help persons with mental health concerns. It is important for us to work upstream to lay strong foundations for our young to lead healthier and more productive lives, starting from those as young as two years old. To this end, I will lead an inter-agency NurtureSG Taskforce with Minister of State for Education Dr Janil Puthucheary. The task force comprises representatives from various Ministries, HPB, Sport Singapore and the ECDA, as well as medical professionals and academics. It will guide the development of the NurtureSG Plan to enhance the health outcomes among our young. The NurtureSG Taskforce will focus on three main areas. First, we will look into developing new strategies and strengthening existing programmes to address salient health issues and negative trends among children and youths. Next, we want to reinforce health promotion efforts at the tertiary institutions so that young Singaporeans will maintain healthy habits beyond the school-going age and well after entering the workforce.”
“An overseas study revealed that those with childhood obesity are four times more likely to be at risk of developing hypertension in adulthood when compared to their non-obese peers. It is, therefore, critical that we curb the rising rates of childhood obesity. A local survey showed that most students are engaging in less physical activities and becoming more sedentary. More than 80% of the students surveyed exceeded the recommended screen time of no more than two hours a day. This is exacerbated by inadequate physical activity. Based on past surveys, only about 10% of mainstream or ITE students and 20% of polytechnic students had sufficient physical activity. In addition, the prevalence of myopia in our children is one of the highest in the world. More than 60% of our Primary 6 students have myopia today. This is undesirable as poor eyesight from myopia can impact learning. And as the condition progresses, it may result in sight-threatening complications as well. We have also found that about half of all our Primary 1 students have dental caries. Poor oral health affects the nutrition, growth and development of our children. We are concerned and are keen to tackle the pervasion of these trends among our young. Apart from their physical growth and development, we will also further strengthen our efforts to help our young to build up their mental resilience to better cope with the stressors of life. Mr Darryl David raised concerns on the mental resilience and well-being of our youths. To comprehensively address the multifaceted aspects of student mental health concerns, we have adopted a three-pronged approach, comprising knowledge and skills-building, facilitating access and referral to mental health services, and parental engagement.”
“For example, trained professional nurses are stationed full-time in selected secondary schools and post-secondary institutions under the Student Health Advisor (SHA) programme, to provide advice on weight management and smoking cessation. 2.15 pm One successful story is that of Ms Tan Su Kheng. For many years, Su Kheng put up with jokes and comments about her weight, which affected her self-esteem. Last year, she joined her school's weight management intervention programme, which helped to kick-start her journey towards a healthier life. On top of receiving many practical tips on healthy living, Su Kheng found additional support through her SHA, who taught her how to incorporate exercise into her busy student life. Apart from exercising thrice a week, she walks home and takes the stairs every day, instead of taking the bus and using the lift respectively. The journey to staying healthy can be challenging. However, I am inspired by what Su Kheng relates to us about her experience. And I quote, "Whenever I feel like giving up, I will tell myself that although I may not be there yet, I am one step closer to success than yesterday." I am happy to share that with her perseverance and encouragement from her SHA, Su Kheng has lost over 20 kilogrammes in just one year. I hear that family and friends have even started approaching her for tips on healthy living. My heartiest congratulations to Su Kheng! Despite these efforts, it worries me that we still see the proportion of overweight children and youths increasing over the past five years. Studies have shown that childhood obesity is likely to persist and progress into adulthood. This results in individuals being at higher risks of developing chronic diseases, such as diabetes and hypertension.”
“Thank you. MOH remains committed to reinforcing the core pillars of a quality healthcare system for our population. This encompasses taking a closer look at the fundamentals of our healthcare system, including developing better preventive health services for our young and strengthening primary care. There is a rising prevalence of chronic diseases amongst our population. One in four Singaporeans aged 40 and above has at least one chronic disease. We are concerned about this increasing prevalence, as these conditions can lead to serious complications if not well-managed. For example, complications faced by poorly-controlled diabetic patients include kidney failure, stroke, heart attack, blindness and even lower limb amputations. The risk of chronic diseases in general can be lowered through simple lifestyle changes. Choosing to live healthily is a habit that we should inculcate from a young age. As pointed out by Ms Tin Pei Ling, it is vital that we go upstream and enhance preventive health services that encourage the formation of healthy habits in our children and youths, even as we continue to step up our efforts in promoting health screening among older adults. All of us have a role to play in keeping our young healthy and fit, especially parents and caregivers. They role-model healthy living, nurture a healthy home environment, influence and guide children to form healthy habits, which, hopefully, will continue through adulthood. In Singapore, we have had a comprehensive school health service since 1921, which underpins the good public health achieved today. The HPB's current strategies and close collaboration with the schools in encouraging students to adopt a healthy lifestyle have served us well.”
“Mdm Chair, with your permission, may I display some slides during my speech?”
“Mdm Speaker, I would like to thank Assoc Prof Fatimah Lateef for the supplementary questions. I would like to assure the Member that MOH takes the security of our PHIs very seriously. I would like to thank her for her suggestion. Yes, MOH will work with PHIs to enhance security awareness programmes and to educate their staff at all levels to remain vigilant. Page: 11 As for the second question on private healthcare institutions, MHA has a set of guidelines to guide all private building owners, including private healthcare institutions, on how to strengthen their physical security with the essential security features and measures. Similar to PHIs in their daily operations, private healthcare institutions also have a baseline level of security that includes surveillance via CCTVs, patrols, immediate responses to incidence by security personnel and access control against unauthorised entry to restricted and sensitive areas. The private healthcare institutions also form part of the Police-led Security and Safety Workgroup where they meet regularly to share good practices and to enhance preparedness for security threats. Mdm Speaker, I would like to reiterate that it is not just the work and duty of the security personnel to keep Singapore safe. It is important that hospitals and the staff on the ground as well as all Singaporeans continue to remain vigilant and look out for any suspicious behaviours and items and report them promptly to the authorities.”
“The review is expected to be completed within a few months' time and will cover preventive security, contingency plans to deal with different scenarios and threat levels, including terrorist incidents and consequence management. The review will also examine the required competency of the security personnel. MOH will work closely with MHA and the Home Team to ensure that our PHIs remain vigilant and alert.”
“Mdm Speaker, in their daily operations, the public healthcare institutions (PHIs) aim to provide a baseline level of security that balances the safety of their patients, visitors and staff while allowing public access without undue hassle. The day-to-day security operations include surveillance via closed-circuit television (CCTV), patrols and immediate responses to security incidents by security personnel and access controls against unauthorised entry to restricted and sensitive areas. Our PHIs also conduct security awareness training for their staff so that they remain vigilant and are aware of the basic security measures that they should take. PHIs also have contingency plans to step up their vigilance during heightened security alerts. These include the deployment of additional security personnel, increasing the frequency of patrolling, tightening of access control and stepping up security awareness training among their staff. For security incidents, like terrorist attacks, the hospital security personnel are expected to contain and manage the situation until the Police arrives at the scene. The Ministry of Health (MOH) and PHIs also participate in whole-of-Government planning efforts to enhance preparedness for security threats and to share good practices. The institutions also work directly with the Police land divisions to develop standard operating procedures and conduct familiarisation and emergency drills to test their preparedness and vigilance. In view of the heightened terrorism threat and the new modus operandi of terrorists, MOH and PHIs are reviewing our security plans, in consultation with the Ministry of Home Affairs (MHA).”
“I would like to thank the Member for the suggestion. As I have mentioned in my reply, it is indeed rather difficult to ascertain the long-term health effects of short-term exposures like those that we have encountered in Singapore. Having said that, I think, we will continue to look at what the other countries have done; the studies that they have conducted. And whatever information that we can get from these studies, we will definitely put them into our planning norms.”
“To this end, Singapore is working closely with neighbouring countries to tackle the haze issue, which is largely caused by irresponsible business practices. The ASEAN Agreement on Transboundary Haze Pollution is the key framework for ASEAN Member States to work collectively and take concerted action against haze. Singapore has also led the development of the ASEAN Haze Monitoring System which would help to increase transparency and accountability of errant companies that are responsible for the forest fires.”
“In individuals with pre-existing chronic heart or lung diseases, short-term exposure may trigger an episode or exacerbate the underlying diseases, such as an asthma attack. Besides widely publicised health advisories, we have put in place several measures to protect and enhance the health and well-being of Singaporeans. First, the Haze Subsidy Scheme (HSS) assists children, the elderly and the lower- to middle-income Singaporeans with their outpatient haze-related medical treatments. We provided subsidies of more than $3.3 million in 2015 which helped with over 77,000 haze-related attendances. Second, my Ministry has also worked with community partners to distribute we-care packs and masks to the needy, ensuring there are adequate supplies of protective masks in the market, educating the public and raising awareness of the health effects of the haze. In addition, my Ministry also welcomed the efforts by ST Dynamics to develop N95-equivalent masks that can fit children's faces. We note that preliminary data from ST Dynamics indicate that the mask should pose no safety concerns when used with the micro-ventilator. To ensure that it is safe for children to wear the masks even without the micro-ventilator, there are plans for clinical trials locally. In the meantime, we have stockpiled these smaller sized masks to ensure that there would be sufficient supply available to the general public. Third, the Ministry of Education (MOE) has school continuity plans in place to take appropriate haze management measures. Two days ago, my colleague from MOE outlined the move to provide air purifiers to all primary and secondary schools to further enhance the well-being of our schoolchildren. Most importantly, we want to prevent haze from occurring in the first place.”
“Mdm Speaker, in Singapore, transboundary haze is a short-term, episodic, recurrent event with varying severity every year. There is currently no data both locally or internationally, that looks into the long-term health effect of short-term, episodic exposure to the haze. Researching this would be highly challenging as any results would be based on observational studies only which would not be able to show a definite cause-and-effect relationship. Hence, it would be difficult to ascertain the direct long-term health effects due to the episodic exposure to haze as there could be many contributing factors to the long-term health outcome we are measuring. For example, it would be difficult to determine that intermittent exposure to haze 20 years ago would have caused the chronic obstructive airways disease in a person, since it could also have been caused by other factors such as smoking, previous lung infection, or existing lung diseases. However, overseas studies on long-term health impact have been based on long-term exposures, which are different from the pattern of exposure here. These studies showed that continuous, long-term exposure to air pollutants over several years may result in lung function abnormalities in children and subsequently, in adulthood. This could lead to greater susceptibility to the effects of ageing, infection and other pollutants, such as tobacco and smoke in adults. Nevertheless, I appreciate that as parents, we are concerned about the impact of haze on our school-going children. The short-term health impact of haze is well documented for children and adults alike. Short-term exposure to high levels of haze particles may cause irritation of the eyes, throat and nose. Such irritation usually resolves on its own.”
“I would like to thank the Member for the question. The penalties for HBR vary, depending on the severity of the offence, and this is consistent with other Singapore laws, for example, the Human Cloning and Other Prohibited Practices Act and the Page: 57 Human Organ Transplant Act. In fact, if you look at the penalty regime, there are basically four tiers to it, the highest being what we call the type 1A kind of offence which warrants a penalty of $100,000 and/or 10 years of imprisonment. With regard to what Mr Pritam Singh has queried – which is with reference to clause 63 – the penalty prescribed is a maximum of $20,000 and/or two years of imprisonment. This is actually quite consistent if you compare it to other equivalent provisions in other Acts. In fact, if you look at some of the other Acts, the penalty imposed in HBR is a little bit more stringent rather than more lax, as mentioned by Mr Pritam Singh.”
“For example, the definitions for "human tissue" and "tissue Page: 56 bank" were adjusted and a clause was added to protect the identity of informers who provide information on contraventions under this Bill. We have conducted extensive consultations on this Bill with both stakeholders and the public. This has provided an avenue for scrutiny of the Bill and further refinement, and all relevant inputs and feedback have been considered and incorporated into the Bill. After the Bill is passed, we will also continue to engage stakeholders and the public on the implementation of the Bill. As such, there is no compelling need to refer the Bill to a Select Committee. Mdm Speaker, let me conclude. This Bill will put in place regulatory frameworks to protect research subjects and tissue donors. These frameworks set out controls and requirements that will help to ensure HBR and dealings in human tissue are conducted in an ethical and responsible manner. They will also provide clarity and certainty as to the rights as well as the duties and obligations of the various parties, whether public or private, involved in HBR and tissue banking. However, beyond the matters of law, ethics and science, we should also remember the human element in this, namely, the human research subjects and tissue donors, without whom HBR would not be possible, as well as all the future patients who will benefit from the advancements in health and medicines that can be brought about by HBR. As Ms Ellen Lee put it so aptly, the goal of HBR is, ultimately, to help all of us achieve healthier and happier lives. I call on Members of the House to give their support to the Human Biomedical Research Bill. Mdm Speaker, I beg to move.”
“The Minister will not have the discretion, using these powers, to expand the scope of what is regulated under the Bill, which can only be done by Parliament, and rightly so. I would highlight the fact that such powers are not unusual and can be found in many pieces of legislation in Singapore. On Dr Benedict Tan's query about the appointment of advisory committees, in selecting the members of these committees, what is important is that the person is suitably qualified, well-experienced and has a good understanding of the biomedical research field and is able to give sound and unbiased advice on the issues at hand. Mr Pritam Singh has raised concerns about the consultation process. MOH has, in fact, consulted widely with stakeholders, particularly the research community in both healthcare and academic institutions, over the past few years at various stages in developing these regulatory frameworks. Prior to the introduction of the Bill, we conducted a series of stakeholder consultations in August and September 2014, involving leaders and key personnel of institutions engaged in HBR and tissue banking. Subsequently, a draft version of the Bill was put up for public consultation in November 2014. The consultation period was extended to January 2015 for a total period of 10 weeks at the request of the stakeholders for more time to consider the Bill and provide their feedback. The feedback was generally favourable and supportive of having a Bill that would protect the safety and welfare of research subjects and tissue donors and which would provide clarity to the roles and responsibilities of those engaged in HBR and tissue banking. The Bill before this House has been refined to incorporate relevant feedback received during the public consultation.”
“The Minister needs to be able to calibrate the regulations of certain types of research or biological material, if they are shown to pose low risk to the safety and welfare of research subjects and tissue donors. By the same token, the Minister also needs to be able to impose additional requirements for certain types of research that are more sensitive and controversial. This will ensure timely and adequate protection for the affected individuals and appropriate controls over the regulated activities. The provisions of this Bill draw on the feedback received during our various consultations in view of the nature of the field of biomedical science, which is complex, Page: 55 highly technical and rapidly evolving. The intent is to continue to consult domain experts where appropriate, to give scientific, technical and ethical advice to the Minister in the exercise of his powers under the Bill. In addition, the First, Second and Fifth Schedules only envisage exemptions or waivers to the general requirements of the Bill where these requirements would be disproportionate to the minimal risks to the safety, welfare and interests of the subjects and will seriously impede valuable HBR or tissue banking activity. It is worth noting that the Minister's power under clause 62 to amend the Schedules, as well as the Minister's power to exempt under clause 57, only function to circumscribe what is regulated under the Bill. Even for the research identified in the Third and Fourth Schedules, where the Minister has the power to impose more and tighter controls, this is research that already comes under the scope of the "human biomedical research" as defined in clause 3 of the Bill.”
“To clarify, human genome editing and germline modification research, which involve the use of human biological material, will be regulated under this Bill. If they involve the use of human eggs or embryos, they will be subjected to tighter controls as "restricted research" under the Fourth Schedule. This additional control is required for all restricted research and is in addition to the individual research institution's IRB review. Restricted research involving human animal combinations will be subject to approvals from MOH, and which will be subject to appropriate conditions being met during the conduct of the research. To this end, a national advisory committee of experts will deliberate upon the ethical and scientific rationale of such research and recommend to the Minister whether or not to approve such protocols. For research on nanotechnology and biosynthetic technology, where the research involves subjecting an individual to any intervention, or where there is use of individually-identifiable biological material or health information, as described in clause 3(2), it will also be regulated under this Bill. This means that the research will be subject to review by an IRB to ensure that the research is conducted ethically and that there is accountability for the safety and welfare of the research subjects. Mr Pritam Singh had shared his reservations on the powers of the Minister under this Bill to amend the Schedules in this Bill and to grant exemptions. The fundamental principle of this Bill is to regulate to ensure the safety and welfare of research subjects whilst not stifling sound, ethical research.”
“The Bill also allows for the appointment of other persons, for example, scientific experts, to assist these "authorised officers" in carrying out their regulatory functions. After the Bill comes into force, MOH will take a risk-based approach to regulation. The focus will be on those research institutions and tissue banks that are assessed to be of higher risk. This may be based on various factors, such as the types of research or tissue they handle, their organisational profile and, over time, their track record. With regard to Dr Chia's query about the suspension of research or tissue banking activities, MOH will have the power to order researchers, research institutions and tissue banks to stop any such activities, and to take necessary remedial action, if MOH has reason to believe that their activities are detrimental to the safety and welfare of research subjects or tissue donors. Such actions will be taken first as a precautionary measure to protect the human subjects and donors. MOH also has powers to conduct such investigations as may be required and, once investigations are completed, will review whether or not the suspension order should remain Page: 54 in force based on the findings. To Mrs Lina Chiam's question on the use of great apes in HBR involving human neural stem cells, MOH had consulted various ethicists and researchers in this area. It is recognised that the greater the possibility of "humanisation" of the animal, the greater the need for restrictions. This is in line with the practices of many countries. We will continue to monitor developments in medicine and science, both locally and overseas. Mrs Lina Chiam had also asked why the Bill is silent on human genome editing, germline modification, nanotechnology and synthetic biotechnology.”
“Documentation is important, but, wherever possible, we will use electronic or other innovative solutions to streamline processes and avoid unnecessary paperwork. Page: 53 Assoc Prof Fatimah Lateef also had some good suggestions on how to smoothen the implementation of the new regulatory framework. We do not intend to rush into bringing the new regulatory requirements into operation. After this Bill is passed, there will be a "sunrise period" before it is brought into force, to allow the affected parties to make preparations, including seeking clarifications, to be compliant with the regulatory requirements under the Bill. During this period, MOH will organise forums and dialogue sessions with the biomedical research community to address any implementation issues that they may have. MOH is also preparing a guidance document to help the research community better understand and navigate the new regulatory framework. After the Bill is brought into operation, MOH will continue to monitor the situation and work with stakeholders to ensure smooth and successful implementation. Dr Chia Shi-Lu asked how MOH plans to audit the research institutions to ensure that they comply with the regulatory requirements and wanted to know who will be the regulator. In short, MOH will be the principal regulator responsible for administering and enforcing the regulatory requirements under this Bill. The Bill provides for the appointment by MOH of public officers and officers of Statutory Boards as "authorised officers" to carry out regulatory functions, such as inspecting and auditing research institutions and tissue banks, and, where necessary, investigating into possible offences under the Bill.”
“Dr Chia Shi-Lu also asked whether tissue donors, whose tissue samples were used in research that subsequently results in commercially successful new products or treatments, are entitled to any remuneration or a share of the profits from commercialisation. Let me clarify and reiterate this point. The principle adopted in this Bill is that all tissue donations must be made voluntarily and altruistically. Among the information that must be provided upfront to a tissue donor during the consent-taking process, under clause 12(2)(e), is that the donor would be renouncing his rights to the donated tissue and any intellectual property derived from the tissue. Therefore, the donor cannot rely on the fact that the donated tissue came from him to assert a right to any financial benefits that may result from successful commercialisation of the research using the donated tissue. Assoc Prof Fatimah Lateef also asked about having a directory or database of institutions that conduct HBR. As mentioned earlier, any organisation that wants to be a research institution under this Bill must formally notify MOH and periodically submit declarations of its compliance as long as it continues to conduct HBR. This requirement applies to all such research institutions, regardless of whether they are medical institutions or not, or whether they are from the public or private sector. Although these notifications and declarations do not amount to a licence or regulatory approval from MOH, MOH will, nonetheless, have a list of such research institutions in Singapore, and this information can be made available to the public. Assoc Prof Fatimah Lateef had requested that paperwork be kept to the minimum. We will certainly keep this in mind.”
“With the new human tissue framework under this Bill, it is possible to use such excess or leftover tissue for research provided that: (a) the doctor responsible for the treatment of the patient has confirmed that all the necessary treatment and diagnostic procedures have been completed, and that the remaining tissue is no longer needed; and (b) appropriate consent has been obtained for the use of the leftover tissue for research purposes. It should be noted here that the consent to use the leftover tissue for research is separate from, and in addition to, the consent to collect the tissue for clinical treatment and diagnosis. The consent for use in research can be taken at the same time as the consent for treatment or diagnosis, or it can be taken later on a separate occasion. Page: 52 This may involve some extra effort on the part of the doctor or the researcher, but, as a matter of principle, it should not be assumed that once a patient consents to having his tissue taken for treatment or diagnosis, he has no say in the use of any leftover tissue for other purposes, such as for use in research. Going forward, with the new regulatory framework for human tissue, getting consent for the use of tissue for research purposes should be the norm and the standard practice for all. As to Dr Benedict Tan's question regarding the waiver of appropriate consent for certain types of HBR under certain circumstances as described in the Fifth Schedule of the Bill, an IRB may waive the requirement to obtain appropriate consent if the IRB is satisfied that all four of the criteria (a), (b), (c) and (d) in paragraph 3, Part 2 of the Fifth Schedule are met.”
“It should be noted that even though some biological materials are excluded from the definition of "human tissue", if a researcher conducts research using a person's biological material, for example, saliva, in such a way that the person is individually-identifiable, that research would be regulated as human biomedical research. The researcher would need to get that person's informed consent to be a research subject. In the case of biological materials, such as human skin grafts or human bone chips to be transplanted into another person, they will, indeed, be regulated as "human tissue". The consent of the tissue donor is required before such tissue can be removed from the donor's body and collected for use. Such tissues should be obtained through altruistic donations and cannot be commercially traded. However, we also recognise that certain tissues may be unavailable or in short supply in Singapore but are, nevertheless, needed for use in medical therapy and/or essential research. Under the Bill, the Minister may grant exemptions for such tissue and, to this end, may convene an expert committee to advise on the circumstances under which such exemptions may be granted. These circumstances include the therapeutic indications, prevailing forms of therapy, available alternatives and whether the tissue can be practically obtained from any other non-commercial source. Dr Benedict Tan spoke of using residual biological specimens, which had originally been collected as part of a patient's clinical treatment, for research purposes.”
“For example, this is practised for Phase 1, or first-in-human, clinical trials, where the pharmaceutical company sponsoring the trial usually underwrites all the medical costs resulting from injuries sustained by the research subjects. As the significance and frequency of risks due to HBR are varied and wide-ranging, research institutions should work in consultation with their IRBs to develop policies on when such no-fault compensation should be provided, and the mechanism for doing so. For example, the research institution could take up appropriate insurance coverage for such research. In any case, research subjects should be informed at the outset during the consent-taking process, whether there are any provisions for compensation for injuries arising from their participation in the research, as well as whether there are any insurance or indemnity arrangements made for the research. There are also questions from Dr Benedict Tan and Assoc Prof Fatimah Lateef concerning the definition of "human tissue". In general, any biological material obtained from the human body that consists of, or includes, human cells, would be considered as "human tissue". However, some biological material, such as hair, nails and natural body secretions and excretion, such as saliva and urine, have been excluded as there is very little risk to the human donor in the collection of such material. There is no need to regulate them under the human tissue framework, the objectives of which are to protect the safety and Page: 51 welfare of tissue donors and prevent commercial trading of human tissue.”
“Nevertheless, as IRB members may be subject to duties arising under general law in discharging their IRB functions, we also expect research institutions to indemnify their IRB members against legal liability arising from the decisions of members who have discharged their duties in good faith. Research institutions should formally assure their IRB members of these arrangements, such as in their letters of appointment. Page: 50 There have been suggestions made about the publication of rejected IRB proposals, serious adverse events and data/findings of studies. We do intend to share some of the information, such as serious adverse events, where beneficial and relevant, from time to time, and we will study how best to do this. Singapore is aligned with the rest of the international research community in this respect. However, as international best practices continue to evolve, we do not rule out the possibility of mandating the publication of relevant information in the future. Dr Chia Shi-Lu asked if research subjects who experience adverse effects due to their involvement in the research would be compensated. The Bill itself does not mandate such compensation. However, as a matter of general law, researchers are obliged to provide compensation where their negligence has caused the subjects harm. The IRB should ensure that researchers, as well as the research institutions, do not seek to exclude or limit their responsibility to provide such compensation for injuries sustained by research subjects. As a matter of ethics, there is an ethical obligation for researchers to offer compensation where subjects suffer significant injury as a result of their participation in the research, regardless of the fault of the researcher.”
“An effective IRB, besides safeguarding the safety and welfare of research subjects by rejecting unsafe and/or unethical research proposals, also helps the research institution to manage the institutional risks by avoiding exposure to unethical research. Conversely, a research institution that does not support the effective functioning of its IRB, or even impairs or interferes in the proper functioning of the IRB, will expose itself to greater institutional risks in the event any adverse outcome befalls a research subject. The fact that a research proposal had been reviewed and approved by an IRB does not necessarily protect the research institution, especially if it is later found that the IRB had not performed its review function effectively. I turn to the point raised by Assoc Prof Fatimah Lateef about the potential liabilities of IRB members, many of whom volunteer their own time to do this important work, often out of goodwill and concern for the safety and welfare of research subjects. IRB members are not paid any salary or wages to review the research protocols and, at most, receive a modest honorarium, or time-off if they are already employees of the research institution. I wish to reassure Members that this Bill does not impose criminal sanctions on individual IRB members for the decisions they make in discharging their IRB functions. As I mentioned earlier, it is the responsibility of the research institution to ensure that the IRB it appoints functions properly and it is the research institution that will, ultimately, be accountable in the event of an adverse outcome arising from a decision made by its IRB.”
“In terms of its composition, the IRB will be required to include at least one scientific member and one lay person, and these persons will not be related to the research institution. In addition, the IRB chairperson must be a registered medical practitioner, as an added measure for accountability. The composition of the IRB helps to ensure that its deliberations and decisions are made with a full understanding of the scientific issues and consideration of the ethical values of the community. These requirements will be specified in subsidiary legislation. In terms of the conduct of IRB members, they must declare, at every meeting, the nature and extent of any actual or potential conflicts of interest in relation to any matters under consideration by the IRB at that meeting, which emphasises the independent role of the IRB when carrying out their assessments. Such members are required to recuse themselves from the decision-making process. While we can mandate certain requirements to help ensure the independence of the IRB, the effectiveness of an IRB in carrying out its ethics review function will also depend on Page: 49 how the research institution governs the research activities under its purview. In this regard, the independence of the IRB should not be viewed in the context of an adversarial relationship between the IRB and the research institution. The governance structure set out in this Bill makes it imperative for a research institution to ensure that the IRB it appoints is competent and can function effectively, as the research institution is ultimately responsible for the research under its supervision and control and may be taken to task for any non-compliance.”
“I would like to reiterate that only the IRB, as a body, and not just the chair alone, may waive the appropriate consent requirements of the Bill if it is satisfied that all the criteria in paragraph 3 (Part 2) of the Fifth Schedule are satisfied, namely, the individually-identifiable Page: 48 human biological material or health information research, as the case may be, may not practically be carried out unless there is a waiver; the use of the individually-identifiable human biological material or health information, as the case may be, involves no more than minimal risk to the research subject or donor; the waiver concerned will not otherwise adversely affect the rights and welfare of the research subject or donor; and the HBR or health information research would reasonably be considered to contribute to the greater public good. The cumulative effect of these criteria means that such waiver will be the exception rather than the rule. So, fundamentally, this is a regime that is prohibitive, with a comprehensive set of measures. Any exemption granted will be subject to very stringent criteria. We expect few to qualify and their operations will be constrained. On the independent ethics review process, I would like to clarify that the effectiveness of the IRB review is based on two factors. Firstly, the rules and requirements governing the IRB itself. Secondly, the very nature of the relationship between the research institution and the IRB in the governance structure set up under the Bill. Under this Bill, we will set the minimum requirements that must be met in terms of the composition and conduct of the IRB.”
“Secondly, the central IRB would detract from the focus on the research institution as the entity responsible for the HBR conducted under its auspices, which is a cornerstone of the accountability framework under the Bill. Thirdly, the workload and responsibility of the central IRB would likely be relatively greater, which may dissuade persons from coming forward to serve as members. Centralisation of IRB reviews would also adversely affect their responsiveness. While Mrs Chiam had suggested that the members be paid a full-time salary, this may create an undesirable situation where board members no longer serve voluntarily but expect to be paid based on the volume of research protocols reviewed. This will not be conducive to conscientious and meaningful review of research protocols, unlike the current framework, where IRB members do not receive any salary or wages to review the research proposals and, at most, receive a modest honorarium. Concerns have been raised that the IRB may have excessively broad powers, particularly the ability to waive the appropriate consent requirements when researchers conduct their HBR.”
“This is to prevent research institutions from evading the requirements of the Bill by circumscribing the scope of their research activities in Singapore to only those that are lawful under this Bill while conducting research that is unethical or even prohibited or Page: 47 restricted under the Bill overseas. An example of such a case was reported in the international media in October 1997, involving a multi-centre clinical trial conducted in the US, Africa and Thailand, to test a new treatment for HIV/AIDS. In that research protocol, test subjects in the control group in Africa were unethically given only a placebo, even though an existing HIV/AIDS treatment was available. In contrast, test subjects in the control group in the US were given the existing HIV/AIDS treatment. The differential treatment of the test subjects in different countries caused an international outcry against the unethical behaviour of the researchers. It is research like this which we should guard against and avoid participating in, if we are to safeguard Singapore's reputation as a world-class biomedical research centre. Regarding Mrs Lina Chiam's suggestion to have a central IRB, there are three key factors MOH considered when deciding not to adopt a central IRB system. Firstly, a central IRB will not have the same degree of knowledge and familiarity with the adequacy of the research institution's systems of oversight, compared to an IRB that is more closely connected to the research institution. This could adversely affect the central IRB's ability to effectively monitor the research institutions or to effectively assess and approve individual research protocols and ensure the safety and welfare of research subjects.”
“Each research institution will still be accountable for ensuring that there is good governance in place for safe and ethical conduct of those parts of the research under its purview. Assoc Prof Fatimah Lateef also asked about the impact of the Bill on international multi-centre research. For research institutions and researchers in Singapore involved in international research collaborations, this Bill will apply to them. Most of the existing international research projects that are already ongoing are not expected to face much difficulty meeting the requirements of this Bill, especially if they involve collaborations with partner institutions in developed countries. This is because the key requirements in this Bill, such as informed consent, independent ethics review and a clear framework of accountability and governance, are already the norm in developed countries. These requirements also should already be familiar to researchers in Singapore. However, not all countries have specific laws governing human biomedical research, or impose similar, if any, regulatory and ethical requirements. In situations where the same international protocol calls for research activities to be conducted in both Singapore as well as overseas, the local research institution will, of course, be responsible for the research activities in Singapore. Additionally, the local research institution will need to ensure that its appointed IRB reviews and approves that protocol in its entirety, and not just the portion of the research activities in Singapore. On its part, the IRB will need to be satisfied that the international protocol complies with the national laws of all the participating institutions as well as internationally-accepted ethical principles.”
“Mdm Speaker, first, let me thank all the Members – Assoc Prof Fatimah Lateef, Ms Ellen Lee, Dr Benedict Tan, Mrs Lina Chiam, Mr Pritam Singh and Dr Chia Shi-Lu – who have given their views and voiced their support for this Bill. In particular, I would like to thank Ms Ellen Lee for her speech on the importance of HBR and the relevance of this Bill to society generally. Firstly, she highlighted that such research advances the standard of healthcare and is conducive to the continued development of medicine and society. Secondly, she reminded us that while we have built a solid foundation after 50 years of hard work in nation-building, our society is changing rapidly and the Government has to ensure that our legal system continues to protect the interests of every Page: 46 member of society so as to ensure social harmony. The Members have raised various questions and made some suggestions on the Bill. Let me address the various questions and comments made by Members. In the case of multi-centre research done locally, Assoc Prof Fatimah Lateef has correctly pointed out that the Bill provides for our local research institutions to come together and appoint a lead institution amongst themselves to coordinate the research they are collaborating on. The Bill also enables the collaborating institutions to appoint the same IRB to review their joint research, which would be more efficient than having multiple IRBs review the same research protocol. However, having such an arrangement does not mean that the lead institution will take over the responsibilities of all the other participating research institutions.”
“The most serious offences, such as commercial trading in human tissue, conducting "prohibited research" or forcing a person to become a research subject against his will, carry the highest maximum penalties, which is a fine of up to $100,000, or imprisonment for up to 10 years, or both. The ultimate objective of HBR is to improve human health and well-being. HBR is essential to understanding the causes and progression of diseases and to the development of new and improved therapies, diagnostics and preventive interventions. Those who donate their tissue or participate as research subjects play an indispensable part in HBR. It is only right that their safety and welfare be protected. This Bill will put in place regulatory frameworks that will protect these research subjects and tissue donors. I hope that Members will show their support for this Bill, as a demonstration of Singapore's commitment towards ethical and responsible biomedical research and handling of human tissue. Mdm Speaker, I beg to move. Page: 104 [(proc text) Question proposed. (proc text)]”
“These are aligned with similar prohibitions against commercial trading of organs in the Human Organ Transplant Act, and of embryos, eggs and sperm in the Human Cloning Page: 103 and Other Prohibited Practices Act. Similar to the HBR framework, the requirement to obtain appropriate consent from tissue donors is an important aspect of the human tissue framework. Tissues may only be removed, stored, supplied and used for research with the donor's consent, and the donated tissue must be used in accordance with the donor's wishes. Additionally, it will be an offence to coerce, intimidate, deceive or mislead a person into providing his tissue. The requirement for appropriate consent and the controls on the removal, storage, supply and use of the tissue are covered in clauses 37 and 38. The human tissue framework also includes controls and requirements to protect the confidentiality of tissue donors and prevent unauthorised disclosure of their personal information. This is covered in clause 39 of the Bill. The clauses in Part 8 of the Bill deal with MOH's powers to administer and enforce the provisions in this Bill. RIs and tissue banks are required to formally notify MOH before they commence operations and have to periodically declare their compliance with the regulatory requirements while they continue operating. MOH will not license them but will have the necessary powers to inspect and audit them to ensure compliance with regulatory requirements. Regarding offences and penalties, the offences in the Bill fall into four tiers, according to the nature and seriousness of the offence.”
“In such a case, an IRB will also scrutinise the research proposal and consider whether the enrolment of these patients is, indeed, scientifically necessary and ethically acceptable. The requirements for appropriate consent are covered in detail in Part 3 and clause 25 of the Bill. Furthermore, clause 26 makes it an offence to coerce, intimidate, deceive or mislead a person into becoming a research subject, or to stop him from discontinuing his participation as a research subject. The HBR framework also includes controls and requirements to protect the confidentiality of research subjects against accidental loss or unauthorised access or disclosure. These are covered in clauses 27, 28 and 29. Clauses 30 and 31 of the Bill provide for certain specified subcategories of HBR to be subjected to tighter controls. These are research that are "restricted" as they are considered "sensitive", such as those using human embryos, and research that are "prohibited" as they are deemed ethically unacceptable and are disallowed completely. Related to the HBR framework is the human tissue framework in Part 6 of the Bill. This regulates the removal of tissue from the human body as well as the procurement, storage, supply and use of human tissue in research. The definition of "human tissue" in clause 2 generally includes any biological material obtained from the human body that consists of, or includes, human cells. The human tissue framework prohibits commercial trading of human tissue, upholding the principle that human tissue should be obtained only through altruistic donations. Clauses 32 and 33 make it an offence to buy or sell, or to advertise the buying or selling of, human tissue.”
“This system of researchers, IRBs and RIs that I have described is covered in the clauses in Part 4 and in clauses 22, 23 and 24. One important aspect of the HBR framework is the requirement to obtain appropriate consent from research subjects. This upholds the principle of voluntary, informed participation, which is an important cornerstone of ethical HBR. In general, before a person is enrolled as research subject, he should have: (a) the right to know what is expected of him, and what risks he will likely be exposed to, as a research subject; and (b) the right to decide whether or not to be a research subject, including the right to change his mind and discontinue being a research subject. There will be standards set for the consent-taking process to ensure that prospective subjects are adequately informed and understand the nature of their participation in the research. There will also be additional safeguards for "vulnerable" groups, such as minors below 21 years of age and those without the mental capacity to give their own consent. For Page: 102 example, for persons without mental capacity, consent can be given by a donee or deputy authorised under the Mental Capacity Act to give consent on such matters. If there is no such donee or deputy, consent can only be given by a family member, such as a spouse, an adult child or a parent. However, as a safeguard, those who are unable to give their own personal consent can only be enrolled in research where their participation is essential because research of comparable effectiveness cannot be carried out without the participation of that class of persons. An example of such research may involve patients with late stage Alzheimer's disease who have lost their mental capacity.”
“The IRB reviews HBR proposals of the researchers under its RI, assessing, among other things, the ethics of the study, the researchers' qualifications and the adequacy of the safety measures put in place to protect research subjects. Page: 101 Even though it is appointed by the RI, the IRB is obliged to make an independent assessment whether to approve or reject the proposed HBR, with the safety and welfare of research subjects being its paramount consideration. The IRB must include a scientific member and a lay person who are not related to the RI. The RI is the overarching entity under which HBR is conducted. It is responsible for the supervision and control of its researchers, including monitoring their HBR, to ensure compliance with the regulatory requirements. It must also appoint the IRB to review the HBR of its researchers and it is responsible for providing the necessary resources and support to ensure the proper functioning of the IRB. It is worthwhile to note that, in this system, it is the RI that will ultimately be accountable in the event that its appointed IRB fails to perform its review functions properly. An RI bears heavy responsibilities, and it is a role that should not be taken lightly. An RI must be a body of persons or an organisation, and an individual cannot be an RI. The RI must also have a place of business in Singapore, with at least two individuals who are ordinarily resident in Singapore responsible for the supervision and control of the HBR it conducts. These prerequisites help to ensure that only bona fide organisations which have adequate resources and personnel capable of performing the responsibilities of an RI, conduct HBR in Singapore.”
“This is described in clause 3 of the Bill and it covers two main areas: the first area refers to any research for clinical or medical-related purposes, involving a human subject, while the second area covers any research involving human embryos, eggs, sperm or human-animal combinations. In regulating the research environment, the Bill defines the roles and responsibilities of three entities. They are the "research institution" (RI), the "institutional review board" (IRB), and the individual "researcher". Together, they form an interlinked system with checks and oversight to ensure that the research is conducted ethically and that there is accountability for the safety and welfare of the research subjects. Let me elaborate on this. Under the HBR framework, every individual researcher must conduct HBR under the supervision and control of an RI. He can either be an employee of the RI or enter into some form of contractual or collaborative agreement to conduct the research under the auspices of that RI. No researcher is allowed to conduct HBR on his own outside this framework, without any oversight or supervision. Before starting any HBR, the researcher must have his research proposal reviewed and approved by an IRB appointed by his RI. He must then ensure that appropriate consent is obtained for each research subject involved in the HBR. When conducting the HBR, the researcher must not deviate materially from the approved protocol without further approval from the IRB. The IRB plays an important role in ensuring the ethical conduct of research and protecting the safety and welfare of research subjects.”
“The feedback received supported having a Bill that would protect the safety and welfare of research subjects and tissue donors and provide clarity to the roles and responsibilities of those engaged in HBR and tissue banking. This Bill incorporates provisions for two separate but related regulatory frameworks, namely, (a) the HBR regulatory framework, and (b) the human tissue regulatory framework. These frameworks also apply to the activities of the Government. The principal objective of these frameworks is to protect the safety and welfare of research subjects and tissue donors, ensuring that their health and well-being are not compromised, and their privacy and autonomy are respected. This Bill does this by: (a) regulating the conduct of HBR, with stricter rules for certain types of restricted research; (b) prohibiting certain other types of HBR; (c) regulating tissue banking activities; and Page: 100 (d) prohibiting the commercial trading of human tissue. The Bill includes many elements that should be familiar to researchers and those who handle human tissue, such as the concept of informed consent and the requirement for independent ethics review. Some of these are reflected in the existing laws and guidelines and are already in practice. This Bill will make transparent a set of standards and requirements that apply uniformly across the board. Let me now describe the provisions of these two regulatory frameworks. In relation to the HBR regulatory framework, the scope of the framework is defined by the term "human biomedical research".”
“With the growth of HBR activity beyond the public sector, and with more non-doctor researchers involved in clinical research, it is timely to bring all types of HBR under a formal legislative framework. This is the key impetus for this Bill. We want to build strong legislative foundations to facilitate research while ensuring high ethical standards and protection for human subjects. Page: 99 In addition, there has been increased demand for human tissue as biomedical research often involves the use of such tissue. With more human tissue being collected and stored in tissue banks and tissue collections of varying sizes in Singapore, it is important to formalise the ground rules for handling human tissue. This will help ensure protection for tissue donors, ethical conduct in the collection of tissue, and good stewardship of this valuable resource for biomedical research. MOH has been monitoring developments in other advanced countries that have well-established biomedical research sectors, such as the United Kingdom, the United States of America (USA) and Australia. MOH has taken bearing from their regulatory frameworks and legislation governing HBR and handling of human tissue. The introduction of this Bill is a proactive measure to help ensure that Singapore maintains its reputation as a biomedical hub of international standing. MOH has also consulted widely with stakeholders, including the research community and the public, throughout the development of this Bill. A formal online public consultation was conducted between November 2014 and January 2015.”
“Mdm Speaker, I beg to move, "That the Bill be now read a Second time." Research in biomedical sciences has led to important advances in knowledge and technology that have improved the health, life expectancy and quality of life of people around the world. In Singapore, despite the relatively short history of research, we have already seen benefits from biomedical research. In the area of cancer research, a team at our National University Hospital developed a novel genetic screening programme that provides more accurate diagnosis of acute lymphoblastic leukaemia in children. This new technology has increased the success rate for the treatment of such cases to over 80%, with fewer side effects and better quality of life. It has also lowered the cost of treatment and reduced the period of hospitalisation. Beyond the benefits to the health of our people, research in the biomedical sciences has the potential to create good jobs for our young people and become one of the key pillars of the economy. However, good quality human biomedical research (HBR) needs to be underpinned by strong ethics governance and protection for people who are subjects of such research. Today, we have laws that cover specific areas of research. For example, the Medicines (Clinical Trials) Regulations only apply to clinical trials for pharmaceuticals. Besides legislation, the Ministry of Health (MOH) has issued guidelines on the conduct of HBR, but these apply mainly to research by public sector bodies or researchers using public research funds. The Singapore Medical Council also has issued ethics guidelines on clinical research, but these apply only to registered doctors.”
“Mdm Speaker, I would like to thank Dr Chia Shi-Lu for that suggestion as well. There are other measures being explored to enhance the pricing transparency to patients and accountability of the clinics for their charges. While it is currently not mandatory for clinics to issue itemised receipts, MOH is looking at these suggestions to make this mandatory for all licensed clinics as part of our review of the Private Hospitals & Medical Clinics (PHMC) Act and Regulations.”
“Mdm Speaker, I would like to thank Mr Baey Yam Keng for his suggestion. MOH is aware that there is a growing suggestion and request for other modalities to check the balances. In our review, we will take into considerations some of these suggestions that have been given to us and we will try our best to make it seamless and easy, especially for the elderly.”
“Mdm Speaker, currently, patients on the Community Health Assist Scheme (CHAS), including Pioneers, can check the subsidy that they have enjoyed for chronic medical conditions and their annual balance through the CHAS website or by calling the CHAS hotline. As the subsidy limits for chronic diseases are refreshed yearly, this enables patients to monitor their usage of the subsidy to date and check their available balance. Each of us – MOM, CHAS clinics as well as the patients – has a role to play to ensure accountability and prevent fraudulent claims. MOH encourages patients to check with their clinics on any queries they may have on the treatment and charges and to request for itemised receipts, so that they are more informed. MOH also closely monitors the CHAS subsidy claims submitted by clinics and takes feedback on potential cases of abuse seriously. We will continue to improve the access to relevant information and strengthen our audit Page: 31 system.”