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Archive for August 2015

Parliament: Human Biomedical Research Bill (Pritam Singh) – 17 Aug 2015

Regulatory Approach of this Legislation

Madam Speaker, the Ministry of Health’s public consultation on the Human Biomedical Research Bill – carried out from November to December 2014 – states that the Bill is light-touch with minimal regulatory intervention. It envisages a system of self-accountability underpinned by risk-based audits and checks.

The Bill covers two major issues – firstly, the biomedical research framework and secondly, the framework governing the use and banking of human tissue.

Madam Speaker, I am concerned that with the light-touch regulatory approach, Parliament and Singaporeans will not be sufficiently informed about the nature of biomedical research carried out under the auspices of this Bill, leaving this House in little control over what members agree to once this Bill passes muster. I am also of the view that this Bill provides a unique opportunity to nudge members into exploring and expanding Parliament’s role, through additional scrutiny, to operationalise Parliament’s educative role in society.

At the outset, a vibrant biomedical research scene is in Singapore’s interest. The prospects of cure for cancer, HIV, Parkinson’s disease, correcting of congenital defects and a host of others medical breakthroughs are exciting, and I certainly hope many Singaporeans, and young Singaporeans in particular dedicate themselves to being at the forefront of these breakthroughs.

Nature of Permitted Research

What does this Bill allow, albeit under restricted conditions? Under the Human Biomedical Research Framework, and under the conditions established in clause 3, it allows for: (a) research involving human embryos; (b) human-animal combination embryos created by the incorporation of human genetic material or human cells or entities created as a result of the introduction of human cells into an animal foetus and; (c) the introduction of human neural cells into a post-natal animal and the introduction of human cells into the brain of a living post-natal animal.

Under the Bill, the Ministry of Health’s approval is required should the introduction of human genes into an animal embryo result in an entity that has human consciousness. These prospects can either cause the layman to look forward towards the future of human biomedical research with keen anticipation, or with an acute sense of dread.

The self-accountability framework underpinning this Bill allows for a research Institute, or a biotechnology company or even an SME to potentially set up Institutional Review Boards (IRBs) to review and assess the work that is being carried out by its researchers. Consent from subjects is an integral aspect of this Bill before biomedical research is carried out, and rightfully so. However the Bill gives extraordinarily wide powers to the Chairman of an IRB, as exemplified by Part Two of the Fifth Schedule, to waive the requirement for appropriate consent to be obtained for human biomedical research involving human biological material or health information, should the research be reasonably considered to contribute to “the greater public good”, a term that would likely only to be determined affirmatively – and not without controversy – in a court of law.

No room for Parliamentary oversight?

In fact, clause 57 affords the Minister even greater powers by permanently exempting any biomedical research activity from this Bill. Equally of concern, clause 62 gives the Minister powers to amend any of the schedules to this Bill, effectively delegating all parliamentary oversight on the Bill to the Minister after its passage in this House, as the five schedules cover the essence of what this Bill seeks to legislate, namely (a) Human biological material excluded from the definition of human tissue; (b) Research, Studies and Matters excluded from the definition of human biomedical research; (c) Prohibited Human Biomedical Research; (d) Restricted Human Biomedical Research and finally; (e) Waiver of Requirements for Appropriate Consent by IRBs.

Should the Minister choose to exercise his powers by virtue of Clause 62, Parliament would have in effect, completely delegated its powers to the Minister to fundamentally alter the Bill in operation – should the scope of the Schedules as listed in the Bill be modified – without having to go through Parliament.

At the very least, should Parliament not place greater reporting requirements on the exercise of such extensive powers, even as we seek to allow our researchers and research institutions as much latitude as possible to produce cutting edge research work? Clause 62 would make Parliament little more than a mere rubber stamp with regard to human biomedical research in Singapore, as this Bill gives complete latitude to the Minister to change the parameters and scope of biomedical research in Singapore without an amendment bill, and without Members having an opportunity to debate any gazetted changes in Parliament.

Madam Speaker, I recognise that Clause 5 of the Act allows the Minister to establish an advisory committee to advise the Minister on any matter arising out of the administration of this act. In effect, the existence of this clause reinforces the point that we are heading into unchartered waters even for the Minister who oversees this legislation. Parliament and the general public should be kept well appraised of the research and controversies carried out under the auspices of this Bill, should Parliament decide to pass this Bill today.

I make this suggestion because in researching for this Bill, I perused the newly released Ethics Guidelines for Biomedical Research, released in late June this year by the Cabinet-appointed Bioethics Advisory Committee (BAC). I found it disconcerting that in the written response received during the public consultation period, the Managing Director of the Lily-NUS Centre for Clinical Pharmacology noted, and I quote,

“…I am quite concerned that there was not more of an effort to engage with stakeholders on this discussion. I was only made aware of the proposed changes when I chanced upon it in a press report, and a couple of investigators in other institutions I spoke with who conduct healthy volunteer research, were not aware of these proposals at all. I would urge a nuanced approach to this matter from the BAC.”

Unsurprisingly, the public consultation on these BAC ethical guidelines revealed that different groups had different views with regard to the conduct of biomedical research. In particular, the comments of the Buddhist Fellowship and the Catholic Medical Guild of Singapore reveal the difficulties in answering the fundamental question of when life begins, and at what point conscientiousness starts – questions that are central to specific aspects of biomedical research.

Regulatory Powers and Proposals

Madam Speaker, in view of the unique nature of this Bill and the significant powers it confers not just on the Minister, but biomedical researchers, institutions and IRBs, it is helpful that clause 63 provides extensive powers to the Minister to make regulations requiring the submission of information, returns and reports as the Director of Medical Services may order.

I would like the Ministry to consider publishing through the media or through Parliament, at regular intervals, the details of research projects rejected by the various institutional review boards and the reasons for their rejection. This is in addition to the details of projects that are submitted to the Ministry of Health for special approval, including details of serious adverse events as identified in clause 2. This is chiefly to keep the public informed and aware of the workings of the self-regulation framework, particularly since this is a highly specialized area that requires significant intervention for the effects of this Bill to be understood by the layman. More specifically, in view of the importance of clause 63 as a regulatory tool for this Bill, I would also like to ask the Minister how the penalty threshold of a $20,000 fine and 2-year imprisonment term was derived, which in my view is set at a rather low threshold.

Madam Speaker, the Workers’ Party is of the view that Parliament ought to form a select committee to better appraise members of what this Bill entails with specific scrutiny paid on the clauses that confer significant powers to various entities, in addition to a detailed primer into the biomedical research this Bill legislates. Secondly, it recommends that the Government commit to publishing details of the human biomedical research that will be carried out under this Bill’s auspices and recommends that reporting regulations to Parliament be placed upon research institutions and review boards that seek to carry out restricted research. As members have not had the opportunity to scrutinise this Bill closely, and in the event a select committee is not formed, the Workers’ Party will abstain from voting in favour of this Bill.

Thank you.

Written by singapore 2025

20/08/2015 at 5:03 pm

Posted in Uncategorized

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