HUMAN CLONING AND OTHER PROHIBITED PRACTICES BILL

HUMAN CLONING AND OTHER PROHIBITED PRACTICES BILL: Resumption of Debate on Question (1st September, 2004), "That the Bill be now read a Second time.". - [Senior Minister of Statefor Health].

Question again proposed.

Mr Ahmad Khalis Bin Abdul Ghani (Hong Kah): Sir, I rise in support of this Bill.

Not many countries are able to venture into stem cell research in spite of the good that we all know it can bring. However, Singapore is well positioned to go into stem cell research. We have the infrastructure, international connections, legal framework and the human resource pool which is well-educated and of good quality. So we did the right thing to seriously look into this area. Having done so, we have to decide on important issues.

Many societies, including ours, are not comfortable with the cloning of humans. In fact, we find it abhorrent. As such, there is a need to distinguish legitimate stem cell research acceptable by society from development of human clones which is not acceptable. Prior to this Bill, the line has not been drawn. This Bill, therefore, serves the very important function of clarifying what is acceptable and what is not in Singapore. Just having this Bill passed into law, to my mind, is in itself a major significant step in the right direction.

Clause 5 of the Bill bans the implantation of any human clone in the body of a human or animal. Since reproductive cloning, as we know it today, requires implantantion of the embryo into a womb, this effectively prohibits the development of a human clone. Clause 7 prohibits against developing human embryo created other than by fertilisation of human egg by human sperm for a period of more than 14 days. In addition, clause 8 prohibits against developing any human embryo outside the body of a woman for a period of more than 14 days. I undersand that embryos less than 14 days old compose of undifferentiated cells. So the Bill allows for stem cell research to be done on these cells for as long as it takes and so long as the embryo is not further developed.

I understand that the 14-day point was recommended because it is at this time thatthe primitive streak appears. Many groups believe that human life begins to exist only later. Thus, clauses 7 and 8, read together, address our objections against experimenting with human life forms while allowing stem cell research.

Some groups believe that human life commences upon the creation of the embryo on the first day. I respect this view as much as we have to consider other views as well. One such other view is that if we take the route of this first-day view, then any stem cell research seems impossible. All its attendant good would be lost. Further, the difference really between the first-day group and the 14-day group is not one of principle. Both agree with the principle that we should stay away from work on human life forms, in the process of which life is experimented upon or even terminated at the sole discretion of a researcher. The difference lies in our different understanding or belief as to what constitutes the beginning of human life. And, moreover, the difference occurs not in clear and obvious areas but in fine abstract ones.

The Muslims in Singapore, on the other hand, after serious deliberations, find the 14-day cut-off point acceptable, but they do not make a firm position as to when human life is deemed to have commenced.

Sir, it is not possible to find an absolute solution to this. According to a Straits Times' report two days ago, even in the USA, they have yet to decide on this issue. Ironically, this indecision means that, at present, even reproductive cloning has not been banned yet.

I think our approach has been a balanced and sensitive one. The public was notified of the issues years ago. The Bioethics Advisory Committee was appointed in December 2000. I do not have the impression that we have rushed through this Bill. But for avoidance of doubt, may I ask the Minister whether he could say whether he is satisfied that ample consultations have taken place, bearing in mind that it touches on religious and ethical positions, and that sufficient efforts have been made to consult the different respective segments of our society? Nonetheless, it appears to me that the policies enunciated in the Bill adequately reflect the concerns and interests of our society in general.

This Bill is not a lengthy one. It spells outin broad and yet clear terms what is allowed and what is not. I think it is a correct first step. We are very new in this area, perhaps still in its embryonic stage. Much still needs to be done and learnt. I urge the Hon. Minister to monitor developments, subsequent to this Bill, very closely and make adjustments as they appear. I would like to ask the Minister whether he would delegate this task to a specific department or committee.

Lastly, I would like to thank the Minister and all those involved in the proceedings that culminated in this very short but very significant Bill.

Mr Ang Mong Seng (Hong Kah): ( In Mandarin ): Mr Speaker, Sir, I rise in support of the Bill before this House.

As of now, most countries in the world, including Singapore, have no clear laws banning the cloning of animals and plants. The research on such cloning aims at decoding genes by bio-engineering. At present, the research is confined to the laboratory. It does not encourage large-scale development because this would involve many issues. If not carefully handled, it may lead to a great calamity in the biological world.

Scientists are now able to clone some higher mammals such as cows and sheep. China has also announced a plan to clone the giant panda. But, there is still a long way before human beings can be cloned successfully. Research shows that the cloned animals have health problems and do not live long. Scientists have experimented on groups of cloned mice, putting them in identical living conditions, same diet and environment. After some time, they discovered that the life span and the health conditions of these white mice were different, despite identical genes and living conditions. Human beings arethemost developed amongst allmammals. This is because, apart from the mammalian characteristics, the most importantdifference is that human beingsare capable of logical thinking. Even if we could successfully clone human beings, like cloning another Ang Mong Seng or another Khaw Boon Wan, the cloned Ang Mong Seng or cloned Khaw Boon Wan may appear to be the same outwardly, but their thinking, intelligence, behaviour, likes and dislikes might be different. So it is difficult or even impossible to control the cloning of behaviour and thinking. This being the case, it will be meaningless and pointless to clone human beings.

Most people are of the view that human cloning is against nature, morals and religious principles. The cloned humans are notnatural creatures.

Under this Bill, the Minister may allow researchers to clone human embryos or to do research on a human embryo less than 14 days old and then destroy it afterwards. Many scientists and religious bodies regard an early embryo as merely a cluster of cells and not yet transformed into a human. I think that the Ministry of Health's permit for this kind of research is based on this understanding.

I would like to ask the Minister: when a woman is pregnant, from which day does the doctor start computing the foetus'gestation period? I have asked gynaecologists and obstetricians about the calculation of the 10-month gestation period. They told me that it is calculated from the date of the last physiological period. In other words, life begins from the very moment when the ovum is fertilised.

Many people and organisations opposed to cloning of human embryos are at the same time actively opposed to abortion. They believe that the life of a foetus begins from the fertilisation of the egg and any action to harm the foetus is unethical. Some religious bodies even hold the view that research on embryos is more inhuman than human cloning. This is because the procedure for embryo cloning is to deliberately create parts that can be used and destroy the embryo thereafter. I would like to ask the Minister to give a clearer definition for the number of days, especially the critical 14-day period, concerning the formation of a foetus.

A few months ago, South Korea announced that it had successfully cloned about 30 human embryos. This generated a stir in the world of science. In August this year, the United Kingdom approved embryo cloning. If we pass this Bill, we will become the third country in the world to have done so. Japan is also planning to pass a similar Bill.

I know there is great potential in such research. It will bring new hope for patients of many diseases. But stem cells need not necessarily be extracted from embryos, although such cells do have greater research potential. Stem cells can also be extracted from cell tissuesother thanembryos. We can encourage researchers to focus on the extraction or cultivation of stem cells from the blood of the baby's umbilical cord or blood taken from an adult.

According to my understanding, the United Nations will also review this issue. Life is priceless and if mankind can manipulate life, there is no guarantee that this technology will not be used by those with ulterior motives. I feel that the practice of deliberately creating a life and destroying it thereafter is a violation of life.

Sir, I hope the Minister will consider encouraging researchers to do research on stem cells from other alternative sources. On other prohibited practices, I feel that the Ministry of Health should also have clear legislation to ban the cloning of babies to extract their organs or cell tissues for transplantation and to ban the cultivation of human embryos in non-human bodies and to ban the sale of embryos. This is because these experiments are very unethical and violate the human life.

I would like to ask the Minister, apart from the punitive measures such as the $100,000 fine and 10 years' imprisonment, will there also be any adequate preventive measures and resources to stop such illegal activities?

Mr Iswaran: Sir, in addressing the sensitive topic of cloning, I think this Bill underscores the balance that needs to be struck between, on the one hand, religious and societal perspectives

on the sanctity of human life and societal concerns about how such new realms of scientific researchare developed and its potential for abuse is curbed, and, on the other hand, managing it against the promise of new therapeutic outcomes which are pathbreaking and the potential economic spin-offs that can emanate from such discoveries, and even the process of research that will create the bedrock for such discoveries.

Sir, the potential benefits are considerable.Many speakers before me and the Minister himself have spoken at great length about the wide range of potential therapeutic outcomes that are possible from stem cell research for diseases which are, at least, atthis point seemingly incurable, like Alzheimer's, Parkinson's, and so on. So the potential to ease human pain and suffering is great. And stem cell technology and other research in areas like gene therapy and so on are at the forefront of such efforts.Although actual outcomes, in the clinical sense, may be five to 10 years away, the work that is done today will be the foundation for such pathbreaking discoveries; at the same time, the economic benefits are also substantial.Allow me to illustrate.

If I just take one particular disease, like Alzheimer's, the worldwide market for Alzheimer's drugs in 2003 was about US$1.3 billion, and it is expected to grow to about US$3 billion by 2008. Some of the key players in this business are, for example, large pharmaceutical companies like Pfizer and Eisai with the drug called Aricept, which has a market value of at least US$700-800 million. In the United States alone, there are at least four million patients who suffer from Alzheimer's. And that is just talking about one potential area of therapy and the Minister has also talked about other potential areas such as in diabetes and other disease conditions for which stem cell discovery can help. On the other hand, if you look at the concerns from the religious and societal perspectives, I think they stem from - no pun intended - profound views on the sanctity of human life, that the embryo deserves special status as a potential, if not actual, human being. And, therefore, stem cell research and any other research involving embryos must be set within a strict ethical and legal framework acceptable to Singapore society. Only that way can we ensure that human life - and potential human life - is always treated with dignity and respect in Singapore.

Sir, even those who support the idea of allowing science greater latitude want tobe assured. How would we ensure that such research will be responsibly and ethically conducted? What safeguards can be put in place to prevent the slide down the slippery moral slope, because the incentives to do so can be quite substantial? And I think how we manage this very delicate area is an essential part of our character as a society. By categorically banning and criminalising reproductive cloning, I think this Bill has, as many speakers have pointed out earlier,drawn a clear line and stated clearly our position on a matter of moral sensitivity and social reprehension. At the same time, the Bill has allowed for therapeutic cloning and with it, all potentially valuable research and work in this field. I believe this balanceis the correct one. As the Minister says, there is near unanimous support for the banning of reproductive cloning. And, therefore, I support the Bill. It is also consistent with the stance in countries like the United Kingdom and Australia. In the United States, the Bill to ban cloning is still pending approval in the Senate. But at the state level the position varies - some ban cloning entirely and others ban reproductive cloning only.

There are some questions however that remain, since we have left the door open for therapeutic cloning and embryonic stem cell research. Many have asked the question: why do we need to use embryonic stem cells? AsDr Amy Khor and Dr Lily Neo pointed out yesterday, there are other sources of stem cells - from adult stem cells, from the cord blood, and so on. I know the technical people talk about pluripotence and multipotence, and so on. The Minister is a doctor and a neurosurgeon at that. I believe he can give a more eloquent exposition, and I think Singaporeans need to hear the justification as to why we have chosen to allow embryonic stem cell research in Singapore.

The second question many have asked is: why must there be a need for therapeutic cloning? In other words, even if you accept that embryonic stem cell based research is essential, why must we allow therapeutic cloning? Again, I believe there are sound medical and scientific reasons, but these should be articulated in this House as part of the debate on this Bill. And I would like to hear from the Minister andthe Ministry theirperspectives on the justification for doing so.

The concern I have regarding this Bill, in a sense,is more about what the Bill does not talk about.The Bill has categorically made reproductive cloning a crime, and I think there is no dispute over that,but the question is: how will we manage the other tricky area of therapeutic cloning in Singapore? In the United Kingdom, for example, any research in public and private laboratories on embryos is subject to strict licensing requirements and it is overseen by the Human Fertilisation and Embryology Authority, which was established in 1990 by theeponymous Human Fertilisation and Embryology Act.

This Bill is silent on how we are going to deal with this vast area of therapeutic cloning, and it is not a trivial point, as the Minister would acknowledge, because therapeutic cloning can easily degenerate and become reproductive cloning. It is really the first step. So we have drawn the line at 14 days andwe stop them from implanting the embryo. But the point really is: how do you address the issue of therapeutic cloning? And I believe there are some merits in considering the UK approach and studying it in greater detail. Because it creates a register of bona fide researchers in this field,and any bona fide researcher should have no qualms about seeking licensing approval from the authorities to conduct legitimate research.At the same time, establishing such an authority will create an entity with the capability to monitor specific research projects andkeep track of general trends in this sector, whichare fast evolving and may well require periodic reviews of the legislation and any subsidiary regulation that arises to govern the space.

My question to the Minister is: how do we manage therapeutic cloning or any embryo-based research today? And going forward, given the fast-moving nature of this sector, how will we do so? Will we consider establishing an authority, as they have in the United Kingdom, for example? The second question I have is a more specific one. It is on why thefine has been kept at S$100,000. Sir, as I elaborated earlier, the monetary rewards in this space are vast. We are talking ofhundreds of millions, if not billions, of dollars, and I am talking of US dollars. We have capped our fine at S$100,000. It does not really communicate to me any deterrent value. So I presume it is symbolic in nature, which then begs the question: why do we have such a provision in the Bill at all?If we are serious about this, then we should have a fine, but leave it unlimited and leave it to the discretion of the courts to decide what isappropriate, based on the nature of the act. And I think that would go much further as a way of managing any kind of delinquent behaviour.

Sir, finally, I have a couple of operational questions. TheDirector of Medical Services has been tasked, I think, in this Bill with the whole area of enforcement. To the best of my knowledge - the Ministry of Health and the Director of Medical Servicesdo not have resources for such enforcement - I do not know what enforcement capability resides within the Ministry of Health. Andas this is a more technical area, obviously you cannot just sendthe average policeman to a laboratory. He needs to know what he is looking for and needs to be guided by technically trained people. So, I would like to ask the Minister: what resources will be made available to the Director of Medical Services so that he or she can fulfilthe responsibilities as required under this Act.

And, finally, what mechanism will the Ministry be putting in place - asmy colleague Mr Ahmad Khalis pointed out - to periodically review or, in fact, regularly review, the field and the developments against provisions in this and any other relevant pieces of legislation to ensure that Singapore remains appropriately positioned in this important area of scientific research.

Mr Chandra Mohan K Nair (Nominated Member): Mr Speaker, Sir, this Bill seems to be necessary in order to prevent experimentation with human embryo cloning and to allow only the natural way of creating human beings. It could be argued whether this Bill is really necessary in Singapore today. Do we have a single case of abuse at all to warrant legislating on this controversial matter? Presumably, the introduction of this piece of legislation is for future deterrence.

Generally, the more popular view with normal human beings, including most scientists specialising in the field of stem cell research, seems to be that prohibition of human embryo cloning, based on scientific information available currently, seems necessary. However, my concern is whether the politicians in Singapore and of the world, and the scientific community in particular, are mixing morality ethics, religious leanings and scientific research and taking the safe way out by banning something we are not that familiar with. Have there been sufficient informed and independent enough discussion and debate with an open mind? I am not sure. Have there been opportunities given to the scientists to argue, without fear, in favour of research and experimentation with the cloning of the human embryo in the interest of scientific research and advancement?

The Government may well have studied papers, consulted experts and obtained scientific feedback from various advanced countries. Which countries did Singapore consult? Which scientific organisations, both local and/or foreign, have advised our Government for Singapore to come to the conclusion that human embryo cloning is to be outlawed? What are the views of different sectors of society on this sensitive matter? Has there been an exhaustive and critical feedback process put in place to get varied views from Singaporeans, for example, from religious groups, racial groups and the research and scientific community in Singapore and even abroad? In exploring the frontiers of scientific research and advancement, it is most crucial to have an open mind and to critically analyse scientific advances and experimentation, as long as the primary goal is to advance the cause of doing good and advancement of the human race. May I propose that this Bill, being innovative and far-reaching, be made available to the public for a thorough discussion by way of a parliamentary Select Committee? Through the Select Committee, varied views can be aired by our citizens and experts in this field. And Parliament and the Government

would be that much richer and wiser. We can then have an improved, well-informed and well-researched piece of legislation.

Stem cells are a kind of master cells that can grow into any kind of cell in the body. Research in this area is revolutionary in today's age. It may not be revolutionary in 10-30 years' time. We must explore the possibility of us being criticised in future that we were rather narrow-minded in legislating hurriedly on something that we are not that quite sure of. Those who favour such research would say that they are just trying to help people who are sick and really, that is an important focus for the advancement of the human race.

People are concerned about the ethical, moral and religious problems when it comes to cloning of human embryos. I believe this matter can be a big debate. But at the end of the day, I do not believemost people will favour cloning of human embryos. The Internetwebsites have a great deal of materials on human cloning, and I would like to quote some to give a flavour of the international debate that is going on, and I quote:

"A White House spokeswoman reaffirmed President Bush's opposition to human cloning. The President has made it clear that he is 100% opposed to any type of cloning of human embryos." said the spokeswoman for the President. The President supported the House legislation to ban human cloning which was passed overwhelmingly. The House of Representatives in USA voted to ban human cloning and set penalties of up to 10 years in prison and $1 million fine for those convicted of attempting to clone humans. The measure was never taken up by the Senate. So it never became law. I believe that is still the position,and I stand to be corrected.

One Senator hoped that the Senate could find a compromise that will allow some cloning research to continue without opening the door to the creation of human beings through clones. The Senate had to draw a line. So it is a resonable line.We can continue medical science and breakthroughs, without crossing the line into something none of us wants to see. These worksset the stage for human therapeutic cloning as a potentially limitless source of immune compatible cells for tissue engineering and transplantation medicine. Anotherquote,"Our intention is not to create cloned human beings but rather to make lifesaving therapies for a wide range of human disease conditions, including diabetes, strokes, cancer, AIDS, and neurodegenerative disorders, such as Parkinson's and Alzheimer'sdiseases." To describe the advances as a very primitive development, the Director of the Centre for Bioethics at the University of Pennyslvannia deemed it a significant one. "When you get to the point where you have made a human embryo even for research purposes, it is a line that is crossed." That is another quotation. The Medical Ethicist said an argument could be made for using the technology to create cells that could be used to treat diseases. If you could makecell lines from these creations and turn them into something that the body would not reject, that would be a wonderful breakthrough, in terms of being able to offer cures to people.

Just a few years ago, an Italian fertility doctor and a US researcher announced plans to clone humans. They said hundreds of couples had volunteered for controversial procedure. The announcement was criticised by officials inseveral countries, and the Italian authorities threatened to ban that doctor from practising medicine if he goes ahead with the experiment. Another organisation in USA moved his research into human cloning outside of the United States after being investigated by the Federal government. That organisation was founded by a member of a religious movement which believes extraterrestrial scientist created life on earth and that cloning is a way of achieving eternal life.

Many nations have either announced bans on cloning research or have legislation pending. I guess Singapore is one of them. The United States of House of Representatives voted to ban all human cloning. The legislation, supported by President George Bush, was passed by265 to 162 votes. In other words, it was not unanimous,60%-odd voted in favour, and whether that could go on to other kinds of cloning research.

But many scientists, patient groups and the biotech industry opposed the ban because it would outlaw cloning for reproduction as well as therapeutic cloning in which scientists make embryonic clones to get stem cells for potential disease treatments. Thus, our piece of legislation is modified in a way that itmay not cover all of these. Meanwhile, the Council of Europe's Convention on Human Rights and Biomedicine has introduced what it is believed to be the first international agreement banning human cloning. The measure called the Protocol on the Prohibition of Cloning Human Beings was drafted in the 1990s following successful attempts to clone mammals, particularly by embryo splitting and nuclear transfer. Twenty fourof the 43 Council of Europe States have signed the protocol. Elsewhere in Europe, a German Health Minister said a few years ago that she was opposed to human embryo cloning, while France adopted a draft law to ban human cloning in medical researchthat year. The French law will place severe restrictions on the use of frozen embryos created as part of a fertility programme but no longer needed or claimed by the parents for the purposes of medical research. Russia approved a five-year moratorium on human cloning, and these are some of the quotes I got from the Internet .

Sir, at the end of the day, this House, including myself, may well support this Bill, based on our gut feel. I really am not sure. Ten years down the road I may well feel happy that I have made this decision if we hear that in other countries there are problems related to human embryo cloning. On the other hand, a young scientist today who is eager to do all the cloning of human embryo research and might well feel he could solve a great deal of medical diseases might be disappointed with the passing of this Bill.

Dr Ong Seh Hong (Aljunied): Mr Speaker, Sir, I support theBill and all its prohibitions. Given the current interest on the issue of cloning, it is important to keep in view the various and considerable concerns relating to the prospect of cloning. Ethicists, religious leaders and even Ian Wilmut, the creator of Dolly, the sheep, believe that we should "reject this proposed use of cloning" in humans. The caution raised to set clear guidelines for prohibition of cloning is understandable.

Many a time, due to the limitations of the human mind, great scientists may not foresee the long-term implications of their discoveries and inventions. For example, weapon of mass destruction - in the past, the explosive bomb and, nowadays, nuclear weapons -can be conceived as undesirable outcomes of a great scientific invention.

In the area of research involving human embryos and cloning, there are still controversies such as the status of human embryos. Are they live form? Are they potential human? Or are they just a mass of cells? Or issues such asthe point on the beginning of life. I think these would not be resolved easily. And I do not intend to dwell on them because I am not an expert. But in general though I feel that we should take a prudent approach. And we must, on the other hand, balance between an overly conservative approach that will stifle scientific progress and an overly permissive one that will give us undesirable long-term consequences.

Sir, I would like to comment on four areas that I think the Billmay not have addressed adequately. Firstly, I would like to talk on the issue of the creation of human embryo solely forresearch purposes.While the Bill explicitly bans the practice of "reproductive cloning of human" by the prohibition of placing human embryo clones into any human body or the body of an animal, and the prohibition of developing the human embryo clone for more than 14 days, the Bill does allow cloning of human embryo up to 14 days, I would like to know what is the rationale behind this. I presume that the reason is, as other speakers before me have alluded to,to allow the cloning of human embryo for other uses, such as therapeutic orresearch purposes.

At present, only very few countries, like the United Kingdom, allow scientists to create embryos solely for research purposes. Other countries, such as Belgium and Italy, have no laws yet becausethey also find it difficult to reach a consensus. Therefore, in these countries, everything goes. Some scientists can carry out experiments in Italy that would be banned elsewhere. In Canada, the Senate approved the Assisted Human Reproduction Act in March this year, addressing the human genetic and reproductive technologies.The creation of human embryos solely for research is not prohibited in Canada. However, research involving human embryos, including embryonic stem cell research, is permitted using embryos created but not used duringin-vitro fertilisation (IVF) procedures. The practice of using surplus embryos is also allowed in certain other countries, such as Finland and Belgium, and others are adopting the same position. Overall, we can observe a trend towards a certain liberalisation of these practices.

Sir, therefore, before the world can reach a consensus on this issue, I strongly urge the Ministry to adopt the middle path and to prohibit the creation of human embryos or human embryo clones solely for research purposes. This is also the position of the Council of Europe's Oviedo Convention.We should only allow human embryo research on surplus embryos for IVF procedures because they would otherwise be discarded anyway.

Secondly, I would like to comment on the practice of "therapeutic cloning" which has not been explicitly covered by the Bill. Sir, like other speakers have explained, the purpose of therapeutic cloning is to harvest stem cells compatiblewith the recipients so that they can be used to treat certain diseases without the problem of tissue rejection. Although there are promises of medical benefits for treating many diseases like Alzheimer's, diabetes, leukemia, using stem cells, we are still quite far away from the clinical application of these promised cures. My understanding is that in fact the research of stem cells at this stage is still very much focused on learning how to switch on these stem cells for their differentiations into the different types of organs. So therapeutic cloning, although the name implies that it is for therapy purposes, is not really therapeutic in that sense. It is still very much research based. Therefore, I would urge the Ministry to

have clear guidelines for what these so-called therapeutic cloning can be used. I feel that we should only allow therapeutic cloning of human embryos strictly for the purpose of treating specific serious medical conditions and only when they are proven clinically.

Thirdly, on the issue of genetic modification, the Bill has included in the definition of human embryo that "any life embryo that has an altered human genome as a human embryo". Therefore, I would likethe Minister to clarify whether it is implied in the Bill that genetic modification would be allowed because you definea human embryo as including those that have their genome altered. By that definition, they can also continue to go into full term. So, I would like this clarification of human genetic modification, because if the Minister intends to permit genetic modifications, then we have to be very cautious and to spell out what are permissible and what are not. Although theoretically we can intervene and modify the chromosomes to treat some hereditary diseases, it also opens up a Pandora's box that we may not be able to handle.

On the lighter side, we may say that in future we will allow parents to have designer babies, eg, today I want to have a baby who is tall, blond, with big eyes and an IQ of 150, just tick the options and you have them. But on a more serious note, I think it canbring the world a step closer to that of a brave new world. For example, supposedly, when the gene or genes that determine sexual orientation, if there are such genes, are located, the technology to alter the genome may also be used to either eliminate the zygotes of a particular sexual orientation, or a country or an individual might finance a programme similar to that of Nazi Germany, whereby humans were bred to maximise certain traits. Once the "super human" is developed,embryo cloning can be used to replicate this individual and, conceivably, produce unlimited numbers of the clones. The same approach could also be used to create a genetic underclass for exploitation, such as creating individuals with very sub-normal low IQs but who are good in doing certain tasks and to be exploited.

Fourthly, I would like to talk about a body to oversee this area of research.I notice that while the Director of Medical Services and his officers will be empowered to enforce the Bill when it is passed, there is no provision of an agency or body to oversee and regulate activities relating to research on human embyros, stem cells and so on.

Sir, let us look at other countries that have legislated in this area. I would just like to use a few countries for comparison. In Germany, their policies are more restrictive. British policies are the most permissive, while the Australian and Canadian policies are somewhere in between. As German laws ban a wide range of activities involving human gene, gamete or embryo research, as a result, they do not have a regulatory body to oversee these activities. On the other hand, the other few countries I mentioned, in the UK, they have a Human Fertilisation and Embryological Authority (HFEA), whose 18-member board decides what is permitted and what is not. The HFEA, as MrIswaran alluded to, requires that public and private institutions working on human embryos are licensed, and it can suspend or revoke the licence of non-complying institutions. Australia and Canada legislatively ban a number of widely condemned activities, leaving a more limited but still significant set of issues open for further consideration by their regulatory bodies. The Australian regulatory body is the National Health and Medical Research Council Licensing Committee. In Canada, under the newly-approved Act, they will have the Assisted Human Reproduction Agency of Canada.

Sir, the Bill on the table is somewhere in between. We are not so open, but we are also not as restrictive as in some countries. So, probably, we would also need to set up a national agency that is tasked to develop and oversee regulations covering these and other permitted activities. The agency shall be tasked to license, register, monitor, audit and regulate all individual scientists, doctors and researchers as well as private and public fertility clinics, research facilities and other institutions whose research or commercial activities involve human embryos or gametes.

Sir, with these comments and suggestions, I support the Bill.

The Senior Minister of State for Health (Dr Balaji Sadasivan): Mr Speaker, Sir, I thank the hon. Members, Dr Lily Neo, Dr Amy Khor, Dr Chong Weng Chiew, Mr Ahmad Khalis, Mr Ang Mong Seng, Mr Iswaran, Mr Chandra Mohan and Dr Ong Seh Hong for their comments and for their support for this Bill.

Many Members were concerned that because we have not specifically banned therapeutic cloning, this maybe the thin wedge that leads to human cloning. Some members of the public also share this concern, especially because of the many sensational media reports about cloning. Dr Amy Khor mentioned a report about Dr Panos Zavos who claimed a few days ago that he had successfully cloned two dead people using cow embryos. There areothers who have made equally sensational claims. First, there was a Richard Seed, a physicist who volunteered himself for cloning and was going to clone himself. Then, there was an Italian doctor who was mentioned who has travelled around Europe with plans to clone a human, and announced that he intended to clone a person in the UK. The UK then passed emergency legislation to prohibit human cloning. Then, there is a journalist called Rael who started a religious cult and formed the company called Clonaid. He claims he met clones when an UFO landed in Canada and they had given him instructions to clone humans. Clonaid has announced that it has cloned a human called Eve, and there were even local media reports that Clonaid may clone Singaporeans and my Ministry was queried.

This Bill will unequivocally make it clear that we prohibit reproductive human cloning and that these self-promoters who want to promote human cloning are not welcome in Singapore for any activity that is related to human cloning.

There were questions asked about adult and embryonic stem cell research. Basically, stem cells are cells that have the potential to divide into any kind of tissue. Adult stem cells can do it, and embryonic stem cells can do it. Most scientists feel that research on all types of stem cells is necessary, but they believe that the potential for a cure is going to come from embryonic stem cells. This Bill has not mentioned therapeutic cloning, and therapeutic cloning is not being done in Singapore at this time. Why may therapeutic cloning be necessary in stem cell research?

Sir,how stem cells would be used to treat diseases is that the stem cells would be used to create cells that a person has a deficit in. These cells would then be given to that person. For example, a person who suffers from diabetes does not have the cells that produce insulin. Therefore, if we were to give him stem cells that convert into cells that can produce insulin, then his diabetes can be cured. But one of the problems would be that these cells may be rejected by the body. But if the make-up of the cell could be altered so that it is genetically similar to that of the recipient, then those stem cells, when given to the patient, will not be rejected by the patient. So, although the stem cell may originally have come from an embryo with a different DNA make-up, the stem cell that went into the patient has the genetic make-up of the patient himself. This process of changing the nucleus of the stem cells would constitute therapeutic cloning. And because it can be an essential part in the cure for many diseases, therapeutic cloning has not been banned in many countries.

Questions were asked whether there wereadequate consultations. The Bio-advisory Committee had been formed in 2000, and a special sub-committee to deal with this was formed in 2001, and this committee wrote to all the religious groups and professional bodies, including the Law Society - this is for Mr Chandra Mohan's information - to get their feedback. All this feedback was collated and published in its report. So, the opinions of everyone is in that report and a proper public consultation was done.

Mr Ang Mong Seng brought up a very important question: when does life begin? The answer to that is: no one has a consensus on it. This is an area in which people are guided by fundamental religious and moral beliefs, and there is a spectrum of views. There are those who believe that life begins at conception and others who believe that life begins much later. And I do not think it is possible to bring all these different religious views in this entire spectrum of views and merge them into a single view. Our position in the Ministry is that we respect everyone and their views. We have recorded their views and we will not force anyone who does not want to donate or be involved in stem cell research to be involved in stem cell research.

However, on the issue of human cloning, all groups are almost unanimous in banning this, because we do not want a world like that described in the Brave New World by Aldous Huxley where people are cloned and manufactured and we have the mass production of human beings, and we do not want such a world. So, in that area, everyone is in agreement, and that is what we are prohibiting in this Bill.

Just like people have a spectrum of views on when life begins, there is also a spectrum of views among countries with regard to legislation in this area. Dr Chong Weng Chiew has commented on the legislation in other countries, particularly the United States, and I would like to clarify some facts about the situation in the US because it is quite confusing there. In the United States, a Bill on cloning was passed in Congressbut was rejected by the Senate. So, at this point in time, the United States does not have a federal law that bans reproductive cloning. The law only prohibits the use of federal funds for research in this area. Some individual states have laws that prohibit the cloning of humans. But in the states where it is not prohibited, it may be legal for a scientist to clone a human as long as state funds are not used. Two states, ie, New Jersey and California, have specific legislation that allows therapeutic cloning. Internationally, at present, there are about 30 countries around the world that have already adopted national legislation or decrees that explicitly or implicitly prohibit reproductive cloning on human beings. When this Bill is passed, we will join these countries in prohibiting reproductive human cloning.

Of the countries that have legislation prohibiting reproductive cloning, about half prohibit therapeutic cloning and half do not. So, the legal position

in Singapore onstem cell research andcloning is somewhat similar to that in the UK and Japan. So we are taking a balance, middle of the road, very conventional approach in regulating stem cell research.

Members have also asked for proper enforcement of this Act. Dr Khor noted that Government institutions are not exempted from the provisions of this Bill.Currently, there is only one company in Singapore conducting research into human embryonic stem cells. Its stakeholders include EDB, NUS and the Monash University and it has complied with both the current PHMC Act in Singapore that regulates this area and the National Institute of Health's regulations in the US. That is why the US Federal Government allows the stem cells from this company to be used in US research laboratories. At this moment, no one is doing therapeutic cloning research in Singapore and no one has applied to do therapeutic cloning researchin Singapore.

A lot of people have asked me howwe are going to look at these embryos in the laboratory and decide whether they have crossed over the 14-day limit.I would like to clarify a little further on this issue. There is a scientific basis for drawing a moral line that research beyond 14 days should be prohibited. In natural fertilisation and development, the embryo starts as a cell with no specific features and then it just divides and divides for 14 days, andit is a tiny little ball of cells with no differentiation. On the 14th day of development,a linear indentation, called the primitivestreak, appears and this is the first sign of differentiation. That is the reason why most legislation uses this 14-day mark. But most research on embryos is actually done in embryos that have not gone beyond five days. In fact, it appears that no one can actually grow an embryo beyond seven days without implanting it into a womb. So there is a seven-day safety margin between what is possible in the laboratory and what would be illegal in the laboratory. Soone of the provisions in the Bill is to prohibit the implantation of cloned embryos into the womb of a human or an animal because without implantation, you cannot clone a human.

This does not mean that in the future, scientists cannot grow embryos to beyond 14 days in the laboratory. With the rapid evolution of science, this cannot be ruled out. And although there is one company in Singapore doing embryonic stem cell work now and no one is doing therapeutic cloning research, it is possible that in the coming years, there may be great interest in this area and we must be prepared to be able to regulate and control research in this area.

Today, the important measure that ensures that human cloning does not occur isthe registration and regulation of IVF facilities because this is where the embryos are. Currently, these facilities are regulated by the PHMC Act. And my Ministry has issued a set of quite detailed guidelines in September 2001. But the PHMC does not make human cloning an offence, nor does it prescribe penalties. It is being administered by the Accreditation Unit of the Ministry of Health. This Bill makes cloning an offence and prescribes penalties. This Bill also makes the Director of Medical Services responsible for the administration and enforcement of the Act.Clause 14 of theBill gives extensive powers to the Director to do this. Anyone who obstructs or hides relevant information is liable to be jailed for a year. My Ministry will work with the universities and other agencies to ensure that best practices are followed when monitoring and regulating research in this area. This Bill empowers the Minister to make regulations as necessary to give effect to the purpose of the Bill.So as thescience of this area evolves, as companies apply to do therapeutic research, we will introduce regulations based on the best practices of that time to ensure that all work being done is ethical.

Finally, with this Bill,we will deter people from attempting human cloning because of the stiff penalties for non-compliance. I agree with Mr Iswaran that $100,000 may not be much for a scientist or a big corporation. But going to jail for 10 years is a serious deterrent.It is not possible to attempt reproductive cloning without the involvement of a big team and every member of the team will be subject to criminal penalties if they are part of the team. And itis unlikely that a big team of criminal scientists and doctors can be assembled in Singapore and that they can conduct attemptedhuman cloning research without our knowledge. It should also be noted that so far, no one has been prosecuted under the legislation prohibiting reproductive cloning anywhere in the world and there has been no credible attempt to do this anywhere in the world, except for the much publicised claims by a few individuals which most scientists find not credible.

Dr Amy Khor had mentioned the Simon Shorvoncase. That episode shows that although an individual may be willing to cross the line and do wrong things, it is difficult to get the whole team to do so.In the Shorvon'scase, when Dr Shorvon crossed the line and conducted research that endangered patients, once his team members discovered that, they pulled out of the team and alerted the Ministry.So action was taken before any patients suffered from wrongful research. Because reproductive cloning requires a big team, it is unlikely that it can happen without detection.

Dr Lily Neo was concerned about the risks of bio-terrorism. Following the SARS' laboratory incident in September 2003, my Ministry has instituted a system of checks and enhanced bio-security at our laboratories. We are also working with the security agencies on this and a Bill on Bio-security is being drafted. We will soon bring the Bill to Parliament and there will be an opportunity for a full debate on the subject.

Finally, I would like to thank Membersfor their comments andsupport of this Bill.

Question put, and agreed to.

Bill accordingly read a Second time and committed to a Committee of the whole House.

The House immediately resolved itself into a Committee on the Bill. - [Dr Balaji Sadasivan].

Bill considered in Committee; reported without amendment; read a Third time and passed.

Mr Speaker: Order. I propose to take the break now. I suspend the Sitting and will take the Chair again at 4.30 pm.

Sitting accordingly suspended

at 4.10 pm until 4.30 pm.

Sitting resumed at 4.30 pm

[Mr Speaker in the Chair]