Human Fertilisation and Embryology Bill
20 May 2008
My Views on the Human Fertilisation and Embryology Bill 2008
The purpose of the Human Fertilisation and Embryology Bill is to update the 1990 Act to ensure that it keeps pace with scientific and medical developments and so ensure that embryo research continues to be tightly regulated. The UK is currently a world leader in stem cell and embryology research. The strong regulatory framework within which such research takes place has maintained public confidence and is attractive to researchers. In 2005/6, the Medical Research Council spent over £14 million on stem cell research split roughly 60:40 between embryonic and adult stem cell research. Charities such as the Wellcome Trust are also investing considerable sums in this type of research.
Stem cells are immature cells that have not yet developed into the specialised cells that make up different parts of the body. There are three main sources of stem cells:
Embryonic stem cells come from embryos that are about five days old – a ball of about 50-100 cells less than the size of a pin head. They are pluripotent i.e. they can give rise (differentiate) into all cell types in the body.
Adult stem cells are multipotent and can develop into a limited number of cell types. For example bone marrow stem cells can give rise to different types of blood cells.
Fetal cord blood contains adult-type stem cells. Some organisations offer banking of this blood in the hope that in the future it may provide stem cells for the donor.
Research on stem cells from these different sources is complementary and closing off one avenue of research could be to the detriment of potential therapies. For further information click here.
The creation of “animal/human hybrids”
One of the most controversial aspects of the HFE Bill is that it will permit research into human embryos that contain some animal material to overcome the limited availability of donated human eggs.
In fact, the current (1990) Human Fertilisation and Embryology Act (HFE Act 1990) already allows the mixing of human and animal gametes (an ovum and a sperm) but this is after licensing for specific experiments and only for the purpose of testing the fertility or normality of sperm and requires that the result of the mixed gametes is destroyed no later than the two cell stage.
In January 2008, the Human Fertilisation and Embryology Authority (HFEA), set up under the HFE Act 1990 to strictly regulate these matters, granted licenses to two different research teams to derive stem cells from human embryos created from animal eggs instead of human eggs. They considered that current provisions allowed this provided the research is considered necessary and desirable to increase knowledge about the development of embryos and serious disease and to enable such knowledge to be applied in developing treatments for serious disease.
Arising from these developments, the current Bill will amend the HFE Act 1990 to clearly define the regulations on the mixing of human and animal material. It will still permit the mixing of sperm with an egg of an animal for the purposes of research into the normality of sperm but, beyond this, does not allow for the creation of true hybrids in the sense it would usually be used i.e. that involving diploid (two stranded) DNA formed from the mixing of genetic material from two gametes (an egg and a sperm each containing single stranded DNA) from different species.
What will be allowed (but only under licence from the HFE Authority) is the insertion of human genetic material into an animal ovum that has had the animal nucleus removed (a “cytoplasmic hybrid embryo”) This is to obviate the need for women donors. The only non-human DNA - less than 1% - in these embryos comes from the mitochondria. These are cytoplasmic organelles concerned with energy generation and not part of the hereditary material in the nucleus. Another term for this type of embryo is “admixed”. Other types of admixed embryos that might be permitted are transgenic human embryos and chimeric human embryos. As with cytoplasmic hybrid embryos, only a small proportion of the DNA in these embryos would come from the animal donor. For an explanation click here.
Personally, I do not think this produces significantly different moral issues to those pertaining to the creation of human embryos on which research is already permitted up till the blastocyst stage - equivalent to 14 days after fertilisation. Such research already requires approval and a licence from the HFEA, to strictly regulate these matters. The current Bill ensures that every research proposal is carefully scrutinised by the HFEA. The 14 day cut-off is based on the earliest time at which the microscopic clump of cells starts to form the beginnings of what would eventually turn into the central nervous system. Up to that stage, the embryo is a hollow ball of about 100 cells, smaller than a full stop, called a blastocyst. The component cells are called stem cells because they have not differentiated but each one has the potential to develop into the different cell types that make up the body. At this stage in development, the majority of cells would go on to form the placenta and so eventually be discarded.
Use of embryos in stem cell research and the availability of alternatives
Below I have reproduced a copy of a statement of my position on using embryos in research, which I wrote in 2001 when there was also a great deal of controversy over this issue. It still broadly reflects my views. As you will note, one of the points I make is that in licensing any research using embryos, the Human Fertilisation and Embryology Authority (HFEA) must satisfy itself that there are no other means of meeting the objectives of the research.
Creation of admixed embryos
I do not accept the assertion that what are described as ‘ethical’ alternatives are more productive than the use of human embryos, whether admixed or otherwise, to provide stem cells for research purposes.
The reference by opponents of the Bill to ‘ethical’ alternatives refers, I believe, to the use of adult stem cells.
Adult stem cells can be relatively easily obtained from various parts of the body and so have been researched for some time and some treatments using them are already well established, such as bone marrow transplants for leukaemia. Research on the use of embryonic stem cells is still at the level of basic science i.e. initial research that has to be conducted before applications using such research can be developed. Despite some advances on alternatives to embryonic stem cells, sometimes the only source of appropriate cells is from early embryos. Therefore, some limited research work on embryonic tissue is essential if we are to make progress in treating diseases and disorders like, for example, Parkinson’s disease and if we are to understand the process of differentiation. Opponents of the Bill have argued that adult stem cells can be re-programmed but this type of tissue engineering is in its early stages and the resulting cells often develop abnormalities. For this reason, the use of reprogrammed stem cells also needs to be carefully regulated.
We must have careful research. Work done in Japan by a group lead by Professor Shinya Yamanaka and at the University of Wisconsin in the United States, to re-programme a skin fibroblast required the use of four genes for that reprogramming, and one was an oncogene—a gene that produces cancer. It is not therefore surprising that when Professor Yamanaka's group injected such stem cells into a four-cell mouse blastocyst and embedded it in a womb, the full-term mouse that developed contained tumours in almost every part of its body.
Understanding the processes of differentiation using stem cells derived from embryos could well improve the prospects for treatments with re-programmed adult cells in the future.
If you would like more information on Human Admixed Embryos, click here for a briefing from the Genetic Interest Group.
Prohibitions in connection with embryos and the Human Reproductive Cloning Act 2001
Clause 3 of the current Bill amends section 3 of the 1990 Human Fertilisation and Embryology Act, which covers prohibitions connected with embryos. Section 3(2) prohibits the placing in any woman of any embryo other than a permitted embryo. I think it will be helpful at this point to reproduce the relevant section from the Explanatory Notes of the Bill which explains what a permitted embryo is and what the current Bill proposes:
30. Clause 3 amends section 3 of the 1990 Act, which covers prohibitions connected with embryos. Section 3(2) prohibits the placing in any woman of any embryo other than a permitted embryo.
31. A permitted embryo is defined as an embryo which has been formed by the fertilisation of a permitted egg by a permitted sperm, whose nuclear or mitochondrial DNA has not been altered and which has not had cells added (except by division of the embryo's own cells). Permitted eggs are defined as eggs produced by or extracted from the ovaries of a woman and permitted sperm as sperm produced by or extracted from the testes of a man. These eggs and sperm must also not have been subject to any alterations to their nuclear or mitochondrial DNA. This clause ensures embryos created by artificial gametes or genetically modified gametes could not be placed in a woman. Similarly, genetically modified embryos or embryos created by cloning cannot be placed in a woman. This prevents reproductive cloning and supersedes the Human Reproductive Cloning Act 2001.
32. A regulation-making power has been provided under new section 3ZA(5) of the 1990 Act to allow the meaning of permitted eggs and permitted embryos to be extended to include eggs or embryos that have been treated in such a way as specified in regulations to prevent the transmission of serious mitochondrial disease 1. In the future, it may be possible to create embryos using an affected woman's egg, her partner's sperm and healthy donated mitochondria. This regulation-making power will enable such embryos and eggs to be implanted in a woman if the technology became available and was proven safe. Further provision is made regarding mitochondrial donation in clause 26, which inserts new section 35A into the 1990 Act.
1 Mitochondria are found outside the nucleus of the cell and contain a small amount of DNA. They are involved in energy production and are present in most cells in the body. If a woman's egg is fertilised by sperm the mitochondria from her egg will become the mitochondria for every cell of the embryo formed. Therefore, if a woman has a genetic medical condition associated with her mitochondria, these will be inherited via her eggs.
This means that if the technology becomes available in the future, it would be legal to use IVF to take an ovum from a woman who carries an inheritable mitochondrial disease and replace the mitochondria or modify the mitochondrial DNA, so that any abnormal mutation can be removed. The purpose of this would be to prevent the transmission of serious mitochondrial disease. These aren’technologies that are available at present but the idea is to ‘future-proof’ the legislation. As with all such techniques their use would only be permitted under the strict regulation of the HFEA.
The Bill also makes provisions on parenthood in cases of assisted reproductionIt may be that further amendments will be tabled as the Bill proceeds through its various stages.
The “need for a father”
At present, fertility clinics have to consider the role of a father before granting treatment. Measures in the Bill would replace the current “need for a father” requirement with a requirement to consider the need for “supportive parenting”. I agree with this proposal, which would end the current discrimination against single women and two women in a committed relationship to consider starting a family with support from a fertility clinic.
In my view it is critically important for a child to be raised in a stable and loving home. Many same-sex couples already raise children in just such an environment and it is logical that the law is changed to reflect this reality and society’s recognition that a homosexual relationship is as valid as a heterosexual relationship for the individuals concerned.
There is no credible evidence to support the suggestion that children of lesbian parents are at any disadvantage developmentally compared to others.
The provisions in the Bill would categorically not remove the existing right of children born to a same sex couple to know or have access to information about their biological parents. This right is already protected by law and will not change as a consequence of this Bill. Information to identify the biological parent is recorded and made available to a donor-conceived person when they reach 18.
The Bill would also recognise same-sex partners, including civil partners, as legal parents of children conceived within their relationship. Currently, same-sex partners must formally apply to adopt any child born in a relationship, in order to become a parent, which is clearly discriminatory.The Bill in no way denigrates the principle of fatherhood but the changes proposed will give more children the chance of recognition of the second parent in a two-parent home where both parents are of the same sex.
The issue of so-called “saviour siblings”
It is not the case that the Bill would allow embryo selection decisions to be made on the basis of providing a future organ transplant. However, the Bill would have the effect of clarifying the circumstances in which it is lawful for an embryo to be selected so that the resulting child is a tissue-match for a seriously ill older brother or sister. Such circumstances will be necessarily exceptional (for example if no matching donor of stem cells can be found in a patient’s family or on a bone marrow registry) and the Bill gives Parliament the opportunity to debate what the precise rules should be. It should be stressed that such embryo selection would only be in very rare cases of extremely serious, incurable disease. To date, licenses have been granted to six families whose affected children have been cured of one of the following serious conditions: aplastic anaemia, Diamond-Blackfan anaemia and beta thallassaemia. Licenses would continue to be considered under a case by case basis and would only be granted if the HFEA is convinced that the child will be a valued member of the family. The welfare of the resulting child is a critical part of the decision-making.
For my part, I would be concerned about embryo selection in these rare cases, if parents were wanting a child only to help an existing child - every child should be a wanted child in its own right. However, if another child was equally wanted, regardless of the serious health condition of their existing child/children, I do not see an ethical problem with considering a process by which an embryo could be selected so that the sibling is a tissue match and does not suffer from the inherited condition. Clearly this is a very difficult area to legislate for but we need to debate the possibility of regulations in this area so that parents in this position must discuss their reasons for a pregnancy with a qualified individual.
It is important to note the safeguards that would be in place in circumstances of embryo selection. Common law provides significant safeguards for children regarding non-therapeutic acts such as the donation of bone-marrow and other interventions. Hospital ethics committees, common assault laws, and General Medical Council supervision of doctors would all prevent the removal of body parts from living children. Even so, the Government also supported a Lords’ amendment that specifically prevents the use of “saviour sibling” legislation to obtain solid organs. Children have always been able to donate tissue to siblings, and our having the ability to do tissue-typing in advance does not change that.
For more information on so called 'saviour siblings', click here for a briefing from the Genetic Interest Group.
Changes to the law on abortion
The Government is not seeking to change the current law on abortion. However, any MP can put down amendments to the Government’s proposals and a number of amendments seeking to reduce the abortion time limit to less than the current 24 weeks have been put down and debated in a Committee of the whole House. It may be that further amendments will be tabled as the Bill proceeds through its various stages: standing committee and report.
The termination of a pregnancy is a matter for sadness and regret and I would prefer that unwanted pregnancies were avoided in the first place. Essentially, I believe that abortion is a conscience issue (within the legal time limit for abortions that should be based on survival rates and the interests of the mother). It is for the conscience of the individual woman to decide whether or not to terminate a pregnancy. If we take that choice away from women, we face the horror of back street abortions. From the end of the Second World War to 1967, illegal abortion was the main cause of maternal death.
The Science and Technology Committee carried out a careful review of the current law and I agree with the view of the majority of Committee members that there should be a change in the law to remove the two doctor requirement and effectively to provide for abortion on request up to at least 12 weeks of pregnancy. I do not think this would affect the number abortions but would help ensure that terminations of pregnancy take place as early as possible. There is likely to be an amendment introducing this provision, which I shall support.
I am aware that two Conservative members of the Science and Technology Committee, Nadine Dorries and Bob Spink did not vote for the report and produced so called ‘right to know’ proposals. These echo calls from some campaigners (who belong to organisations that would wish to outlaw abortion altogether) who have recently called for counselling to be made compulsory for women seeking an abortion. Of course counselling should be offered and this should look at all the options and not just be seen as an intervention that would discourage termination. I do not agree with compulsion for two reasons. Firstly, counselling someone under duress is not likely to be successful. Secondly, forcing someone to undergo counselling may well result in women waiting longer to seek help, thereby leading to later terminations. Abortion is not a procedure to undergo without careful consideration. Most women who have abortions do not regret their decision.
On the issue of the period of gestation up to which termination may be permitted, I am again in agreement with the conclusions presented in the majority report of the Science and Technology Select Committee that there is no evidence from those compiling survival rates that there has been any significant improvement below 24 weeks gestation. Only a very small proportion of terminations take place during the later stages of pregnancy (1.6 per cent of abortions after 20 weeks) but a more restrictive time limit would penalise the most disadvantaged and vulnerable women. Women seeking later abortion are facing exceptional and distressing circumstances — most commonly because of late diagnosis (peri-menopausal women or women using contraception); women ‘in denial’ because of trauma at conception (rape or abuse); serious NHS delays (this is particularly a problem in N Ireland); or due to catastrophic changes in their life circumstances (serious issues with an existing child or domestic violence).
On the issue of the definition of ‘serious handicap’, I again support the conclusions of the Committee. The Committee refers to information from the Faculty of Sexual and Reproductive Healthcare, which proposes a medical definition of ‘serious abnormality’ based on what is agreed between the pregnant woman and her consultant, taking into account all the clinical information available from pertinent specialists and, ideally, the wishes of both parents
SHOULD EMBRYOS BE USED FOR RESEARCH?
by Lynne Jones MP
The Human Fertilisation and Embryology Act, 1990 is the law which was introduced originally to govern the creation of embryos from in vitro fertilisation (IVF) treatment for infertility and what research can be done on those embryos. IVF treatment inevitably creates more test tube embryos than can safely be implanted into the mother. In the 8 years after the 1990 Act, with the permission of the donors, almost 50,000 embryos were given to researchers from the more than 750,000 produced from women undergoing IVF programmes. 250,000 were destroyed.
Research on embryos is permitted up to 14 days after fertilisation and requires approval and a licence from the Human Fertilisation and Embryology Authority (HFEA) set up under the 1990 Act to strictly regulate these matters. The 14 day cut-off is based on the earliest time at which the microscopic clump of cells starts to form the beginnings of what would eventually turn into the central nervous system. Up to that stage, the embryo is a hollow ball of about 100 cells, called a blastocyst, smaller than a full stop. The component cells are called stem cells because they have not differentiated but each one has the potential to develop into the different cell types which make up the body.
The purposes for which such research is permitted were set out in a list in the HFE Act and it was always envisaged that this could be added to by secondary legislation. The original list included infertility and contraception. Since 1990, research has opened up the possibility of using early embryonic cells to investigate how mature cells can be reprogrammed to the more immature state found in stem cells and made to turn into replacement cells or tissue for diseased organs. The cells used for this research can continue to be derived from IVF treatment or could be blastocysts "cloned" from the nucleus of an adult cell and a human egg cell from which its own nuclear DNA has been removed. The eggs used could only be taken with the consent of a woman donor, most likely a woman undergoing fertility treatment.
Both the HFEA, the Human Genetics Commission and the Donaldson Committee, expert groups set up by the Government, have now concluded that this type of research does not raise fundamentally new ethical issues than those debated when the 1990 Act was introduced. The Act was amended in December 2000 to broaden the range of research that will be permitted to include stem cell studies that have the aim of treating disease and disorders. Despite warnings from the Science and Technology Select Committee the Government, on legal advice, took the view that reproductive cloning (the creation of a viable human life) was already technically illegal but stated its intention to legislate to make it specifically illegal. There is no clinical reason why society would wish to make a genetic copy of a person and to attempt to do so would be extremely difficult and dangerous.
Opponents of the use of embryonic stem cells have pointed out that stem cells can be derived from other sources, notably blood cells taken from the umbilical cord at the time of birth and some adult tissue. These stem cells hold real promise but there are some significant limitations to what can be accomplished with them. The expert groups took the view that the understanding that will come from studying the process of differentiation in embryonic stem cells will enable the techniques that are only presently possible with embryonic stem cells to be possible with stem cells from adult tissue or cord blood. In licensing any research using embryos the HFEA must satisfy itself that there are no other means of meeting the objectives of the research. If the research is successful, it will be possible to derive all stem cells needed through direct conversion of a patient’s skin cells without the need to use embryos. However, as the only source of appropriate stem cells at present is from early embryos, some limited research work on embryonic tissue is essential if we are to achieve an understanding of the conditions under which cells can be programmed.
The Association of Medical Research Charities and the Parkinson’s Disease Society are strongly in favour of the research which could lead to breakthroughs in the treatment of many debilitating conditions but "pro-life" groups are opposed strongly citing a European Parliament vote in favour of a ban on stem cell research. However, the EU motion also opposes the IVF techniques mentioned above that have been permitted in this country since the 1990 Act. Almost all Labour, Tory and Liberal Democrat MEPs opposed the Christian Democrat motion. Furthermore, the European Union does not have legislative competence in the area of scientific research, and so this Resolution acts to express an ethical opinion only.
Fundamentalists will continue to argue that at the moment of fertilisation, a potential person is born. Yet, ever since the birth of ‘Dolly’ the sheep, we have known that all the cells in the body have the potential to be unique individuals. As I see it, the rights of a patient who would benefit from stem cell research are more important than the rights of a pre-implantation embryo that lacks a brain, a heart or any recognisable feature. I look forward to the day when we will be able to take an adult cell, say from a speck of skin, and re-programme it so that it becomes equivalent to an embryonic stem cell which can then be converted to cells and tissues for transplant. In the end, I would like to think that both sides of the debate will share this view and welcome the possibility of being able to grow a patient’s own tissue without the need to clone embryos at all.