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The safety of using the techniques has not yet been established. They would need to be assessed carefully before being deployed as options for patients in treatment. The regulating power would allow for that consideration through a full consultation, to gather the views of the public, ethicists and relevant stakeholders on the appropriate use of using donor eggs for that purpose. For example, as some hon. Members have pointed out today, and as has been raised in the House before, there would need to be consideration about the status of the egg donor if donations from which only the mitochondria is used were made.
In addition to the public consultation, we believe that Parliament should not be asked to decide on this issue now, for precisely the reasons that have been mentioned: the facts should be before Parliament before it makes a decision. It should be asked to take the decision only when all the facts are clearly available.
Amendment No. 41 seeks to limit the regulating powers so that embryos or eggs that have undergone cell nuclear replacement could not be permitted for use in treatment. Following debate in another place and in this House, the Government carefully considered the drafting of proposed new section 3ZA of the Human Fertilisation and Embryology Act 1990, and whether it needed to be amended.
After careful consideration, the Governments view is that the drafting is clear and does not require amendment. The precise process by which mitochondrial diseases may be treated is not yet clear, and amendment to the regulating powers would inadvertently risk and reduce the scope and the process for treatments to be allowed. Secondly, the regulation-making power is limited to the treatment of mitochondrial diseases only. Thirdly, the regulations would be subject to considerable public consultation and then to debate in Parliament. That would enable all the concerns to be raised. In taking that forward, the Government are balancing the need to have the facts before taking decisions with the recognition that the power is about helping couples conceive a child that is genetically theirs, but without the fatally flawed mitochondria that affect the maternal line. That is the balance that we are trying to strike; we have left things open for further consideration. That is why we are proceeding as we are.
Mr. Drew: I hear what my right hon. Friend says, but does she understand the concerns that some of us have? We are being asked to trust the Government, and, more particularly, to think that any future regulation, over which we would have no control through primary legislation, will be fit for purpose. In the context of these issues, that is quite a leap of faith.
Dawn Primarolo: I am asking my hon. Friend to think about being involved in the consultation, participating in the public debate and improving the draft regulations if and when they come forward. He should then fully participate in an affirmative resolution debate in the House before the regulations are passed. I am asking hon. Members to thinkand that is a reasonable thing to do.
Amendment No. 49 seeks to limit the regulating power so that only embryos or eggs that have been subjected to processes to prevent the transmission of mitochondrial diseases through cytoplasm could be
permitted for use in the treatment. I absolutely understand and appreciate the intention behind it. I have to say, however, that the amendment is ambiguousa point that has been touched on in the debate. Everything in a cell could be considered to be cytoplasm, including the mitochondria and the nucleus, and restricting regulating powers to prevent the transmission of serious mitochondrial diseases via the cytoplasm would not necessarily achieve the aim of excluding transmission via the cells nucleus. For that reason, there was no need to put the amendment before the House.
There are other more appropriate ways in which mitochondrial disease transmitted via a cells nucleus could be treated. We are looking specifically, through pre-implantation, at genetic diagnosis of the embryo. On that basis, I hope that the hon. Member for Southport (Dr. Pugh) will accept that we are attempting to strike the right balance, while leaving open the final decisions until the information is available and this House has taken a final view, following consultation.
Amendment No. 73 would prevent any research from being undertaken in the UK the purpose of which is to develop techniques of germ-line genetic modification. It would have the effect of prohibiting research projects from being licensed by the Human Fertilisation and Embryology Authority where the purpose of the research was to develop techniques for the genetic modification of human embryos. In addition, the amendment would restrict the regulation-making power to prevent the research. We are not aware of any researcher who would want to undertake such research, particularly in the light of the international agreements in place to prevent such activities from being applied for reproductive purposes. The Bill clearly sets out a prohibition on the reproductive application of such practices, and any research licensed by the HFEA would also need to satisfy the criteria that the use of embryos was necessary for the research, and that the research was necessary or desirable.
Amendment No. 50 and new clause 24 would introduce a regulating power that requires the Secretary of State to make it an offence to place human gametes in an animal. The Bill does not change the legal position achieved by the 1990 Act, which made no prohibition on the artificial insemination of an animal with human sperm. Such a prohibition was believed unnecessary at the time because of the inability for humans and animals to produce offspring successfully. Equally, the 1990 Act legislated on the creation of human embryos in vitro and on reproductive services. The subject matter was very different from that of the artificial insemination of animals. Since 1990, our knowledge of the ability of humans and animals to procreate has not changed, and there is still no published evidence to suggest that any insemination of an animal with human sperm, whether as part of a scientific study or not, has resulted in pregnancy. Members touched on the regulations that exist and support the legislation in the Animals (Scientific Procedures) Act 1986. The Government believe that the combination of the existing legislation in this area is sufficient, and we are not aware of any developments that require revision of that position.
Amendments Nos. 51 and 52 relate to the regulation-making powers in the Bill to extend and alter its definition of embryo, eggs, sperm, gametes and human admixed
embryos. They provide that those powers can be used by the Secretary of State only on condition that they are necessary and desirable. It is important that hon. Members understand exactly how that would interact with the rest of the Bill.
Amendment No. 47 has been substantially debated this afternoon with regard to a definition of human admixed embryos that include a catch-all category. That category refers to an embryo containing both human and animal DNA in which the DNA of the animal does not predominate. In other words, those embryos are more human than animal. I touched on the conditions under which a licence would have to be sought in an earlier intervention.
Amendment No. 47 refers to embryos containing human and animal cells created by a process of tetraploid complementation. In the type of embryo created by the process to which the amendment refers, the cells of an early animal embryo are altered, so that they contain twice the usual complement of DNA. Such cells are destined to give rise to only extra-embryonic tissue. When placed with those altered animal cells, human cells would give rise to the embryo proper, because the animal cells are capable of forming only extra-embryonic cells. The implantation of the embryo created in that way is therefore prohibited by the Bill.
Amendment No. 47 seeks to add a further category to the existing categories. Hon. Members have talked about their fear of a loophole that needs to be closed. In looking at the range of issues that have been raised, the Government believe that the embryo created by the process that I have described should be considered as a human admixed embryo, which is regulated under the definition in proposed new section 4A(6)(e) of the 1990 Act, so there is no loophole.
In conclusion, let me return to the point about cloning. The Government are absolutely clear that we are committed to banning human reproductive cloning, and the Bill continues to provide for that.
Mr. Devine: Will my right hon. Friend place it on record that the Bill has nothing to do with Stalinist or Nazi tests, which is what we heard from the Opposition earlier?
Dawn Primarolo: Hon. Members know that the Bill is about helping the one in seven couples who need assistance with their fertility. It is about research to deal with the dreadful diseases and the debilitating attacks on their health from which many in our society suffer. The Bill is about combining science with an ethical framework that works on behalf of humankind, and I think that the House knows that.
The provisions of the Bill continue to prohibit reproductive cloning and retain the existing penalty of up to 10 years in prison for anyone attempting reproductive cloning. I say this to all hon. Members, whatever their fears: please be reassured that the penalty is there. The prohibition continues. The Bill contains specific powers to allow the House to return, when the information is there and the consultation has been completed, in order to be clear about whether we would permit any further expansion in that area of research.
We have had a long and extremely important debate. Much of the ground has been covered in previous debates. It is always important to clarify the Governments intentions. Every Member of the House has a free vote
tonight. I urge them to support the Bill and to reject the amendments, as the best way forward to ensure that science prevails in an ethical framework that is acceptable to the House.
Question put, That the amendment be made:
It being after Six oclock, Mr. Speaker then proceeded to put the Questions necessary for the disposal of the business to be concluded at that hour, pursuant to Order [this day].
Amendment proposed: No. 41, page 3, line 26 , at end insert
(5A) Regulations made under subsection (5) may not provide for an egg or embryo whose nuclear genetic material has been altered by genetic modification, or whose nucleus has been replaced by the nucleus of a somatic cell, to be a permitted egg or a permitted embryo.
(5B) In this section, genetic modification includes the alteration of the nuclear genetic material of an egg or embryo by
(a) recombinant nucleic acid techniques which change the DNA sequence of nuclear chromosomes of the egg or one or more cells of the embryo, or
(b) the introduction into the egg or into one or more cells of the embryo of a stably-maintained artificial chromosome, virus or plasmid.. [Mr. Drew.]
Question put, That the amendment be made:Next Section | Index | Home Page |