Memorandum submitted by Dr E Allan (HF 2)

 

Dear Ms. Primarolo,

 

I am very glad to see that the Government will be reassessing its position on Clause 3 and associated clauses.

 

This clause places very tight restrictions on what types of embryo can be implanted into a woman, under new sections 3ZA(2)-(4). Unfortunately, potentially all these restrictions could be overturned under new section 3ZA(5) via secondary regulation, to prevent the transmission of serious mitochondrial disease.

 

I understand that the Government currently intends that some form of nuclear transfer combined with IVF (pronuclear transfer into an enucleated one-celled embryo or enucleated egg, or oocyte nucleus transfer followed by IVF) would be the procedure to prevent transmission of mitochondrial disease. However, section 3ZA(5) would allow a much broader interpretation, allowing considerable flexibility in the type of embryo that could be implanted for this purpose.

 

Under sections 3ZA(2)-(4):

 

there can be no alteration in nuclear and / or mitochondrial DNA of a 'permitted' egg, sperm or embryo

eggs must have been produced by or extracted from ovaries and sperm from testes

embryos may not have other cells added that are not the embryo's own cells

the embryos must have been created by fertilization

 

However, since 3ZA(5) can potentially overturn all the above, this means that to prevent the transmission of mitochondrial disease and subject to affirmative resolution, a 'permitted egg' and a 'permitted embryo' could:

 

have alterations to their nuclear and / or mitochondrial DNA

need not have been created by fertilization

need not use eggs obtained from ovaries nor sperm from testes

may be created using material from two women (Clause 26)

may have other cells added to it that are not the embryo's own cells

 

This clearly allows considerable latitude.

 

Germline genetic engineering of nuclear DNA could therefore be permitted under 3ZA(5) since 3ZA(2)(b), 3ZA(3)(b) and 3ZA(4)(b) need not apply. This is compounded by Schedule 2, paragraph (2)(3).

 

I have attached some diagrams regarding the loopholes in this clause that would allow, via affirmative resolution, embryos to be implanted that have had various types of alterations in nuclear and mitochondrial DNA, to prevent transmission of serious mitochondrial disease. These include germline genetic engineering of nuclear DNA to prevent transmission of mitochondrial disease of nuclear origin and reproductive cloning using somatic cell nuclear transfer into an enucleated donor egg with healthy mitochondria (however unlikely) to prevent transmission of mitochondrial disease of mitochondrial origin, in addition to oocyte nucleus transfer followed by IVF, or pronuclear transfer into an enucleated egg or one-celled embryo, also to prevent transmission of mitochondrial disease of mitochondrial origin.

 

I have previously sent this information to several Members of the Committee.

 

I am very glad that you have repeatedly stated your opposition and the Government's opposition to reproductive cloning. I am sure that you wish the proposed legislation to reflect that absolute ban. However, although sections 3ZA(2)-(4) would ban reproductive cloning:

 

Section 3ZA(5) can over-ride sections 3ZA(2)-(4)

Clause 26 can also over-ride sections 3ZA(2)-(4)

Schedule 2, paragraph (2)(3) can also over-ride sections 3ZA(2)-(4) and

Clause 3(6) and Schedule 8 repeal the Human Reproductive Cloning Act 2001

 

It would therefore be possible for a future government to permit reproductive cloning via affirmative resolution.

 

The statement in Clause 3(6) that the Human Reproductive Cloning Act 2001 is superseded by the preceding sections in Clause 3, is therefore unfortunately incorrect. In practical terms, reproductive cloning could occur under 3ZA(5) by using an enucleated egg from a woman with healthy mitochondria and an adult somatic cell or nucleus of a cell from the woman with unhealthy mitochondria, to prevent transmission of mitochondrial disease.

 

Whilst this is a most unlikely route to choose, especially considering the medical risks for the foreseeable future; and whilst I also appreciate that it is not the intention of this present Government to use somatic cells for nuclear transfer, nevertheless, the potential is there, since a ban on reproductive cloning would be taken out of primary legislation and the option would be there under secondary regulation. Furthermore, should section 3ZA(5) be modified to incorporate infertility, reproductive cloning would then become an option via secondary regulation for those who are infertile.

 

Given the implacable opposition to reproductive cloning by this Government, does this Government really wish to remove an absolute ban on reproductive cloning from primary legislation and leave it open to future governments to exploit this loophole?

 

The Government has already acknowledged that there are loopholes in section 3ZA(5) additional to those that they intend to use. The amendments that would permit artificial gametes have been specifically linked to 3ZA(5) for the very reason that this section can elude the tight restrictions introduced by 3ZA(2)-(4). The Government has clearly stated its opposition to artificial gametes via 3ZA(5) thus acknowledging implicitly that this section could indeed potentially permit more than the nuclear transfer techniques plus IVF that they wish to use to prevent the transmission of mitochondrial disease.

 

It is the same loophole as described above. In this case, stem cells have been mentioned as a possible source of artificial gametes. Since 3ZA(5) can over-ride 3ZA(2)(a), 3ZA(3)(a) and 3ZA(4)(a), this would be one way that the loophole in 3ZA(5) could operate to permit artificial gametes for implantation (although not being restricted to this).

 

In the same way, germline genetic engineering of nuclear DNA could be used to prevent the transmission of mitochondrial disease of nuclear origin, and reproductive cloning could be a potential way to prevent the transmission of mitochondrial disease of mitochondrial origin. Various modifications of embryos could therefore be permitted via secondary regulation in addition to the nuclear transfer techniques plus IVF that are currently envisaged by the Government. I therefore welcome the reconsideration of these clauses by the Government.

 

 

June 2008