APPENDIX 9: LETTER TO THE CLERK FROM
THE DEPARTMENT OF HEALTH ON THE PROVISIONS ON INTER-SPECIES EMBRYOS
1. Thank you for letter of 24 May asking for
an indication of the amendments the Government would propose to
make to the draft Bill to bring it in line with the Government's
policy position on inter-species embryos as stated in the introduction
to the Bill command paper.
2. I should first stress that we see it as highly
important to have clarity as to what is meant by 'hybrids' and
'chimeras' in the context of the remit of the draft Bill. This
is necessary, amongst other things, to ensure that entities that
come within the Home Office's licensing remit, for example the
'Down's mouse', are not inadvertently caught by human embryology
legislation and that it captures only those appropriate to a regulator
of human embryos.
3. We therefore describe at clause 17 of the
draft Bill which types of inter-species embryos (hybrids and chimeras)
we believe should come within the remit of the Bill. The clause
will introduce a new section 4A to the Human Fertilisation and
Embryology Act:
- section 4A(5)(a)—an embryo
created by using human gametes and the gametes of an animal (ie
'true hybrids')
- section 4A(5)(b)—an embryo created by replacing
the nucleus of an animal egg or a cell derived from an animal
embryo with a human cell or the nucleus of a human cell (ie 'cybrids')
- section 4A(5)(c)—a human embryo that has
been altered by the introduction of any sequence of nuclear or
mitochondrial DNA of an animal (ie 'human-animal transgenic
embryos')
- section 4A(5)(d)—a human embryo that has
been altered by the introduction of one of more animal cells (ie
'human-animal chimeras')
- section 4A(5)(e)—any other embryo that
contains both—
(i) any haploid set of human chromosomes, and
(ii) any haploid set of animal chromosomes or
any other sequence of nuclear or mitochondrial DNA of an animal
(i.e. any other embryo that is at least 'half'
human).
4. As indicated in the introduction to the draft
Bill command paper, the Government has taken account of the report
and recommendations of the Commons Science and Technology Committee
and has accepted the principle that legislation should provide
for certain inter-species embryos to be created for research purposes.
The approach we propose is for the Bill to provide that the creation
and use of the types of inter-species embryos listed at the proposed
new section 4A(5)(b) to (d) may be authorised by research licence,
without the need for secondary legislation (regulations) to this
effect.
5. The re-drafting of the clauses will have to
include addressing associated provisions such as consent to the
use of the embryos and their storage, licence conditions and directions.
6. I should also point out that section 4(A)(5)(e)
is intended to provide the flexibility for the Bill to cover new
types of inter-species embryos that emerge without the need for
primary legislation to amend the definition. Our proposed approach
is that neither embryos under section 4(A)(5)(e) nor 'true' hybrids
under section 4(A)(5)(a) would be allowed unless affirmative regulations
under the proposed new paragraph 3(3) of Schedule 2 to the 1990
Act (introduced by paragraph 6 of Schedule 2 to the draft Bill)
provided for their creation to be authorised by research licence
in the light of evidence of the need for it.
7. An exception to this is the mixing of human
sperm with a hamster's egg for the purpose of testing the fertility
or normality of the sperm up to the two-cell stage. This is allowed
under the Human Fertilisation and Embryology Act and is the position
the draft Bill maintains.
8. As the committee will be aware, an alternative
approach to allowing on the face of the Bill the reatiocn and
use of inter-species embryos to be authorised by research licence
would be for regulations under the new paragraph 3(3) of Schedule
2 to provide for it.
9. We are asking Departmental lawyers and Parliamentary
counsel to produce revised draft clauses for the approach we have
in mind, which we will provide to the committee as soon as they
are available.
10. As indicated in the draft Bill command paper,
we very much welcome the committee's views. For example, whether
the description of inter-species embryos at clause 17 captures
the right type of entities appropriately; whether the proposed
balance between allowing their creation on the face of the Bill
or through regulations is right; and whether the Bill contains
sufficient flexibility and future-proofing powers. We would appreciate
any suggestions for any alternative approaches they may wish to
recommend.
MR TED WEBB
DEPUTY DIRECTOR SCIENTIFIC DEVELOPMENT AND BIOETHICS
DEPARTMENT OF HEALTH
12 June 2007
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