APPENDIX 2: HUMAN FERTILISATION AND EMBRYOLOGY
BILL [HL] — GOVERNMENT AMENDMENTS
Supplementary memorandum by the Department of
Health
Introduction
1. This supplementary memorandum sets out delegated
powers which have been amended, removed, or added as a result
of amendments made to the Human Fertilisation and Embryology Bill
in the House of Commons[2].
An earlier memorandum ("the original memorandum") on
the Human Fertilisation and Embryology Bill was submitted to the
Committee on 8 November 2007.
2. This memorandum covers three areas:
· amendments to powers relating to the definition
of human admixed embryos, and the circumstances in which they
can be kept or used;
· powers relating to appeals committees
and reconsideration of licensing decisions; and
· powers to make consequential and transitional
provision.
Commentary on Amendments
Clause 4(2): Prohibitions in connection with genetic
material not of human origin
Powers conferred on: Secretary of State
for Health
Powers exercised by: Regulations
Parliamentary procedure: Affirmative procedure
New power to restrict keeping and use of human
admixed embryos
3. An amendment[3]
was made that introduces a new regulation-making power, which
mirrors an existing power relating to human embryos. The power
enables the Secretary of State to restrict the circumstances in
which human admixed embryos can be kept or used under licence.
This could be used, for example, if it became necessary to shorten
the 14 day time limit for keeping or using a human admixed embryo
in some circumstances. This power is inserted by clause 4(2) of
the Bill and forms new section 4A(5) of the Human Fertilisation
and Embryology Act 1990 ("the 1990 Act"). The amendment
is intended to ensure consistency with powers available in respect
of human embryos.
Replacement of a regulation-making power with
a 'catch-all' provision
4. The original memorandum (paragraph 28) described
a power in new section 4A(5)(e) of the 1990 Act which conferred
a regulation-making power on the Secretary of State, subject to
the affirmative procedure, to include "such other thing that
may be specified in regulations" within the definition of
human admixed embryo. This would have enabled other entities to
be brought within regulation, for example following developments
in scientific methods to combine animal and human DNA. In the
Committee's report of 27 November 2007 this power was not considered
to be inappropriate.
5. However, Government amendments were brought
forward in light of concerns expressed by Peers that this regulation-making
power was not a sufficient future-proofing mechanism. It was proposed
instead that a general category of human admixed embryo could
be drafted to ensure that any new methods of creating a human
admixed embryo would fall within regulation without the need for
further legislation.
6. An amendment[4]
removed the regulation-making power and replaced it with a 'catch-all'
provision. This brings all embryos which do not fall within paragraphs
(a) to (d) of new section 4A(6) of the 1990 Act, but which contain
both nuclear or mitochondrial DNA of a human and nuclear or mitochondrial
DNA of an animal in which the animal DNA does not predominate,
within regulation as human admixed embryos. A consequential amendment[5]
was made to ensure that this new category of human admixed embryos
would be caught by the power to amend the definition.[6]
7. Amendments were also made to ensure that a
research licence could be granted to authorise the creation, keeping
and use of all human admixed embryos, as defined in the Bill (as
amended). An amendment[7]
removed the power that was provided in Schedule 2 to enable a
licence to authorise the creation, keeping and use of any new
type of human admixed embryo which had been brought within regulation
by exercise of the power under new section 4A(5)(e). A further
amendment[8]
removed the reference to this power later in the Schedule. Consequential
amendments[9]
reflected the changes to the definition set out above.
8. Consequential amendments[10]
removed references in clauses 30 and 31 to the regulation-making
powers that were removed from section 4A(5)(e) and paragraph 3(5)
of Schedule 2 to the 1990 Act. A reference to the new regulation-making
power under new subsection 4A(5) was also inserted into clause
30.
Clause 21, new sections 20A and 20B: Reconsideration
and appeals
Powers conferred on: Secretary of State
for Health
Powers exercised by: Regulations
Parliamentary procedure: Affirmative procedure
9. The original memorandum set out the powers
in new sections 20A and 20B inserted by clause 21. New section
20A requires the Authority to maintain one or more appeals committees
and a regulation-making power is conferred on the Secretary of
State under new section 20A(3) to ensure that the constitution
and proceedings of such appeals committees will be set out in
regulations. In addition, new section 20B(2) requires regulations
to make provision about the procedure to be followed for reconsideration
of licensing decisions.
10. Both these regulation-making powers were
previously subject to the negative procedure. Following further
consideration of both powers in light of discussion during Public
Bill Committee, it was deemed appropriate to make both powers
affirmative due to the importance and likely interest in the detail
of the regulations.
11. An amendment[11]
was made to add these two sets of regulations to the list under
clause 30, inserting new section 45A into the 1990 Act, of those
regulations subject to the affirmative procedure.
Clause 64: Power to make consequential and transitional
provision etc.
Powers conferred on: Secretary of State
for Health
Powers exercised by: Order
Parliamentary procedure: Affirmative procedure
12. Clause 64 confers power on the Secretary
of State to make, by order, consequential and transitional provisions,
including modification of other enactments in consequence of,
or to give full effect to, the Bill's provisions. This is subject
to constraints as set out in that clause. It does not currently
provide for sections of the 2008 Act itself to be amended.
13. Clause 53(2) deals with interpretation of
references to "father" in any enactment, deed or any
other instrument or document, so that references to fathers can
be read as references to female second parents. This follows from
recognition of legal parenthood for same-sex couples elsewhere
in the Bill. Clause 53(5) excludes from this general rule any
enactments where express provision has been made.
14. An amendment[12]
was made so that section 53(5) of the 2008 Act, when passed, can
be updated if an order was made under section 64 to expressly
amend other legislation. This ensures that the general rule in
section 53(2) would not apply to references to fathers where express
provision is made in future.
Department of Health
October 2008
2 This memorandum refers to HL Bill 120, as printed
following Commons Committee stage Back
3
Amendment number 2 Back
4
Amendment number 3 Back
5
Amendment number 5 Back
6
This power, originally in new section 4A(7) of the 1990 Act enabled
the Secretary of State, by regulations, to amend the definition
of human admixed embryos within new section 4A(5) (Bill print
of 9 November) in any way. The Committee's report of 27 November
2007 recommended replacement with a narrower power. Government
amendments were made at Report stage in the House of Lords to
replace this with a power to amend but not to repeal any of the
categories of human admixed embryos. The power can only be exercised
if it appears to the Secretary of State necessary or desirable
in the light of developments in science or medicine. This power
is now found in clause 4(2), inserting new subsection 4A(11) into
the 1990 Act. Back
7
Amendment number 47 Back
8
Amendment number 48 Back
9
Amendment numbers 46 and 49 Back
10
Amendment numbers 24, 26 and 27 Back
11
Amendment number 25 Back
12
Amendment number 43 Back
| 
