APPENDIX 7: MEMORANDUM ON BEHALF OF
THE CHAIRMAN OF THE HOUSE OF LORDS SELECT COMMITTEE ON DELEGATED
POWERS AND REGULATORY REFORM
1. This memorandum responds to your invitation
of 5 June to the Delegated Powers Committee to contribute to your
Committee's scrutiny of the draft Human Tissue and Embryos Bill.
The Committee considered the draft bill at its meeting this morning
and I am replying to you in Lord Goodhart's absence abroad.
2. We value the opportunity to contribute to
the pre-legislative scrutiny of this draft bill and set out below
an overview of our opinion on the proposed delegations. In making
these observations, our opinion should not however be taken to
prejudge our position should a bill be introduced: we will report
to the House at that stage on whether its provisions inappropriately
delegate legislative power or whether they subject the exercise
of legislative power to an inappropriate degree of parliamentary
scrutiny. I should also note that we have considered each issue
purely as a question of delegation: this draft bill raises difficult
issues of policy and the Joint Committee may well wish to recommend,
on policy grounds, that it is inappropriate to delegate certain
other matter in the draft bill. We have been assisted by a memorandum
by the Department of Health about the significant delegations
in the bill.
General
3. There is nothing in the delegations in this
draft bill which is not precedented in other areas. What is unusual
is the number of powers subject to affirmative procedure: but
this is appropriate due to the subject-matter. We also note that
the 1990 Act, which Part 2 of the draft bill would amend, contains
more detail than is usually found in Acts dealing with other licensing
schemes, where more tends to be left to delegated legislation.
This reflects that the 1990 Act covered new ground and the sensitivity
of the subject-matter. Unless Parliament considers that there
has been a significant reduction in public concern about the matters
regulated by the 1990 Act, it is appropriate for the pattern of
that Act to be repeated in the new legislation. We also note however
the extent to which this area is regulated by the European Union
and so subject to secondary legislation under the European Communities
Act 1972.
Definitions—clause 14(5)
4. Section 1 of the 1990 Act defines "embryo",
"eggs", "sperm" and "gametes". These
expressions are central to the Act: for example, the basic prohibitions
in sections 3 and 4 are framed in terms of embryos or gametes,
e.g. the prohibition on keeping or using an embryo without a licence.
Clause 14(1) to (4) of the draft bill amends the definitions.
In addition, clause 14(5) gives power to the Secretary of State,
by regulations subject to affirmative procedure, to expand (but
not contract) the definitions. This, and the associated restrictions
on the power, are explained at paragraphs 25 and 26 of the memorandum.
5. The use of an affirmative procedure order
to bring additional matters within the scope of an Act is well
established. Since the power in this case may be used only in
the light of developments in science or medicine, and cannot be
used to apply the Act to items which could not reasonably be described
as embryos, eggs, sperm or gametes, we do not consider the approach
inappropriate.
Permitted eggs and embryos—clause 16(5)
6. Section 3(2) of the 1990 Act (as amended by
clause 16(2) of the draft bill) prohibits placing in a woman an
embryo other than a permitted embryo, and gametes other than permitted
eggs or permitted sperm. Permitted embryos, eggs and sperm are
defined in new section 3ZA, inserted by clause 16(5). New section
3ZA(5) enables the Secretary of State (by regulations subject
to affirmative procedure) to provide that "permitted egg"
and "permitted embryo" can include an egg or embryo
which has undergone a process to prevent transmission of serious
mitochondrial disease. This is explained at paragraphs 53 and
54 of the Explanatory Notes; and paragraph 30 of the memorandum
explains that the resulting eggs or embryos would have a genetic
contribution from 3 individuals.
7. As a delegation, the power is well circumscribed
with a clear principle. The extension might have serious and complicated
knock-on effects (see clause 34 and paragraph 11 below), but the
extent of the extension is apparent from the bill itself and can
be debated and amended if this draft were introduced as a bill.
Although we would not have difficulty with the delegation, there
may be policy reasons for excluding the provision from the bill,
regardless of whether or not the extension is in the bill itself
or delegated to the Secretary of State.
Research licences: inter-species embryo etc.—Schedule
2, paragraph 6 and clause 23
8. Clause 17(2) (new section 4A(2) of the 1990
Act) prohibits mixing human and animal gametes or creating, keeping
or using an inter-species embryo without a licence. Schedule 2
to the 1990 Act, as amended by the draft bill, sets out in detail
the specific activities (in connection with treatment, non-medical
fertility services, storage and research licences) which may be
licensed. To reflect clause 17(2), new paragraph 3(3) of Schedule
2 to the 1990 Act, inserted by paragraph 6 of Schedule 2 to the
bill, enables the Secretary of State, by regulations subject to
affirmative procedure, to authorise activities falling within
new section 4A(2) of the 1990 Act.
9. In contrast, paragraph 3(1) of Schedule 2
to the 1990 Act is specific about the activities which may be
licensed in connection with human embryos. If a bill were introduced
containing provision similar to paragraph 6 of Schedule 2 in the
draft bill, we would require a more convincing explanation than
that provided in paragraphs 33 to 36 of the memorandum as to why
the bill itself cannot specify which activities the regulations
may authorise for inter-species embryos. A similar point arises
on clause 23 (paragraphs 37 and 38 of the memorandum).
Licensing procedures etc.—clauses 27 and 28
10. The Regulatory Authority for Tissue and Embryos
(RATE) is empowered by the draft bill to prescribe its own procedures
for licensing and reconsideration of decisions. In other regulatory
contexts, this is sometimes done by the Secretary of State by
regulations subject to a parliamentary procedure, but empowering
a regulatory body to set its own procedures is not an inappropriate
or unprecedented way to proceed. The Joint Committee should note
however that, if this latter model is chosen, Parliament cannot
expect to retain powers of scrutiny over the procedures.
Mitochondrial donation—clause 34
11. Clause 34 is explained at paragraphs 56 and
57 of the memorandum and paragraphs 149 and 150 of the Explanatory
Notes. The power (subject to affirmative procedure) is to modify
specific provisions of the 1990 Act in relation to particular
circumstances specified in the bill (an egg or embryo created
from material provided by two women). The scope of the delegation
is not inappropriate, but the exercise of the power would raise
difficult issues, some of which are identified at paragraph 57
of the memorandum. These issues justify the affirmative procedure
provided, but we do not accept that this is appropriate for delegated
legislation simply because the modifications are contingent upon
regulations being made under section 3ZA(5) (paragraph 56 of the
memorandum). If a bill were introduced containing this provision,
we would need to be convinced as to why the modifications should
not be set out in the bill itself, even if they would need to
be expressed to have effect contingent upon regulations being
made under section 3ZA(5).
Fees—clauses 35, 68 and 69
12. The draft bill confers a power direct on
RATE to charge fees and does not confer power on a Minister to
prescribe what the Authority may charge (paragraph 58 of the memorandum).
Under new section 35B(2) of the 1990 Act (inserted by clause 35)
the Secretary of State and the Treasury have an element of control:
they must each approve RATE's charging scheme; but there is no
Parliamentary control. (Neither is there any Parliamentary control
over the fees of the HFEA at present.) What the draft bill proposes
is not inappropriate as a matter of delegation but there are other
models available as a matter of policy. For example, a common
alternative model is for the Secretary of State to prescribe by
regulations what the public authority may charge; and those regulations
are often subject to a parliamentary procedure. The same applies
to clause 68 (licences under the 2004 Act).
13. Clause 69 enlarges the powers conferred on
a Minister of the Crown to make subordinate legislation under
section 2(2) of the European Communities Act 1972, as explained
at paragraph 66 of the memorandum. Though the extension is modest
in its scope (being limited to implementation of the Directives
referred to in clause 2), we would require the fullest justification
for the need for this provision if this were an actual bill. For
example, the department would need to explain what limitation
in the 1972 Act prevents the implementing legislation from authorising
fees, so far as the Directives require, authorise or do not prevent
charging fees; and why this case justifies overriding any such
limitation.
Embryo testing and sex selection—Schedule 2,
paragraph 3
14. Paragraph 3 of Schedule 2 to the bill alters
the list of activities which may be licensed under the 1990 Act.
It inserts new paragraphs 1ZA and 1ZB of Schedule 2 to the 1990
Act, which deal with embryo testing and sex selection respectively.
This is explained at paragraphs 63 to 69 of the Explanatory Notes
and paragraphs 70 to 72 of the memorandum. New paragraph 1ZC enables
the Secretary of State, by regulations subject to affirmative
procedure, to amend paragraph 1ZA and make consequential amendments
to paragraph 1ZB. Paragraph 1ZC(3) restricts the power so that
it cannot be used to enable the authorisation of embryo testing
etc. to establish sex except on grounds relating to the health
of the resulting child.
15. Paragraph 71 of the memorandum explains that
the power will enable testing for new purposes that may be developed
in the future to be regulated. The power may be used to add to,
or remove from, the list of permitted purposes or alter the restrictions
in paragraph 1ZA(2) to (5). This power is not inappropriately
wide in principle but, if there are any particular ways in which
Parliament would not wish the power to be exercisable, those ways
should be specified in the bill, in addition to the restriction
about sex selection on non-health grounds.
LORD SHAW OF NORTHSTEAD
13 June 2007
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