APPENDIX 3: CALL FOR EVIDENCE
SCOPE OF THE COMMITTEE'S INQUIRY
The Joint Committee will be looking at all provisions
in the draft Human Tissue and Embryos Bill and welcomes Written
Evidence on all aspects of it.
However, as the Committee has to report by 25 July,
it has had to prioritise some provisions of the Bill on which
it would particularly welcome Written Evidence. These are:
The draft Bill overall
1. Are the proposals in the draft Bill necessary,
sufficient and workable? Could the proposed outcomes be achieved
by better means?
2. Does the regulatory architecture set out in
the draft Bill contain the right balance between:
(i) Parliamentary control via primary legislation
and secondary legislation (regulation making powers);
(ii) Regulation by the regulatory body (or bodies);
(iii) Appropriate flexibility and freedom for
clinicians and researchers; and
(iv) Appropriate opportunities for individuals
to access treatment.
3. How should Parliament and the regulatory body
or bodies ensure an appropriate ethical framework to secure and
maintain public confidence?
RATE and the new regulatory architecture
Clause 1 of the draft Bill proposes a new Regulatory
Authority for Tissue and Embryos (RATE) to replace the existing
Human Fertilisation and Embryology Authority (HFEA) and the Human
Tissue Authority (HTA). Schedule 1 sets out the constitution of
RATE and how it will operate.
4. (a) What are your views on the proposed transfer
of the functions of the HFEA and HTA to a single new regulatory
authority, RATE?
(b) What are your views on the provisions in Schedule
1 about RATE's constitution and administration?
Funding RATE
The Government proposes to continue existing funding
arrangements so that RATE would be funded in part by grant-in-aid
from the Department of Health, with the bulk of the costs of regulation
recovered via licence fees (see Regulatory Impact Assessment,
paragraph 4.42). Clauses 35, 37, 38, 68 and 69 of the draft Bill
allow RATE to charge fees in respect of licenses.
5. Would the proposed funding of the regulatory
body or bodies allow it (or them) to carry out its functions fully
and effectively?
6. Should the regulatory body or bodies be allowed
to make charges for licenses?
PART 2 of the Draft Bill
Definitions
Clause 14 of the draft Bill revises the statutory
definitions of 'embryo', 'egg', 'sperm' and 'gamete'. Clause 15
revises the statutory definition of 'nucleus'. Clause 14 also
gives the Secretary of State regulation-making power to expand
these definitions if it appears to him to be necessary or desirable
to do so in the light of developments in science or medicine (subject
to some restrictions).
7. (a) Do you agree with new definitions in the
draft Bill of 'embryo', 'egg', 'sperm', 'gamete', 'nucleus'? If
not, how would you propose to amend them?
(b) Should the Secretary of State have the regulation-making
power to expand these definitions as proposed in the draft Bill?
Inter-species embryos (for example, cytoplasmic
hybrid embryos)
The text of the draft Bill (particularly in clause
17 and Schedule 2) reflects the position in the Government's White
Paper that the creation of hybrid and chimera embryos in vitro
is prohibited, but that a regulation-making power would allow
Parliament to agree exceptions to that prohibition for research
purposes.
On publication of the draft Bill, the Government
announced that it now intends to accept (in part) the approach
advocated by the Commons Science and Technology Select Committee,
that legislation should provide for certain inter-species entities
to be created for research purposes under licence by the Regulator
within a 14-day limit. The Government proposes that the entities
to be permitted should be limited to those listed in clause 17(2)
inserted section 4A(5)(b) to (d) on page 9 of the draft Bill (see
also paragraph 1.12 of the introduction to the draft Bill on page
ix). This would exclude from the licensing regime "pure hybrids"
as described in clause 17(2) inserted section 4A(5)(a) and (e)
on pages 9 and 10.
The Science and Technology Committee, in its recent
Report "Government proposals for the regulation of hybrid
and chimera embryos", goes further than the Government's
new position and recommends that legislation should be permissive
and provide that "in general, the creation of all types of
human-animal chimera or hybrid embryos should be allowed for research
purposes" under licence by the Regulator (recommendations
22 and 26 on page 63 of that Report). Furthermore, the Committee
recommended that licensing should not allow for the development
of interspecies embryos past the 14-day limit unless proved necessary.
8. (a) Do you support:
(i) the approach signalled by the Government
in the White Paper,
(ii) the new approach announced by the Government
(as outlined above); or
(iii) the approach recommended by the Commons
Science and Technology Committee?
Research licences
In addition to the new provisions on inter-species
embryos, clause 18 and Schedule 2 of the draft Bill consolidate
the purposes for which licences for research can be granted and
extend the principle purposes listed in paragraph 6 of Schedule
2.
8. (b) How should Parliament approach legislating
for those purposes for which licences for research may be granted
in the future (arising out of future research) but that are not
yet determined? Should such judgements be left to the regulatory
body or bodies to determine?
9. How should Parliament or the regulatory body
or bodies take public views and public engagement into account?
Embryo testing and sex selection practices
Clause 18 and Schedule 2 of the draft Bill propose
changes to existing statutory limits on those activities that
can be licensed. This covers conditions under which embryo testing
may be carried out, for example to test for tissue compatibility
that could be used to treat siblings with a life-threatening medical
condition (tissue typing), or testing for an abnormality that
may affect the embryo's capacity to result in live birth. It also
covers the conditions under which practices involving sex selection
may be licensed—where there is a particular risk of a woman
giving birth to a child with a chromosomal abnormality involving
a significant risk of developing a serious physical or mental
disability, a serious illness or any other serious medical condition.
Sex selection for non-medical reasons is not permitted, nor is
it permitted to select specifically for an abnormality, such as
deliberately choosing an embryo which would result in a deaf child.
10. What are your views on the provisions in
paragraph 3 of Schedule 2 setting out the conditions under which
(a) embryos can be tested and (b) sex selection practices can
be carried out?
Consent to storage and use of gametes and embryos
Clause 20 (and Schedule 3) make changes to existing
provisions about consent to, and use of, gametes and embryos.
11. What are your views on the proposed changes
to consent provisions?
Treatment conditions
Clause 21 of the draft Bill proposes changes to
the conditions of licences for providing treatment services. It
proposes to remove from the existing conditions of licences the
requirement to take account of "the need of that child for
a father" before treatment services can be provided.
12. What are your views on the proposal in the
draft Bill to remove from the existing conditions of treatment
the requirement to take account of "the need of that child
for a father" before treatment services can be provided?
Clause 21 also extends the requirement to take
account of the welfare of the child to all treatment services
(not just those currently covered by the 1990 Act) as a result
of the European Tissue Directive.
13. What are your views on the approach to the
welfare of the child provisions in clause 21?
Storage limits
Clause 22 of the draft Bill proposes to increase
the statutory storage period for embryos from 5 years to 10 years
to match the statutory storage period for gametes.
14. Do you support the proposal to increase the
storage period from 5 to 10 years? Should the storage period for
gametes and embryos be limited by statute at all?
Register of information and access to the Register
Clause 32 of the draft Bill replaces existing
legislative provisions about the Register of information with
new provisions about the Register of information that RATE must
keep and the entitlements of certain persons to access information
on the Register. This includes extending to a donor-conceived
person about to enter a civil partnership the existing provision
allowing a donor-conceived person to obtain information about
whether they are related to the person they intend to marry. Clause
33 contains restrictions on the disclosure of information.
15. What are your views on the provisions about
the Register and access to it in clauses 31, 32 and 33 of the
draft Bill?
PART 3 of the draft Bill
Parenthood and the use of sperm or transfer of
embryo after death
Part 3 of the draft Bill (clauses 39 to 64) makes
provision for legal parenthood in cases involving assisted reproduction,
including making more precise provision for unmarried couples
or partners and clarifying provisions about consent that must
be provided before treatment.
16. What are your views on the provisions covering
parenthood and consent in Part 3 of the draft Bill? Are there
any particular provisions in these clauses you would seek to change?
PART 4 of the draft Bill and other provisions
Legislating for future scientific development
In certain places, the draft Bill seeks to legislate
now to regulate future scientific developments that are necessarily
uncertain. In particular, it seeks to make provision:
(i) for Parliament to pass Regulations
to allow relevant provisions of the Act to have effect in cases
where an egg or an embryo has been created from mitochondrial
material provided by 2 women (sometimes called "artificial
gametes") (clause 34); and
(ii) for Parliament to pass Regulations
making the sale, supply and advertisement of sperm sorting kits
an offence, if such kits are developed in the future (clause 65).
17. Is it either desirable or appropriate for
Parliament to seek to legislate in this way for future technology,
both in general terms and in the particular cases identified?
Is such legislation likely to be legally effective?
Embryo transfer in treatment
The draft Bill does not cover regulations relating
to the conditions of transfer of embryos during treatment.
18. Should this be a matter for the regulatory
body? Or for the National Institute for Health and Clinical Excellence
(NICE)? Should it be regulated at all?
Other issues
19. Are there any other provisions in the draft
Bill, or provisions you would like to see in the draft Bill, on
which you would like to give your views?
| 
