APPENDIX 2: HUMAN FERTILISATION AND EMBRYOLOGY
BILL [HL]
Memorandum by the Department of Health
1. The purpose of the Human Fertilisation and
Embryology Bill ("the Bill") is to amend aspects of
the law relating to assisted reproduction treatment and embryo
research. It implements the policy proposals contained in the
White Paper Review of the Human Fertilisation and Embryology
Act: Proposals for revised legislation (including establishment
of the Regulatory Authority for Tissue and Embryos) published
in December 2006 (Cm 6989). The Bill was published for review
by a joint committee (the Joint Committee on the Human Tissue
and Embryos (draft) Bill) in May 2007. The committee published
a report[15] on the Bill
and the main recommendations of the committee have been incorporated
into the Bill. In particular the proposed merger between the Human
Fertilisation and Embryology Authority (HFEA) and the Human Tissue
Authority to form the Regulatory Authority for Tissue and Embryos
has been dropped. A delegated powers memorandum was produced for
the draft Bill. Comments on this can be found in appendix 7 of
the report.
2. The Bill comprises 69 clauses. It has three
Parts and has eight Schedules. In amending the Human Fertilisation
and Embryology Act 1990 ("the 1990 Act"), the Bill takes
account of the amendments made by regulations[16]
implementing the European Union Tissue and Cells Directive[17]
as laid before Parliament on 25 April
Review of the Human Fertilisation and Embryology
Act
3. The 1990 Act prohibits bringing about the
creation of an embryo or keeping or using an embryo without a
licence. An embryo is defined as a live human embryo where fertilisation
is complete.
Treatment licences
4. Paragraph 1 of Schedule 2 to the 1990 Act
sets out a list of activities which a treatment licence may authorise,
including bringing about the creation of an embryo in vitro,
keeping embryos, using gametes, placing any embryo in a woman,
carrying out the "hamster test" in relation to sperm[18],
and practices to ensure that embryos are in a suitable condition
to be placed in a woman or to determine whether embryos are suitable
for that purpose. There is also a regulation-making power to extend
the list of activities.
5. A licence for treatment under the 1990 Act—
- may be granted subject to conditions
specified in the licence;
- can only authorise an activity if the activity
appears to the Human Fertilisation and Embryology Authority ("the
Authority") to be necessary or desirable for the purpose
of providing treatment services; and
- cannot authorise altering the genetic structure
of any cell while it forms part of an embryo
(Paragraphs 1(2) to (4) of Schedule 2 to the 1990
Act).
Research Licences
6. Paragraph 3 of Schedule 2 to the 1990 Act
provides that a research licence may authorise:
- bringing about the creation of
embryos in vitro, and
- keeping or using embryos for the purposes of
a project of research specified in the licence.
7. Paragraph 3(5) of Schedule 2 provides that
the "hamster test" may also be authorised under a research
licence (for explanation, see reference in paragraph 4 above).
8. A research licence under the 1990 Act—
- may only authorise an activity
if it appears to the Authority to be necessary or desirable for
one of the research purposes (detailed in paragraph 3(2) of Schedule
2); and
- may only authorise an activity if the Authority
is satisfied that the proposed use of embryos is necessary for
the purposes of the research;
- may be granted subject to conditions specified
in the licence;
- cannot authorise altering the genetic structure
of any cell while it forms part of an embryo.
Storage licences
9. Paragraph 2 of Schedule 2 to the 1990 Act
enables a licence to authorise the storage of gametes or embryos
or both. A storage licence can form part of a treatment or research
licence or be free standing. A licence under paragraph 2 may be
granted subject to conditions specified in the licence.
10. The 1990 Act also contains some absolute
prohibitions including:
- placing in a woman a live embryo
other than a human embryo, or live gametes other than human gametes
(section 3(2));
- keeping or using an embryo after the appearance
of the primitive streak (section 3(3)(a));
- placing an embryo in any animal (section 3(3)(b));
- keeping or using an embryo in any circumstances
in which regulations prohibit its keeping or use (section 3(3)(c))[19];
- replacing a nucleus of an embryonic cell with
a nucleus taken from a cell of any person, embryo or subsequent
development of an embryo (section 3(3)(d));
- using female germ cells taken or derived from
an embryo or foetus, or an embryo created by using such cells,
for the purpose of providing fertility services for any woman
(section 3A(1)).
11. The Authority functions as a statutory licensing
authority and oversees all activities under the 1990 Act. The
activities regulated by the Authority are, by their nature, fast
moving with scientific and clinical developments continually taking
place.
12. In the 1990 Act, there are several delegated
powers that have already been exercised. As described above at
paragraph 6 a research licence can be granted to create, use or
keep an embryo for one of the research purposes listed under paragraph
3(2) of Schedule 2 to the 1990 Act. There is a regulation-making
power under paragraph 3(2), which enables the Authority to authorise
research activities for additional purposes as specified in regulations.
The Human Fertilisation and Embryology (Research Purposes) Regulations
2001 (SI 2000/188) were made under this power. These regulations
enabled the Authority to licence stem cell research[20].
This is an example of how regulation-making powers have enabled
the legislation to be updated to reflect scientific developments.
13. The Government has built upon this model
of regulation-making powers within the Bill to continue to allow
rapid responses within a broad framework agreed by Parliament,
and subject to further scrutiny by Parliament.
Overview of delegated legislative and other
powers
14. The Bill contains 29 delegated powers (18
regulations, 6 orders, 4 direction-making powers and 1 scheme).
Of these, many are subject to the affirmative procedure reflecting
both the ethically sensitive subject matter and the Commons Science
& Technology Select Committee's view that Parliament should
have maximum involvement in relation to matters concerning assisted
conception and embryo research. Some regulation-making powers
will enable primary legislation to be amended by regulation. Such
"Henry VIII powers" will be subject to the affirmative
procedure.
15. A full list of all the delegated powers is
in the table at Annex A. Examples of those that have been included
to take account of scientific developments in the future are:
- inclusion within the definition
of "sperm", "eggs" and "embryo"
of things which would not otherwise fall within those definitions
(clause 1(5) of the Bill, which inserts section 1 (6) into the
1990 Act));
- to allow eggs and embryos with altered mitochondrial
DNA to be classified as "permitted" eggs and embryos
and thus to be implanted in a woman (clause 3(5) of the Bill,
which inserts section 3ZA(5) into the 1990 Act);
- to allow changes relating to embryo testing.
This will allow, for example, the purposes for which embryos can
be tested to be extended, where this would be desirable (paragraph
3 of Schedule 2 to the Bill which inserts paragraphs 1ZA, 1ZB
and 1ZC into Schedule 3 to the 1990 Act).
16. Powers conferred by the Bill are exercisable
either by the Secretary of State or in a limited number of cases
by the Authority.
Territorial effect
17. In cases where the power is not conferred
on the Authority, powers are to be exercised by the Secretary
of State. However, the Scottish and Welsh Ministers and the Department
of Health, Social Services and Public Safety in Northern Ireland
must be consulted before an order is made under clause 64 containing
provision which would, if included in an Act of Parliament, be
within the legislative competence of the relevant Parliament or
Assembly. This position reflects the fact that the Bill relates
to reserved matters, but that some consequential changes (e.g.
in relation to birth registration) impact upon devolved areas.
The same consultation requirement applies before an order can
be made under clause 30, inserting section 45A into the 1990 Act.
Analysis of powers
Clause 1: Meaning of "embryo" and "gamete"
18. Clause 1 of the Bill amends section 1 of
the 1990 Act (meaning of embryo and gamete). The meaning of embryo
has been amended to ensure that the 1990 Act applies to all live
human embryos regardless of the manner of their creation. This
brings the term "embryo" up to date with technologies
that have been developed since the time of enactment of the 1990
Act, such as cell nuclear replacement.
19. The term "gametes" under section
1(4) of the 1990 Act has also been amended to expressly encompass
not only mature eggs and sperm, but also immature gametogenic
cells such as primary oocytes, and spermatocytes or gametes created
in vitro (sometimes referred to as artificial gametes).
20. Clause 1(5) of the Bill inserts section
1(6) into the 1990 Act and grants a regulation-making power to
the Secretary of State to expand the definition of embryos, egg,
sperm or gametes. The purpose of this power is to ensure that
types of embryos and gametes resulting from new scientific developments,
which may not be covered by the existing provision, can be brought
within the scheme of regulation. The power does not extend to
allowing anything containing any nuclear or mitochondrial DNA
that is not human to be treated as an embryo or as eggs, sperm
or gametes. If the power were exercised, it would be possible
to make any amendments to new section 4A of the amended 1990 Act
(prohibitions in connection with genetic material not of human
origin) as appear to the Secretary of State to be appropriate
as a result of exercising the power.
21. The Department of Health does not have any
immediate intention to exercise this power. The power is intended
to be a means of responding, over time, to developments that may
require new types of gametes and embryos to be brought within
the scheme of regulation. The power will also be used to prevent
uncertainty as to what falls within the scope of the 1990 Act.
22. This power is subject to the affirmative
resolution procedure (by virtue of the amendment of section 45
of the 1990 Act by clause 30 of the Bill). This is appropriate
because the power enables primary legislation to be modified.
Clause 3: Prohibitions in connection with embryos
("permitted eggs, sperm and embryos")
23. Clause
3 of the Bill amends section 3 of the 1990 Act to provide that
only permitted embryos or gametes can be placed in a woman. A
permitted embryo is defined as an embryo which has been formed
by the fertilisation of a permitted egg by a permitted sperm,
whose nuclear or mitochondrial DNA has not been altered and that
has not had cells added (apart from by division of the embryo's
own cells). Permitted eggs are defined as eggs produced or extracted
from the ovaries of a woman and permitted sperm as sperm produced
or extracted from the testes of a man. These eggs and sperm must
also not have been subject to any alterations to their nuclear
or mitochondrial DNA.
24. Clause 3(5) of the Bill inserts new section
3ZA(5) into the 1990 Act and grants a regulation-making power
to the Secretary of State to extend the definition of permitted
egg or permitted embryo to include an egg or embryo that has had
applied to it a specific process to prevent the transmission of
a serious mitochondrial disease. If research demonstrates that
treatment to prevent mitochondrial disease is safe and effective,
it may be desirable to allow eggs or embryos which have been treated
in this way to be used for reproductive purposes.
25. It is necessary for this power to be delegated
to be exercised by regulations because data on safety and efficacy
of this technique are not yet available. The power raises important
ethical considerations because it covers the creation of an embryo
using three separate genetic contributions. It is therefore appropriate
that this power is subject to the affirmative procedure (see the
amendment of section 45 of the 1990 Act by clause 30 of the Bill).
Clause 4: Prohibitions in connection with genetic
material not of human origin
26. Clause 4 of the Bill inserts new section
4A into the 1990 Act to provide that certain types of embryo and
gametes cannot be placed in a woman. This includes non-human embryos,
inter-species embryos and non-human gametes. Section 4A also prevents
the mixing of human and animal gametes, the creation of an inter-species
embryo and the keeping or using of an inter-species embryo, without
a licence. Inter-species embryos are defined in section 4A(5)
as:
- human-animal hybrid embryos: created
by the fertilisation of a human egg by the sperm of an animal,
or fertilisation of an animal egg by a human sperm (paragraph
(a)(i)) or the creation of an equivalent entity using one human
pronucleus and one animal pronucleus, taken from a single cell
embryo (paragraph (a)(ii))
- cytoplasmic hybrids (cybrids): created by techniques
used in cloning, using human genetic material and inserting it
into animal eggs or cells, which have had their genetic material
removed. The embryos would genetically be predominantly human
except for the presence of animal mitochondria - (paragraph (b))
- human transgenic embryos: these are embryos created
by the genetic modification of a human embryo, specifically by
the addition of animal nuclear or mitochondrial DNA into one or
more cells of a human embryo- (paragraph (c))
- human-animal chimeras: these are human embryos,
altered by the addition of one or more cells from an animal -
(paragraph (d)).
27. The definition of an inter-species embryo
is precise because a broad definition could have captured the
whole spectrum of entities containing both human and animal DNA,
including predominantly animal entities that are regulated under
the Animal (Scientific Procedures) Act 1986.
28. New section 4A(5)(e) of the 1990 Act grants
a regulation-making power to the Secretary of State to include
other "things" within the definition of inter-species
embryo under the 1990 Act. This enables other entities to be brought
within regulation, for example following developments in scientific
methods to combine animal and human DNA. The power is wide because
the Department of Health cannot predict what form such entities
will take or the methods that will be used to create them. There
may also be existing entities that the Department of Health is
unaware of but that should be regulated, the power is therefore
not limited to future changes in science but can respond to the
current situation.
29. Another regulation-making power is taken
under paragraph 6 of Schedule 3 to the Bill (amending paragraph
3(5) of Schedule 2 to the 1990 Act) to enable research licences
to be granted in relation to any new forms of inter-species embryo
specified under the power in section 4(5)(e) (see paragraphs 40
and 41 below).
30. Section 4A(7) of the 1990 Act also grants
a regulation-making power to the Secretary of State to amend the
definition of inter-species embryo under new section 4(5). This
power is necessary because it will enable changes if, for example,
new types of embryo are created in future that would be inappropriately
captured by the definition and therefore regulated by the Authority.
This could not be achieved using the regulation making power in
4A(5)(e), which only allows additional categories not changes
to the existing categories.
31. As both powers, if exercised, will amend
primary legislation and the remit of the Authority, it is appropriate
that they are subject to affirmative procedure (see the amendment
of section 45 of the 1990 Act by clause 30 of the Bill).
Clause 8: Power to contract out functions etc.
32. Clause 8 inserts new section 8B, 8C and 8D
into the Act. New section 8C enables the Authority to contract
out its functions. Subsections (1) and (2) of new section 8C specify
certain functions that may not be contracted out. New section
8C(1)(c) confers power on the Secretary of State by order to specify
other functions that may not be contracted out. The purpose of
this is to ensure that where the Secretary of State considers
that it would be appropriate for only the Authority to deal with
a specific function, he can limit the discretion of the Authority
to contract out that function. This power is subject to the negative
procedure (see new section 45B(3), inserted by clause 32 (Orders
under the 1990 Act).
Clause 11 and Schedule 2
Paragraph 3: Embryo testing and sex selection
33. Although the 1990 Act does not specifically
address embryo testing, the courts have determined that the Authority
has discretion to make licensing decisions on this issue. Paragraph
3 of Schedule 2 to the Bill inserts paragraph 1ZA to 1ZC into
Schedule 2 to the 1990 Act to make express provision for embryo
testing under the 1990 Act in the future.
34. Paragraph 1ZA(1) lists the purposes for which
embryo testing can be carried out and clarifies that where embryo
testing for an abnormality is carried out, there has to be a significant
risk that a person with that abnormality will have or develop
a serious illness, disability, or other medical condition.
35. Paragraph 1ZB maintains the existing policy
that sex selection will only be allowed for medical reasons. Paragraph
1ZB(1) prohibits all sex selection practices. Sub-paragraph (2)
makes an exception for embryo testing in accordance with paragraph
1ZA and sub-paragraph (3) makes an exception for other sex selection
practices where there is a particular risk that a woman will give
birth to a child who will have a serious gender related disability,
medical condition or illness.
36. New paragraph 1ZC of Schedule 2 to the 1990
Act introduces a regulation-making power for the Secretary of
State to amend paragraph 1ZA . The power allows any necessary
or expedient consequential amendments to be made to new paragraph
1ZB as a result of any amendments to paragraph 1ZA. However, such
regulations cannot allow sex selection for non-medical reasons.
37. It is possible that in the future new techniques
will be developed to test embryos for new purposes which are not
covered by paragraph 1ZA(1). If considered appropriate by the
Secretary of State, additional purposes could be added to the
list in paragraph 1ZA(1) to enable the Authority to issue a licence
for embryo testing for other purposes. If this power is exercised,
these regulations will amend primary legislation in an area of
particular ethical sensitivity. This power is therefore subject
to the affirmative procedure (see the amendment of section 45
of the 1990 Act by clause 30 of the Bill).
Paragraph 6: Licences for research
38. Under paragraph 3 of Schedule 2 to the 1990
Act, a research licence may authorise the creation, keeping and
use of human embryos for the purposes of a project of research.
Paragraph 6 of Schedule 2 to the Bill substitutes new paragraphs
3 and 3A for the existing provision.
Hamster test
39. Paragraph 3(5) of Schedule 2 to the 1990
Act currently enables the Authority to grant a research licence
for the mixing of sperm with the egg of a hamster (or other animal
specified in directions) in order to carry out research into more
effective techniques for determining the fertility or normality
of sperm. New paragraph 3 (2) of Schedule 2 to the 1990 Act, as
inserted by the Bill, replicates this provision and retains the
power for the Authority to expand the test to other animals under
directions. This direction-making power is required in case other
animal eggs can be used for this purpose.
Licence conditions for new types of inter-species
embryos
40. New paragraph 3 of Schedule 2 to the 1990
Act enables research licences to be granted for specified activities.
This includes creating, using and keeping inter-species embryos
under new section 4A(5)(a) to (d) (paragraph 3(3)).
41. New paragraph 3(5) of Schedule 2 to the
1990 Act introduces a regulation-making power to allow the Authority
to issue research licences to create, use and keep new types of
inter-species embryos specified in regulations under new section
4A(5)(e) - see paragraph 29). New paragraph 3(8) provides that
the regulations may specify mandatory licence conditions in connection
with research involving such new forms of inter-species embryos.
Research purposes
42. A research licence granted under paragraph
3 of Schedule 2 to the 1990 Act may not authorise any activity
unless the Authority considers it to be necessary or desirable
for one of the specified "research purposes" (paragraph
3 (2) of Schedule 2)). The list of purposes for which research
may be licensed has been replaced by new paragraph 3A(2) of Schedule
2 to the 1990 Act and expanded to include research which is undertaken
for the purpose of increasing knowledge, not only about serious
diseases, but also about other serious medical conditions. This
clarifies that licences may be granted for research into conditions
such as neural trauma or other tissue damage, which are arguably
not diseases. The Authority will also be able to licence research
into the underlying principles of cell biology which requires
the use of embryos, where such research is dedicated to the understanding
or treatment of serious diseases and medical conditions.
43. New paragraph 3A(1)(c) introduces a regulation-making
power for the Secretary of State to allow research licences to
be granted for additional specified purposes where this is considered
necessary or desirable. This power replicates the power under
paragraph 3(2) of Schedule 2 to the current 1990 Act which was
exercised under SI 2001/188 (see paragraph 12 above). Provision
has been made for a delegated power because the Department of
Health cannot anticipate what purposes might be considered to
be appropriate in the future. As this power extends the purposes
for which embryos may be used in research it is appropriate that
it is subject to the affirmative process (see the amendment of
section 45 of the 1990 Act by clause 30 of the Bill).
Clause 19: Procedure for refusal, variation and
revocation of licences
44. Clause 19 of the Bill introduces new section
19(6) of the 1990 Act and provides a regulation-making power for
the Authority to make additional provisions about procedure in
relation to the carrying out of functions under sections 18, 18A
and 19 of the 1990 Act. New Section 18 concerns the revocation
of licences either under application or of the Authority's own
volition. New Section 18A concerns the variation of a licence,
again either under application or of the Authority's own volition.
Section 19 sets out the procedure to be followed where the Authority
proposes to refuse the grant, revocation or variation of a licence
or where it intends to revoke or vary a licence of its own volition
or where it intends to impose conditions on the licence in accordance
with provisions in Schedule 2 of the 1990 Act.
45. The procedure set out in new Section 19 includes
a right for the applicant to require the Authority to consider
representations before the decision is made. The regulation-making
power is limited to making additional provision about the procedure
to be followed where representations are made, as well as the
procedure to be followed where an application is made for the
revocation or variation of a licence, or if the Authority seeks
to vary or revoke a licence of its own volition.
46. Among other things the regulations may deal
with the procedure to be followed by the Authority in determining
such applications.
47. Clause 19 of the Bill also inserts new section
19B into the 1990 Act to grant the Authority the power to make
directions concerning licence applications, specifically about
the form and content of applications or the information which
must be supplied with an application (section 19B(1)). New section
19B(2) enables the Authority to make regulations making other
provision about licence applications, in particular in relation
to decision-making procedures. These regulations can include provision
for requiring people to give evidence or produce specific documents
and determine the admissibility of the evidence.
48. While the Bill includes provisions relating
to the giving of notice about decisions and for representations
to be made, detailed provisions have not been included in the
Bill either about procedure or the form of application. Regulations
under new section 19(6) or 19B(2) will be statutory instruments,
but they are not required to be laid before Parliament. Clause
30 of the Bill amends section 45 of the 1990 Act so that only
regulations made by the Secretary of State are subject to Parliamentary
control.
49. The Department of Health takes the view that
this is appropriate in these cases, given that the regulations
will concern purely administrative and procedural matters. Regulations
made by statutory instruments provide legal certainty because
they show that the text included in the regulations was in force
at a particular time.
Clause 21: Reconsideration and appeals
50. Clause 21 substitutes sections 20 and 21
of, and introduces new section 20A and 20B in, the 1990 Act.
51. Substituted section 20 sets out the rights
of appeal against licensing decisions of the Authority.
52. New section 20A provides that the Authority
must maintain one or more appeals committees. The constitution
of appeals committees and the manner in which their proceedings
must be carried out will be set out in regulations made by the
Secretary of State. The regulations may also provide for advisors
to be appointed to appeals committees. This is so that the committees
can receive specialist scientific, legal and other advice.
53. New section 20B provides that reconsideration
of licensing decisions and suspension notices will be by way of
a fresh decision. It provides for regulations to make provision
about the procedure to be followed. Those regulations may in particular
include provisions concerning the right of the appellant and the
Authority to appear before the committee, for the committee to
consider written representations, requirements concerning evidence
and the production of documents; and requirements concerning decisions
of the committee.
54. Again, detailed provisions concerning appeals
have not been included on the face of the Bill because, in the
Department's view, it is appropriate for these to be dealt with
by regulations in order that a degree of flexibility is maintained.
The nature of the decisions against which appeals may be made
to the Authority may require different and specialist committees
to consider them. Regulations will provide the flexibility to
ensure that appeals committees may be set up to ensure that proper
regard is had to the Authority's policy role as well as to ensure
that appellants have confidence in their impartiality in making
decisions. In addition, best practice in administrative appeals
is developing over time and the regulation-making power will provide
the necessary flexibility to ensure that the Authority's appeals
process is kept up to date.
55. Regulations under new sections 20A and 20B
must be made by the Secretary of State and are subject to the
negative procedure (see the amendment of section 45 of the 1990
Act by clause 30 of the Bill
Clause 22: Directions
56. Section 24 of the 1990 Act makes provision
about directions in relation to particular matters. Clause 22(4)
inserts new section 24(4B) into the 1990 Act to grant a regulation-making
power for the Secretary of State to require or authorise the Authority
to give directions in relation to activities involving inter-species
embryos (under new section 4A(2) of the 1990 Act). This power
is necessary because it is not possible to anticipate all the
necessary controls that may need to be placed on such research
given the current low level of activity in this field. The power
will allow the Department of Health to respond in the future to
ensure that this area is properly regulated. Regulations under
section 24(4B) will be subject to affirmative procedure (see the
amendment of section 45 of the 1990 Act made by clause 30 of the
Bill).
57. Clause 22(2) of the Bill inserts new section
24(3B) into the 1990 Act and provides a power for the Authority
to authorise by directions the keeping of embryos in the course
of the carriage between premises. This ensures that where necessary
inter-species embryos can be transported without triggering the
requirement for a licence. This makes equivalent provision as
for embryos under section 24(3) of the 1990 Act and will avoid
imposing additional regulatory burdens where this would be impractical.
58. Clause 23(3) of the Bill amends section 24(4)
of the 1990 Act so that the power in section 24(4) for the Authority
to issue directions authorising the import or export of gametes
and embryos is extended to inter-species embryos. The directions
can specify conditions and modify the licence conditions under
sections 12 to 14 of the 1990 Act. This power enables the Authority
to monitor and regulate import and export, it is therefore important
that the power extends to inter-species embryos.
59. Clause 22(5) introduces new section
24(5A) into the 1990 Act, which enables the Authority to
issue directions for the purpose of dealing with a situation arising
in consequence of variation of a licence, or a licence ceasing
to have effect. Further detail about these directions is found
in new subsections (5B) to (5E). These subsections replace similar
provision currently in section 24(7) to (10) of the 1990 Act.
Directions may be required if for example a licence ceases to
have effect to ensure that certainty is maintained and that information
and material is secured. It is necessary for this to be determined
in directions because the nature of what is required will vary
according to the circumstances of each case.
Clause 24: Register of information
60. Section 31 of the 1990 Act requires the Authority
to keep a register of information obtained by it which relates
to the provision of treatment services to any identifiable individual,
or the keeping or use of any gametes of any identifiable individual
or an embryo taken from an identifiable woman. It also requires
the Authority to keep a register of information obtained by it
about people born as a result of treatment services. This section
also makes provision for people conceived as a result of donated
gametes and born since the 1990 Act came into effect to require
the Authority to provide them with certain information.
61. Clause 24 replaces the existing section 31
of the 1990 Act with substituted sections 31 to 31ZE. Section
31ZA enables a donor conceived person ("the applicant")
to obtain information about their donor and about whether they
are related to a person who they intend to marry or enter a civil
partnership with or with whom they are having or intend to have
an intimate physical relationship.
62. Clause 24 of the Bill inserts new subsection
31ZA(2)(a) into the 1990 Act and empowers the Secretary
of State to specify in regulations what information relating to
the donor of an applicant should be provided to them by the Authority.
This power corresponds to the existing power in section 31(4)(a)
of the 1990 Act and, as with the existing power, is subject to
affirmative procedure (see the amendments of section 45 of the
1990 Act in clause 30). If identifying information was provided
to a clinic at a time when the Authority could not have been required
to give information of that kind regulations cannot subsequently
require the Authority to disclose it.
63. Regulations[21]
were made in 2004 which prescribed the information that the Authority
must provide (by virtue of section 31(4)(a) of the 1990 Act))
in response to a request from a person, who was, or may have been,
born as a result of assisted conception including the use of donated
sperm, eggs or embryos. The regulations specify the information
that must be provided to the applicant if the donor provided the
information from 1st April 2005 when the regulations
came into force, including identifying information. The power
to make regulations is therefore retained in case additional information
needs to be set out in new regulations in the future. The 2004
regulations are retained separately rather than incorporated within
the primary legislation so that any future amendments may more
easily be made.
Clause 25: Restrictions on disclosure of information
64. Clause 33 of the Bill inserts new section
33A(1) of the 1990 Act and prohibits the disclosure of information
contained in the register except in accordance with specified
exceptions. Where the prohibition on disclosure does not apply,
the common law on confidentiality and the Data Protection act
1998 will still apply.
65. Clause 25 of the Bill inserts new section
33B(1) into the 1990 Act and enables the Secretary
of State to make regulations providing for additional exceptions.
This is subject to the limitation of that power in section 33B(2)
which does not allow the regulations to enable disclosure of information
relating to donor identities or legal parenthood. This delegated
power allows flexibility to introduce new categories where the
prohibition on disclosure will not apply, whilst at the same time
ensuring that unless an exception applies an additional layer
of confidentiality applies. Where the prohibition on disclosure
does not apply, the common law on confidentiality and the Data
Protection Act 1998 will still apply. Regulations made under this
power would require affirmative resolution (see the amendment
of section 45 of the 1990 Act made by clause 30 of the Bill).
66. Clause 25 of the Bill also inserts new section
33C(1) into the 1990 Act and enables regulations to be made to
require or regulate the processing of information held on the
register for the purposes of research. Currently information relating
to treatments cannot generally be utilised by medical researchers
because of the restrictions around disclosure of information.
The information on the register could be of great value for researchers
enabling them to understand more about the long-term consequences
of assisted conception treatments. This power is conferred on
the Secretary of State to exercise if he considers it to be in
the interests of improving patient care (in the case of disclosure
for medical research) or in the public interest (in the case of
disclosure for medical or other research). The regulation making
power does have limits. The Bill provides that the Secretary of
State may not enable or require the disclosure of identifying
information if it would be reasonably practicable to achieve the
intended purpose without the disclosure. The regulations may also
require compliance with prescribed conditions in connection with
the disclosure of protected information. Also, any disclosure
under the regulations will still need to be consistent with the
Data Protection Act 1998. There is a similar power in section
251 of the National Health Service Act 2006.
67. Under section 33C(2)(d) of the 1990 Act,
the regulation-making power in section 33C(1) enables one
or more bodies to be established to exercise prescribed functions
in relation to processing of the protected information. This will
allow a specific body to be established either in a part of the
UK where there is currently not one with a similar function or
one to serve the whole of the UK. This regulation-making power
will allow information on the register to be utilised in specific
instances. This power has been introduced to deal with the technicalities
involved with establishing a process for releasing information,
taking into account differences in established procedures throughout
the UK. When exercising this power the Secretary of State will
need to ensure that any regulations are compliant with the European
Convention on Human Rights.
68. The power to make regulations under section
33C is subject to affirmative procedure (see the amendment of
section 45 of the 1990 Act made by clause 30)
Clause 26: Mitochondrial donation
69. New section 35A as inserted by clause 26
grants a regulation-making power to the Secretary of State to
amend specified provisions under the 1990 Act if regulations are
passed under new section 3ZA(5) (see paragraph 24) to include
embryos or eggs that have been modified to avoid the transmission
of a serious mitochondrial disease in the definition or "permitted
embryo" or "permitted egg". This would result in
an embryo or egg being created using genetic material from two
women.
70. The following provisions of the 1990 Act
could be amended under this regulation-making power:
- register of information (section
31 of 1990 Act),
- provision of information (sections 31ZA-31ZD
of 1990 Act),
- consent to use gametes and embryos (Schedule
3 of 1990 Act)
- parental orders (section 60).
71. For example it might be appropriate to make
modifications to provisions on parental orders, to clarify that
the woman who donated the egg with healthy mitochondria could
not apply for a parental order on the basis of only having provided
mitochondrial DNA (rather than nuclear DNA as well). Or it may
be desirable to make provision that the consent must be obtained
from the woman donating the egg with healthy mitochondria to be
used for this specific purpose. The power to make these regulations
is necessary because such changes to the 1990 Act will not be
relevant until such time when the power under new section 3ZA(5)
is exercised. The question of which provisions ought to apply
to mitochondrial donors should be subject to consultation at the
time when such regulations are made in order to ensure that the
policy reflects appropriately the views of society at the time.
The power is subject to affirmative procedure and is exercisable
by the Secretary of State (see the amendments of section 45 of
the 1990 Act made by clause 30 of the Bill).
Clause 27: Fees
72. Clause
27 inserts into the 1990 Act a new section 35B providing for fees
under the Act to be determined by the Authority in a scheme subject
to the approval of the Secretary of State and the Treasury. The
scheme is not made by statutory instrument or subject to any parliamentary
procedure. This reflects the existing position in relation to
the fees mentioned in 16(6) of the 1990 Act, which are fixed administratively
by the Authority. The power in the new section 35B is mentioned
here for completeness, but is not regarded as a delegated legislative
power.
Clause 28: Powers of inspection, entry, search
and seizure, Schedule 5, paragraph 4
73. Clause 28 inserts new section 38A into the
Act which provides for new Schedule 3B to have effect. It also
inserts new schedule 3B (which is set out in schedule 5 to the
Bill) into the Act. Paragraph 4 of this new Schedule relates to
the execution of warrants and includes a regulation-making power
to enable the Secretary of State to specify what information should
be contained within the 'appropriate statement' given to a person
on the premises during the execution of the warrant. The power
is subject to negative resolution procedure (by virtue of the
general provision in section 45(5) of the 1990 Act). This power
is delegated to enable changes to be made to the content of the
statements which must be given when the warrants are executed
under Schedule 5 of the 1990 Act.
Clause 31: Power to make consequential provision
74. Clause 31 introduces new section 45A into
the 1990 Act. This enable the Secretary of State to make an order
to modify any provision made by or under any enactment as he sees
necessary or expedient to after introducing regulations under
the following provisions of the 1990 Act:
- section 1(6) - power to include
things within the meaning of "embryo" and "gamete"
etc.
- section 4A(5)(e) - power to include things within
the meaning of "inter-species embryo"
- section 4A(7) - power to amend the definition
of "inter-species embryo"
75. The power to make such amendments by order
is necessary to ensure that any relevant legislation can be updated
as appropriate should regulations be made to alter definitions
of embryo or inter-species embryos. The Department of Health is
unable to predict how the regulations will be used and therefore
what other legislation might need to be modified. The order would
be subject to affirmative resolution by virtue of new section
45B (4), as inserted by clause 32.
Clause 55: Parental orders: supplementary provision
76. The Bill makes provision as to parenthood
in cases involving both assisted reproduction and surrogacy. There
are new provisions extending the categories of couples who can
apply for a parental order where a child has been conceived using
the genetic material of one of the couple, and has been carried
by a surrogate mother, and where specified conditions apply. Currently,
only married couples can apply for a parental order. Under the
new provisions, civil partners would also be able to apply, as
would couples who are not married or not in a civil partnership
but who are in an 'enduring family relationship'. The other provisions
relating to parental orders remain the same as the existing provisions
of the 1990 Act. A single person remains unable to apply, but
would be able to apply to adopt the child from the surrogate mother.
77. Clause 55(1) of the Bill introduces
a regulation-making power for the Secretary of State to apply
certain legislation about adoption to parental orders, with any
necessary modifications. It also provides a power to require that
references in any enactment to adoption, an adopted child or an
adoptive relationship be read as references to a parental order,
a child who is the subject of such an order, or a relationship
arising from such an order.
78. A similar power is currently to be found
in section 30(9) of the 1990 Act and has been exercised in the
Parental Orders (Human Fertilisation and Embryology) Regulations
1994 (SI 1994/2767). One provision made by these regulations,
is the application to parental orders of the duty under the Adoption
Act 1976 to promote the welfare of a child who may be adopted.
The 1994 regulations will have to be revoked and replaced by new
regulations on implementation of the Bill, in order to take account
of the changes to be made by the Bill and provision made by the
Adoption and Children Act 2002.
79. The purpose of this delegated power is to
enable such of the existing legislation concerning adoption as
is considered appropriate to be applied to parental orders, rather
than replicating it all in the primary legislation. The policy
to date has been to apply provisions about the effect of adoption,
birth registration and so on, but not to apply provisions requiring
detailed consideration of the suitability of the applicants (on
the basis that at least one of them is genetically related to
the child) The regulation-making power also allows for any changes
that may be made in the future to adoption legislation, to also
apply to parental orders. It is a delegated power because it is
not possible to know what amendments to the legislation relating
to adoption may be made. This regulation-making power is subject
to affirmative resolution (see clause 62(4)).
Clause 56: Schedule 6: Amendments relating to
parenthood in cases involving assister reproduction
80. Clause 56 provides for Schedule 6 to the
Bill to take effect.
Paragraph 26 inserts new section 4ZA into the
Children Act 1989: Acquisition of parental responsibility by female
second parent
81. Paragraph 26 of Schedule 6 to the Bill introduces
new section 4ZA to the Children Act 1989 ("the 1989 Act").
Paragraph 4ZA makes provision for the female second parent to
acquire parental responsibility for a child by registering as
the child's parent in the register of births under any of the
enactments listed in section 4ZA(2) of the 1989 Act, by making
a parental responsibility agreement with the child's mother, or
by obtaining a court order. Subparagraph (3) of new section 4ZA
of the 1989 Act gives power to the Secretary of State to make
an order to amend the list of enactments referred to in new section
4ZA (2) of the 1989 Act. The order making power is required so
that if any new legislation is introduced that allows a person
to acquire parental responsibility for a child, this could be
applied to those who are female second parents by virtue of the
provisions in the Bill. This order would be subject to affirmative
resolution according to section 104 of the Children Act 1989,
as amended by paragraph 29 of Schedule 6 to the Bill.
Clause 64: Power to make consequential and transitional
provision etc.
82. Clause 64 of the Bill gives power
to the Secretary of State to make, by order, consequential or
transitional provisions that are considered necessary or expedient
to give full effect to the provisions of the Human Fertilisation
and Embryology Bill. An order may in particular amend or repeal
any existing primary or secondary legislation. Before making an
order under this power that would fall within the legislative
competence of the Scottish Parliament, National Assembly for Wales
or Northern Ireland Assembly a consultation requirement is imposed.
Orders under clause 64 are subject to negative resolution. However
if an order amends or repeals existing legislation then the affirmative
procedure will apply.
Clause 67: Extent
83. Clause 67(3) of the Bill provides that the
provisions in the Bill can be extended to apply to Guernsey. The
provisions can be extended either in an amended form or as they
appear in the Bill. This does not enable extension to Guernsey
of provisions of the Bill which amend other enactments which do
not extend to Guernsey. This delegated power is an order which
can be exercised by Her Majesty the Queen in Council.
Clause 66: Commencement orders
84. Clause 68(2) introduces the power to bring
provisions of the Bill (other than those mentioned in clause 68(1))
into force. This is exercisable by the Secretary of State by order
made by statutory instrument. In accordance with the usual practice,
no Parliamentary procedure will apply to such orders.
Department of Health
November 2007
| Clause No. | Section No. (Amended Act - where applicable)
| Instrument | Wording | Power conferred on
| Procedure (where applicable) | Reference in memo
|
| 1(5) | 1(6) | Regulations
| If it appears to the Secretary of State necessary or desirable to do so in the light of developments in science or medicine, regulations may provide that in this Act (except in section 4A) "embryo", "eggs", "sperm" or "gametes" includes things specified in the regulations which would not otherwise fall within the definition.
| Secretary of State | Affirmative
| 20 |
| 3(5) | 3ZA(5) | Regulations
| Regulations may provide that:
(a) an egg can be a permitted egg, or
(b) an embryo can be a permitted embryo,
even though the egg or embryo has had applied to it in prescribed circumstances a prescribed process designed to prevent the transmission of serious mitochondrial disease.
| Secretary of State | Affirmative
| 24 |
| 4(2) | 4A(5)(e) | Regulations
| (5) For the purpose of this Act an inter-species embryos is—
(e) such other things as may be specified in regulations.
| Secretary of State | Affirmative
| 28 |
| 4(2) | 4A(7) | Regulations
| Regulations may amend the definition of inter-species embryo in subsection (5)
| Secretary of State | Affirmative
| 30 |
| 8 | 8C(1)(c) | Order
| This section applies to any function of the Authority other than - (c) a function excluded from this section by the Secretary of State by order.
| Secretary of State | Negative
| 32 |
| 11
Schedule 2 paragraph 3 | 1ZC
(Schedule 2)
| Regulations | (1) Regulations may amend paragraph 1ZA (embryo testing). (2) Regulations under this paragraph which amend paragraph 1ZA may make any amendment of sub-paragraphs (2) to (4) of paragraph 1ZB (sex selection) which appears to the Secretary of State to be necessary or expedient in consequence of the amendment of paragraph 1ZA (embryo testing).
| Secretary of State | Affirmative
| 36 |
| Schedule 2 paragraph 6 | Schedule 2 paragraph 3(2)
| Directions | A licence under this paragraph may authorise mixing sperm with the egg of a hamster, or other animal specified in directions, for the purpose of developing more effective techniques for determining the fertility or normality of sperm, but only where anything which forms is destroyed when the research is complete and, in any event, no later than the two cell stage.
| The Authority | | 39
|
| Schedule 2 paragraph 6 | Schedule 2
paragraph 3(5)
| Regulations | If regulations so provide, a licence under this paragraph may authorise any of the following -
(a) bringing about the creation in vitro of things that are inter-species embryos by virtue of regulations under paragraph (e) of section 4A(5), and
(b) keeping or using things that inter-species embryos by virtue of regulations under that paragraph, for the purposes of a project of research specified in the licence.
| Secretary of State | Affirmative
| 41 |
| Schedule 2 paragraph 6 | Schedule 2
paragraph 3A(1)(c)
| Regulations | A licence under paragraph 3 cannot authorise any activity unless the activity appears to the Authority;
to be necessary or desirable for such other purposes as may be specified in regulations.
| Secretary of State | Affirmative
| 43 |
| 19 | 19(6) | Regulations
| The Authority may by regulations make such additional provision about procedure in relation to the carrying out of functions under sections 18 and 18A (revocation and variation of a licence) and this section as it thinks fit.
| The Authority | | 48
|
| 19 | 19B(1) | Directions
| Directions may make provision about -
(a) the form and content of applications under this Act, and
(b) the information to be supplied with such an application
| The Authority | | 47
|
| 19 | 19B(2) and (3) | Regulations
| (2) The Authority may by regulations make other provision about applications under this Act.
(3) Such regulations may, in particular, make provision about procedure in relation to the determination of applications under this Act and may, in particular, include -
(a) provision for requiring persons to give evidence or to produce documents;
(b) provision about the admissibility of evidence.
| The Authority | | 48
|
| 21 | 20A(3) | Regulations
| Regulations shall made provision about the membership and proceedings of appeals committees.
| Secretary of State | Negative
| 52 |
| 21 | 20B(2) | Regulations
| Regulations shall make provision about the procedure in relation to reconsideration.
| Secretary of State | Negative
| 53 |
| 22 | 24(3B) | Directions
| Directions may authorise, in such circumstances and subject to such conditions as may be specified in the directions, the keeping, by or on behalf of a person to who, a licence applies, of inter-species embryos in the course of their carriage to or from any premises.
| | | 57 |
| 22 | 24(4B) | Regulations
| Regulations may make provision requiring or authorising the giving of directions in relation to particular matters which are specified in the regulations and relate to activities falling within section 4A2 (activities involving genetic material of human origin).
| Secretary of State | Negative
| 56 |
| 22 | 24(5A) | Directions
| Directions - for subsection (5) to (10) substitute (5A) to (5E). Directions may make provision for the purpose of dealing with a situations arising in consequence of -
(a) the variation of a licence, or
(b) a licence ceasing to have effect
| The Authority | Procedure is set out in section 23 of the 1990 Act
| 59 |
| 24 | 31ZA(2)(a) | Regulations
| The applicant may request the Authority to give the applicant notice stating whether of not the information contained in the register show that a person ("the donor") other than a parent of the applicant would or might, but for the relevant statutory provisions, be the parent of the applicant, and if it does show that -
(a) giving the applicant so much of that information as relates to the donor as the Authority is required by regulations to give (but no other information).
| Secretary of State | Affirmative
| 62 |
| 25 | 33B(1) | Regulations
| Regulations may provide for additional exceptions from section 33A(1). (Power to provide for additional exceptions to 33A)
| Secretary of State | Affirmative
| 65 |
| 25 | 33C(1) | Regulations
| Regulations may -
(a) make such provision for and in connection with requiring or regulating the processing of protected information for the purposes of medical research as the Secretary of State considers necessary or expedient in the public interest or in the interests of improving patient care, and
b) make such provision for and in connection with requiring or regulating the processing of protected information for the purposes of any other research as the Secretary of State considers is necessary or expedient in the public interest.
| Secretary of State | Affirmative
| 66 |
| 26 | 35A(1) | Regulations
| Regulations may provide for any of the relevant provisions to have effect subject to specified modifications in relation to cases where:
(a) an egg which is a permitted egg for the purposes of section 3(2) by virtue of regulations made under section 3ZA(5), or
(b) an embryo which is a permitted embryo for those purposes by virtue of such regulations, has been created from material provided by two women (mitochondrial donation).
| Secretary of State | Affirmative
| 71 |
| 27 | 35B(2) | Scheme
| The amount of any fee charged by virtue of subsection (1) is to be fixed in accordance with a scheme made by the Authority with the approval of the Secretary of State and the Treasury.
| Secretary of State | | 72
|
| 28 Schedule 5 paragraph 4 | Schedule 3B paragraph 4(5)
| Regulations | In sub-paragraphs (3)(b)(ii) and (4)(b)(ii), the references to an appropriate statement are to a statement in writing containing such information relating to the powers of the person executing the warrant and the rights and obligations of the person to whom the statement is given as may be prescribed by regulations made by the Secretary of State.
| Secretary of State | Negative
| 73 |
| 31 | 45A | Order
| The Secretary of State may by order make such provision modifying any provision made by or under any enactment as the Secretary of State considers necessary or expedient in consequence of any provision made by regulations under any of the relevant provisions of this Act.
| Secretary of State | Affirmative
| 74 |
| 55(1) | | Regulations
| Regulations may provide:
(a) for any provision of the enactments about adoption to have effect, with such modifications (if any) as may be specified in the regulations, in relation to orders under section 54, and applications for such orders, as it has effect in relation to adoption, and applications for adoption orders, and
(b) for references in any enactment to adoption, an adopted child or an adoptive relationship to be read (respectively) as references to the effect of an order under section 54, a child to whom such an order applies and a relationship arising by virtue of the enactments about adoption, as applied by the regulations, and for similar expressions in connection with adoption to be read accordingly (Parental orders: supplementary provision).
| Secretary of State | Affirmative
| 77 |
| 56 Schedule 6 paragraph 25 | 4ZA(3) of the Children Act 1989
| Order | The Secretary of State may be order amend subsection (3) so as to add further enactments to the list in that subsection.
| Secretary of State | Affirmative
| 81 |
| 64 | | Order |
The Secretary of State may by order make
(a) any supplementary, incidental or consequential provision,
(b) any transitional or saving provision, that the Secretary of State considers necessary or expedient for the purposes of, in consequence of, or for giving full effect to, any provision of this Act.
| Secretary of State | Affirmative
| 82 |
| 67(3) | | Order
| Her Majesty may be Order in Council provide for any of the provisions on this Act to extend, with or without modifications, to the Bailiwick of Guernsey.
| Her Majesty the Queen |
| 83 |
| 68(2) | | Order
| The remaining provisions of this Act come in to force in accordance with provision made by the Secretary of State by order.
| Secretary of State | | 84
|
15 Human Tissue and Embryos (draft) Bill. Volume I:
Report Back
16
The Human Fertilisation and Embryology (Quality and Safety) Regulations
2007 Back
17
Directive 2004/23/EC of the European Parliament and of the Council
of 31 March 2004 on setting standards of quality and safety for
the donation, procurement, testing, processing, preservation,
storage and distribution of human tissues and cells Back
18
A test designed to determine fertility or normality of sperm
by using it to penetrate a hamster egg (or other animal specified
in directions). This must be destroyed as soon as the test is
complete and, in any case, no later than the 2-cell stage. Back
19
No such regulations have been made. Back
20
The new research purposes for which research can be licensed
were - (a) increasing knowledge about the development of embryos;
(b) increasing knowledge about serious disease, or (c) enabling
any such knowledge to be applied in developing treatments for
serious disease Back
21
Human Fertilisation and Embryology Authority (Disclosure of Donor
Information) Regulations 2004 (SI 2004/1511). These were made
under section 31(4). Back
| 
