Mark
Simmonds: My concern with new clause 2 is about the
extremely broad nature of the phrase “blood relative”.
Has the hon. Gentleman thought about narrowing it down to a sibling,
son or daughter of the donor to exclude third cousins twice removed and
so
on?
Dr.
Harris: That is a fair point. There are questions about
whether the wording is broad. I am not wedded to the wording of the new
clause, so I accept that it might need further work. I have never
claimed to be a parliamentary draftsman, despite what was said earlier,
and I do not seek to be one. My cup overflows
already. I
wish to make a further point about surrogacy. I have not tabled an
amendment on this, but any provision would be very similar to new
clause 2, so the matter relates to this debate. The Human Fertilisation
and Embryology (Statutory Storage Period for Embryos) Regulations 1996
specify the period for which gametes and embryos respectively can be
stored in cases where the patient is, or will become, permanently
infertile. In extending the normal five-year storage period, the
regulations enable patients to preserve their last chance to conceive
their own genetic child until the female patient in question is
approximately aged 55. Although the Bill extends the normal embryo
storage period from five to 10 years, which I think is a good idea, it
does not amend the special regulations for extended storage. I think
there is a case for the regulations to be updated to benefit patients
conceiving their own children through surrogacy. Surrogacy patients are
explicitly excluded and, in practice, it seems to me—and to
those advising me—that it is utterly arbitrary that a woman who
has had her ovaries removed due to cancer can store her eggs and
embryos until she is 55, but a woman who has had a hysterectomy due to
cancer can store her eggs or embryos for only 10 years. That seems to
be somewhat unfair, so I was wondering if the Minister would consider
there to be scope to bring the situations more into line—if not
in this Bill, through
regulations.
Dawn
Primarolo: I ask the hon. Gentleman not to press new
clause 2 to a Division because I think that he raises a number of
difficult issues with regard to some aspects of the regulation. As he
has pointed out, there are regulation-making powers under the 1990 Act,
and the Bill allows changes to regulations, such as those relating to
statutory storage periods of gametes.
The hon.
Gentleman made the point that it is not always wise to make primary
legislation on the basis of one case. Perhaps if I could tell him when
the regulations will be available for consideration, he might rightly
feel—as I do—that that would be the appropriate place to
raise these considerations. New policies will be proposed in
regulations and they will need to be consulted on. The timetable for
those regulations is such that the drafts will likely be available
toward the end of this year.
I think that
the points that the hon. Gentleman raises could be appropriately dealt
with in that consultation and the consideration of those regulations,
rather than through new clause 2, because there will be other points to
consider. For example, the hon. Gentleman touched on surrogacy, which
is not addressed by the new clause. There might well be other
exceptional circumstances, but it would be wise to address them all in
one place in the
regulations. I
hope the hon. Gentleman and the hon. Member for Hazel Grove accept that
the Government see that this issue needs to be addressed and intend to
ensure that that happens during the consideration of the regulations,
which will take place before the end of the year. That will be the
appropriate point of the consultation to add in some of the points that
the hon. Gentleman is
suggesting.
Dr.
Harris: I thank the Minister for that response, although
she did not necessarily say that she agreed that there should be a
solution. I think she did accept that there was a problem in this
case.
Dr.
Harris: I am sorry if I
misunderstood.
Dawn
Primarolo: No, no, with respect, I do not know whether
there will be a solution. I agree with the hon. Gentleman that it would
be desirable to find a solution and the appropriate vehicle for this is
the regulations. At this time, I do not know, so that is my only
point.
Dr.
Harris: I apologise to the Minister. I am satisfied that
she recognises that there is a problem and that she suggests that
rather than trying to amend primary legislation through new clause 2,
or another version of it, the appropriate time would be either during
the drafting of regulations, or their redrafting following the
consultation. I am delighted because she has confirmed that there will
be a consultation on drafts, which we discussed earlier. That is always
good when regulations are being considered because once they are laid,
it is impossible to amend them unless the regulations are
withdrawn.
I am grateful
to the Minister for indicating that she hopes that the drafts will
capture, if possible, a solution to a problem that she acknowledges. I
am sure that my hon. Friend the Member for Hazel Grove, who might be
listening to the debate using new or old technology, will share my
gratitude—and, I suspect, that of his constituent—to the
Minister for her positive response.
Question
put and agreed
to. Clause
15 ordered to stand part of the
Bill.
Clause
16Grant
of
licence Amendments
made: No. 41, in clause 16, page 12,
line 14, at end
insert— ‘( ) in paragraph
(c), after “application” insert “or a licence
under paragraph 3 of that Schedule authorising activities in connection
with the derivation from embryos of stem cells that are intended for
human application”,
’. No.
42, in
clause 16, page 12, line 15, after
‘(ca)’ insert ‘— (i)’.
No. 43, in
clause 16, page 12, line 16, at
end insert— ‘(ii) after
“that Schedule” insert “authorising activities
otherwise than in connection with the derivation from embryos of stem
cells that are intended for human application”,
and’.—[Dawn
Primarolo.] Clause
16, as amended, ordered to stand part of the
Bill.
Clause
17The
person
responsible 3
pm
Mark
Simmonds: I beg to move amendment No. 142, in
clause 17, page 12, line 23, at
end insert— ‘(1A) In
subsection (1)(b) for “equipment is” substitute
“equipment and premises
are”’. Although
the premises would have been inspected before the licence was granted
or renewed, it is also important for the person responsible to ensure
that the right equipment and parts of the premises are used for each
procedure, and that there is no risk of cross-contamination between
admixed embryos and IVF embryos, for example. On my visit to the Centre
for Life in Newcastle I saw that it undertakes different types of
medical research or treatment in separate parts of the same building.
It is obviously the responsibility of the licence holder to ensure that
there is no transfer or confusion between the
two. There
is an inconsistency. There is no mention of equipment and premises in
clause 17, yet in clause 18(d) and (e) they are mentioned as specific
reasons for the potential revocation of the licence. Will the Minister
explain that
inconsistency?
Dawn
Primarolo: The amendment would add a requirement to
section 17 of the 1990 Act to ensure that it would be a duty of the
person responsible to secure appropriate premises as well as equipment
in which to carry out activities as they are licensed under the Act.
Furthermore, the requirements of the Human Fertilisation and Embryology
(Quality and Safety) Regulations 2007, which incorporate the European
Union tissue and cells directive into the 1990 Act, would apply to any
embryos that are intended for human application. The directive made
various extensions to licence conditions, which are set out in schedule
3A to the Act and incorporated by section 14A. The provisions ensure
that appropriate equipment and materials are used as well as suitable
facilities and premises. It means that any licence that relates to
gametes and embryos intended for human application must satisfy those
conditions. If they do not, they will be in breach of the
licence. I
hope that I have put the hon. Gentleman’s mind at rest. The HFEA
always ensures that the person responsible will secure the appropriate
premises as part of the licence application. The suitability of the
premises is already part of the HFEA inspection process so the twin
arrangements are catered for and, if that were not the case, it would
be a breach of the licence,
Mark
Simmonds: I am grateful to the Minister for clarifying the
fact that there is not an inconsistency between the two clauses. I beg
to ask leave to withdraw the
amendment. Amendment,
by leave,
withdrawn. Clause
17 ordered to stand part of the Bill.
Clause
18Revocation
and variation of
licence
Mark
Simmonds: I beg to move amendment No. 143, in
clause 18, page 13, line 29, after
‘person’, insert ‘and is so
qualified by training and
experience’. The
amendment relates to the variation of a licence. Under section 16 of
the 1990 Act, the initial applicant had to satisfy the licensing
committee that the character, qualifications and experience of the
applicant were suitable. My understanding is that, under this Bill, the
person to whom the licence is transferred will not need to satisfy the
authority that they are anything more than suitable. There is a
difference between those two definitions. One could have a suitable
character without the required qualifications and necessary experience.
Is the Minister happy with that difference? Would she not prefer a more
robust system, with a new inspection under the person responsible or
the licence
holder? Will
the Minister also clarify whether there is a prohibition on the sale of
a licence? Can a licence effectively be bought and sold within the
context of the criteria I have just mentioned?
I have one
further issue with regard to this amendment. In proposed new section
18A(3), a very clear distinction is made between
“the person
responsible”
and
“the holder of
the licence (if
different).” Will
the Minister say how many licences have been granted where the person
responsible and the licence holder are not the same person? In the
revocation categories, again, it refers only to “the person
responsible”, not the licence holder, which implies that one,
“the holder of the licence”, is a subset of the other,
“the person responsible”. If they are different, why are
they not different in the revocation categories, and if they are the
same, why is there a distinction in the first part of clause
18?
The
Chairman: The hon. Gentleman has indicated a rather broad
range of questions, which effectively constitute a stand part debate. I
am perfectly content with
that.
Dawn
Primarolo: The Bill simplifies provisions in order to
allow the HFEA to determine applications by a licence holder in a more
flexible manner. However, this does not change the strict criteria for
determining whether people are suitable to be the person responsible.
That remains the same.
In 2005, the
HFEA, in consultation with stakeholders, took a decision to revise its
assessment process for the person responsible, and there are now formal
assessments to ensure that the designated person is proficient in their
role and up to date with the latest developments in their field. This
process consists of various assessments that the person must satisfy.
For a research licence, for example, the assessment consists of three
workbooks that must be completed by the designated responsible person.
One is on the regulatory framework, one is on quality management and
risk, and the third covers research regulations. The workbooks also
include details outlining certain person specifications,
including
qualifications. They state all relevant medical, biological, scientific
or professional healthcare qualifications, and require the applicant to
demonstrate experience, including experience and extensive knowledge of
fertility-related management, clinical and scientific developments and
treatments, including ethical
viewpoints. The
hon. Member for Boston and Skegness went on, as he did before, to ask
about the process and refusals in varying or revoking a licence. All
the decisions relating to granting, revoking, suspending or varying a
centre’s licence are taken by the licence committee of the
authority, based on inspection. Inspections need to assess quality,
effectiveness of the clinical management, and a whole list of things
that I will not read into the record. I will write to him about
them.
He asked
specifically whether a licence could be sold, passed on or transferred
to another responsible person. It could be, but the HFEA must approve
any transfer of licence, and it would need to be satisfied that the
transfer would go to a responsible person and under all the conditions
that I have outlined, as agreed after the 2005 consultation
process.
I do not know
the answer to the hon. Gentleman’s last question about whether
there is a difference between a responsible person and a licence
holder. I have a feeling that there is not, but I do not want to commit
myself unnecessarily to that and I will come back to him. I hope that
he is satisfied that measures are still there to ensure that the
responsible person is properly qualified and experienced in the
relevant fields, and that the HFEA will scrutinise the licence and the
responsible person very closely.
Mark
Simmonds: I am grateful to the Minister for that reply.
The only outstanding issue is the one to which she referred at the end.
It would be helpful if after the Committee I could explain to her in
more detail what I feel is not consistent. Perhaps I was not clear
enough in my explanation—I will not go through it again now, but
it is something that should be looked at. I am happy to receive a
response from the Minister after she has had a chance to discuss it
with her officials and I beg to ask leave to withdraw the
amendment.
Amendment,
by leave, withdrawn.
Clause 18
ordered to stand part of the Bill.
Clause
19Procedure
for refusal, variation or revocation of
licence
| 
