Dawn
Primarolo: The provision is a reciprocal
arrangement with proposed new section 8B. New section 8E will permit
the HFEA to provide services to other public bodies, such as the Human
Tissue Authority or the Healthcare Commission, undertaking inspections
in the same premises as the HFEA. They might arrange for the HFEA to
cover their inspection in the course of the authority’s
inspection regime. The HFEA, not the Healthcare Commission or the Human
Tissue Authority, would then carry the cost of undertaking the
inspection. The provision gives a mechanism for sharing the benefits of
reducing the burden to those who are inspected and the cost to the
public authorities performing the
inspections.
Mike
Penning: I thank the Minister for being so clear. I only
wish that this part of the Bill, which is quite long and detailed, had
given us a couple more sentences, as the Minister has done. The
provision is very simply put: “as it thinks fit”. I do
not wish the Minister to disappear soon, but other Ministers will be
around to take her place. They will see the provision in the Bill, and
the situation is not as clear in the Bill as the Minister has
described.
Dawn
Primarolo: But the clauses interact
together, so if we rewind to the debate on better regulation and the
obligations of the HFEA in discharging its duties as a public
authority, the same duties apply to the Healthcare Commission or the
Human Tissue Authority. Those public bodies would act responsibly and
accountably. I think that the hon. Gentleman is concerned that the HFEA
would act in a predatory fashion by charging another public authority
for the purposes of income generation, following which there would be a
dispute.
I do not know
why parliamentary draftsmen settle for these phrases, although they are
excellent people who do fantastic things and get our legislation into
understandable forms, whatever the hue of the Government. I assure the
hon. Gentleman that the measure does not provide for some sort of turf
war or disagreement on charging, and I hope that he accepts that. It is
reasonable to reduce regulation, and when there is a gain to one
authority because another authority has undertaken work, there will be
a sharing of benefits between the authorities, as well as a clear
benefit to the establishment that was inspected, because it will end up
with only one inspection, rather than
two. Question put
and agreed
to. Clause 9
ordered to stand part of the Bill.
Clause
10Power
to delegate and establish
committees Question
proposed, That the clause stand part of the
Bill.
Mark
Simmonds: Again, I just have a few
questions for the Minister. Will she clarify the exact possible
workings of clause 10, which deals with contracting out to, and the
setting up of, committees? The clause gives the authority the power to
delegate and establish committees, and there is concern over the
accountability and transparency of the process. Will the Minister tell
us her thoughts on which committees the HFEA thinks it might be
appropriate to set up? To whom would it delegate and on what terms, and
what would be the relationship between the committees and the
HFEA? 5.30
pm I also
understand that the committees can include people who are not members
of the HFEA, thereby potentially linking back to some of our
discussions on earlier clauses about the appropriateness, the
qualifications and the relevance of some of the people who may serve on
the committees. Will the Minister explain exactly why it is necessary
for the authority to be able to set up the committees? What has not
worked well in the HFEA to date that makes it necessary? Why is it
necessary to be able to bring in outside people who are not members of
the authority? I would
also like to make sure that clause 10 will not allow the authority to
move away from decisions licensed by the senior level in the authority
and from responsibility for the code of practice. I understand that the
purpose—again, it would be helpful if the Minister confirmed
this—is to speed up the decision-making process. There is
clearly concern about the time that some licensing decisions take, but
it is important to maintain transparency and accountability. Some
clinics have serious concerns about licensing being renewed at a purely
executive level, not an authority level. A confirmation is needed that
the appeal process will remain in place, despite the powers to delegate
down, and that it will remain the same structure and fall to the people
on the appeal panel, not the people who made the original
decisions.
The Minister
will also be aware of the context. There has been judicial criticism of
the former chief executive. I do not want to go into detail, but it may
in part drive some of the concerns. Of course I understand that a
process is needed for speeding up decision-making for granting
licences, but it would be helpful if she would confirm whether
delegation applies to all categories set out in the Bill for which the
HFEA has responsibility, which include licensing, variation, suspension
and
revocation.
Robert
Key: The explanatory notes to clause 10
have, I regret to say, managed to confuse me. I should be grateful for
clarification on two simple points. If the Minister can convince me, my
mind will be at rest. I am not clear whether it is meant that staff
will be able to take licensing decisions and develop the code of
practice. That is what it seems to say. Can she also point us to the
measure in the Bill—if she cannot, could she tell us—what
functions will still be able to be exercised only by members of the
HFEA?
Dawn
Primarolo: At present, the 1990 Act
requires HFEA members to be involved in all licensing decisions. As
hon. Members have said, there has been comment about whether that is
overly restrictive on the speed with which decisions are taken,
particularly with regard to what might be considered routine licence
applications. Clause 10 provides that the authority can set up
committees to which it can delegate any of its functions. It will give
the HFEA the flexibility to determine how best to manage its licensing
process. That may involve divisions between more routine decisions and
decisions that are slightly more challenging or
contentious. The
new provisions mean that there will no longer be a specific requirement
for a licence committee to be set up, nor will any such committee be
required to comprise only HFEA members. Under the new provisions, for
instance, the delegation to any committee could include members as well
as a member of staff.
Under the 1990 Act, the
authority could not delegate any function relating to licensing in that
way. The Bill ensures that the HFEA can delegate licensing decisions to
staff, ensuring that such decisions can be made quickly and within a
framework set by the authority. There will need to be an escalation
procedure to ensure that difficult or more contentious decisions are
taken with the appropriate authority under these delegated powers.
Therefore, we are asking the HFEA to consider how to deal speedily with
licence
applications.
The provisions are sensible and
provide flexibility so that the authority can speed up its decision
making and meet requirements of better regulatory practice. That will
help the authority respond proportionately to its functions, delegating
when appropriate, which should speed up decision making and cut costs.
We thought that this provision was sensible to modernise regulation and
would be in keeping with the Bill. It was particularly necessary
following the removal of the proposal to establish the regulatory
authority for tissue and embryos. As we took that part of the
regulation out, we needed to have something in this clause instead. The
provision should help to speed up the matter, but it does not remove
the responsibility of the entire authority for the decisions that are
taken. It is a question whether—I am struggling for the words to
describe this—there are less complicated decisions that could
then be endorsed by the full Committee, but that could be considered
more quickly. The question of the appeal process and everything that
needs to be in place is there. That is the main requirement.
Arrangements are continuing to be reviewed and put in place to ensure
that the provision is robust.
I hope that
members of the Committee will be reassured that this is a proportionate
response to criticism of lack of speed in agreeing licences,
particularly when they are straightforward. The provision recognises
the full range of expertise in the authority, but none the less makes
it clear that decision making has to be speeded
up.
Robert
Key: I should be grateful if the
Minister would be so kind as to write to me in response to one of my
points and share the letter with members of the Committee. I asked her
what functions could be exercised only by the members and could not be
delegated.
Dawn
Primarolo: I am happy to do that. The
members will still be responsible for all decisions, because there will
need to be an endorsement. In that sense, there is no removal of power
from the members of the board. As regards providing flexibility to the
HFEA, I will be happy to write to all members of the Committee, through
you, Mr. Gale, to explain the sort of things that we would
want to interact to ensure that there is no loss of accountability,
expertise and scrutiny in this area by the regulatory authority that we
have put in
place.
Mark
Simmonds: My hon. Friend the Member for
Salisbury has, as always, hit the nail on the head. I am very grateful
to the Minister for consenting to his request to circulate a
clarification letter to the Committee. I think that there would be
concerns if the HFEA was allowed to delegate the totality of functions,
including licence suspension or revocation, without retaining control
over the key ones. I am grateful to the Minister for giving way and
also for agreeing to send us a letter, which we will look at
closely.
Dawn
Primarolo: I am more than happy to do
that. This was a matter that the pre-legislative scrutiny Committee
looked at when considering flexibility for the HFEA, although not
necessarily in this area. I assure the hon. Members for Boston and
Skegness and for Salisbury that the points that they have raised were
precisely those that I and my officials, who will remain nameless,
focused on. We wanted to ensure that the regulatory authority continued
to discharge its statutory duties correctly. I happily undertake to get
those details to members of the Committee as quickly as I
can. Question put
and agreed
to. Clause 10
ordered to stand part of the Bill.
The
Chairman: For clarification, and in case anyone thinks I
have had a brain storm, clause 11 was taken on the Floor of the
House.
Clause
12General
conditions of
licences
Dawn
Primarolo: I beg to move amendment No. 39, in
clause 12, page 8, leave out line 31 and
insert— ‘(1) Section 12 of
the 1990 Act (general conditions of licences under that Act) is amended
as follows. (2)
In’.
The
Chairman: With this it will be convenient to discuss
Government amendments Nos. 40 to 43, 106, 108 and 115 to
117.
Dawn
Primarolo: I was looking for clause 11, Mr.
Gale—it has been rather a long afternoon already.
During the passage of
the Bill through another place, a debate took place on the use of
embryonic stem cells derived under research licences in therapeutic
applications. The Government subsequently wrote to all peers involved
in that debate setting out how, in the Government’s view,
embryonic stem cells derived under an HFEA research licence could be
used in therapeutic applications. The amendments are consequential to
the
Government’s taking that view in another place. They will ensure
that research centres deriving embryonic stem cells that are intended
for therapeutic use are required to abide by the quality and safety
standards set out in the European tissues and cells directive, in
relation to stem cells and the embryos from which they are
derived. The directive
lays down standards of quality and safety for human tissues and cells
intended for human application, including gametes and embryos. The
relevant requirements already apply to embryos used in reproductive
treatment under the Human Fertilisation and Embryology (Quality and
Safety) Regulations 2007. Stem cells derived from embryos are also
regulated under the Human Tissue (Quality and Safety for Human
Application) Regulations 2007. It is important that those standards are
applied also to the embryos used to derive stem cells in human
applications in order to ensure the necessary levels of quality and
safety of tissues to be used in treatment.
I commend the amendments to the
Committee.
Mark
Simmonds: I am grateful to the Minister for introducing
this batch of amendments. I have one or two queries. I understand the
logic of what she said, but there is no mention anywhere else in the
Bill of therapeutic applications for humans. Indeed, on the Floor of
the House I and the hon. Member for Oxford, West and Abingdon tabled
separate amendments and new clauses to allow licence for therapies to
take place, but they were rejected by the Minister.
It would be helpful if the
Minister were to explain the wording used in the letter that she kindly
sent Committee members. How does the
phrase “intended for
non-reproductive therapeutic application for humans”
fit in with her view that she will not
allow licences for therapies in the Bill? That letter then refers
to “Directives
on safety and quality of cells and tissues for human
applications” and
“the relevant requirements”. What are the relevant
requirements to which the Minister refers? The letter refers
euphemistically to “these safeguards”. Will the Minister
explain what they
are? After the debates
in the other place, I initially thought that the application of the EU
directive did not apply to non-medical fertility services. However, the
Minister has confirmed today that it does apply to them. Will she
clarify that matter? Does it also cover the provision of gametes for
such purposes for both non-medical fertility services and
non-reproductive therapeutic
applications? 5.45
pm
Dr.
Harris: I seek your advice, Mr. Gale. I think
that the last two important questions raised by the hon. Member for
Boston and Skegness, were clause stand part-type questions, because the
deletion of the exception for non-medical fertility services is already
in clause 12. We are debating, initially, additional amendments to
that. Will you let me know shortly whether you wish me to deal with my
questions around non-medical fertility services?
The hon.
Member for Boston and Skegness has raised an important issue. I am
aware that we cannot really reopen the question of licences for therapy
at this stage, but, as he said, the issue involves stem cells intended
for non-reproductive therapeutic applications to humans. My question
for the Minister is simple. Would that cover non-research applications
to humans, or would that always cover research applications for the
lifetime of the Bill? If it includes non-research applications, then
further questions are raised about whether the Government are right to
be confident that any applications of stem cells derived from embryos
created under a licence could be created under a licence for research,
because there will always be research involved in the process? We
cannot reopen that discussion here, and I am not proposing to, but it
would be helpful for the Minister to clarify her view. Would those
non-reproductive therapeutic applications to humans apply to
non-research applications? Does her definition of research apply to
clinical trials? That is one understanding—research carried out
under a research ethics committee approval, with a clear protocol. Or
is research to be read more widely—some would say much more
widely? I will make
two more points. It is important, looking at the 1990 Act as amended,
that the safeguards apply here. The safeguards referred to include the
transfer of money and information and maintaining proper records. The
clause is important, therefore, because those are the general
conditions of
licences. My second
question I cannot remember. I might seek to intervene on the Minister,
if it occurs to
me.
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