Dr.
Harris: I point out to my hon. Friend that there is a
difference between declarable interests that one might want to make
Parliament aware of and registerable interests. The registrar is quite
fussy about what he or she thinks it is necessary to
register. My point
concerns the issue of HFEA mission creep. If the Minister will permit
me, I think that it is appropriate to raise it here, because it is
relevant to proposed new section 8ZA(2), which
says: “In
carrying out its functions, the Authority must, so far as relevant,
have regard to the principles of best regulatory practice (including
the principles under which regulatory activities should be transparent,
accountable, proportionate, consistent and targeted only at cases in
which action is
needed).” It is
a minor concern, but I hope that the Minister can set my mind at rest.
A couple of years ago, the HFEA sent out a mission statement to Members
of Parliament. The mission statement did not stick to what Parliament
had intended the HFEA to do. The HFEA decided that part of its job was
to maintain public confidence in the law. If Parliament makes the law,
it is Parliament’s job to maintain confidence in the law.
Otherwise, acceptable activity that Parliament has said should be
licensed and considered appropriately should not be subject to extra
regulation because of a perceived need to keep public opinion on
board. Otherwise,
newspapers could raise scare stories and, if the HFEA’s mission
has crept to include a general issue of public confidence rather than
what is set out in proposed new section 8ZA(2), it might say,
“Well, we might have licensed this and permitted it, but it
might kick up a fuss. There’s an institutional risk.”
That is the other thing. The HFEA’s policy documents include a
little section saying what the risk is to itself of bad headlines,
rating them low, medium, high or whatever. It is inappropriate for the
HFEA, which was set up by Parliament to do a job—a job that,
generally speaking, it does well—to start having regard to
interests such as what the Daily Mail might say about its
decisions. The HFEA
rowed back from that position when I raised the matter, asking where it
came from, as I could not find it in the HFEA’s own terms of
reference or the statute. It would be helpful if the Minister confirmed
that the excellent paragraph that she proposes to insert in the Bill
makes it clear that
“activities should
be...targeted only at cases in which action is
needed”,
and that nothing in the statute requires
the HFEA to distort what it is doing in order to please what it
perceives as public or media opinion. Unfortunately, it is in the
firing line. I respect the HFEA for what it does, because it gets a lot
of hassle from some in the media, and indeed some politicians, when it
takes a decision that they do not like. However, it would be open to
greater criticism if it bent towards that or away from implied
criticism. I hope that she will make it clear, albeit only briefly,
that the HFEA’s job is to implement the law as Parliament has
laid it down and develop policy where appropriate. Perceptions of
public opinion, short of formal consultations where the HFEA feels them
to be relevant, are not part of its remit.
Dawn
Primarolo: It is always surprising what things catch a
Minister in Committee. I thought that clause 7 was very
straightforward. Perhaps I can explain why the Government did it and
then answer the
points. Of
course the Government expect all public authorities to operate
effectively, efficiently and economically. That is not a reflection on
the HFEA’s past practice or performance. It is simply that the
principles of better regulation were implemented following the Hampton
report, which was quite a long way after the 1990 Act. They require
regulation to be transparent. Regulators should be open and keep
regulations simple and user-friendly. Regulation must be accountable.
Regulators must be able to justify decisions and be subject to public
scrutiny. It must be proportionate. Regulators should intervene only
when necessary. Remedies should be appropriate to the risk posed and
costs must be identified and minimised. The principles also require
regulation to be consistent whereby rules and standards must be joined
up and implemented fairly. They require regulation to be targeted so
that it is focused on the problem and minimise the side
effects. The
Government took the opportunity provided by the fact that we were
updating the 1990 Act and included the principles in the Bill. They
have been widely accepted by the House. It was no more, no less than
that. Such action was not a reflection on the performance of the HFEA.
We just took the opportunity offered by the Bill to put on the record
something that we already expected. We did so for clarity. We did not
mean to cause difficulties in Committee. In answer to the points that
have been made, I must say that it is nothing to do with whether I
continue to be the Minister; it is simply a tidying-up
exercise. The hon.
Member for Southport raised a different issue—a register of what
is declared. I am not exactly sure about what detail is provided
publicly at the moment, but I agree with him. I shall put to the HFEA
the point that such a register should exist and be accessible. It would
be good practice and I thank the hon. Gentleman for raising it with
me. The
hon. Member for Oxford, West and Abingdon asked me to confirm that the
measure is about complying with the Bill, not with the views of the
media. I am happy to confirm that. I think that he wanted to make sure
that that was on the record, and I am pleased to assist him. I hope
that members of the Committee will accept that there was no other
motive behind the provision,
expect that it is a good principle. I hope that I have put their
concerns to rest, and that they agree that what must be the most modest
clause in the entire Bill should now stand
part. Question put
and agreed
to. Clause 7
ordered to stand part of the
Bill.
Clause
8Power
to contract out functions
etc. Question
proposed, That the clause stand part of the
Bill.
Mark
Simmonds: I have one or two queries about the clause. It
gives the HFEA the power to contract out particular functions to other
Departments or public offices. How would the contracted-out bodies be
accountable? It would be helpful if the Minister could give us an idea
of which bodies might be involved? Will it be the Human Tissue
Authority, the Department of Health or the Medicines and Healthcare
products Regulatory Agency? In what circumstances does the Minister
think that the powers would be
necessary? To make
sure that my understanding of the Bill is correct, I must know whether
contracting out will exclude licensing and the guidance of the HFEA,
and that there will be no opportunities for licensing, for example.
What about inspections? We discussed that earlier. They are not
specific to the granting of a licence, but are relevant to it. Such
matters go to the authority for discussion and consideration. Will
issues be confined to a public authority or will the HFEA contract out
to the independent sector, including the private sector? What criteria
will be put in place by the Department of Health or will it be left to
the HFEA to make sure that the contractee will have the relevant level
of appropriate skills and expertise, experience and qualifications to
do the particular
job? My third and
final specific question about clause 8 concerns proposed new section
8C(2)(c) that states:
“it is a function of making
subordinate legislation (within the meaning of the Interpretation Act
1978).” Perhaps the
Minister could clarify what is meant by subordinate legislation, and
whether it is the same, or different, from
regulation.
5.15
pm
Dr.
Harris: I thought that the hon. Member for Boston and
Skegness asked interesting questions. I am particularly interested in
the answer to the last one, as I, too, had that written down.
Inspections would not be excluded from being contracted out under
proposed new section 8C(2), and that leads to the question about
whether it is necessary to identify other people who can provide
inspections, albeit apparently public bodies.
My purpose in
supporting clause 8 is to recognise that in this increasingly complex
area of regulation, particularly with the advent of potential stem cell
therapies, it is important that the HFEA is able to hand over this
aspect of its work and contract it out, under negotiation and with
consultation, to the HTA or the MHRA, so that there is a smooth working
arrangement. The MHRA, for example, could take the lead and would
obviously have to refer back on occasion to the HFEA. From the
reading that I have done of some of the complexities around the European
directive on cells and tissues for human application, it seems that
that sort of thing will be necessary. I hope that the Minister
will confirm that. I understand and
hope—again I might be wrong—that one of the other points
of this is to ensure that the authority can delegate certain powers to
a sub-committee, which might speed up processes. There is concern in
the clinical world that it can take a very long time for the authority
to make a decision. I think that without that provision, the authority
has to meet as a full authority to sign off a number of things, and
that potentially refers to the creation of sub-committees or committees
of the authority. Again, I would be grateful if the Minister could
clarify that.
Mark
Simmonds: The hon. Gentleman is
absolutely right. Perhaps I may refer him to clause 10, which relates
to the power to delegate and establish committees. The purpose of that
clause is to speed up the licence process. He is right to highlight the
concern of many clinics about the time it takes for the HFEA to make
its decisions.
The
Chairman: Order. The hon. Gentleman is right—we
shall come on to clause 10 in due course.
Dr.
Harris: I agree with you, Mr. Gale. The hon.
Member for Boston and Skegness is right, and perhaps that answers the
point. Clause 10 deals with that concern, not clause
8.
Dawn
Primarolo: At present, the 1990 Act does not allow the
HFEA to enter into an arrangement with either a public or private body
to undertake any of its functions. That means that there is limited
flexibility when carrying out some of its functions, which could lead
to the duplication of inspections or other aspects of its regulatory
work. The new provision in clause 8 introduces more flexibility to the
way in which the authority operates. The provisions work together with
those in clause 9—we are coming on to that—that enable
the HFEA to assist other public bodies. It will help the authority to
carry out its functions more effectively and avoid duplication, thus
reducing the burden on clinics and others subject to licensing. The
provision was thought to be sensible to modernise the regulation and
keep certain issues within the Bill, following the removal of proposals
to establish the regulatory authority for tissue and embryos.
Proposed new
section 8B gives the authority power to make agency arrangements with
Government bodies, other public authorities or holders of public
office, and provides for that body to exercise the authority’s
functions, or for it to provide services to the authority. Such
arrangements may include, for example, those with the Human Tissue
Authority or the Healthcare Commission to carry out inspections on its
behalf. Both those authorities are regulated, transparent and
responsible. However, the responsibility for the functions themselves
would remain with the HFEA, so that body would still be
accountable. Proposed
new section 8C gives the power to make a contract with any person to
carry out functions of the authority. However, under the provision, the
authority cannot contract out functions related to
licensing
decisions, the right to enter, the search or seizure of property, or
other functions prescribed in an order made by the Secretary of
State. For example,
the provision allows a private company to undertake inspections of
laboratories on behalf of the authority, and the clause provides that
the authority remains in control of its functions and responsible for
all acts or omissions under such arrangements. We are seeking to remove
duplication with other public authorities when that is sensible, thus
reducing the number of inspections and the regulatory burden. Any
powers in the area would have to be subordinate to the legislation, and
that includes the regulating-making powers. It could also include
powers such as making orders. The approach is quite straightforward,
and because of the exclusions on specific issues, I hope that hon.
Members will accept that this is about using similar inspections and
expertise in the public sector and reducing duplication, not the HFEA
losing control of its responsibilities or transparency. I hope they
will also accept my points about what cannot be contracted out and what
will remain absolutely central to the work of the
HFEA.
Mark
Simmonds: I might have misunderstood what the Minister
said. Did she clarify the point about this relating only to other
public sector bodies so that no independent or private sector
charitable or voluntary organisations will get involved, particularly
with regard to inspections? Inspections are not specifically excluded
as are, quite rightly, licensing and the other issue with regard to the
code of practice. What about the specific point regarding the interim
inspections?
Dawn
Primarolo: May I help the hon. Gentleman by making an
intervention? Proposed new section 8C gives authority to contract with
another person to carry out functions and sets out exclusions. In the
example I gave, such a function might be undertaking an inspection of a
laboratory on its appropriateness, but would not include the other
functions: licensing, right of entry, and search or seizure. That would
occur in limited circumstances, and that possibly could go beyond a
public authority. However, others provisions relate to public
authorities.
Mark
Simmonds: I am grateful for that clarification, as I
understood what the Minister just confirmed: the HFEA is going to be
allowed to contract out not just to the public sector, but, in very
specifically defined circumstances, to the independent sector, as the
Minister
explained. Question
put and agreed to.
Clause 8 ordered to stand
part of the Bill.
Clause
9Power
to assist other public
authorities Question
proposed, That the clause stand part of the
Bill.
Mike
Penning: I will not detain the Committee
for long. I find the clause quite interesting because of the ambiguous
language in the Bill. It allows the authority to assist other public
authorities and then, quite naturally, to charge them should it do so.
I am conscious that
those bodies could be some of the ones that the authority has already
contracted out to that could be charged for the work that the authority
does for them. I am particularly concerned about proposed new section
8E(2), which
states: “Assistance
provided by the Authority under this section may be provided on such
terms, including terms as to payment, as it thinks
fit.” Could
we be in a situation in which one department—the
authority—is charging another part of Government, but they do
not agree and therefore the work cannot be done? The measure is very
ambiguous. This is the second time this afternoon that we have seen
such terminology—“as it thinks fit”—in the
Bill, so will the Minister clarify
it?
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