Mark
Simmonds: I beg to move amendment No. 144, in
clause 19, page 15, line 12, leave
out subsection
(7).
The
Chairman: With this it will be convenient to discuss
amendment
No. 145, in
clause 19, page 15, line 14, at
end insert— ‘(8)
Notification to the applicant of a decision whether to grant or refuse
a licence must be given within a specified time period to be determined
by
regulation.’.
Mark
Simmonds: Again, I shall be brief; these are probing
amendments. Perhaps the Minister could clarify why on page 15 there
seems to be some duplication. In clause 19A there are four distinct
categories: “In
the case of a decision to grant a licence, the Authority shall give
notice of the decision to—
(a) the applicant,
and (b) the
person who is to be the person
responsible”. and
those seem to be exactly the same for the four categories: granting,
revocation and the two types of variation. I understand that in clause
19A(7) a distinction is drawn with subsections (2) and (4), but I
cannot see why it is broken down into four distinct categories under
19A and not two or three. The people who must be notified after
decisions are taken are exactly the same. That is the purpose of
amendment No. 144.
Amendment No.
145 has been tabled because there are clearly delays that can be
damaging both to business and research—particularly the latter
as research grants elapse after a certain period of time. Under the
current provisions, the authority can take as long as it chooses to
decide whether to grant or refuse a licence. The amendment would ensure
that the authority understands that it would be helpful if a specific
time period—specified in the regulations after
consultation—could be set out to help provide clarity. Perhaps
the Minister and her officials could give that some thought.
Most public
bodies have specific time scales within which they must respond. For
example, the Department of Health is supposed to respond to
correspondence from MPs within 20 days. I am sure that the Minister
will be the first to acknowledge that that is not always the case, but
attempts are always made to ensure that the time scale is met. There is
concern within the industry—if I can call it that—that
there may have been unacceptable and unreasonable delays in specific
circumstances. I would not seek to specify the time period in the Bill;
that will have to come through discussions and be put through
regulations after consultation. However, it is a key point and requires
addressing.
Dawn
Primarolo: I understand the hon. Gentleman’s point
perfectly and the reasons why he seeks to set a time limit, or at least
to get an indication of one. This issue is often raised. I accept that
the HFEA should respond in reasonable time, and recognise that
regulations would allow a suitable period to be determined in
consultation with interested
parties.
3.15
pm However—the
hon. Gentleman touched on this, so I think that what I am about to say
might help—setting out such a time limit in statute would
restrict the HFEA in having the added flexibility that might be needed
in certain situations in the more complex licence applications. I can
reassure him and the Committee, however, that the HFEA is committed to
notifying the applicant of its decision either to grant or refuse a
licence within set time scales. It has a self-imposed target of three
months for licence applications, and four for any new treatment and
storage licences. It is right that we allow it that
flexibility. Over
the past 12 months—I accept that this would not necessarily
apply to the more complex applications—the HFEA has received
three applications for research licences, all of which were processed
and decided upon within the required three months. That indicates that
currently it is processing applications in a timely fashion, although
we would expect it to be thorough as well. I hope that the hon.
Gentleman accepts that his probing amendment on time limits is dealt
with. Proposed
new section 19 provides that reasons must be given for certain
licensing decisions and provides an opportunity for representations to
be made before a decision is taken. It sets out the person to whom
notice is to be given when the decision is made. The new provisions set
it out that if the HFEA agrees to an application from a licence holder
or person responsible to vary or revoke, it does not need to give
reasons for its decisions when giving notice to the specified persons.
That makes sense, because the HFEA is granting what was requested. That
measure is aimed at reducing the unnecessary bureaucratic measures that
have also been mentioned. When a decision goes against a request,
proposed new section 19A(5) will require the applicant to be given
reasons for the refusal. I think that that provision satisfies the
concerns raised in relation to the
amendment. The
hon. Gentleman then asked about the reason for the different
categories. It is to cover the different areas—granting,
revocation, application or any other variation—so that they are
all covered by slightly different notification requirements based on
the relevant application. I accept that that might appear more
complicated in the Bill, but in practice it will speed up and make
clear what applies in the case of different decisions. I hope that that
deals with his
questions.
Mark
Simmonds: Again, I thank the Minister for her response.
Amendment No. 144 is really a probing amendment on which she has
clearly satisfied me. I hear what the she says about amendment No. 145,
but I urge her and the relevant officials in the Department to monitor
the situation carefully, because there is concern among those applying
for
licences. I
am intrigued that the Minister says that there has been no delay in
applications in the past 12 months—that is not what people have
been telling me. What was the point of Tuesday’s debate on
delegated powers to speed up the process, if it does not need speeding
up? From what she has said today, the process seems to be working well.
I suspect, however, that because of the additional potential licence
areas with which the HFEA will have to cope when the Bill is enacted,
it will receive more licence applications than it has to date. The
situation therefore needs to be monitored
carefully.
Dawn
Primarolo: I hope that I did not convey any complacency in
explaining what has happened in the 2007-08 period. I accept that
comments have been made, and the hon. Gentleman is right about needing
to be vigilant and ensuring that the process continues to be accurate
and timely—without unwarranted delay—unless there is
complexity.
Mark
Simmonds: I confirm that the Minister certainly did not
give the impression of complacency on this particular occasion. On that
note, I am happy to beg to ask leave to withdraw the
amendment.
Amendment,
by leave,
withdrawn. Clause
19 ordered to stand part of the Bill.
Clause
20Power
to suspend
licence
Mark
Simmonds: I beg to move amendment No. 146, in
clause 20, page 15, line 38, at
end insert— ‘(2A) No more
than four consecutive suspensions under subsection (1) can be granted,
totalling a maximum period of twelve
months.’. The
amendment relates to the number of consecutive suspensions that the
HFEA may allow. Of course it is right that the HFEA should have the
power to suspend a licence quickly and efficiently if it has reasonable
grounds to believe that the terms of the licence might be broken. It
also has the power to renew such a suspension
indefinitely. The
amendment will either place an upper restriction on the number of times
that a suspension may be renewed to a period of up to one year or
establish why that is not acceptable to the Government. Clearly, a
suspension for even a short period could be damaging to a business or
research project that had a licence up to that point. In my view, it is
correct that a decision should be made within a year. By then, the
appeal process should have been gone through, if appropriate, and the
authority should have had sufficient time in which to investigate,
clarify its concerns and rectify any problems.
I would like
to make an additional point if I may, Mr. Gale, about the
timing of the appeal procedure. How quick will it be? Will it be dealt
with within the three-month period, or is that one of the main reasons
why there is no limit on the number of times that a suspension may be
renewed? Clearly, if appeals can be heard and clarified expeditiously,
that will benefit the authority and those who previously had a fully
operational, licensed business or research
facility.
Dawn
Primarolo: Proposed new section 19C retains the right of
the authority to suspend a licence, where it considers there are
grounds to do so, for a period of three months and for further periods
of three months after that, if it sees fit. In my view and in the
experience of the authority, given the work that it has undertaken,
that is the correct way to proceed and there should be no specification
of the number of times that a suspension period has been
repeated. The
hon. Member for Boston and Skegness touched on a case from June 2007 in
which the HFEA used its powers to suspend a licence for three months,
and then suspended it for another three months while it considered an
updated report. He will be aware that there was interaction with the
High Court in that case and a judicial review of the decision. I am
sure he accepts that it is quite difficult to have a maximum period in
such circumstances, because the suspension is needed until a decision
is taken and there might be external factors to consider, such as
judicial appeal or a High Court
judgment. Where
we are is right. The period should be three months, with an option to
suspend again. Clearly, we expect things to be speeded up—part
of the flexibility given in the appeals procedure and the structure of
the licensing committee is to ensure that matters are dealt with in
that period. That will further reduce the time involved. However, to
pick an exceptional case and then argue for a limit given those
exceptional circumstances is incorrect. I hope the hon. Gentleman
accepts that.
The hon.
Gentleman then asked about the period for the appeal. The new
provisions permit an appeal to be made within 14 days. Within the new
framework for appeals, that will be set out in regulations. Safeguards
remain in place to ensure that the suspension continues pending
resolution of the appeal in order to protect public safety. It is right
that we do not have a maximum period because of other interactions. It
is right that we give the HFEA, as we have elsewhere in the Bill, the
opportunity to speed up those considerations wherever possible.
However, it would be unwise of us, with sometimes complex cases, to set
a maximum period when the right resolution could not be achieved. We
are talking about patient safety and quality of care. I hope that the
hon. Gentleman accepts my
comments.
Mark
Simmonds: I thank the Minister for that response. I accept
her arguments, particularly on judicial review and the time that those
often complex cases take. I also take her reassurance on a focus on
speeding up the decisions and considerations wherever possible. It is
right that safety and quality of provision have to be fundamental to
everything that happens under the
Bill. Following
that explanation from the Minister, I beg to ask leave to withdraw the
amendment. Amendment,
by leave,
withdrawn.
Mark
Simmonds: I beg to move amendment No. 147, in
clause 20, page 16, line 4, at
end insert— ‘(6) During a
period of suspension all necessary, suitable and appropriate steps must
be taken by the Authority to ensure there is no damage to the cells,
embryos and gametes that were the responsibility of the licence holder
or person responsible when the licence was
suspended.’. The
amendment relates to the authority having the power to suspend a
licence quickly and efficiently in cases where there are reasonable
grounds for the terms of a licence perhaps having been broken.
Obviously, for the authority to have that right is correct. However, is
it right that during the suspension the people undergoing treatment at
that centre could suffer or, worse, lose their embryos or
gametes? I
am not sure from either the 1990 Act or the Bill whether there is a
duty on the authority to ensure that clients are unaffected during a
licence suspension and can continue treatment at other licensed
premises. Therefore, there is a crossover in how that impacts on the
confidentiality of information going between the
two. Also,
what happens to the gametes and embryos stored in a facility that is
ultimately closed or has its licence removed? Are they transferred
automatically to another facility under the auspices and guidance of
the HFEA, or are they just allowed to wither, so to
speak?
Dawn
Primarolo: I assure the hon. Gentleman that the HFEA,
within its requirements when it suspends a licence, has to issue
special directions. Those special directions allow for the continued
storage of gametes and embryos at the clinic. The HFEA would also
expect the clinic to make appropriate arrangements for the continued
treatment of its patients if a licence were revoked. Furthermore, it
would expect gametes and embryos to be moved to another licensed
clinic. As
with suspension, the HFEA would also expect the clinic to make
appropriate arrangements for the continued treatment of its patients.
The HFEA already has the
power to do that, so I do not think it necessary to give it further
powers under the
Bill. The
hon. Gentleman has raised a series of important questions, but I hope
that in each of those circumstances continued treatment of patients,
safe storage and/or transfer of gametes and embryos will all be dealt
with under the special directions, which are part of the licensing
requirements. 3.30
pm
Mark
Simmonds: I am grateful to the Minister for clarifying the
safety and continuing existence of those gametes and embryos that have
been put in storage in these particular licence facilities, were one to
have a licence revoked or suspended. On that basis, I beg to ask leave
to withdraw the
amendment. Amendment,
by leave,
withdrawn. Clause
20 ordered to stand part of the
Bill.
Clause
21Reconsideration
and
appeals
Mark
Simmonds: I beg to move amendment No. 148, in
clause 21, page 17, line 2, leave
out from ‘wholly’ to ‘and’ in line 3 and
insert ‘of persons who were not members of
the initial grant, revocation or variation
committee.’. I
hope the Minister will confirm that the amendment is not necessary, and
that what it proposes already happens in practice. Clearly, however, it
is important that those who were involved in an original decision are
not also involved in the appeals process. It is certainly important
that the appeals process is not only seen to be fair and independent,
but is fair and independent, and that there are therefore no prejudices
that might have been instilled through the original
process. We
have discussed this before. There are, however, concerns surrounding
conflict of interest on the licensing committee, and having an entirely
new appeals committee mandated in the Bill would prevent such an
incidence occurring, and in particular prevent it from occurring
again.
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