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Division
No.
2] Question
accordingly negatived.
Question
proposed, That the clause stand part of the
Bill.
Mark
Simmonds: Just for clarification, do I need to withdraw
amendment No. 157 formally?
The
Chairman: It is deemed as having been
withdrawn.
Mark
Simmonds: I do not wish to detain the Committee by getting
the Minister to tell us verbally what the answers are, but it would
help if she could furnish the Committee with the relevant information.
Clearly, as we have said, there is concern about the HFEA charging
regime and how it might grow. I imagine that people in the HFEA have
done projections for the next three years about how they imagine the
fee income will grow, how they imagine their expenditure and cost base
will
expand, and what those additional costs and expenditures will be spent
on. Will the Minister put that information in the public domain,
because financial implications clearly arise from the changes proposed
in the Bill—particularly if birth registration is changed. As
the HFEA grows in its remit, the expectation is that increasing
expenditure will be met by fee income. It would be helpful if the
Minister could write a letter to members of the Committee or place
something in the House of Commons Library on that matter. Doing so
would ensure that both the Committee and the wider public have detailed
financial information about the proposals on the financing of the
HFEA.
Dawn
Primarolo: I am not quite sure how I can help the hon.
Gentleman any further than I already have. The agreements in terms of
finances for the HFEA are subject to public scrutiny through the
information that it provides. I have said that the HFEA will consult on
the level of fees. In addition, the Department would expect the
enactment of the Bill to result in the HFEA reflecting on its future
requirements and submitting a business case to us on the additional
grant aid it might need to deal with the Bill’s implications. A
letter would say no more than that until the Government are in a
position to say more publicly, because all these matters are about to
be consulted on. The fees and the future liabilities will need to be
considered in the context of the Bill, which is not yet an
Act. I
hear what the hon. Gentleman is saying and I will keep him informed of
developments once the Bill is enacted. Until then, I am not able to say
a great deal more because the HFEA will have to reflect on the
matter. Question
put and agreed
to. Clause
27 ordered to stand part of the
Bill.
Clause
28Inspection,
entry, search and
seizure 12.30
pm Question
proposed, That the clause stand part of the
Bill.
Mark
Simmonds: Will the Minister help the Committee by saying
how many times the powers of entry, search and seizure under warrant
have been used between 1990 and the present time, and how many times
they have resulted in prosecutions, if any? I think that the powers
were granted under section 38 of the 1990
Act. My
understanding is that the clause allows for members of the authority to
be in possession of embryos, gametes or human admixed embryos in the
course of their employment. I just wondered what that means. Does it
mean that members of the authority are allowed to seize embryos,
gametes or human admixed embryos from licensed premises as part of
their employment or that they can hold them separately in a different
function? Will the Minister also confirm that this is only the case if
the cells have been seized?
It would also
be helpful if the Minister explained, in the context of the clause, the
procedure for informing donors and owners of these embryos and gametes
that they have been seized, and if she described the methods and places
for their storage to prevent degeneration and loss. As well as seizing
property, gametes and embryos from licensed premises, can the authority
take control of a facility where it believes somebody has broken the
clauses of the
licence?
Dr.
Harris: I want to raise the unfortunate recent case of Dr.
Taranissi’s clinic and the HFEA. My understanding of the clause
and new schedule 3B is that this is a significant move. It must be done
carefully and not carelessly. In the Taranissi case, the appropriate
steps were not taken when a sudden inspection entry involving search
and seizure took place. It was unfortunate that it happened with
television cameras from “Panorama” present down the
street. I
am sure the Minister would agree that the clause covers a serious
business and that inspections should not be carried out for the implied
benefit of the media. The HFEA, which gets a lot of unfair criticism,
should not be using its powers to have a public relations exercise to
show “Panorama”, the BBC or any other broadcaster or
media that it is being tough. The powers that it has speak for
themselves. Implemented responsibly, they can do the job. I hope that
the Committee agrees that there should be no repetition of that media
circus in these matters. The HFEA was in court and had to settle a
significant sum of money at the public expense for using the powers
inappropriately.
Dawn
Primarolo: Two sets of questions have been raised. The
hon. Gentleman raised the Taranissi case and whether the current powers
are being used correctly. The hon. Member for Boston and Skegness asked
for clarification.
It is
clearly not appropriate for me to comment on the case to which the hon.
Member for Oxford, West and Abingdon referred. He speculates—I
put it delicately—as have others, as to whether the powers of
the HFEA, which I think he accepts are appropriate in the
circumstances, were used appropriately in that case. That continues to
be debated. The hon. Gentleman does not raise questions about the
inappropriateness of the 1990 Act, as amended by this Bill, but he does
raise issues that the HFEA needs to reflect on. The HFEA is following
these proceedings carefully, and I am sure that it will note the points
raised. The
requirement to inspect licensed premises at least every two years was
set out in regulations under a European Union directive. Previously,
the 1990 Act had provided for inspection every year, although that
requirement could be waived by a licence committee, if the authority
considered an inspection in that year to be unnecessary. All this
clause does is bring those requirements for inspection, entry, search
and seizure in line with the changes that the Bill makes regarding
electronic records. It means that there is a regulating power to ensure
that the legislation is future-proof. That power will enable the
Secretary of State to specify what information should be contained in
the appropriate statement given to a person on the premises during the
execution of a warrant. The requirements and what actually happens are
not being varied from the principle.
The hon.
Member for Boston and Skegness asked for details of specific seizures
or cases—how many times and where. I cannot remember what time
period he asked about. I am afraid that I will have to write to the
Committee with those statistics, as I do not have them to hand. He then
asked what the possession of gametes means. It means that in the course
of duty, HFEA staff could seize embryos but would not be exempt from
needing a licence in other circumstances. As I tried to explain, we are
bringing the new provisions in line with the existing
framework. The
hon. Member for Oxford, West and Abingdon raised questions on a
particular case, and while it is entirely inappropriate for me to
comment on it, I will perhaps see, having consulted the HFEA, whether I
can put in writing to the Committee something helpful with regard to
the interpretation of its
powers. Question
put and agreed
to. Clause
28 ordered to stand part of the
Bill.
Schedule
5Schedule
inserted in the 1990 Act as Schedule
3B Question
proposed, That the schedule be the Fifth schedule to the
Bill.
Mark
Simmonds: I have a couple of questions about the schedule,
which provides detail on inspection, entry, search and seizure. First,
are the premises searched and the dates on which they are searched
publicised? Is it public information? Is compensation paid if search
and seizure has taken place but there was no prosecution or variation
in licence? That is one reason why I asked a little earlier—a
question that the Minister could not today answer—how many
seizures have taken place since the 1990 Act came into
force. Secondly,
how much notice, if any, needs to be given for entry under the
schedule, or is it merely random, with those doing the inspection
turning up as and when they see fit? Indeed, it may be sensible for
someone to be there to demonstrate that there is nothing wrong or
untoward with the licence.
If my
understanding is correct, provisions in earlier parts of the Bill allow
third parties to be contracted by the HFEA to enter and inspect
premises under the schedule. Will permission need to be granted by the
authority for those arm’s length bodies to undertake that work
in individual cases, or will it be a block contract, with the bodies
inspecting on behalf of the HFEA acting on their own
discretion?
The Minister
answered my question about two years, but I want clarification of a
further matter in relation to paragraph 7(1)(a) to proposed schedule 3B
about seizure in the course of inspection. I am puzzled as to why the
HFEA or a body acting on its behalf would want seize anything when
granting a licence or varying a licence at the request of a person who
already has one. I understand why seizure might be applicable in
revocation or suspension cases, particularly if it is to be used for
evidence for the proceedings detailed in paragraph 7(2) to proposed
schedule 3B.
Dawn
Primarolo: We covered the question of qualified inspectors
not directly employed by the HFEA in a previous debate, and what they
would inspect—the laboratories and equipment, rather than some
of the other issues. It would be necessary for that person to be a
qualified inspector.
As for
periods of inspection and notice of inspection, I do not have
information to hand on that; it operates at present, and as far as I
know we have not had any problems. However, if the evidence justifies
it, we need to allow for spot inspections. I shall need to include that
in the letter that I have written to the hon. Gentleman; it will be a
subset. He asked whether details of seizures will be made
public—perhaps on the HFEA website—and if there is no
such obligation, why not. There may be some caveats, so I shall
certainly write to him on that.
The last
point raised by the hon. Gentleman was about compensation when a search
has taken place. No provision has been made for compensation. The whole
point is that those making inspections and seizures under the 1990 Act
should act reasonably. That means within a certain time, and it also
requires a reason for the inspection. All that would have to be
demonstrated, and I will put that into the letter
too.
12.45
pm This
regime has worked well. The hon. Gentleman will need to be satisfied
when I give him the details of how many revocations there have been and
how many inspections have resulted in revocation, but I say to him that
the whole point of the regime is that it does not need to be used often
and in the period since 1990—apart from the required
inspections—those spot inspections or seizures have not been
used often. I hope that I will be able to reassure him and other
members of the Committee on that in
writing.
Mark
Simmonds: I am grateful to the Minister for that answer.
Perhaps she could add to that list of paragraphs in the letter that she
is going to write a brief explanation of the last point that I made
regarding paragraph 7(1)(a). In other words, why is it necessary to
have as grounds for the seizure the purposes of the authority’s
functions relating to the granting or variation of a licence, which
would include the variation of a licence at the behest of a licensee? I
cannot think of any situation where anything would be seized in those
circumstances.
Dawn
Primarolo: I am happy to confirm that I will address that
point. I apologise for missing it.
Question
put and agreed
to. Schedule
5 agreed
to.
Clause
29Offences
under the 1990
Act
Dr.
Harris: I beg to move amendment No. 173, in
clause 29, page 33, line 20, at
end insert— ‘(10B) It is a
defence for a person (“the defendant”) charged with an
offence of doing anything which, under section 3(1) or (1A), 4(1)(a) or
4A(2), cannot be done other than in pursuance of a licence, to prove
that at the material time the defendant believed on reasonable grounds
that what they did was not something to which the Act
applied.’.
This
amendment, which deals with a potential new defence under the clause,
is a probing one that tries to clarify what will happen in the new
situation. The problem is caused by the new definition of an embryo,
which clearly has been decided already during the procedure and has
been debated in this Committee. It is now accepted that that issue will
not be re-opened, and that an embryo is as defined at the beginning of
the Bill, in clause 1. It must be recognised that that is a new
definition that, from enactment, will capture issues that are not
currently captured, and which are therefore not subject to regulation
and do not require licences. As a consequence, the criminal law will be
brought into new areas.
That creates
a new problem: due to the nature of science, it is not entirely clear
when something might be defined as an embryo under the Bill. We touched
on that problem when we debated the clause in question, and following
an exchange that I had with the Minister, it was covered in a letter
that was sent to you, Mr. Hood, your co-Chairman and members
of the Committee. That letter makes it clear that there is, as far as
researchers are concerned, a particular problem.
I shall set
out briefly the problem that might require defence. I draw attention to
the fact that it was first raised in the House of Lords, following
representations made in a briefing to all relevant peers by the Academy
of Medical Sciences, the Medical Research Council, the Law Society, the
Wellcome Trust and the Association of Medical Research Charities. That
briefing set out the problem in relation to the amendment, which I have
re-tabled to try to take the debate on. The briefing
states: “Embryos
are broadly defined under the Bill to include ‘an egg that is in
the process of fertilisation or is undergoing any other process capable
of resulting in an embryo’. Gametes are also broadly defined to
include germ line cells at any stage of maturity. Our
understanding”— that
is, the scientists’ or science’s
understanding— “of
the processes by which eggs develop into embryos and cells develop into
germ line cells is incomplete. It is therefore possible that a
researcher could store or carry out research on cells that are not
currently known to be or destined to become germ line cells, or could
carry out research on eggs that are (unknown to current science)
capable of resulting in an
embryo.” The
argument—the thrust of the amendment—is that it should be
a defence for a researcher if they can prove that they reasonably
believed that what they stored or were creating was not a gamete,
embryo or interspecies embryo as defined in the Bill. Of course, the
researcher would have to cease their activity, seek a licence or
destroy the material as soon as it became reasonably clear that that
was
necessary. There
is an analogous defence in the Human Tissue Act 2004, which the
Minister in the other place mentioned in the debate on the amendment.
She
said: “The
noble Lord, Lord Patel, said that the Human Tissue Act had a similar
defence and asked why it was not appropriate for the Human
Fertilisation and Embryology Bill also to have a similar defence.
Although this is a defence under the Human Tissue Act, the activities
that require a licence under the Human Fertilisation and Embryology Act
1990 relate to the handling of human embryos and gametes, and the
sensitivity of these activities means that it is imperative that
scientists are aware of whether their activities require a licence
under the Act.”—[Official Report, House of Lords,
28 January 2008; Vol. 698, c. 469.]
That is true, but I do
not believe that it answers my point. We are not talking about a
defence based on ignorance of the law, and it is unfortunate that that
did not come across clearly in the Lords debate. Unquestionably,
researchers in the field know what the law is and that an embryo that
is created—that outcome is likely or at least
possible—predictably and reasonably comes under the Act. This is
about the uncertainty of the law, not the science.
Clearly,
such a defence was felt necessary for inclusion in the 2004 Act, which
also dealt with sensitive matters. It therefore seems reasonable to
include a similar, if narrower, defence in the Bill if we accept that
there is a
problem. I
should set out the circumstances in which such a defence could be
required. Again, I am grateful to the Newcastle scientists for meeting
me last night to provide me with more specific information. They said
that several centres in the UK—the problem is not
rare—are carrying out in vitro research on human eggs with the
approval of a research ethics committee but not under an HFE licence,
which is unnecessary because regulations under the HFEA exempt such
research unless the eggs are fertilised or stimulated specifically to
develop into an embryo. Lord Patel pointed that out in the Lords
debate, and Mary Herbert, who is an expert in meiosis at the North East
England Stem Cell Institute, has confirmed that although it is rare,
the division of an egg cannot be ruled out because it may occur
spontaneously and unexpectedly. There is no intention to create an
embryo, but it is possible that any cultured egg may divide
parthenogenetically; very occasionally—this is the
point—the cell may continue to divide to a two-cell stage with a
full set of
chromosomes. It
is the view of those scientists and the Government that such an entity
would be covered by the definition in clause 1. Therefore, an offence
would in theory have been committed if such a thing occurs in an
unlicensed laboratory. Will all research on eggs in vitro require a
licence to avoid the problem? Are we unravelling the whole point of the
regulations made under the 1990 Act shortly after it was passed that
allowed gamete research to continue without a licence, as it
does?
It is
important to give one example of the work specifically concerning the
investigation of the meiosis process, because it is ongoing. Meiosis is
the division of chromosomes in the egg immediately before
fertilisation, so that the number of chromosomes is reduced by half.
Errors occurring during meiosis result in miscarriage and cause
congenital abnormalities such as Down’s syndrome. The studies
involve measuring proteins and other molecular signals within an egg as
it undergoes meiosis. Research on how to store the eggs of young women
to preserve their fertility before chemotherapy is another
example.
In our
exchange, which I shall not repeat, the Minister said that either
embryos should be licensed or that the eggs that this might happen to
should be destroyed, but her letter was clear. It is important that we
recognise what it said. The Government’s letter to the Committee
said
that “eggs
can spontaneously activate and begin to divide without having been
fertilised...It is highly unlikely that a human parthenote could
implant and/or develop into a baby. However they do divide for several
days in vitro allowing some research to be carried out on
them.”
That would be research
under a licence, because it would involve a parthenogenetic embryo.
However: “As
well as occurring spontaneously, it is possible to stimulate
parthenogenesis by exposing eggs to a specific chemical or by
stimulating them with an electric
shock.” Again,
that would require a licence under the Bill, which is fair enough,
because one anticipates that that sort of thing will continue. The
letter said that such embryos would be covered by the definition, and
went on to
say: “As
far as we understand, there are very few research projects involving
human eggs which do not involve fertilisation of the eggs. The majority
of research on eggs would involve creating an embryo, and therefore
would require a license from the HFEA. However, we accept that where
there was non-licensed research on eggs being carried out, there is a
possibility that an egg may spontaneously begin to
divide. The
Human Fertilisation and Embryology Act 1990 states that you cannot
bring about the creation of an embryo in vitro without a license from
the HFEA. Therefore, if a researcher were concerned that this might not
be the case, they would need to obtain a license. The Bill does not
change this
position.” I
do not seek to argue with the letter; I am just setting it out to save
time. The Bill changes the position. There was some doubt before, but
now it is clear that spontaneous parthenogenesis, because it involves
the creation of an embryo, albeit not deliberately, would require a
licence. Is it the Department’s advice and the HFEA’s
likely advice that anyone culturing eggs in vitro, even if there is no
intention of stimulating them or creating embryos, will require a
licence?
If that is
the case, certainty is needed about it, or researchers may believe that
even if it is not their intention, the research ethics committee does
not feel that it is a possibility and they do not publish anything
about parthenogenetic embryos, they may still be liable for a criminal
offence. Although they may be able to “not have a
problem”, as it were, now that the matter has been raised in the
House of Lords and here, it is important to be absolutely clear for
those researchers and to realise that there will be more research
licences—and, pursuant to previous debates, more income for the
HFEA—and an increase in regulation. I look forward to the
Minister’s
response.
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