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Session 2007 - 08 Publications on the internet General Committee Debates Human Fertilisation and Embryology Bill [Lords] |
Human Fertilisation and Embryology Bill [Lords] |
The Committee consisted of the following Members:Hannah Weston, Celia
Blacklock, Committee Clerks †
attended the Committee Public Bill CommitteeTuesday 10 June 2008(Afternoon)[Mr. Jim Hood in the Chair]Human Fertilisation and Embryology Bill [Lords](Except clauses 4, 11, 14 and 23, schedule 2, and any new clauses or new schedules relating to the termination of pregnancy by registered medical practitioners)Clause 29Offences
under the 1990
Act Amendment
proposed [this day]: 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.’.—[Dr.
Harris.] 4
pm Question
again proposed, That the amendment be
made.
The
Minister of State, Department of Health (Dawn Primarolo):
Before we broke this morning I was responding to the amendment tabled
by the hon. Member for Oxford, West and Abingdon about offences under
the Human Fertilisation and Embryology Act 1990 and the Bill.
The 1990 Act
makes it clear, as I said this morning, that it is an offence to store
gametes, or to create, use or store an embryo, without a licence. The
Bill introduces further offences relating to the creation without a
licence of human admixed embryos, to come alongside the provisions that
already exist. Those offences apply whether or not a person intended to
create an embryo or human admixed embryo. In addition, it is expected
that any person working in the field will know the rules under the Act
when they apply, and when a licence is needed. The point that the hon.
Gentleman has raised in relation to his amendment is about things that
happen accidentally or without being planned, because of the nature of
division before fertilisation. I shall answer his specific
points. It
is my view, and that of the Government, that the clear set of rules
that has been set out is appropriate. That is because we are dealing
with one of the most sensitive areas, which Parliament has deemed it
appropriate to regulate. I appreciate—the hon. Gentleman quoted
from the letter that I circulated to the Committee—that there
are occasions when an embryo could be created when that was not the
intention. An example would be the accidental creation that the hon.
Gentleman referred to this morning.
Amendment No.
173 would add a new defence to the 1990 Act for a person charged with
an offence of creating, storing or using an embryo or admixed embryo,
or storing gametes, without a licence. It would allow a defendant to
raise the defence that at the material time they believed that what
they were doing was not something to which the Act applied. As I said
this morning, it is not acceptable in this complex area for the law to
include a caveat to the effect that, despite the fact that incredibly
knowledgeable people are engaged in highly complex activities, the test
should be what was or was not in the mind of the researcher as to
whether the creation was accidental.
I reiterate
what I said this morning: there is no defence in the 1990 Act, and for
a prosecution to be brought under that Act some safeguards or
additional points need to be borne in mind. The Crown Prosecution
Service must first obtain the consent of the Director of Public
Prosecutions to proceed. That is not a common proceeding for criminal
offences. It is reserved for offences in relation to which weighing the
discretionary factors relevant to the decision whether to prosecute is
likely to be a sensitive and difficult task. That makes it desirable
for the CPS to obtain prior approval for a prosecution. If an offence
were committed under the 1990 Act, the facts of the case would be
looked at carefully and in detail before any proceedings were brought.
That is necessary in such a complex area.
The hon.
Member for Oxford, West and Abingdon quoted from the letter that I
circulated to members of the Committee last week. Where there is any
doubt about particular research projects, it would always be wise to
talk to the HFEA about whether a licence was required. Indeed, there is
currently a licensed project in connection with the research that we
are discussing, which indicates that such projects are covered by the
current definitions, so no further clarity is required.
I would,
however, go further. The amendment says that, although the individual
creates an embryo, they do not think that the Act applies to them.
However, we have talked about the responsible person and the
circumstances under which a licence would be granted or revoked, and
the obligations are quite clear: the emphasis is on the researcher to
understand and comply with the law.
Clearly, a
researcher storing eggs will know that they could divide and thus
create an embryo. Such people are at the forefront of their science and
need to be aware not only that such things can happen, but of the
consequences. Equally, they should know that the 1990 Act regulates
their activities. It is therefore incredibly difficult to see how the
defence in the amendment could work, given that it is based on what
each researcher will know, instead of taking a clear line from the
Bill, with the caveats that I have outlined regarding when a
prosecution might proceed. This is not a new issue, and there is no
indication that we should move away from the current
arrangements. Dr.
Evan Harris (Oxford, West and Abingdon) (LD): Even despite
the caveats, it is clear from what the Minister is saying and from her
letter—at least she is being clear—that anyone who
cultures eggs in vitro will have to get a licence because the eggs
might divide. I wanted to confirm that there is no escape from that and
that things that did not previously require a licence will now require
one for safety.
There is a
further problem, because storing gametes is a licensable activity.
Where, in terms of the development of the germ line cell, does the
gamete start? If work is
being done to generate IV-derived gametes, researchers will require a
licence because an early-stage IV-derived gamete, even if it is just a
germ cell at an early stage—a stem cell—will be covered.
If the Minister can make that clear, there will at least be
clarity.
Dawn
Primarolo: No, I am not making that clear. The hon.
Gentleman seeks to get me to make a general rule in a highly complex
area of science. I have made myself quite clear. I am not taking
responsibility for the scientific judgments and the understanding of
those involved in such research. The clear indication that I am giving
is that an embryo developing spontaneously from an egg is a rare
occurrence—that is what I said in my letter, and it is true.
Whether a researcher working on eggs would require a licence would
depend on the specific project. For example, if a project used donated
frozen eggs to analyse their components at a molecular level, the eggs
would not necessarily be cultured, so there would be no chance of the
parthenote developing. It is therefore not the case that every
researcher working on eggs would need a licence from the HFEA. However,
it is the researcher’s responsibility to be fully acquainted
with the arrangements in the Act and to ensure that he or she complies
with them.
This is a
highly complex area. The steps to prosecution do not follow the normal
criminal prosecution route—if I can put it that way—as
there must be consent from the Director of Public Prosecutions, which
is not common. The hon. Member for Oxford, West and Abingdon argues
that there should be a general rule, licensed or not. The Government
are trying to travel a narrow line by regulating where appropriate, but
not allowing a caveat whereby some research might deem itself not to be
covered by the Act and the offence. The responsibility goes squarely
back to the researchers, the purpose of their research and the
circumstances under which a licence should be acquired. If they have
any doubts, they should refer them to the HFEA. That is the right place
to put it.
To have a
general rule means that we are in great danger of opening up areas of
research that we intended to be regulated, but which are not regulated
as we cannot get the legislation in line with all the objectives. This
is a good, balanced and fair position to be in. It is not a new issue.
It has worked over the period since the 1990 Act, and I see no reason
why it should not work further. I do not suppose that I have convinced
the hon. Member for Oxford, West and Abingdon with those comments, as
he may hold very strong views on the matter, but I hope that at least
he can clearly see the Government’s reasoning behind remaining
at this position.
Dr.
Harris: I can see clearly what the Minister is saying. I
said that this was a probing amendment and I was not wedded to it. I do
not have strong views about the amendment, and a defence is not the
ideal way to deal with this. However, it is necessary for the Committee
to be certain about what is going to happen. I never spoke about
“every researcher working with eggs”—which is what
the Minister said—because obviously, if eggs are frozen, they
are not in culture and they are not going to divide. I spoke about
“every researcher who is dealing with eggs in culture”.
Considering the situation, including this debate and what has been said
in the Minister’s letter, it appears that those researchers will
have to get a licence. I do not believe that that was the previous
position—I know that it was not. There will be more licences,
and regulation will extend. If regulation must extend as a by-product
of a wider definition for other reasons then so be it, but it is
important that researchers understand that.
Some
researchers have a view on the matter. Those at Newcastle told me that
it would be a disappointment to researchers that the spectre—as
they put it—of the need to get a licence was going to hang over
anyone working with eggs where the purpose did not involve
fertilisation and so forth. At least now there is clarity about the
Government’s position on that. The HFEA will have to work
quickly before and after enactment, to ensure that everyone is
clear.
One other
area is not absolutely clear. The Minister has finished her
contribution so I am not necessarily expecting a reply, but I would
like her, and those reading the proceedings, to reflect on this. An egg
is defined as a cell of
the “female
germ line at any stage of
maturity”. If
one has an embryonic stem cell that is pluripotent, at what point does
that become an early stage bone marrow or germ line stem cell? It is
pluripotent; in theory, from that embryonic stem cell, a cell from that
line could be differentiated into a germ line cell—that is the
point of them. There is therefore another question about at what stage
people who are researching solely on stem cell lines—separate
from the embryo work that another group may be doing—may
themselves need a licence. The entity that they are working with may be
heading with differentiation towards a germ line cell, and it may be
considered to be captured. The storage of such cells is a licensable
activity.
The point
that I was making in tabling the amendment was that the breadth of
regulation might well have increased, but it is not a question of
scientists not knowing either the law or what they are doing. I was a
little surprised by the Minister and do not think that she was serious
when she said that I was arguing that senior scientists did not know
what they were doing. The way science works means that it sometimes
surprises people, and many discoveries are made through surprising and
serendipitous findings, so no scientist is able to say in a protocol
that something definitely will or will not happen. That is the nature
and excitement of research. Clearly, any scientist working in this
field has a responsibility to know and accept the law. When it is
likely that an embryo, or something that could possibly be defined as
an embryo, will be created, they will have to get a
licence.
4.15
pm I
do not want it to be left in anyone’s mind that scientists do
not understand the law or are seeking to avoid it. It is just that
there will now be extra regulation. If the Minister could reflect on
the question about embryonic stem cells and when they become germ line
cells at any stage of development, it might be useful to clarify that,
because the HFEA will certainly have
to.
Dawn
Primarolo: Does the hon. Gentleman accept that
discretionary factors are already in place that can be considered
before a decision is taken on whether to prosecute, and that those
discretionary factors are intended
to deal precisely with some of the issues that he has identified? He has
not made a case for why that is not enough; he simply reasserted that a
licence is needed for everything. I clearly stated the conditions under
which we would expect them to consider whether a licence was
necessary.
Dr.
Harris: I apologise to the Minister for not dealing with
that, although it was my intention to. They clearly have a choice: they
can get a licence or rely on the fact that there would be discretion in
prosecution. I am sure that that discretion would be used wisely, but
many people do not like the idea that, although there can be an
investigation, there could be a decision later in that process not to
prosecute. We saw that during the debates in the House on religious
hatred.
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