Dr.
Harris: I am grateful to the Minister for her exposition
on the amendments, which I followed on a track changes
document—I think that that is the only way to do it. First, in
response to a point made by the hon. Member for Norwich, North, I am a
little confused. I had a meeting with Alison Murdoch last night, who is
a clinician in Newcastle. I am sure that he would have been entitled to
attend had I known that he was around and
interested.
Dr.
Harris: I did not think that it was illegitimate to meet a
clinician—
Dr.
Gibson: What a
cheek!
Dr.
Harris: And to ask her to e-mail
me— [Interruption.]
Dr.
Harris: I did not think that it was unreasonable to meet
someone and ask them to e-mail me a couple of points because the
meeting was coming to an end, and then to raise them in Committee. That
is entirely appropriate. In respect of the hon. Gentleman’s
point earlier, I checked with Newcastle about the mitochondrial DNA and
I checked my e-mail. I understand that that was sent to all members of
the Committee. I merely quoted from a document sent to all members of
the Committee about the research on mitochondria and IV-derived
gametes.
Dr.
Gibson: That may be so, but in my conversation with them I
made it clear that I had not seen that document. They may have sent it,
and these things happen now and again. The hon. Gentleman is in a
difficult position if it is seen that he may be a lobbyist, rather than
a full member of the Committee. I will be
watching carefully throughout our proceedings to see whether the
individual views of scientists or others are available to all hon.
Member, in terms of the whole context of what they have given to
him.
Dr.
Harris: I object to that. If the hon. Gentleman used the
term lobbyist as a smear, I object to it, and I object to the assertion
that when I and, for that matter, Lord Patel and Lord Turnberg meet any
scientist to express concerns about the Bill, we are somehow not doing
our job. It is reasonable to do that and we have been diverted in a
peculiar way, Mr. Hood. I am happy to hand the hon.
Gentleman a copy of the e-mail that was sent to me by Alison Murdoch
last
night.
The
Chairman: Order. I am sure that the hon. Gentleman will
get back to the
debate.
Dr.
Harris: I am keen to do so, but I thought it was right to
defend the normal activities of Opposition Members. For 10 years I have
been meeting people who are concerned about legislation, and I will
continue to do so despite the hon. Gentleman’s
admonitions.
I want to
make two points on the Government’s provisions. Am I correct in
understanding that amendment No. 45 does two things, which are brought
together in one amendment because proposed new (h) follows on from
proposed new paragraph (g)? New paragraph (g) is an important amendment
because it makes it clear that the disclosure that would not be
permitted is where any individual can be identified from the
information, rather than a disclosure whereby no individual to whom the
information relates could be identified. That is a separate and helpful
amendment, and proposed new paragraph (h) is much more in keeping with
the rest of the amendments. They are simply brought together by a good
fortune of drafting, that (h) follows (g).
I understand
the Minister’s specific point about getting general consent at
the beginning. I think that the problem is merely one of interpretation
by the HFEA, and what she said will be helpful. In normal clinical
practice, information is not divulged without consent; it is divulged
with implied consent. When people see a GP they do not have to sign
anything to say, “You have my permission to send the information
on to a consultant”, because when someone seeks a referral from
a GP, it is implied that that information will be transmitted. When the
medical or surgical team want to write to GPs to explain that someone
is in hospital and has received treatment, that is not done without
consent, because it is implied.
Dawn
Primarolo: I hope that the hon. Gentleman forgives me, but
I forgot to cover that point. I absolutely accept what he says about
data protection and general confidentiality, but I remind him that the
EU tissues and cell directive sets standards of safety and quality for
human tissue intended for human application, which includes areas that
we are discussing, and goes further than the Data Protection Act. When
I alluded to other legislation that would impinge on confidentiality, I
had not meant to be more specific than that. It explains why there is a
higher
hurdle.
11.30
am
Dr.
Harris: The Minister has no need to apologise, because I
assumed that that was what she meant, and I was going to raise that in
my points at the beginning. I thought, given what she had said
previously, that I would not raise it in advance. I have a question
about it, so it is useful that she has raised
it.
Coming back
to what I was saying, there is implied consent; treatment is not done
without consent. Because of the nature of this treatment, and because
of the complication of identifying donor information, there needs to be
a process. Otherwise relying on implied consent can lead people to fall
into traps of not knowing where the division goes. I understand the
reason why there is a need for an explicit or written consent. Consent
is a process, and written consent is a sign that there has been a
process and it is useful. However, there is a problem with
interpretation by the HFEA, because clinicians tell me—I believe
that this is on the record in the House of Lords debates as
well—that they are required, or feel that they are required, by
the HFEA, whether in their code of practice, in their inspection system
or by some other means, to get a consent form filled in for every
visit, every procedure and every test, even when the general consent
form has been filled in at the beginning.
There may be
scope here not for legislation, but for it to be made clear to the
authority, which may feel that it is doing its job and playing safe,
that the requirements of the tissues and cells directive, 2004/23 EC,
particularly article 14, can be met by a written general consent at the
beginning, and that specific consent is unnecessary as long as patients
are made aware that they can at any point change the terms of that
consent. That should be straightforward to do, and specific requests
can be made for certain information not to be provided. I think that
requiring a form each time is
unnecessary. I
am hoping that the Minister can assure me that the extra requirements
created by the directive would not prevent a general consent at the
beginning as long as the patient knows
that.
Dawn
Primarolo: I am happy to confirm that to the hon.
Gentleman. When we were discussing consent at the beginning of our
proceedings, we noted that discussions are taking place between the
Department and the HFEA, and the HFEA is considering the whole question
of consent, the exceptions, and how it is provided. That point might
have been raised by the hon. Gentleman. Some of the things that he is
saying now would need to be clarified within that discussion. The HFEA
would need to take forward those discussions and the support and advice
given to clinics.
Dr.
Harris: That is good news indeed. The Government
amendments are an improvement on the existing situation. Using the
Minister’s words today—I hope that I have got this
right—a general, specific consent at the beginning does not have
to be augmented, although it can be resiled from at any point by a
patient; they must have the right to change their mind in respect of
future disclosures or for new
treatments.
Dawn
Primarolo: Just to put a qualification in there: of
course, that should be within the limitations of the 1990 Act. It is
about identifying and non-identifying information about the donor. For
example, the identifying
information cannot be made available until the child reaches 18; that
cannot be the case, and nobody can vary
that.
Dr.
Harris: I completely accept that, and I have had no
representations from clinicians questioning the need for such clear
separation. They understood that part of being licensed was to
understand the sensitivity of that. I welcome the fact that there are
ongoing discussions and note that the Government amendments are an
improvement. It should be possible to reduce the pressure. The criminal
offence worries clinicians, and perhaps they are also playing safe. If
the HFEA could make it clear that if they fulfil certain
requirements—particularly for patients who give the general
consent at the beginning that is not retracted at some point—it
should be
reasonable. The
only other point to bear in mind is that there is a continuing concern
about the differentiation between licensed and non-licensed
individuals, licensed and non-licensed treatments, licensed clinics and
non-licensed premises. Some of that is inevitable. We cannot have a
licence and say that there should not be a difference. The fact that
one has to have a licence is because there is a difference, and that
creates a difference. The Minister should have a discussion with the
HFEA—I emphasise that for the columns of
Hansard—about making sure that there is not what seems to
be an unfair burden on someone doing normal work who happens to be
licensed, or on someone doing work that could take place in an
unlicensed place, but who happens to have a licence because they do
other work. If it can be shown that they are not unfairly at risk, or
facing unfair or unreasonable burdens, people will welcome the progress
made, both in the legislation and in our
debates.
Mark
Simmonds: I thank the Minister for her response to my
amendments and for her explanation of the Government
amendments. I
accept what the Minister says about amendment No. 37. The list is
clearly comprehensive and well thought through. It is correct that if
there are to be regulations, or there is a necessity for them, they are
subject to the affirmative procedure so that they have to be discussed
in Parliament. Everyone on the Committee wants to see the Bill, when it
becomes an Act, to last effectively at least as long as its
predecessor, the 1990 Act. That is the whole purpose, so regulations
can keep up to date with scientific advances as the years go
by. On
amendment No. 38, again I thank the Minister. I understand what she
says. It is right that there is general consent at the beginning of
treatment, within the limitations of the Act, but she seemed to suggest
that there was an ability for conditional consent—for
information to be passed on. Her example was if the GP might be a
family member. Is the Minister saying that exclusions can be specified
on the consent form about whom is not able to receive that information,
or, as I suspected originally, will there be generic
consent? On
the implied consent argument and the exchange that has just taken place
between the Minister and the hon. Member for Oxford, West and Abingdon,
it is quite right that there is a higher hurdle when we are talking
about such issues, as well as about human tissues. I am pleased that
there are ongoing discussions with the HFEA and licensed premises,
because I am
concerned, like the hon. Member for Oxford, West and Abingdon, about the
potential to put unreasonable bureaucratic burdens on licensed
premises. I hope that those ongoing discussions will facilitate such a
situation not
occurring. With
regard to the Government amendments, I have one question for the
Minister relating to amendment No. 54, which I am not clear about.
Proposed new subsection (3) of that amendment
reads: “Consent in respect of a
person who has not attained the age of 18
years”— referred
to in the amendment as
“C”— “may
be given...by C, in a case where C is competent to deal with the
issue of
consent”. If
I read that correctly, that implies that someone below the age of 18
could give consent. How young could that person be to give consent?
Would they have to be above the age of 16 but below 18? Could they be
12? Could they be eight? There does not seem to be any clarification
elsewhere in the Bill or anywhere in the group of
amendments.
Dawn
Primarolo: The hon. Member for Boston and Skegness asked
about consent. What I described as general consent is the position that
all the consent works from for disclosure of information. The patient
is able to put exceptions into that. If the hon. Gentleman recalls the
exchange between myself and my right hon. Friend the Member for
Coatbridge, Chryston and Bellshill in last Thursday’s sitting,
my right hon. Friend said that he might be prepared to give consent for
certain types of research, but that he would want to make exceptions in
other areas. We were talking about cases in which the donor was
deceased. However, that starts from a general consent in which patients
have the option to put in exceptions.
Although we
are talking about general consent, patients should have the ability to
make explicit exceptions to their consent for the disclosure of that
information if those exceptions are not overridden by any of the other
exceptions. It would be much too complex to have the two consents
working in different ways against different principles. I understand
that matters would proceed in very much the same way, but it is crucial
that the HFEA examines the issue very carefully when it takes on new
considerations of consent. There will clearly be active discussion of
those particular considerations with stakeholders and the individuals
and organisations that have made representations on this part of the
Bill. I hope that I have made clear how the process will
operate. The
other question that the hon. Member for Boston and Skegness asked was
how old a person needed to be for the purposes of consent. The system
does not work on the basis of age, but on whether an individual has
sufficient understanding of the implications of the decision. That is
obviously a fine judgment that needs to be made. I do not think that we
can take that away from clinicians because individuals vary in their
understanding. That is why there is not a specific age. I do not think
that that is at odds with how we test competency elsewhere. Everybody
has to be satisfied that an individual understands the
implications.
The hon.
Member for Oxford, West and Abingdon asked me a question about
Government amendment No. 45, and I think that I answered it. The
amendment specifically ensures that the provisions cannot be used to
require the HFEA to disclose identifying information about donors for
which specific provision is made elsewhere in the 1990 Act and the
Bill. The amendment is constraining in that it reflects the wish to
keep the measure very tight to the specific purpose. It was a result of
clarification and tidying up following the very extensive debate on
these measures that was held in another
place. I
think that I have answered all of the questions that I was asked. If I
have not, the hon. Gentleman needs to say now. I hope that the
Committee will support the Government amendments, which I shall move
formally at the appropriate
time.
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