Dr.
Harris: I am grateful to have the opportunity to respond
to the Minister. I was listening carefully to what she said. In my
opening remarks, I did not answer my own question or put the
Government’s case. I raised two points that I thought that the
Minister might use in her response and raised further points on them to
save time. I thought that that would be easier than seeking to
intervene on the Minister, which might not be her preference, during
her response.
In respect
of her second point about the need to have this information for
follow-up, even for unsuccessful treatment cycles, that follow-up is
done by the doctor and the clinic. That is the same with any medical
treatment. There are often follow-up treatments in medicine. It is not
usual to be required to record all the details, including identifying
information, on the central database in order for there to be an
appropriate follow-up. Because of the stringent confidentiality
requirements, which we are about to discuss, it might be difficult for
one doctor to pass on to another doctor information about previous
treatments. I am not sure whether the matter will be helped by this
form of national database. I do not believe that future doctors would
use the resource to check what existing treatments someone has had;
they would normally ask the patient. I do not understand why the issue
of follow-up is a good reason to hold this information about
unsuccessful treatment cycles.
The Minister
also argued in respect of long-term research. I said that I did not see
how that was different from any other form of medical treatment in
which there is a research interest. I said that research can be done
through the usual consent arrangements prospectively or even
retrospectively, again with the appropriate consents
and ethical approval. My understanding is that there has not been any
useful research based on all the information on the database by the
HFEA. I know that amendments have been tabled to make such research
easier in the future, but it did not seem to be a good argument. That
was why I raised my points in advance. It was not to answer my own
question, but to help move forward the debate by asking whether they
could be addressed. The Minister may feel that she has done that, but I
do not feel that there has been sufficient justification. However, I
understand her point about not knowing whether there is going to be a
pregnancy and therefore needing to collect the information in advance.
If people from abroad, or in this country, do not opt to go back for a
post-natal follow-up, that data set is incomplete. In the end, we rely
on patients coming back for
follow-up. Dawn
Primarolo: The hon. Gentleman will concede, I hope, that I
also made the point that follow-up was much wider than on the
individual patient’s cycles. There is also follow-up about the
impact of drugs and incidents of cancer 20 years on. It is about access
to information from longer term studies and to understand why one cycle
was not unsuccessful and another one was. That may be something that
needs to be studied over time. The information was necessary for that
type of follow-up as
well.
Dr.
Harris: I understand that justification. As I said
earlier, I would argue that it is not necessary to have a national
database to do that. We do not have a national database in any other
form of medicine, but prospective, case-controlled, and retrospective
epidemiological trials are done. Also, no useful data have been
gathered from this database in the nearly 20 years that it has been
going. I accept, however, that the Bill changes provisions to allow
more research. I guess we will know in the future whether that is
possible, not only prospectively for new patients, but for all the
patients that have been
treated. I
understand what the Minister is saying about motives. I am not arguing
that this is some form of malevolent intervention. I happen to be of
the view—I accept what she says about the consultation and that
this is not a majority view—that the benefits of this type of
central database for the treatment of donor cells from pregnancy are
not worth the regulatory burden. However, I was pleased to hear what
she said about the fact that the data collection and entry may be made
easier due to technological advances. I think that we all have our
fingers crossed on that, given the possibility of these things going
wrong. I think that I have made my case, and the Minister has put the
Government’s case, and on that basis, I shall
finish. Question
put and agreed
to. Clause
24, as amended, ordered to stand part of the
Bill.
Clause
25Restrictions
on disclosure of information
Mark
Simmonds: I beg to move amendment No. 38, in
clause 25, page 26, line 4, at
end insert— ‘(za) the
disclosure is made— (i)
on clinical grounds, as part of the patient’s medical care, to a
practitioner who is bound by the ordinary duty of patient
confidentiality, or
(ii) in order to ensure the safety of medical
treatment which the patient is to receive outside of licensed
premises.’.
The
Chairman: With this it will be convenient to discuss the
following: Government amendments Nos. 45 and
46. Amendment
No. 150, in
clause 25, page 27, line 27, at
end insert— ‘(v) the
disclosure is made in order to ensure the safety of medical treatment
which the patient is to receive outside of licensed
premises.’. Amendment
No. 151, in
clause 25, page 27, line 27, at
end insert— ‘(v) the
disclosure is made, on clinical grounds, as part of the
patient’s medical care, to a practitioner who is
bound by the ordinary duty of patient
confidentiality.’. Government
amendments Nos. 47 to
54. Amendment
No. 37, in clause 25, page 28, leave out
line 46 to line 8 on page
29.
Mark
Simmonds: Clause 25 relates to the sharing of
information—between and with whom—the restrictions on
disclosure, and the exceptions to those restrictions. I shall speak
specifically to amendment No.
38. In
proposed new section 33C to the 1990 Act, the Bill provides for
consultation and regulations to be made to allow the disclosure of
identifying information without consent for the purposes of medical or
other research that
is “necessary
or expedient in the public interest or in the interests of improving
patient
care”. However,
as the Minister and many members of the Committee will be aware, this
was debated at some length in the House of Lords. Members of the Lords
believed that the confidentiality provisions of the Bill were too
tight, thus preventing sufficient research on children born by IVF. In
situations in which women conceive through IVF, there is no procedure
for the woman’s obstetrician to be told about the method of
conception. Clearly, this must be looked at in the context of patient
confidentiality. Obviously, if a woman does not want that information
to be passed on, her privacy should be protected.
However,
there are cases in which sharing such information would be beneficial,
and there seems to be a presumption against that information flow,
although perhaps the presumption should be in favour of it, even though
I do not think that it is relevant that obstetricians need to know who
the donor was, or whether it was the partner’s sperm or a donor
sperm that fertilised the egg. Clearly, with IVF, women undergo
treatment and complex procedures that change the body. Such a thing
would, in some circumstances, enhance patient care in the context of
strict confidentiality, which does not apply to other sensitive or
personal conditions, such as considerations of mental health. The
amendment would allow for the sharing of information between medical
practitioners, which could improve patient care, in the context of
confidentiality. The woman’s privacy would be respected, and
consent for that information to be passed on could be withdrawn, if she
wished.
Amendment
No. 37 would remove the regulation-making power in proposed new section
33B of the 1990 Act. My understanding is that the power enables future
additional exceptions to be made on who can request information,
who must be informed, and with whom it can be shared. However, if
consent is the cornerstone of the Bill, such issues should be debated
and put on the face of primary legislation. Members of the Committee
will see a very comprehensive list of exemptions on the main thrust of
the clause in paragraphs (a) to (u) of proposed new section 33A(2). The
matter has obviously been thought through very carefully, but will
Minister put on record why she feels that it might be necessary to
amend the list, given that it has clearly been thought through in great
detail? Can she give the Committee an example of an amendment that
might occur in future, although I understand that it might be difficult
to find an additional category that is not covered in paragraphs (a) to
(u)? My final
point about the clause concerns proposed new section 33A(3)(a), which
details the interrelationship between the Bill and the Congenital
Disabilities (Civil Liability) Act 1976? Will the Minister explain how
the measures work
together? It
would be helpful if the Minister could clarify whether the Government
amendments are all tidying-up provisions, or whether they would
actually change the meaning of the clause. They seem to remove certain
provisions, but that could just be tidying-up
drafting. 11
am
Dr.
Harris: I tabled a couple of the amendments in the group,
but it might be best to hear the Minister’s description of the
effects of the Government amendments. They are better drafted than
those in my name and, if I may say so, those tabled by the hon. Member
for Boston and Skegness. The right hon. Lady’s amendments are
comprehensive and complex, and if she is willing to accept questions
after she has explained them, that might speed things
along. Amendment
No. 151 states that an exception would be made for disclosure on
clinical
grounds “as
part of the patient’s medical care, to a practitioner who is
bound by the ordinary duty of patient
confidentiality.” Those
of us who want the rules on confidentiality to be loosened are not
talking about a free-for-all. We just want to bring the provisions
more, albeit not totally, in line with standard medical care rules
under which medical notes are confidential. There are significant
professional and, indeed, possibly criminal consequences from a breach
of medical confidentiality, which is something that I feel strongly
about. I have argued that the same procedure should apply to
politicians and their children in respect of vaccinations, given that
many in the media think that that should be a free-for-all, although I
disagree. Nevertheless,
several clinicians have raised a problem with me. I shall not repeat
what Lord Patel and Lord Winston said in the other place because that
can be read, but scientists from Newcastle have explained that when a
treatment is provided in a separate tertiary clinic, there is a clear
distinction between the initial investigation of the problem and the
subsequent provision of treatment. In a tertiary NHS referral centre,
it is likely that the initial investigations and counselling will be
carried out in a general infertility clinic. That might also occur a
long time from the possible treatment. For instance, an unmarried
18-year-old with a severe pelvic infection will be counselled about the
potential impact on fertility and the need to consider IVF. Such
records—I
guess because this is a carried out in a licensed centre by a licensed
person—are currently included in law under strict
confidentiality regulations because they refer to IVF, and that is
inappropriate. There
are two ways in which to tackle the problem. We could argue that only
limited information should be included in the provisions and that they
should be loosened to enable communication between doctors in the best
interests of the patients in good faith. Doctors should always be
answerable in respect of complaints to medical regulators and the
professional regulator, the General Medical
Council. The
Government have heard such concerns in the House of Lords on several
occasions and I note that their amendments represent a response to
that. I look forward to hearing the right hon. Lady explain their
effect in detail. I hope that the clinicians who have contacted me will
be satisfied by what she says, as well as the potential of the
regulation-making power. I share the view of any Opposition
parliamentarian that wide-ranging, regulation-making powers are
questionable, but I feel more comfortable with the inclusion of the
provision, given that I do not think that this debate has
ended. IVF
still has a cachet, which makes it sensitive, but as its special status
becomes less special, and as it becomes more routine, for many
patients—it will always be their decision—it might well
become appropriate to change the provisions to ensure that we keep up
to date with what is practical and appropriate, rather than stick to
what was felt to be appropriate in
1990. Dr.
Ian Gibson (Norwich, North) (Lab): I wonder,
Mr. Hood, whether I could have your view on an issue about
the running of this Committee that is beginning to bother me. Several
documents are being floated by people who have tabled amendments.
During my time in Parliament, I have sat on several such Committees,
and when documents are received from experts, it is important that
every Committee member sees them so that we can come to a balanced
judgment. Could you rule, Mr. Hood, that if people read from
documents from eminent professionals, they be made available to the
whole Committee? I say that because, advisably, I challenged a document
before, and within an hour, I was being challenged by those who put the
document in. My answer to them was, “Why didn’t you send
it to all of us? How do I know whether what you are saying is true?
Give us the evidence so that we can see.” I think that we are
getting restrictive readings from different documents and that the
Committee is hearing only half the story. We all feel passionately
about this issue and want to get seriously
involved.
The
Chairman: I thank the hon. Gentleman for his point, but
that is not a matter for the Chair. If Members receive information from
other sources, it is for them to deal with that as they see fit. If
evidence was given to the Committee per se, all members of the
Committee would have that information, so that would not be a matter
for the
Chair.
Dr.
Gibson: Perhaps the organisations or individuals that send
in such information are not aware of Committee procedure. By floating
it to one Committee member,
they restrict other’s involvement in the debate. When something
is put forward, perhaps it should be presented by the individual to the
Clerks so that they can judge whether it should be
distributed.
The
Chairman: Again, the hon. Gentleman makes his point, but I
reiterate that that a matter for not the Chair, but those supplying the
information to Members and, indeed, the Members
themselves.
Dawn
Primarolo: The HFEA is required to collect details of
licensed treatments for its register of information, which contains
identifying information about everyone who has received treatment,
including IVF or donor insemination. The 1990 Act prohibits the
disclosure of such information by either the HFEA or a licensed
practitioner, and that is subject to a criminal offence, as the hon.
Member for Oxford, West and Abingdon reminded the Committee. The Bill
provides for exceptions to be made to that provision, so we have moved
from the requirements of the 1990 Act to the exceptions, some of which
we have dealt with this morning. Such exceptions are when a person
identified in the information to be released has consented to its
release, with the exception, of course, of donor information—we
covered this in the previous clause—which is protected to a
particular age; when the information would not identify any individual;
or in an emergency, when a woman who has received treatment or services
is in imminent danger that makes it necessary for information to be
released. The list of exceptions consolidates those already permitted
under the 1990 Act, as well as introducing some new ones. Furthermore,
as the hon. Member for Boston and Skegness mentioned, the Bill contains
a regulatory power that enables additional exceptions to be
made.
When the
hon. Member for Boston and Skegness referred to amendment No. 37, he
asked me specifically why we need the regulatory measure. He referred
to paragraphs (a) to (u) of proposed new section 33A(2). To be frank,
the answer is that every exception that we can think of is already
there, although we cannot think into the future in terms of
future-proofing. The regulation-making power was in the 1990 Act.
Measures would be subject to the affirmative procedure and the power
would be a method of future-proofing the Bill, just in case. The hon.
Gentleman is right to say that we made every attempt to put everything
in the Bill, but we still believe that this measure is necessary in
case—as has happened in the past—we need further
exemptions. The regulations would not change the principles within
which the exemptions work. He asked whether I could name any; I am
afraid that I cannot because we think that we have been quite
thorough.
I shall deal
with amendments Nos. 38, 150 and 151 and respond to the questions asked
by both hon. Gentlemen before moving on to the Government amendments.
The amendments would provide additional exceptions for the disclosure
of information. Specifically, they relate to the situation if the
disclosure is made on clinical grounds as part of the patient’s
medical care to a practitioner who is bound by the ordinary duty of
patient confidentiality, or if it is necessary to ensure the safety of
medical treatment that the patient is to receive outside licensed
premises. Again, the hon. Member for Oxford, West and Abingdon drew
comparisons with what happens elsewhere in medicine with regard to the
exchange of information.
The
Government’s view is that consent on disclosure should always be
obtained when possible, and that doing so need not necessarily be
burdensome. We appreciate that there are occasions when, during the
course of treatment, it would be necessary for clinicians to share
information with other health professionals. However, because of the
consent arrangements in the Bill—I will go on to make further
points—we feel that it is more appropriate to provide for the
obtaining of general consent from the patient for that purpose at the
beginning of treatment. That would enable clinicians to be confident
that they were not acting outside the patient’s wishes, while
also allowing them to share appropriate information regarding the
treatment of the
patient. There
are circumstances in which patients would perhaps want to limit the
people who could be told about their treatment—perhaps they
would not want such information to go to a GP who is a relative or a
friend. By consenting at the beginning of treatment, the extent of
information sharing could be limited accordingly. Again, that echoes
back to a theme that we have discussed in previous clauses about the
importance of clear explanation to the patient and clear adherence to
consent.
Even after
amendment, the provision would not provide scope for clinicians to
disclose confidential patient information without the patient’s
consent. I am not referring to drafting; I will reference other
requirements. I should say something to the hon. Member for Oxford,
West and Abingdon as a caveat because I have been a Member of the House
for 21 years—quite a long time in opposition, although not
recently, thank goodness. It is hard to draft amendments because
parliamentary counsel are highly skilled. His amendments are about
making progress on the principle, and I understand entirely what he
wants to
do. 11.15
am The
amendments would not provide for that because before information was
disclosed to the health care professionals involved in a
person’s treatment, the doctor would still need to consider
whether disclosure was compatible with the Data Protection Act 1998,
common law and any other relevant law where consent is generally
required. Therefore, requiring the consent right at the beginning, and
allowing that general disclosure, is in our view much more secure for
the clinicians as well. They would have to satisfy themselves in all
those other areas that they were disclosing information in the correct
way. It is the Government’s view that the Bill strikes the right
balance in respect of requiring consent to be obtained before
identifying information is disclosed, even when that is to other health
care professionals, with the exception of emergency situations. Consent
to such disclosure in the course of treatment can be obtained, as I
said, prior to the initiation of treatment, when the patient is
consenting to that
treatment. The
amendments that would introduce an exception to the disclosure are, in
the Government’s view, inappropriate. The disclosure of
identifying information without consent should be permitted only where
there is good justification. There was a lot of discussion about that
between the Government and stakeholders. The British Medical
Association supported the Bill’s position. Obtaining consent for
disclosure to health care professionals is possible. Therefore, the
exception proposed by the amendments is not justified.
The hon.
Member for Oxford, West and Abingdon made a point about the problems of
disparity between different medical professions and that we are setting
a higher level. I hope that I have dealt with that point, because a
general consent at the beginning gives greater certainty and clarity to
clinicians than having to satisfy themselves subsequently about data
protection, common law and other law relating to confidential
information, which is what the amendments would
require. The
hon. Member for Boston and Skegness asked about the Congenital
Disabilities (Civil Liability) Act 1976. That did not trip off my
tongue—I was prompted on the exact date, I hasten to add. The
1990 Act extended the reach of that legislation to cover infertility
treatments. Basically, the Bill does not alter that position. The 1976
legislation was carried over to the 1990 Act, which made the
cross-reference and put infertility in, but the Bill, as it amends the
1990 Act, is silent on that, because it does not alter the positions. I
hope that that deals with his
point. On
the Government amendments, I suppose the quick response, although I
might have to give a little more detail, is yes, they mostly tidy up
the consent exceptions, following discussion in another place. The
changes are tidying-up measures. However, there is one instance in
which we need to be absolutely clear with regard to the interaction of
the exceptions. We have to ensure that we do not inadvertently open up
the consent to disclosure of non-identifying information or cause some
difficulties in that regard. We are managing two types of
information—the identifying and non-identifying—and under
what basis it can be disclosed.
We recognise
that it is very important that the 1990 Act and the Bill strike the
right balance between safeguarding the confidential information of
patients, their partner, donors and children held by the HFEA and
clinics while, at the same time, allowing information to be disclosed
by the HFEA and clinics in circumstances that warrant it. However, the
1990 Act is not always as conducive as it could be in that regard. For
example, it prohibits the HFEA from disclosing identifying information
about patients, even in cases in which the patient consents to such
disclosure. That is one issue that needs to be addressed.
I will go
through the Government amendments very quickly and return to them if
Members have further questions. Amendment No. 45 amends and simplifies
the wording in new section 33A(2)(g) to (j) and clarifies it to strike
the important balance on consent, including identifying information as
long as individuals have given their
consent. Amendment
No. 46 is consequential to the new wording in proposed new section 33A
about the disclosure of information, and replaces wording removed by
amendment No. 50. It clarifies that the HFEA can disclose identifying
information from its register to avoid imminent danger to a
person’s
health. Amendment
No. 47 removes wording from proposed new section 33A about consent to
disclosure when treatment services are provided to two people together
and both are identifiable. It recognises the provisions in proposed new
section 33AB whereby the consent of each individual identified must be
obtained. Amendment
No. 48 removes wording that is consequential and replaces it with
wording that will be introduced by amendment No. 54. Amendment No. 49
clarifies that the disclosure of information for the purpose of
investigating an offence or suspected offence, or in connection with
legal proceedings, does not apply to identifying donor
information. Amendment
No. 50 removes wording from new section 33A consequential to the
replacement wording that is introduced by amendment No. 46. Amendment
No. 51 reflects the fact that the Bill introduces provisions for
fatherhood agreements for unmarried couples in which donor sperm is
used. Amendment No. 52 is consequential on amendment No. 45. Amendment
No. 53 defines what the term “identifying donor
information” means with regard to new section 33A(2), which is a
consequence of amendment No. 45. Amendment No. 54 applies in
conjunction with amendment No. 45.
Therefore,
without going into any detail, I am trying to indicate to the hon.
Member for Boston and Skegness that we are cross-referencing and making
it absolutely clear that the exemptions fit together and do not breach
any of the principles. Overall, the Government amendments provide
clarification rather than a change of policy by continuing to strike
the balance between disclosure of identifying information, particularly
that which might be helpful for follow-up research into the health of
patients and their children, and ensuring that consent is properly and
rightly obtained.
If I have
not covered any of the points, Mr. Hood, I would be happy to
catch your eye and return to them.
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