The
Committee consisted of the following
Members:
Ainsworth,
Mr. Peter
(East Surrey)
(Con)
Bain,
Mr. William
(Glasgow, North-East)
(Lab)
Cox,
Mr. Geoffrey
(Torridge and West Devon)
(Con)
Creagh,
Mary
(Wakefield)
(Lab)
Harris,
Dr. Evan
(Oxford, West and Abingdon)
(LD)
Iddon,
Dr. Brian
(Bolton, South-East)
(Lab)
Ingram,
Mr. Adam
(East Kilbride, Strathaven and Lesmahagow)
(Lab)
Kirkbride,
Miss Julie
(Bromsgrove)
(Con)
Merron,
Gillian
(Minister of State, Department of
Health)
Naysmith,
Dr. Doug
(Bristol, North-West)
(Lab/Co-op)
Pugh,
Dr. John
(Southport)
(LD)
Simmonds,
Mark
(Boston and Skegness)
(Con)
Slaughter,
Mr. Andy
(Ealing, Acton and Shepherd's Bush)
(Lab)
Thornberry,
Emily
(Islington, South and Finsbury)
(Lab)
Waltho,
Lynda
(Stourbridge)
(Lab)
Wilson,
Mr. Rob
(Reading, East)
(Con)
Mark Oxborough, Committee
Clerk
attended the
Committee
Eighth
Delegated Legislation
Committee
Tuesday 2
March
2010
[Mr.
Jim Hood in the
Chair]
Draft
Human Fertilisation and Embryology (Disclosure of Information for
Research Purposes) Regulations
2010
4.30
pm
The
Minister of State, Department of Health (Gillian Merron):
I beg to
move,
That
the Committee has considered the draft Human Fertilisation and
Embryology (Disclosure of Information for Research Purposes)
Regulations
2010.
The
Chairman: With this it will be convenient to consider the
draft Human Fertilisation and Embryology (Parental Orders) Regulations
2010 and the draft Human Fertilisation and Embryology (Parental
Orders) (Consequential, Transitional and Saving
Provisions) Order
2010.
Gillian
Merron: The statutory instruments are necessary to
implement provisions under the Human Fertilisation and Embryology Act
2008. There was extensive debate on those provisions during the passage
of the Bill, and this debate is therefore of a technical nature.
[Interruption.]
The
Chairman: Order. There is a wee bit of humming on the
Government Back
Benches.
Gillian
Merron: I think that we are excited. I will deal with
that.
The
Human Fertilisation and Embryology (Disclosure of Information for
Research Purposes) Regulations are made under section 33D of the Human
Fertilisation and Embryology Act 1990, as amended by the 2008 Act. The
register maintained by the Human Fertilisation and Embryology Authority
records every in vitro fertilisation and donor insemination treatment
cycle carried out in the United Kingdom since August 1991. It is one of
the mostif not the mostcomprehensive databases in the
world and contains more than 800,000 entries. It has long been
recognised that the register has the potential to be of significant use
to researchers, enabling more extensive research on different
treatments and their effectiveness. I am aware that some hon. Members
were members of the Houses Science and Technology Committee in
2005, which considered that research was being hampered by prohibitions
on the disclosure of identifying information. The Committee recommended
that the register data be used as far as
possible.
Since
the 2008 Act came into force on 1 October 2009, patients and their
partners can consent to disclosure and can vary or withdraw that
consent at any time. That is good news for future researchers, but the
real value of the HFEA register for current research is the wealth of
data it already has. The 2008 Act therefore introduced a
regulation-making power to allow identifying information
to be released for research purposes under certain conditions without
consent. That process is not new. It brings fertility data in line with
the access by researchers to other areas of medical records. The
authorisation process for such a release is set out in the disclosure
of information for research purposes
regulations.
Under
the regulations, researchers will need to demonstrate that their
project meets strict criteriafor example, that it is not
reasonably practical to obtain the information other than under the
regulations. When it is not satisfied that the research project is
necessary or that it will improve patient care, the HFEA can, of
course, refuse to grant authorisation.
While parents
can choose to give consent to disclosure of identifying information
about children who have already been born, they cannot give prospective
consent about a child who may not even be conceived. That could
compromise research relating to children born as a result of treatment
services. The Government do not want researchers and clinics to have to
chase former patients to ascertain their wishes. We also do not want
new parents to have to consider such matters when they have obviously
far more pressing
concerns.
We
have therefore extended the authorisation process created by the
regulations to apply to data about children recorded on the register at
any time on or after 1 August 1991. The authorisation criteria will be
exactly the same as for historic data. The regulations do not apply to
all the information that is held on the register. Information on the
donation and use in treatment of donated gametes and embryos is
excluded. That information is especially sensitive, and it would be
unacceptable to release it without the knowledge of those
involved.
The
regulations were the subject of two public consultations between
January and March 2009, and between October and December of that year.
While I hope that people will be prepared to assist with important
research, individuals will be entitled to withhold their identifying
information if they so wish. The Government will work with the HFEA,
patient groups and others to publicise the purpose and effect of the
regulations.
I would like
to draw the Committees attention to two numbering errors in the
printed regulations. In regulation 4, paragraph 6 is
numbered in error. Paragraph 7 should be numbered 6,
paragraph 8 should be numbered 7 and so on until the
end of that regulation. The last sentence in regulation 6 was numbered
sub-paragraph 2 in error. They will be amended in the final version of
the regulations, and I apologise for that
error.
I
turn to the draft Human Fertilisation and Embryology (Parental Orders)
Regulations 2010, which are made under section 55 of the 2008 Act. In
passing the Human Fertilisation and Embryology Act 1990, Parliament
accepted that occasionally, women are prepared to act as surrogates to
help couples who are unable to have children of their own. Parental
orders were introduced by the 1990 Act as a way of transferring
parental responsibility from a surrogate and her partnerif she
has oneto the intended parents, referred to as the
commissioning couple. A parental order is made by the
court. It requires agreement between the parties, and is therefore
based on their freely given and unconditional consent. Eligibility
criteria were set out in the 1990 Act, which included the requirement
that either one or both of the commissioning couple are the
childs genetic parents. However, it also specified that
the applicants must be a married couple. Since that time, around 50
parental orders have been granted by the courts each year.
Under current
law, when same-sex and unmarried couples enter into a surrogacy
arrangement, the only option for them to acquire parental
responsibility for a child is through adoption. However, the 2008 Act
replaced the parental order provision in the 1990 Act to also allow
same-sex and unmarried couples to apply for parental orders. The
regulations before us will apply current adoption legislation, with
modifications, to parental orders, bringing the orders into
line.
The
regulations will make the welfare of the child the paramount
consideration of the court when deciding whether to grant a parental
order. That emphasises the value of the childs interests and is
in line, as I said, with the approach to adoption cases. The welfare
checklist set out in the Adoption and Children Act 2002 will also be
applied, with modifications, to parental orders. That is designed to
support the courts by specifying the matters they should
considerfor example, the particular needs of the child. The
regulations were subject to consultation for three months in the autumn
of 2009, and the responses received demonstrated broad agreement with
the approach
taken.
Finally,
I come to the order on consequential, transitional and saving
provisions, which will revoke the 1994 regulations on parental orders,
but saves part of them for specific purposes. It makes the necessary
consequential amendments to other legislation. The order also sets out
the transitional arrangements for applications made under the 1990 Act
that are not disposed of when the new parental order provisions in the
2008 Act and the regulations come into force. Such applications will
continue to be processed under the 1990 Act.
I commend
both sets of regulations and the order to the
Committee.
4.39
pm
Mark
Simmonds (Boston and Skegness) (Con): It is a pleasure to
serve under your guidance this afternoon, Mr. Hood. The
Minister and the Committee will remember the, I hope, constructive role
that we on the Opposition Benches played during the passage of the 2008
Act both in the Chamber and in the detailed consideration and scrutiny
in Committee. The Opposition had a completely free vote throughout its
passage due to the complex, ethical, scientific and moral issues. There
was extensive debate at the time, and I see no requirement to reopen
those
debates.
However,
there are one or two matters on which I would like to press the
Minister this afternoon. A key issue that is not before us in these two
statutory instrumentsI understand it is in subsequent
regulations; perhaps the Minister will clarify whether this regulation
will be similarly debatedis the great extension of the ability
to store embryos. It was increased from 10 years, which was agreed in
Committee stage, to 55 years under the subsequent regulations. When
will that be debated? Many hon. Members on both sides have concerns
about those changes in
regulations.
As
the Minister rightly said, there was extensive discussion not only as
the Bill passed through Parliament but at the pre-legislative scrutiny
stage. Indeed, the Bill shrank quite considerably from its original
format.
The Minister was also right about the significant wealth of
data on the register. It is absolutely right that there are strict
criteria, as set out in these regulations, which must be adhered to to
gain information in relation to potential research. I agree
wholeheartedly with the Minister about the importance of the
information on gametes and embryos and the great importance that we
must attach to that information being put into the academic research
that will take place if approval is given by the HFEA.
I have a few
questions on the first statutory instrument on the disclosure of
information for research purposes. Regulation 4(4)(c) refers to an
additional category of other research, by which it
means in addition to medical research. Will the Minister outline what
other research she and her officials envisage might be relevant to this
particular statutory instrument? Perhaps she could provide
examples.
Under
regulation 4(5), authorisations for the information to be given to
those doing the research can expire. How long does the HFEA envisage
granting for each use of this particular application and can it be
renewed? If so, what is the complete length of time that the data will
be made available for
research?
In
terms of the fee that will potentially be charged for accessing the
data and information, it appears from the regulations that an upper
limit of £5,000 has been set. How has that figure been reached
and will the HFEA have the ability to vary it without returning to
Parliament? It is important that the total cost is covered by those
applying for the data. Neither should there be a situation where the
HFEA is subsidising research facilities. It is important to understand
how the figure has been arrived at, and whether it is fixed or can be
varied downwards against that
ceiling.
In
regulation 9, the research establishment applying to access the data
can vary the additional conditions on the use of information. Does the
HFEA have the power to vary the additional conditions once the
authorisation has been granted? What mechanisms will be in place to
ensure that the data is being used for the purposes for which it was
originally intended? In regulation 11, within what time scale should
applicants expect to be informed of the decision after the original
application? Clearly, there needs to be a time scale within which the
HFEA needs to respond to the applicationsfor the sake of
clarity, if nothing else. Indeed, regulation 18 talks about the
information being destroyed in the case of a revocation of the licence.
Will the Minister outline under what circumstances a licence may be
revoked and whether both the research and the original disclosed
information will be destroyed together rather than just the
information from the research that has come out of that information
before the revocation of the licence? Does the applicant have a duty to
inform the HFEA of any information security breaches? Clearly, a lot of
the information is extremely
confidential.
Regulation
21 sets out details of a committee being formulated. Who will sit on
the committee? How will they be selected and what will be their
backgrounds? Will they be remunerated and where will the costs of their
expenses and remuneration come
from?
Interestingly,
the final regulationregulation 22appears to
include a provision that could completely override the regulations and
allow the HFEA at any point in the future to set up a new regulatory
structure,
which could be changed at any point in the future. It would be helpful
to understand whether I have misinterpreted regulation
22.
We
had extremely lengthy discussions in Committee about the statutory
instruments relating to surrogacy, when we went into great detail about
the ethical and moral issues, as well as some of the practical issues.
In the context of todays statutory instruments, I want to
return to one or two of those issues as we move into the
detail.
I
want to ask the Minister, on the record, how birth
certificateson which we got clarity in Committeerelate
to surrogacy. The birth certificate should at least be some genetic
record, rather than just being a social statement. From what I
understand, in some circumstances someone could succeed in getting a
parental order such that neither of the parents named on the birth
certificate would have any genetic relationship to the child.
I would argueas we debated in Committeethat
the solution might be to have a long and a short version of the birth
certificate.
Clearly,
because there was significant consultation, I do not intend to go
through all the consequential amendments to existing legislation
included in the statutory instruments. However, I want to ensure that
the Minister and her civil servants have taken into account child
benefit in the structure, because I could not see any mention of that
in the list of the amendments to existing legislation set out in the
statutory instruments before us
today.
Will
the Minister confirm whether a single person can apply for a parental
order or, as the Act stipulates, must there be an enduring relationship
between two people before a parental order can be applied for? Can the
Minister clarify the definition of an enduring
relationship, whether in her mind or as fleshed out in
regulations? We went into that in great detail and were told that the
issue would be reported on at a later
stage.
Finally,
will the Minister confirm whether the Government have undertaken a
review of the surrogacy laws in the UK, which differ hugely from those
elsewhere in the world? That could have a significant impact on
parental orders in the second set of regulations. Have the Government
begun to resolve the issue of stateless children? I shall give the
Committee a brief explanation of what I mean. In the UK, the child is
the offspring of the genetic
parent
4.48
pm
Sitting
suspended for a Division in the
House.
5.3
pm
On
resuming