House of Commons portcullis
House of Commons
Session 2009 - 10
Publications on the internet
General Committee Debates
Delegated Legislation Committee Debates



The Committee consisted of the following Members:

Chairman: Mr. Jim Hood
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 most—if not the most—comprehensive 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 House’s 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 criteria—for 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 Committee’s 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 partner—if she has one—to 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 child’s 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 child’s 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 consider—for 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 instruments—I understand it is in subsequent regulations; perhaps the Minister will clarify whether this regulation will be similarly debated—is 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.
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 applications—for 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 regulation—regulation 22—appears 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 today’s 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 certificates—on which we got clarity in Committee—relate 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 argue—as we debated in Committee—that 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—
 
Contents Continue
House of Commons 
home page Parliament home page House of 
Lords home page search page enquiries ordering index

©Parliamentary copyright 2010
Prepared 3 March 2010