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There are specific things which are done to human embryos in culture which might produce unpredictable epigenetic effects. Those include embryo freezing. We have evidence in my own laboratory that when human embryos are frozen under certain routine circumstances, gene expression changes; that is, the genes change the protein that they produce, at least only temporarily. One of the genes that we have looked at protects against cancer. I am not suggesting an alarmist reaction to this work, but it was published in a very important peer review journal and was obviously acceptable to that journal. We have to say that there is a need for continuous follow-up for the sorts of thing that we do in in vitro fertilisation over a long period.
Embryo freezing is by no means the only procedure that should be under surveillance. Prolonged culture—where embryos are kept in culture for more than three days, up to five or six days—is a growing trend in in vitro fertilisation at the moment. We know from work in mice that that also may produce anomalies of gene expression under certain circumstances. The third area I can think of immediately, though there are many others, is changes in the culture in which the embryo is produced.
None of those should prevent us continuing to offer in vitro fertilisation. There is clearly no evidence of major abnormalities as a result of in vitro fertilisation —at least in this country—compared with people who had babies by the other method. When I say “the other method”, I remember my six year-old sitting at the breakfast table once saying to me, “Dad, tell me, are more babies born by the test tube or by the other method?”. In a family like mine it becomes a routine thing. I hope the Committee will forgive the digression.
It is important that we recognise that it should be easier to survey children long-term, keeping proper records of those children if we can, in order to promote research rather than hinder or prevent it. One way of doing that is to avoid the unnecessary restrictions on confidentiality which do no good for the patient and which are now obsolete in terms of treatment. The routine issues of informed consent and the normal confidentiality that exist with virtually every other medical procedure should suffice for in vitro fertilisation as well.
Lord Alton of Liverpool: The noble Lord, Lord Winston, was right to take us back to the debate that we had about OHSS and to remind us of remarks that had passed across the Committee about the implications of freezing for subsequent disability. He is also right to tell us that there is no need for scaremongering or alarmism about this, but it is something about which we should take a long-term view. My noble friend will be pleased to know that I agree with him that the routine collection of this kind of data is crucially important as we understand what happens as a result of the use of in vitro fertilisation.
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I have another question for him in this brief intervention concerning the issue of commercial exploitation. We all want to strike the right balance between providing information for the kind of creditable research that is needed and ensuring that there is no commercial exploitation of that kind of information in the future. If the noble Lord can give that assurance, many of us in the Committee will find the arguments that he has advanced very compelling.
Baroness Barker: I rise to support the noble Lord, Lord Patel. He and I have discussed this matter at some length over the past couple of days. I support him for two reasons. The one that I think is the most important was put to us by the British Fertility Society. Parents who have donor-assisted children and are going through the process of IVF do not object to the proposals the noble Lord is putting forward. They are somewhat surprised when they discover that all the treatment they would expect to go through in the course of a pregnancy will be hindered at various stages by the prevention of transmission of information, not for commercial purposes, not to outsiders, but to other practitioners, usually within the NHS.
The most compelling argument is that the fact that a pregnancy has resulted from IVF makes a distinct difference to the tests that are carried out throughout a pregnancy. Adjustments have to be made to such things as amniocentesis tests and even the analysis of scans, because that is a relevant factor. Those are fairly compelling reasons for your Lordships to accept the noble Lord’s amendment.
Earl Howe: My Amendment No. 65 is grouped here and I shall speak to it briefly. New Clause 33C will enable the Secretary of State to make regulations requiring or regulating the disclosure for research purposes of certain information held by the HFEA. Information could be disclosed for research where the Secretary of State considered it necessary or expedient in the public interest or in the interests of improving patient care. The Explanatory Notes to the Bill say that there is an expectation that the power will be used only in such circumstances where it would not be possible to obtain consent to the disclosure. This provision raises a number of questions and it would be helpful if the Minister could explain more fully what is intended.
My concern rests chiefly on the disclosure of personal information provided by patients in good faith, and which they have a right to expect will be kept confidential. As a normal rule, medical confidentiality should be sacrosanct unless there are overriding public health reasons to break that confidentiality. I am not sure that I see data held by the HFEA as a compelling candidate for disclosure. The words “necessary or expedient” ring alarm bells with me. The bells, I confess, ring all the louder if the provision is intended to apply retrospectively. People who have received IVF treatment
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My second main concern relates to the kinds of reason that Ministers may regard as strong enough for them to exercise the power given to them by the new clause. I can well see that there may be some public benefit in establishing, for example, the long-term health outcomes of children conceived by IVF. However, if the database is to be released to researchers, their reason for accessing it has to be because the findings that might be expected to emerge from an analysis of it are of major public importance. Merely to conduct a fishing expedition would not, I think, constitute a sufficiently good reason.
I hope the Minister will be able to reassure me that, if consent is given, data would be released to researchers on a restricted, need-to-know basis. The HFEA is a widely respected organisation, but I hope it is not unfair to say that, for some, it is a little faceless and impersonal. At times, it can give the impression of behaving like a Star Chamber in its decision-making. It is important that, if these provisions are agreed to, the HFEA takes account of the need to explain to the public why it is releasing data, why doing so does not represent an unacceptable breach of trust, and what they see as the likely benefits of disclosure.
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Lord Winston: I am grateful to the noble Earl, Lord Howe, for giving way. However I do not think that anyone is pleading for anything more than might happen, for example, after neonatal care in a neonatal establishment or after obstetric care in an obstetric unit. Under the existing rules, there must be proper ethical approval of any research project. I would not be pleading for any more than that. Obviously one would support proper ethically conducted research. Certainly, one does not want a free-for-all. We want no more than any other research procedure on children elsewhere. That is what I am aiming for.
Earl Howe: It is extremely helpful to hear that from the noble Lord, Lord Winston. At the same time, it would be equally helpful to hear from the Minister what the Government envisage from the use of this power.
Lord Davies of Coity: I understand that we want to regulate the arrangements in the most appropriate way, but I have to advise the House. I have four daughters and eight grandchildren, seven of whom were born in what my noble friend Lord Winston describes as, “the other way”.
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However, one of them was born as a result of IVF, eight years ago. That child is a normal, beautiful grandchild of mine. She was born as a result of my youngest daughter devoting her eggs to my second daughter in order that that child could be born. The grief that my second daughter experienced, as a result of not being able to have a second child, was enormous. When my youngest daughter said, “I’ve got two children. I will devote my eggs to her”—the noble Lord, Lord Winston, knows about this because I discussed it with him at the time—this child was born and is now a beautiful, eight year-old youngster.
Whatever regulations and protection you want to introduce, for heaven’s sake, never destroy the opportunity for a young woman to have a child as a result of IVF, because that would be damaging to everyone. That is the circumstance I have experienced. I hope that the Government will recognise that.
Lord Darzi of Denham: Although the provisions on access to information are not, perhaps, the most high-profile element of this Bill, they have attracted strong views from those in the fertility sector. Let me first address the two amendments tabled by the noble Lord, Lord Patel. The first, Amendment No. 64A, relates to disclosure of identifiable information held on the HFEA register with consent. The second, Amendment No. 64B, relates to disclosure of information without consent.
During the public consultation on the Bill, the view was expressed that the additional level of protection applied to identifying information about treatments and other activities regulated by the 1990 Act was unnecessary, that it hindered the legitimate exchange of information and that the protection provided by the Data Protection Act 1998 and the common law on confidentiality, which regulate disclosure of information from most other health records, would provide sufficient safeguards for patients, gamete and embryo donors, and offspring.
In my clinical practice, I am well used to working within these controls, so I can appreciate why that view is held. It is certainly shared by the noble Lord, whose amendments would relax the prohibition on disclosure of identifying information with, in the case of Amendment No. 64B, the practical effect of leaving identifying information essentially subject to the requirements of the Data Protection Act and the common law. However, in setting the level of protection for identifying information covered by the 1990 Act and this Bill, the Government are obliged to have regard to the requirements of a European Union directive that sets standards of quality and safety in relation to human tissues, including gametes and embryos, intended for human application.
The Government are of the view that Article 14 of the directive, which sets the requirements on data protection and confidentiality for health records, requires statutory protection that goes further than that which the Data Protection Act and the common law provide. This is due to the fact that it involves the use of a person’s tissue for someone else. We consider that this level of protection is achieved by the prohibition on disclosure in new Section 33A.
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We have, however, added some new exceptions in new Section 33A that will ensure that disclosure for legitimate purposes, such as patient care or the investigation of a potential offence, is not inappropriately impeded. Moreover, the power in the 1990 Act to make regulations adding further exceptions to the prohibition is still included in the Bill, in new Section 33B. Therefore, if it becomes evident that there are further circumstances in which disclosure legitimately needs to be made, it will be possible to make regulations to allow for this.
The noble Lord’s Amendment No. 64A would allow disclosure of identifying information with the consent of the persons to whom the information relates. However, it could also permit disclosure of information to those who were conceived using donated gametes or a donated embryo. The exceptions relating to donors and those born as a consequence of donation apply in a different way from those that relate to people who have received treatment services. In particular, identifying information about donors cannot be released to those conceived using their donation until the donor-conceived person reaches 18 and chooses to find out the donor’s identity. Separate provisions for donor information are necessary to prevent information being disclosed to a donor-conceived person outside the system provided for in the new sections inserted by Clause 24. The amendment could lead to a donor-conceived person, possibly a young teenager, obtaining identifying information about their donor outside the system provided for in new Section 31ZA. I imagine that that is not what the noble Lord was seeking.
With regard to information about those who have received treatment services, the aim of the amendment is already achieved by the exception in new Section 33A(2)(h). This, together with the exceptions allowing wider disclosure by the HFEA, HFEA-licensed establishments and others to whom the prohibition in the 1990 Act applies, will allow the type of disclosure that the noble Lord seeks.
New Section 33A strikes an appropriate balance between the obligation to protect the confidentiality of patients, children and donors, and ensuring that information can be disclosed where it is necessary.
I turn to the amendment of the noble Earl, Lord Howe. A key recommendation of the 1984 Committee of Inquiry into Human Fertilisation and Embryology, chaired by the noble Baroness, Lady Warnock, was the creation of a register of assisted conception treatments that would allow the long-term health implications for children born as a result of those treatments to be monitored. Since August 1991, the HFEA register has kept a record of every IVF and donor insemination treatment cycle carried out by licensed clinics in the UK, including, where known, its outcome. The HFEA register represents one of the most comprehensive stores of information on these treatments in the world. For that reason the Government intend to ensure that the Bill will pave the way to enabling better use to be made of this valuable resource, to improve our knowledge about these treatments.
We will remove the barrier in the 1990 Act that prevents patients giving their consent to the disclosure of identifying information from the HFEA register. Patients will have the opportunity and the choice, on
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I assure the noble Earl that before such regulations are introduced, it is appropriate that a full consultation takes place. Following this, the proposed model for releasing the information for research will be included in regulations, which will be debated in both Houses.
We intend that it will be possible to disclose identifying information under the regulations only where the research is necessary in the public interest, or, in the cases of medical research, in the interests of improving patient care. As the data on the HFEA register and records held in licensed clinics go back to 1991, it may no longer be practical to obtain consent to disclosure from persons to whom the information relates. Without the authorisation process, which this clause enables the Secretary of State to put in place, using regulation, it is likely that the data from a large number of records would be barred from use in research, thereby limiting the benefits that could be derived from this information.
A practical outcome of such a restriction might be that researchers could not be given a complete set of data on patients who have undergone a specific type of fertility treatment, such as intracytoplasmic sperm injection, or ICSI, and so might not be able to assess fully whether this treatment has any link with the development of particular genetic conditions in some of the resulting children. Similarly, researchers hoping to link HFEA data with information held in other health registries, such as a local cancer registry, would not be able to have a complete data set, again limiting their ability to determine whether there is any indication of a link between a certain type of fertility treatment or process and the onset of a particular medical condition.
Regulation-making power of the type proposed in new Section 33C is not new. A similar authorisation procedure already exists in England and Wales for the NHS or privately funded healthcare systems. A system where an application made to the Secretary of State for access to confidential patient information, without consent, was established under the regulations made under Section 251 of the National Health Service Act 2006. The patient information advisory group advises the Secretary of State on the appropriateness of approving applications for the disclosure of information under those regulations. Section 33C(2) includes powers to establish one or more bodies to consider applications for access to identifying information from the HFEA register and from health records held by licensed establishments. The process established by the regulations will need to work equally in all four home countries.
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Clinical and scientific professionals have long regarded the audit of clinical practice and studies into the long-term results of medical treatments to be one of the most important parts of healthcare service and vital if we are properly to serve the interests of our patients and the wider public. Treatments such as IVF are widely considered to be safe for both patients and offspring, but I believe we would be failing those patients and children if we did not take every opportunity to ensure that long-term follow-up studies can take place to confirm that view.
The authorisation process allowed for in this clause is intended to provide a method of last resort. It cannot be used by researchers to circumvent the need to seek patients’ consent, where it is reasonably practical to consult them. New Section 33C(5) sets the obligation that the regulations may not enable or require identifying information to be disclosed or processed for any purpose, if it would be reasonably practical to achieve the purpose by other means. I hope that will reassure the noble Lord and he will feel able to withdraw his amendment.
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Baroness Carnegy of Lour: Before the noble Lord sits down, in his response to the two amendments of the noble Lord, Lord Patel, I understood that the nub of the problem was that data protection law in Europe was frustrating the noble Lord's aspirations. Have the Government looked at how the matter is dealt with in other countries in Europe? Do they get round the problem in a way that the noble Lord, Lord Patel, wanted? There is obviously an aspiration among consultants to achieve that.
Lord Darzi of Denham: I am grateful for the noble Baroness's intervention. I will seek legal opinion on that, but if the Bill receives Royal Assent, it will contain a number of exceptions that will permit disclosure, as the noble Lord, Lord Patel, suggested, when it is justifiable. For example, licensed establishments passing information to other licensed establishments for the purpose of their function as such would not breach the Act. Nor would a licensed establishment breach the Act if it disclosed identifying information to a healthcare professional or for a referral involved in the patient’s care if it had the relevant consent.
Lord Turnberg: Before my noble friend sits down, does the European directive include any suggestion that criminal proceedings should be taken against someone who discloses information in relation to IVF as against other forms of fertility treatment?
Lord Darzi of Denham: I will not do my noble friend justice if I answer that question. I will seek opinion in relation to it.
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