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Baroness Barker: My Lords, I support the noble Lord, Lord Patel, as I did in Committee. I have always been slightly surprised that the issue is so powerful and emotive. Clearly, that was so when the noble Baroness, Lady Warnock, did her report; and we have had the legislation that we have had. I say that because the first successful IVF treatment resulted in such huge coverage in every newspaper in the world. The birth of Louise Brown and the way in which it was reported sent a general feeling throughout the land about this treatment. I firmly believe it is in part because of that that today, informally, this is not a great matter of shame; it is very commonly talked about. I say that because, apart from the issues that the noble Lord, Lord Patel, has rightly raised about the damaging limitations that these strictures place on care—particularly the antenatal care of individual woman—it is wise, when considering this matter, to take into account public opinion, which if anything has become much more open and well disposed towards disclosure over the past 20 years.
In 2005, the department, as part of its review of the HFEA Act 1990, proposed that confidentiality provisions should be revised so that information about assisted reproductive treatment was treated in exactly the same way as any other medical information. That element of the consultation brought forward general agreement. People could not, in general, understand why this information should be treated differently. I note the point made by the noble Lord, Lord Jenkin, about anonymised data, but my understanding is that the amendment would simply replicate that which is in the Human Tissue Act, so there would be no question of individual patient data being widely reported outside the medical profession. That is not what is proposed, as indeed it should not be. The amendment would make a tremendous difference to healthcare practitioners
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Baroness Royall of Blaisdon: My Lords, the amendments of the noble Lord, Lord Patel, address the important issue of the disclosure by the Human Fertilisation and Embryology Authority, by HFEA licence holders and others, of identifying information about people who receive certain types of licensed infertility treatment, those born as a result of such treatment and those who donate their gametes or embryos for certain types of treatment, or for research. The issue calls for very careful consideration of the value of such information being shared—for instance, with other health professionals involved in patients’ care—balanced against the rights of patients to have their information treated confidentially.
This is a complex area and it may be helpful if I outline the aims of the 1990 Act and the Bill in this respect. Essentially, the 1990 Act provides that the HFEA, people who work in licensed centres, and certain others, shall not release identifying information about certain types of patient, donors or those born as a result of certain types of treatment. The Act also provides exceptions to this prohibition so that it does not apply in specified circumstances. This recognises the principle of patient confidentiality while also acknowledging that there are circumstances where it may be appropriate to disclose such information. I also stress that it is not a case of disclosure being able to take place if the prohibitions in the 1990 Act and the Bill were not to apply. The provisions of the Data Protection Act 1998 would remain relevant, as would the common law on confidentiality and other relevant laws.
Clause 25 introduces new sections setting out in one place the prohibition on the disclosure of identifying information which the Act imposes and the exceptions to that prohibition. These sections consolidate the exceptions contained in the 1990 Act and add new ones. They also introduce a new regulation-making power subject to the affirmative procedure—new Section 33C—which will enable regulations to be made allowing the disclosure of identifying information without consent for the purposes of medical or other research which is necessary or expedient in the public interest, or in the interests of improving patient care. The regulations are required to be subject to consultation beforehand.
The exceptions in the Bill have been extended in recognition of the fact that a wider range of people may now need access to the information held by licensed centres, the HFEA and others; for example, those working under a contract with the HFEA to discharge its statutory functions. The exceptions have also been extended to cover circumstances where the disclosure of information would be justified, such as disclosure of some types of information with the consent of persons to whom the information relates.
Amendment No. 132 concerns one of the exceptions to the prohibition on disclosure I have already referred to—subsection (2)(i) of new Section 33A. Currently, only recipients of infertility services can consent to their identifying information being disclosed. Those
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The purpose of the noble Lord’s amendment appears to be to simplify the circumstances in which the particular exception at subsection (2)(i) of new Section 33A will apply. The exception applies where the people identified in the information consent to its disclosure. It would not, however, enable disclosure of information to a person born as a result of treatment services when they are under the age of 18 or enable consent to be sought from such a person.
The amendment is helpful. The provisions in the Bill are intended to simplify how the disclosure of identifying information with consent will work. I agree that the amendment would provide further simplification. On that basis I am happy to take it away for further consideration.
Amendment No. 133 adds a further category to the list of exceptions to the prohibition on disclosure of identifying information contained in the Bill. It would introduce a wide-ranging exception, lifting the prohibition on disclosure without the patient’s consent if, essentially, it is necessary or expedient in the public interest or in the interest of improving patient care. This would introduce a wide range of circumstances in which the prohibition on disclosure would not apply but where the patient’s consent to disclosure has not been obtained. I understand that the noble Lord is seeking to ensure that the prohibition on disclosure is not unreasonable, but I can assure him that we have sought to provide in the Bill a comprehensive list of exceptions to the prohibition on disclosure so that the prohibition will not apply in circumstances where disclosure is justifiable.
The NHS code of practice on confidentiality makes clear that confidential patient information should generally be disclosed only for healthcare purposes or purposes associated with healthcare with patient consent. We have therefore extended the categories of person in the Bill who can consent to disclosure of their information. We do not consider it appropriate for disclosure to be possible in the wide range of circumstances set out in the noble Lord’s amendment, where the relevant consents have not been obtained. For instance, it would lift the prohibition on disclosure of information about a patient’s care—for example, for medical diagnosis—where the patient does not consent to it. Further, the Government consider that the breadth of the exception would not provide sufficient certainty for the purpose of implementing the European Union tissue and cells directive.
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It may be helpful if I mention a couple of additional points. Some believe that disclosure can be made only to a named person and that this is unnecessarily prohibitive. But it is a misconception that disclosure of identifying information to health professionals can be disclosed only to a specific, named individual. That has not been the case since the amendments made to the 1990 Act by the Human Fertilisation and Embryology (Disclosure of Information) Act 1992. We have not included in new subsection (6C) of the 1990 Act a requirement that disclosure must be to a named person. In any event, the current legislation already exempts the need for a named individual where disclosure is in connection with the provision of treatment services for the person giving consent.
There are also misconceptions about disclosure and written consent. Neither the 1990 Act nor the Bill requires consent to disclosure of identifying information to be in writing. It has to be said, however, that written consent does provide clarity that consent has been obtained.
I listened carefully to points made in the debate, especially by those noble Lords who work in healthcare. The Government’s considered view is that no further concessions are necessary in this area. However, it does seem to be the clear view of noble Lords that enabling further consent would be for the patient’s well-being. Healthcare seems to be the reasoning behind their arguments. Therefore, it is beholden on me to take this amendment back and take another look at it. We will then see whether it might be appropriate to have a similar amendment in the other place and whether this would fit into the broader picture in relation to the Human Tissue Act, human rights legislation and other things. I do not know whether that will be possible, but I am willing to take it back and ask my colleagues in another place to have a look at it.
Lord Winston: My Lords, I should like to give a brief scenario. A woman is attending for in vitro fertilisation and has started her treatment. As noble Lords will appreciate, it is an ongoing treatment. During the course of that treatment, some parallel evidence comes to light which suggests that there is a history of child abuse in that family. The only way of getting that information would be to seek advice, perhaps from another medical practitioner, possibly her general practitioner, but the patient refuses to give consent for any contact with another professional or with social services. What is the doctor’s responsibility under the law? It is certainly not clear to me.
Baroness Royall of Blaisdon: My Lords, that is an important and valid question. At this stage, the answer is not clear to me either. I will come back to the noble Lord in writing.
Lord Patel: My Lords, I thank the Minister for her response. Most of all, I thank those noble Lords who so strongly supported this amendment. I was merely a spokesman for colleagues, who hold a licence to treat infertile women and to provide in vitro treatment, and who come across this problem on a daily basis. The amendment clearly does not apply to situations in which gametes or embryos are donated. It applies to women who are undergoing in vitro fertilisation.
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I shall give another example of something that used to happen on a weekly basis. When my colleagues, who were treating patients with infertility, were successful in achieving pregnancy by in vitro fertilisation and their patient’s care was passed on to me as an obstetrician, they used to have whisper the name of the patient to me in the corridor. I would then go and mark the notes with a red star so that my team would understand what that meant. Not being a licence-holder, presumably I was not committing a criminal act. However, if my colleague had put that down or written me a letter saying, “Please look after this lady”, that might, without consent, have been regarded as a criminal act.
Therefore, there are issues to be handled. The Minister was hesitant in replying, which meant that she was finding difficulty in knowing why such draconian confidentiality rules are put there in the first place. They are draconian and unnecessary. We are talking about what is now a well accepted medical treatment for people who are infertile. It is not 1978, when Louise Brown was born. It is not even 1990, when this Act was passed. It is today and more than a million children are born through this procedure. I am sure that the noble Lord, Lord Winston, will know the exact figures.
Lord Winston: To a single one.
Lord Patel: Touché. I hope that when the Minister says she will look at this and will ask her department to look at it, she will do so very seriously. On that basis, I beg leave to withdraw the amendment.
Amendment, by leave, withdrawn.
[Amendment No. 133 not moved.]
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Clause 26 [Mitochondrial donation]:
Lord Darzi of Denham moved Amendment No. 134:
On Question, amendment agreed to.
Clause 28 [Inspection, entry, search and seizure]:
Lord Darzi of Denham moved Amendment No. 135:
On Question, amendment agreed to.
Clause 29 [Offences under the 1990 Act]:
Lord Darzi of Denham moved Amendment No. 136:
On Question, amendment agreed to.
Lord Patel moved Amendment No. 137:
“(10B) It is a defence for a person (“the defendant”) charged with an offence of doing anything which, under section 3(1) or
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The noble Lord said: My Lords, I am sure that Ministers will be pleased to hear that this is the last of my amendments. It is a probing amendment that relates to the defences to the various criminal offences under the Human Fertilisation and Embryology Act and the Bill. The penalties for those criminal offences are rather draconian, or rather stringent, as they probably ought to be but, none the less, there is a problem. A number of criminal offences are set out in the Bill. They include doing any of the following without a licence: storing gametes and creating, storing and using embryos. The terms “embryos” and “gametes” are, rightly, broadly defined in the Bill. For example, “embryos” include eggs that are in the process of fertilisation or are undergoing any other process capable of resulting in an embryo. “Gametes” are defined as including germ-line cells at any stage of maturity. The interpretation of both those terms, and therefore the application of the Bill and the requirement for licences are dependent on the current state of our scientific knowledge. However, our understanding of the processes by which eggs develop into embryos and cells develop into germ-line cells is incomplete. It is therefore possible that a researcher could store or carry out research on cells that are not at the outset of their research understood to be germ-line cells at any stage of maturity but, through developments in science, become recognised as early-stage germ-line cells, the storage or use of which requires a licence. It is also possible that a researcher could carry out procedures involving human cells that, contrary to current scientific understanding, give rise to gametes that are capable of resulting in embryos and are therefore embryos for the purposes of the Bill, the use and storage of which requires a licence.
It is essential that all researchers who knew or should have known that they are storing or using gametes or creating, storing or using embryos and therefore require a licence should be liable to criminal charges if they fail to obtain one. However, there should be a defence in those limited circumstances where a researcher can prove that he or she reasonably believed that what he or she was storing or creating was not a gamete or an embryo as defined in the Bill. This is a very limited defence because in practice it is likely to arise only in circumstances where the HFEA itself did not recognise the activity at the time it was commenced as being regulated; otherwise the researcher’s belief that the Act did not apply would generally have been unreasonable. Furthermore, under the defence, the researcher would have to cease the activity and seek a licence or destroy the material as soon as it became reasonably clear that that was necessary. I note that a similar defence is contained in the Human Tissue Act 2004. Ideally, it might have been better to amend the definitions, but that is probably not a viable option at this stage, or even in the near future. However, this is a real issue: the accidental creation of a parthenote is one such example, but there are many others. I ask the Minister to consider this amendment as a probing amendment. I beg to move.
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Baroness Williams of Crosby:My Lords, perhaps I may throw into the debate some worries I have about what appears to be an eminently sensible amendment. Generally speaking, in the range of laws limiting what a citizen can do, the argument that one does not know the law is not usually provided as a reason why the person concerned may be exempted from the law. Indeed, if that were the case, a great many laws could not be applied at all. In this instance, one would expect most researchers to be familiar with the law or to have an obligation to make themselves familiar with it.
The other thing that troubles me very much about the amendment—though I recognise that it is eminently sensible in many ways—is how one proves that one did not know. It becomes a very subjective judgment whether the person concerned can show that they did not know what the legislation enabled them not to do. That troubles me because there would be a substantial reward for those who could go ahead with research that was not allowed by the licence but which could, if it happened, be beneficial in commercial terms.
Those two worries are such that they make it impossible for me to accept or support the amendment. I thought that I should raise the issue early so that other noble Lords can see whether they share my concerns.
Lord Alton of Liverpool: My Lords, I support the important points that the noble Baroness has just made. I was delighted to hear my noble friend Lord Patel say that this was a probing amendment. Unlike the earlier amendments which he moved, when he put forward very good clinical grounds by centring on the care and the needs of the patient, this time we are looking at something altogether different. It is the retrospectivity of this that worries me in addition to the points that the noble Baroness has just made—the ability to put something right after the event which is implied in the amendment. My noble friend said when he moved the amendment that he recognised—these are his words—that there should be stringent penalties and there ought to be proper prohibitions. I agree with him about that. The kind of people who will be carrying out this research, as the noble Baroness has just intimated, will be competent individuals who should have read the regulations and know the law.
I look forward to hearing the Minister’s reply in due course. In a way, however, I think that the answer to the conundrum that my noble friend offers the House is in the penultimate line of his amendment where he talks about “reasonable grounds”. If there are reasonable grounds and a researcher were to be prosecuted, then I am certain that the courts would find in favour of the litigant rather than on behalf of the person who was bringing the prosecution, possibly on vexatious grounds. I think that the answer is already in the amendment. I therefore hope that my noble friend will not feel the need to press this too far.
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