Clause 24
Human Fertilisation and Embryology Bill [Lords]
10:30 am
Evan Harris (Shadow Minister, Innovation, Universities and Skills; Oxford West and Abingdon, Liberal Democrat)
I take this opportunity to welcome you to the Chair, Mr. Hood. We have made excellent progress and I am sure that we shall do so today. As I said during the debate on the amendments to the clause, I have a couple of brief questions to ask. What is the basis for the current amount of data that is collected? The main problem that has been raised with me is the regulatory burden of a full amount of information given in the register of information for all treatment cycles, the majority of which do not result in a pregnancy.
We have debated why it is necessary to maintain a register of information in respect of the treatments that produce a pregnancy and a child. There are at least two main reasons. The first is to enable contact to be made in the future, if requested by a child born through in vitro fertilisation, particularly in respect of donor gametes and non-identifying or identifying information about the genetic parent when the person is not the legal or social parent. The second reason is to ensure that the data is accurate on the outcomes of IVF clinics, given the nature of the business and the relatively high stakes involved compared with other businesses, and thus the potential vulnerabilities of the patients, who are the consumers of the business. The clinicians understand those two reasons, but they ask why it is necessary to have identifying information in such great detail about all patients even when a pregnancy does not result or is not known to result. I imagine that reasons will be given for such action, but I just want to deal with them in advance.
It is necessary to retain information in case of adverse effects of some treatment. However, in that sense, it is not different from any other treatment. It is necessary for medical records to include information so that it is possible to track any potential problems caused by drugs. The potential for risks would be the same as that posed by full medical treatment, but for no other full medical treatment is there a central database, especially on treatment that does not result in pregnancy on which a huge amount of information is collected with patients’ names attached. The clinics that have contacted me about such matters understand that it might be necessary to provide information centrally and use patient numbers, but identifying patients would provide an additional burden that they consider unnecessary unless pregnancy results, in which case such a situation should be possible. I have dealt with the second argument for the need to collect the data and information about outcomes so that success rates are recorded. However, that can be done without the need for detailed, identifying information as set out under the Bill.
Will the Minister say whether the Human Fertilisation and Embryology Authority has received the same representations as I have about the extent to which the regulatory burden of the register of information and requirements will be onerous? Does it recognise that there might be scope for reducing the amount of information, particularly identifying information, that is held on a central database for no good reason over and above the reason that such information is available in medical notes on safety and outcome measures, when no child is produced or known to have been produced? If it recognises that that is a regulatory burden, has any consideration been given to how it could be reduced? While that might have been appropriate in 1990, standard IVF and insemination, particularly where, sadly, it does not result in a pregnancy, are now routine medical techniques and interventions.
It is peculiar that for those routine medical interventions, a great amount of information must be submitted to a central database which has not as yet been used for any research purpose. Without having a central database of identified patients, it is still possible to do research where non-licensed treatments—which could be more extensive in terms of drugs and surgery—are not subject to such requirements. It is a valid point, and I would be interested to hear the Minister’s response.
Mark Simmonds (Shadow Minister, Health; Boston and Skegness, Conservative)
I join the hon. Member for Oxford, West and Abingdon in welcoming you to the Chair, Mr. Hood, and let me say how much I am looking forward to serving under your guidance and chairmanship. I have three quick questions for the Minister on clause 24 stand part that we did not manage to cover in the debate on the amendments.
The first point is about counselling. Under the clause, the donor is informed when a request has been made for information about them. In most circumstances, there will be many years between the donation that leads to the genetic offspring and the genetic offspring asking for information about the donor. It is a minimum of 18 years, but it could be much longer. Clearly, I welcome the stipulations in schedule 4 that relate to counselling for the person requesting the information, but what about counselling for the original donor? Obviously, it should not be compulsory or mandatory, but there may be significant changes of circumstances—the donor’s life may have changed dramatically, they may be in a marriage or another relationship and it could be extremely traumatic to bring such a new piece of information into their life. I wonder why no counselling is offered in the Bill for the original donor.
The second point is about the disparity in ability to request information at different ages. As I understand it, the donor-conceived person is able to request non-identifiable information at 16, but other information is available only at 18. Perhaps the Minister could put on the record the logic behind that particular difference. It may be simply that people are legally allowed to be in sexual relationships at the age of 16, while 18 is the general cut-off point for moving into adulthood.
The third point is about proposed new section 31ZB, which deals with checking whether people in intimate relationships are genetically related. It is about getting the permission of the other party in that intimate relationship. What happens if both parties in that intimate relationship are under the age of 18, and therefore only able to receive non-identifying information, when the point of getting that information is specifically to identify whether the partner in that intimate relationship is related to them?
Dawn Primarolo (Minister of State (Public Health), Department of Health; Bristol South, Labour)
Good morning, Mr. Hood; I welcome you to the Chair. I will deal first with the questions raised by the hon. Member for Oxford, West and Abingdon. I wish to make a request to help me focus on answering the points raised. I say now that there is absolutely no criticism implied, bit it is difficult when the hon. Gentleman puts the case and then put the Government’s case as well. He answers his own questions and ends with a series of questions that he has already answered in the course of what he has said. I will repeat them on this occasion as the Government’s position as well, but we need to try to focus.
The hon. Gentleman asked specifically about the disclosure of information regarding patients, particularly where there have been unsuccessful cycles of IVF. He went on to give the answer. As he pointed out, the answer is, first, that the information has to be collected because at the beginning of the cycle it cannot be known that the cycle is going to be unsuccessful—that there will not be a resultant child. Secondly, the information could be relevant to subsequent courses of treatment and follow-up cycles for the individual. Thirdly, the collection of information clearly provides for long-term consideration and research into fertility drugs and comparing the effects on women, whether there is a pregnancy or not. The information provides the basis for further research. Finally, there may be other important areas in the consideration of treatment—that links back to the question of identifying information, particularly follow-up information. Therefore, the hon. Gentleman put the case for why the proposals are as they are, and he answered on behalf of the Government’s position as well.
The hon. Gentleman asked two further questions. The first was about representations that he had received. He asked whether the Government had received the representations that he had received about the collection of information and asked what was our response? Yes, we did receive those representations. It was not a majority view that the requirements were onerous—there were a few of that view. We considered the information powers, because we appreciated the comments. However, we remained of the view that it was important for the HFEA to collect data for all licensed treatments and that we were striking the correct balance between protecting the confidentiality of patients and allowing disclosure under justifiable circumstances. The BMA supported us in that approach. The hon. Gentleman’s second question was specifically geared to how the provision might create regulatory burdens. My response is that the HFEA’s new electronic data interchange system with clinics should certainly help to ease any feelings that the there is an undue burden of collection of information.
In putting all of those points together, the hon. Gentleman clearly justified the system. We considered some of the views put before us and discussed the matter further. We came to the conclusion that we had struck the right balance. We were supported in that by other stakeholders. We believe that the regulatory burden will be considerably alleviated by the system of electronic exchange.
The hon. Member for Boston and Skegness asked a series of questions, particularly about the disparity—which I will deal with first—between the information to which people are given access at 16 and 18. Again, he touched on the answer in his remarks. We have spoken to all of the stakeholders and, of course, the Committee does not come cold to the discussion. We are talking about a consultation of more than a year, with the consultation results published, followed by draft legislation and the pre-scrutiny stage, and then consideration in another place, before the proposals get here. We have had the opportunity for consideration a number of times. The view was that 18 was the suitable age—in terms of other legal requirements and maturity—to give people access to identifying information about donors. This is, of course, significant personal information that could have a dramatic impact. We cannot be sure that the individual knows already that they are the result of a donation of either sperm or egg. We are relying on the parents to have had discussions with their son or daughter. It was agreed that in extreme cases where the individual has not been informed, 18 is the sensible point for access to information.
The hon. Member for Boston and Skegness also asked why we set the age for access to non-identifying information at 16. I am assured that access at that point is sufficient to ensure that within the records there is no family connection. At that point it is not necessary to know the identity; it is enough to be assured. I am not clear whether in extreme circumstances there would need to be a loop back into the information, and the HFEA would need to consider whether or not identifying information was in the best interests of the individual. I will check that matter and come back to the hon. Gentleman. There are two steps. One applies to, for instance, an individual who at age 16, with consent, is going to get married. It also applies where the parents know that their son or daughter is planning to live with or, as the hon. Gentleman said, be sexually active with a partner, and they want to make sure of the information.
Then the hon. Gentleman asked about counselling for the donor. That was covered in previous debates about counselling when the donor becomes involved in the IVF programme. Of course, an individual has to be aware that the request for information could happen rather a long time ahead and their circumstances could be different by then. That is part of the complexity of counselling when an individual is considering being a donor; it must be thorough. It might be the case that the donor would have access to counselling information at the time that the request for identification was made, just in case. That is not an absolute condition, but it would have to come back round the loop. Counselling would be part of their preparation at the very beginning, as they took the decision to be a donor, but would be accessible again at the time when identifying information could be made available. I understand that there is provision for that. These are delicate points.
The hon. Member for Boston and Skegness asked a question about new section 31ZB and the fact that it does not enable the applicant to find out identification. It does, however, provide access to the information to ensure that there is not an issue that would lead to the need to identify the donor. Should, for some reason, the result that came back from the HFEA raise an issue of concern, that would open up the debate automatically, regardless of age, because the individual would need to know why. Imagining all the circumstances, it is difficult to see that there would not be some pressure on the system at that point. The HFEA would have to deal with that. I hope that I have dealt with the points that were raised by both the hon. Member for Boston and Skegness and the hon. Member for Oxford, West and Abingdon. On the question of consent and information, they have tabled amendments to the next clause that specifically focus on those issues and when consent is needed for the passing on of information. Perhaps some of the other points will be picked up again then.
Evan Harris (Shadow Minister, Innovation, Universities and Skills; Oxford West and Abingdon, Liberal Democrat)
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 (Minister of State (Public Health), Department of Health; Bristol South, Labour)
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.
Evan Harris (Shadow Minister, Innovation, Universities and Skills; Oxford West and Abingdon, Liberal Democrat)
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.