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My Lords, I declare an interest as a former chairwoman of the HFEA. When I was approached for the job, I explained that, at my school, we were not even taught what were then called the “facts of life”. It turned out that this did not matter, as the task of the HFEA chairwoman was to explain to the public, in language that everyone could understand, what was happening and the ethical problems. That is the approach that I am taking today.
The UK was a first in pioneering and regulating in vitro fertilisation. As in other fields, being first is something to be proud of, but it risks us falling behind what is required as the years go on—as in our railway system—and not being sufficiently visionary to encompass future developments. This is not to belittle the global achievement of Baroness Warnock and her committee, when they produced the report that laid the ground for the HFEA and its followers in regulation the world over. I hope that we can now once more be leaders in bringing that law up to date, future-proofing it and coming into line with societal changes. I am well aware of the complexities and time commitments involved in reforming the law, and the risk that legislators will pile in with restrictions and other issues that are not in accord with the root needs, but we have done it before, with Acts reforming the original Human Fertilisation and Embryology Act 1990, and we can do it again with a progressive government.
Many of the patients are desperate, and the clinicians are competitive. This is where the dangers of statistics become apparent. More important than generalities, the basic elements in statistics have to be the age of the woman being treated and the age at which her eggs were frozen. Clinics offer extras in treatment, for which the patient pays more, and it is suspected that they are not sufficiently improving to be worth it. These so-called add-ons need to be reported to the HFEA, which they are not at the moment. Another issue of concern is that the NHS does too little of the work. It is a postcode lottery. IVF is private, eye-wateringly expensive and commercialised. Of course, one understands that fertility treatment is regarded as of less urgency in the struggle for funding compared with life-threatening diseases, but it is a painful situation.
Since 1990, the fertility sector has transformed beyond recognition, with new technologies, new family structures, new ethical questions and new challenges for patients. When I started as chairwoman, the burning question was whether treatment should be offered only to married couples. Now, of course, same-sex and single people are provided for by statute. The HFEA itself acknowledges that, while much of the 1990 Act remains fit for purpose, it has been updated by statute only once, in 2008, and now contains significant technical gaps, outdated consent rules and insufficient regulatory powers. The HFEA has made proposals for modernisation.
At the same time, the law governing surrogacy, the Surrogacy Arrangements Act 1985, was drafted for a world in which surrogacy was rare, poorly understood and feared. Today, surrogacy no longer raises eyebrows, with the number of children born that way increasing fourfold over the last decade. However, with increased use comes the increased danger of exploitation of poor women and risk to their health and their babies’ welfare. Families are left uncertain in that situation. Clinics are constrained, judges strain the legislation to make it workable, and the UK risks falling behind in welfare protection. However, reforming surrogacy, and the very concept itself, is hotly contested.
Comprehensive reform of both areas is on the table, and we have before us two reform proposals—first, the HFEA’s 2023 proposals to modernise the law, and, secondly, the Law Commission’s 2023 recommendations for a new surrogacy framework. The HFEA proposals tend to an innovative, ethical, patient-centred system of reproductive law. The Law Commission’s proposals about surrogacy are different. As I have looked into this recently, I am less certain than I was that surrogacy and reproductive law can be resolved—certainly not in one statute. Parliament needs to take the lead in scrutiny.
The HFEA’s case is clear: the fertility sector has outgrown the 1990 Act; it has expanded dramatically in size, complexity and commercialisation. Clinics now operate in hybrid, online and in-person models; donor-conceived people have new rights to information; and scientific developments, from mitochondrial donation to embryo research, have outpaced the statutory framework.
Yet the HFEA’s regulatory powers remain narrow, limiting its ability to enforce patient safety and good practice. The consequences are inconsistent clinic standards, complex consent rules, legal uncertainty around parenthood—especially in cases of relationship breakdown and posthumous conception—and a regulatory regime that cannot keep pace with innovation.
Surrogacy law is far more controversial. The Law Commission’s review found consensus that the current law is outdated and unclear. The surrogate remains the legal parent at birth, even in gestational surrogacy where she has no genetic link to the child. Intended parents must apply for a parental order, a process that can take six months, during which they cannot make legal or medical decisions for the child; the child’s status is uncertain and so is that of the parents. But the interests of the surrogate are not fully considered, not least in that she may be burdened with unwanted legal responsibility or even left literally holding the baby.
Meanwhile, cross-border surrogacy is increasing, often involving commercial arrangements that UK law neither permits nor adequately regulates. We have all read concerning stories about poor women, often abroad—for example in Nigeria or Ukraine—delivering in war zones, with uncertain future steps to safeguard the baby. I have great respect for the Law Commission and its logic is impeccable, but its plans to reform surrogacy would reduce the time a surrogate mother has to change her mind. They would reduce the oversight by the family court and Cafcass for domestic arrangements. They would transfer rights to the baby at birth, taking away fresh consent from the surrogate, and they would relax other requirements and safeguards.
Children’s rights and mothers’ rights would suffer if the law tilted too much towards the commissioning parents and away from the surrogate mother. Although the commissions do not propose major changes for cross-border arrangements, they recommend improvements to immigration processes and the recognition of intended fathers for nationality purposes. One wishes that these international transactions could be more controlled or even prevented, but that seems to be impractical.
As I get older, my inner Mary Whitehouse has real concern about single male parent surrogacy and the exploitation of women. Surrogacy welfare checks must be made as stringent as they are for adoption. When I started to research this speech, I thought that surrogacy law and a reformed HFEA law could be combined in one. I am still convinced that there are urgent needs for HFEA reforms—even limited, such as statutory instrument provision for the possible extension of a 14-day embryo limit and protection for new types of gametes. But surrogacy still needs more wariness and consultation, not least because the HFEA seems unwilling to take on surrogacy regulation.
Public attitudes and family structures have changed. The 1990 HFE Act was drafted for a world in which heterosexual couples were the assumed norm. The 2008 amendments widened access for same-sex couples, but the underlying structure remains in assumptions that no longer reflect modern family life. So the HFEA’s 2023 recommendations focus on four key areas. The first is strengthening patient safety and regulatory power. They propose expanded inspection and enforcement powers to ensure that clinics meet high standards of care. The regulator must have flexible tools to protect patients—for example, fining rather than closing clinics.
We need improved access to donor information. Donor-conceived individuals can now access identifying information at age 18. The HFEA proposes going further: removing anonymity from birth for all future donations, with appropriate counselling and support. This reflects a growing consensus that identity matters and that donor-conceived people have a right to know their origins. It was once feared that the removal of anonymity would reduce the willingness to donate but, as it has become more acceptable, that fear is diminishing. Moreover, there are genetic search engines online, enabling people to find their parents without official interference. Frankly, there is no point in keeping the current identity rules, and donors and patients should be warned that it is unlikely that they can remain unknown.
We need to clarify the consent rules. The current regime has led to difficult litigation, especially in cases of relationship breakdown or posthumous use of gametes. The HFEA calls for clearer statutory definitions to protect all parties and reduce judicial uncertainty. Posthumous taking of gametes by violating a corpse is certainly not the way forward—not without consent. There should be automatic record sharing between clinics and the NHS central records system. This fits with the record-sharing provision in the NHS modernisation Bill and could be an amendment to it. There should be more reminders to patients that they can donate unused embryos to research. There is even a suggestion of a national embryo research bank.
We have to prepare for scientific innovation. As I said, I am no scientist and I will leave the details to the distinguished experts who are speaking in this debate. But there are three areas that impinge importantly on the foresight needed in regulation. They are the keeping of embryos beyond the 14-day limit, stem cell-based embryo models and in vitro-derived gametes. The extension of the 14-day rule is linked to the research capability required for the latter. It is being reviewed by the Nuffield Council on Bioethics, which is consulting with the public. In vitro-derived gametes are created by reprogramming other cells—for example, skin. Under current law, they could be used for research but not reproduction. The advantages are that they would eliminate the need for gamete donation, but they will need separate definition in the HFE Act, fresh consideration of the definition of parenthood and, of course, much more research.
The frameworks of regulation must deal with anticipated developments here and their ethics. There are also stem cell-based embryo models, which are lab-grown models made from human stem cells that mimic early stages of human embryonic development. They may verge on becoming real human embryos, and the voluntary code of practice developed in Cambridge needs to be embedded, with a view to developing a distinct method of regulating them—not bad for someone with no biology O-level.
What must Parliament do? It must modernise the Human Fertilisation and Embryology Act. Parliament should plan by setting up a Select Committee to examine the HFEA’s proposals to expand regulatory powers, simplify consent rules, modernise donor information provisions and create a flexible framework for future scientific developments. A Select Committee also needs to look at the Law Commission’s surrogacy reforms as a second-order issue. As I said, I am not at all sure about integrating fertility and surrogacy law into a whole.
The noble Baroness, Lady Merron, has said that the Government are deciding how to take this forward, and there was a Bill about this in the Commons last year. Let us start by updating our fertility law, in keeping with the UK’s history of an ethically cautious and scientifically informed approach, which has made us a global leader. Will the Minister move forward with a Select Committee and pre-legislative scrutiny of a draft Bill to reform the HFEA? I beg to move.
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My Lords, I thank the noble Baroness, Lady Deech, for bringing this matter to the House. At present, the HFEA regulations are under a law that is over 35 years old, as identified by the noble Baroness, Lady Deech, and the legislation is unfit for the purpose in many areas. The HFEA has no flexibility to adjust its powers according to regulatory performance; it needs to reduce the regulatory burden for compliant clinics and focus oversight on those not meeting the required regulatory standards.
The noble Baroness, Lady Deech, summed it up when she talked about fining not closing clinics. The HFEA wants to achieve the greatest impact with the most proportionate sanction for the fertility sector as it is today, with many licensed clinics being part of large private equity-backed groups and more than 70% of patients self-funding. Should there be a financial penalty, which HFEA cannot impose at present? This must be better than removing or suspending a licence. The aim must be to improve compliance while not impacting existing patients.
The current regulations are also out of date where patient safety and other areas are concerned, but it has to be said that treatment in a UK-licensed fertility clinic continues to be very safe. However, we should not rest on our laurels. The UK needs to stay ahead of technical advances by reforming the legislation; the current law is inflexible and does not easily allow for scientific and medical innovation in an area where new treatments and extraordinary advances, such as stem cell-derived gametes, are around the corner. The HFEA is still considered globally the gold standard in fertility regulation, and the UK must not lose that reputation.
The UK fertility laws were enacted in 1990 and only partially reviewed in the HFE Act 2008. After over 35 years, it must be time for a new review of aspects of the legislation. Is the Minister able to give any hope that this sensible change can happen?
It is also very ironic that it is difficult for many patients to access publicly funded fertility treatment in the very country where IVF was originally pioneered.
The noble Baroness, Lady Deech, said she was not this and not that, but spoke with great eloquence. She said there would be many distinguished speakers speaking at length. I do not count myself among them and will listen with eagerness to what they have to say.
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My Lords, I would like to come down to earth a little bit. First of all, I suggest that infertility is not a disease; it is actually a symptom of something wrong, and that is the basic problem here. What we are doing here with in vitro fertilisation is using a medical treatment for a symptom without actually making a diagnosis. That is almost universal; it is not only in this country but in every other country. In my view, that is something that neither the Human Fertilisation and Embryology Authority nor NICE have done. In fact, they have made it very difficult to investigate patients to find out what is wrong.
There are at least 100 causes of infertility, some of which are extremely serious and end up with people being childless. They could be treated far more cheaply in all sorts of ways but are not, because in vitro fertilisation is seen, as we have just heard, as the gold standard. Believe me, it is not the gold standard. Indeed, it is not well regulated, for reasons I will explain, and cannot be in this situation.
One issues we have to think about is whether we should really be doing some kind of special regulation for one small treatment in the whole medical spectrum. In my sense, that no longer works. The HFEA was an important body in its time, when there was public unrest about the human embryo and it was very clear that in vitro fertilisation was going to be a new treatment. It is now absolutely essential that IVF is normalised. That will be very complicated, but it is something that this Government could do; they could regulate it far more effectively with the vast things at their arm.
In vitro fertilisation is of course increasingly expensive, as the noble Baroness, Lady Deech, pointed out, because it is largely in private practice. It is in the National Health Service a bit, but the National Health Service is making a profit out of in vitro fertilisation. One president of the College of Obstetricians and Gynaecologists said to me, “Don’t say too much about NHS IVF: we need it because it is currently, together with abortion, paying for maternal care”. That was what he said privately as a president of the college. How we fund the health service is a real issue to think about.
At the moment, private clinics are making vast sums of money. Clinics are being sold for several hundred million pounds at a time; the equipment in them is probably worth about £15 million at best. There is very little understanding and regulation of that, nor is the inspections situation sufficient. In my own laboratory, I remember one year we had a fantastic review saying it was the best lab they had ever visited. We were not then treating patients; we were simply doing research, with some patients being involved in that research. The following year, having changed nothing that was praised, we got a terrible review—for no reason other than the fact there was a different set of examiners, some of whom were in private practice and were jealous of what we were doing. That is a real issue.
That resulted in my closest colleague, Kate Hardy, who was one of the best embryologists in Europe, finally saying she did not want to do embryo research any more—she was in tears—and she never did. She was actually so depressed by that review that she gave up and ended up doing other work on the ovary, which did not involve in vitro fertilisation. We lost one of the best scientists we could have had in that field. She had papers in Nature and many other journals. We had worked together, for example, as the first people to do pre-implantation diagnosis, to look at genes in the embryo, and she was one of the four authors of that paper. She gave it up because of what the HFEA had done to her mentally. She really suffered.
I want to make it clear that we need to do something much more serious about this. As much as I respect the noble Baroness, Lady Deech, we cannot say that it is the envy of the world: it is not. As a so-called expert in in vitro fertilisation—whatever that means—I have visited virtually every civilised country where in vitro fertilisation is done. They laugh at the idea of the HFEA. It does not matter where you are: they do not think that our regulations are fit for purpose.
One of the issues is the way we understand the results of in vitro fertilisation. I mentioned this in the King’s Speech debate the other day, when I pointed out that one area of in vitro fertilisation that is hopelessly accounted for is egg freezing. I showed the data: there are something like a quarter of a million eggs recorded as available which have been frozen. So far, some 34,000 of those have been unfrozen in the past year for the purposes of treatment. Of that number, 2,000 embryos were produced, and only 900 pregnancies were produced. We do not even know the number of live births. People do not want to have an embryo transfer; they want to have a baby. That is why they come.
The problem is that, right from the beginning, we ignore the fact that the treatment is a long process. It starts with an assessment of what is wrong, which should mean a diagnosis, wherever possible. Secondly, we have to look at the hormonal control of ovulation. Particularly, we have to understand that the eggs must be matured properly before they can be treated with sperm, otherwise you do not get normal embryos. When that is done, we have the problem, in some cases, of finally getting embryos. But before we do that, we have to understand male infertility, which is very poorly served and really not dealt with at all by the HFEA, even though it is an integral part of infertility. We need to have far more expertise in dealing with male fertility. We have just ignored it completely, quite unnecessarily. All sorts of research could be employed—but we do need more research.
Once we have an egg that seems to be fertilised, we culture it. It spends up to five days in a dark medium, the constituents of which we do not know, because the constituents of the media that are available commercially are secret. We have been doing extensive work on this to find out what the ingredients are. One of my colleagues, Sheba Jarvis, has looked with spectroscopy and we found 302 different proteins which we did not know were in one particular medium. That is really quite serious, because some of these proteins may be bioactive and could have an effect on the outcome of the culture. After that black box is opened and the embryo is taken out, if it has produced an embryo—which it does in some cases—we hopefully end up with an implantation.
All those stages carry a failure rate, which is not recorded properly in the statistics. In fact, when I recently asked the HFEA to write to the Minister, I was told that we do not know how many eggs are being frozen, how many end up fertilised, how many become embryos or what happens to those embryos—we only know the number of embryos transferred to uteruses and the number of pregnancies. We do not even really know the number of miscarriages, which seems to be at about 15%. That is not satisfactory.