In this session, Venessa Smith, Quality Manager at Assisted Conception Unit – Guy’s and St Thomas’ NHS Foundation Trust, discussed IVF, egg donation and other procedures and its laws and regulations in the UK.
In this webinar, Vanessa Smith talks about the legislation in the UK regarding fertility treatments. Vanessa has been in the fertility sector for over 20 years. She started as an embryologist at the Hammersmith Hospital and then worked privately, but also in the NHS. She joined the London Women’s Clinic, became the lab manager and then ran the sperm bank, so she’s very interested in donation.
Currently, she’s working at Guy’s Hospital; thus, she’s back in the NHS once again as the quality manager. She’s also very interested in regulation as well as in the science field since that’s where she came from. In addition, she’s a member of the HFEA Licensed Centres Panel where she gets to discuss topics that are coming up in that sector and, hopefully, offer good guidance to the clinics in the UK.
You may know about Louise Brown. She was the first IVF baby to be born, and it was through the help of Bob Edwards, Patrick Steptoe, and Jean Purd, who was the nurse at that time.
Louise Brown was born in 1978, and she’s doing well. She’s got her own family now, and when this happened, people became very concerned about how IVF would affect the population, as things were very different back then. As a result, the Warnock report was born and gave 64 recommendations as to how treatment in the UK could be regulated in the best possible way to ensure that patients are protected and nothing unethical is done.
It all started with the Human Fertilization and Embryology Authority Act of 1990, which did the following:
The HFEA was born to become the Regulator after the 1990 Act and it makes sure that fertility clinics and research centers comply with the law.
According to Vanessa, as someone who works in a fertility clinic, she’s very aware of the increasing number of people that are coming through for treatment and that’s why it makes regulations so important.
As you can see in the graph, both fresh and frozen cycles are on the increase. This data is actually collected by the HFEA and it allows to ensure that they can get all the data from the treatments that are occurring in the UK and, consequently, do good research and work on ways to improve their services and treatments of patients.
The purpose of the HFEA is very clear. It works for the Department of Health but not as part of the department; it answers directly to the government.
All clinics in the UK have to have a license to be able to practice. These licenses can be a maximum of 4 years long and during that time you will be inspected.
Generally, inspections occur every 2 years and these are planned inspections; however, you can also have unannounced inspections. Therefore, when inspectors just show up and, for instance, there’s an incident at your clinic, they may do some further investigation.
Now, with the COVID situation, things have been a bit different. All the inspections have been desk based. It’s been quite a hard work getting all the paperwork sorted out and all correct.
The CQC regulates hospitals in the UK. In order to ensure they offer appropriate standards of care; they’ve developed a manual called the Code of Practice.
This is currently the ninth edition. It provides guidance about the different treatments that you can have and how the patients should be treated.
It also summarizes the qualifications that staff members need to have to be able to practice.
It’s generally a guide about the law surrounding treatment and what the clinics can follow to ensure they’re acting lawfully.
As Vanessa said, this regulation is very important because of the following:
On a practical level, according to Vanessa, it’s really important if you’re embarking on treatment that you consider where you go: being close to where you live your clinic is really helpful because the process is stressful enough without adding a two-hour journey every time you need to go and visit a doctor or a nurse.
Following Vanessa’s words, when you get that data, you need to bear in mind that it’s about two years old because they have to collect all the data from all the clinics and then analyze it and validate it. That takes a little bit of time, so the most useful outcome data for you to get is directly from your clinic. You can just ask your clinic for success rates, pregnancy rates, live birth rates, and for someone in your age group or with your particular requirements.
For instance, if you’re using donor sperm, if you’re 40 and above, if you need any other particular thing, if it’s a male factor issue, then it’s worth asking for success rates that are exactly related to your position. A lot of HFEA success rates are quite general, and you want to know your position.
Moreover, if you have treatment with a clinic that’s licensed by the HFEA and you’re unsatisfied by it, you can give feedback and they can resolve complaints if its necessary.
We hope that you’re not going to have a bad experience; your clinic will be able to sort out these issues for you themselves. – says Vanessa.
Consent and multiple embryo transfer generally affect everyone. In addition, as previously said by Vanessa, she’s very interested in donations, and she’ll develop further in her presentation.
Other areas are legal parenthood and other techniques that are available for you, both from the NHS and privately.
As Vanessa talked about the HFEA providing brochures, you can see a couple that were produced and are quite interesting. There are more recent ones, they’ve published one about trend analysis for treatments that have been undertaken in May, so it’s very up to date with lots of data, surrounding births and pregnancy rates.
The most important part of your treatment is to make sure that you understand what you’re being treated with, how that will be done, and how that will affect you in the long term. For this reason, the HFEA created a whole pack of consent forms that should follow you through your treatment. You’ll be provided with these forms at the beginning, so they need to be completed before any kind of egg collection, embryo transfer, or insemination.
The most obvious one to look at first is the consent disclosure form and this will be given before you start your treatment. This is important because it allows the medical team to talk to your GP, if you have other healthcare professional, and ensures that they know who you’re linked with. For example, if you’re coming through with a partner, it allows them to know if they can discuss your case with them as well.
Moreover, it also allows them to be told whether you’re happy for your information to be passed on to research bodies, which is very important, and to ensure that their treatment processes become better and better.
You’ll also be given forms to cover your treatment, as you can see in the following picture:
This is a woman’s consent form, men’s consent for,m and, more recently, gender-neutral forms were also created. Within these forms, you’re allowed to consent to the type of treatment you’ll have, such as the creation of embryos using your sperm or eggs, or those of a donor, and consent to the length of time you want these embryos to be stored for if you’re lucky to have a surplus once after your treatment.
This is also very important because it’ll connect you with your partner, so they can use your embryos, eggs or sperm if necessary. In addition, in the event of your death, the medical team will know what the idea is and what you want them to do with any gametes that they still have in storage for you. These must be completed in advance.
The website also has a lot of information to help you complete these forms which are exactly identical in whatever clinic you go to in the UK. Furthermore, more importantly as part of the consent process, the HFEA insists that you have access to counselling.
There are a lot of people who get tiny involved in the actual treatment process; they’re kind of like the practical elements of it, but it’s essential to make sure that you’re supported emotionally as well. For this reason, it’s a regulatory issue for the HFEA that each person is offered counselling, usually free of charge, to discuss the implications of their treatment, particularly if you’re using donor gametes or donor embryos because they want to make sure that you know the long-term implications of that for you and your family.
Historically, it was very common for twins and triplets to be born, which had a massive impact on special care baby units in the UK.
A report in 2006 produced two graphs where you can see that the number of twins and triplets continue to increase at a massive level; thus, the HFEA decided that they needed to look at a way of regulating this process to reduce the number of twins and triplets, but not impact on the chances of you being pregnant.
A lot of people decide that if they have two embryos back, they have more chances of having a pregnancy. It’s been repeatedly proven that it’s not like that. If you have two embryos back, you’re more likely to have a twin pregnancy, not increase your chances of having a single pregnancy at all. Therefore, Vanessa says that they tend to encourage people to do is to keep their embryos if they’re having IVF up to day 5, which is the blastocyst stage, and by that stage, your embryos will have largely decided which is the best, which is developing the most nicely and, therefore, which one’s most appropriate to be transferred.
Moreover, as they have a great freezing process, called Vitrification, blastocysts can also be frozen and, therefore, not wasted. This means that you can go in the first cycle, have a single embryo transferred at the blastocyst stage (day five), have a good chance of pregnancy and then, hopefully, go through later on to have a sibling, all in the safest possible way.
Historically, when embryos were transferred at earlier stages, for example, on day three, it was much more difficult to decide which ones were the best; thus, people tended to request to have two put back. Now it’s actually against the law to put more than two embryos back unless you’re over the age of 42. Most people are encouraged to have one embryo, and most clinics have their own multiple-birth minimization strategy that they use to ensure they offer their patients the most appropriate outcome. This may be related to age, the quality of your embryos or the number of treatments you’ve had already. As Vanessa explained, it is very unusual to have three embryos back, but it’s much more usual to have two back if you’re over the age of 40.
As you can see in the graph, their strategy worked well. They were aiming to make sure that clinics only had 10 multiple birth rates, they kept a really close eye on it, and it’s actually very unusual to have three embryos put back. Nowadays, most people are opting just to have one.
In comparison, the success rates continue to increase, thankfully, the number of healthy live birthing continues to increase as well. It’s difficult to not say that this is linked to people deciding to only have one embryo back at a time.
Some clinics have objected to the HFEA, legislating regarding the number of embryos to put back, but so far, it’s worked well for most clinics.
I know in the clinic that I work with, the multiple pregnancy rate is 3% and we’re proud of that because we hope that there will be healthy births too. – expresses Vanessa.
In the following graph, also published by the HFEA, you can see the number of cycles that use donor sperm and donor eggs which is on the increase at all times.
This increase can be for several reasons and one of them is that more people are accessing treatment. Vanessa mentions they’re increasingly treating same-sex couples and single people who go to the clinic.
As you can see, there’s a small dip in the use of donor sperm, and that’s largely been put down to the increased use of ICSI during that time. This means you can inject one sperm into each egg; therefore, men who had very low sperm counts and had previously been told that their only chance of success was using donor sperm could try with their sperm first.
However, since 2010, the amount of donor sperm in particular being used has increased, and it’s become more acceptable to use donor eggs as well.
We’re happy that people feel comfortable now going forward and using donor eggs, and in some cases using donor eggs and donor sperm, and still going on and having happy and healthy pregnancies. – comments Vanessa.
In the UK, the legislation surrounding donations is some of the strictest in the world, thus, Vanessa talks about some of the things you need to consider and think about if you’re using a donor now.
Since 2005, a donation has always been an ID release; before that, you could be an anonymous donor, which meant you could go to the clinic, donate your sperm, and not think much more about it. Nevertheless, it was decided that this wasn’t helpful to children that were born from donation, so the law changed in 2006. Everyone was panicking because they thought there wouldn’t be any donors as nobody would want to be ID released and, in fact, at that time, Vanessa was running the sperm bank, and she too had that concern. However, they saw a different type of donor coming forward; there were fewer students and more guys who were a little bit older, and maybe even had a family of their own, so losing the anonymity status wasn’t a problem at all.
This means that all egg donors and sperm donors agree to sign up on the donor register, which includes all identifying information. The most important elements of the register are:
“I think it’s important to know that the donors don’t get any access to any information. This is largely to ensure that children that don’t want to meet their donor don’t have to, but from my experience, most donors are happy to be contacted,” informs Vanessa.
Another important element is that donors can only contribute to a maximum of 10 families. This doesn’t mean 10 children; it means 10 families. If a family decides to have four children, potentially, the number of siblings and half-siblings can dd up. So, generally, it can be expected to be up to 20 siblings or half-siblings.
You need to bear in mind that if you’re using a donor from overseas, like many people are increasingly doing, and importing sperm from America, for example, you need to consider that the limit of 10 families is only limited to the UK. If that donor’s being used elsewhere, that may mean there’s a cluster of families in, for instance, America, Australia, Denmark or Europe. Thus, you need to consider that if you decide you want to import samples, either sperm or eggs from overseas. If you do want to do that and want to have treatment in the UK, those donors could not be anonymous.
Moreover, increasingly, people go abroad for treatment, and the most common one is Spain. They do some anonymous donations, but it’s really important, if you do that, you need to take into account that you won’t be able to have subsequent treatments in the UK using those embryos because the donor is anonymous. If you want to do that for a sibling, you would have to make a special request to the HFEA, but the positive outcome is not guaranteed. Therefore, if you’re using a donor sperm, it’s really important to understand legal parenthood.
Legal parenthood came to pass in 2009 because the law changed. People that weren’t in a civil partnership or weren’t married, they were able to become legal parents. The way to accomplish this is by filling in two forms: WP and PP. These need to be compcompleted beforeatment starts, so before donor insemination or before you have embryos created with that donor.
These forms felt quite complex when they were first introduced, an as a result of that, the HFEA decided to do an audit of clinics to ensure that they were completing these forms appropriately. Unfortunately, several cases were picked up where the forms weren’t completed correctly, and that led to a lot of clinics being taken to court and having to pay vast sums of money, as they should do to ensure that the second parent would be recognized as a legal parent.
Thankfully, people’s understanding of these forms now and training that has been received throughout the UK is so much better that these errors are really rare, but even so, the HFEA feel it’s still important to regulate on this matter. So, all clinics do keep on top of it.
Furthermore, an additional form was introduced, the PBR, to ensure that if you filled it out and you had spare embryos in storage, it would guarantee that the second parent would be able to be registered as a legal parent, even in the event of their death. Therefore, if you do have a surplus of embryos created from donor sperm, it’s really important to ensure that this form is filled out effectively and accurately.
At Guy’s Hospital, Pre-Implantation Genetic Testing is done, but this isn’t offered at all hospitals. If this is something that you need, you must do your research.
Pre-implantation testing was formerly known as PGD (pre-implantation genetic diagnosis), and it’s only recently changed, so it’s still often referenced as PGD. This testing is for those patients coming through who have a known disease in their family that’s genetically linked. Quite often, these families already have an affected child and, therefore, it’s a very emotive treatment to have.
The HFEA licenses treatment because it must be done ethically and only by people who have the best experience and qualifications.
So far, in the UK, there are about 600 genetic conditions that are licensed, but that doesn’t exclude other genetic conditions. If you have a disorder that currently isn’t being tested for, your clinic can apply for a license to do that testing and, as long as it’s proven necessary, those licenses will be agreed upon. This means that you have your embryos created, and then they’re biopsied and tested to ensure that the embryo that you’re having replaced isn’t suffering from the disorder you’ve previously experienced.
It’s very important to remember that this is for medical testing only. In the UK, they’re not allowed by law to sex select or for family balancing. For example, in the US, you’re able to have sperm sorting, which allows you to select a male or female child, but in the UK, that’s against the law.
This is something the HFEA has studied very carefully. When you have your treatment, there’s an IVF routine procedure that involves lots of techniques accepted on a day-to-day level and have been proved to be really effective in helping you have a child.
The difficulty is when you’re having treatment, you’ll often be prepared to do whatever it takes to try and increase your chances. Most clinics are very sensible and straightforward and will only offer you treatments that will be helpful, but some other clinics do offer treatments for which it’s unclear whether they’ll increase your chance of a pregnant,cy and increasingly, these are in private clinics where you have to pay additional costs. For this reason, the HFEA created a traffic light system.
Green techniques: Those techniques are known to work well and do prove effectiveness. There have been several studies published about the good quality.
Amber techniques: There may be some studies that say it’s helpful and some studies that say it’s not, but what’s important is that this research is of good quality and further research is ongoing.
An example of this is EmbryoGlue that many clinics use, the type of transfer to try and increase their rates of implantation.
Red techniques: These are like assisted hatching, which used to be very common historically, but these are techniques for which there’s no evidence to show that they improve your chances of success. There’s no decent research, and it doesn’t mean there won’t be in the future, but currently, there isn’t.
These are the techniques that the HFEA suggests you should avoid. If you do go to your clinic and they offer you something in addition to you routine of IVF of ICSI, it’s important to go to the website and double check where they stand with regards to research and effectiveness. Too end the presentation, Vanessa shows a quote that comes from the HFEA website, because according to her, regulation can seem a bit dull and a bit unnecessary, but in fact it’s really good.
This is important when you’re trying to create your family.
It, unfortunately, depends on where you’re living. It also depends on your age and other factors, so what you need to do is approach your GP and ask them about the status in your particular area. Increasingly, it’s been recognized that not treating single people is discrimination, and if you can get hold of the sperm that you need to be treated, you will likely be able to get the treatment you need. Of course, you need to think about what treatment is best for you. If you’re over the age of 36, you maybe want to consider IVF; below that age, you might want to think of donor insemination, but as I said, unfortunately is dependent on where you live. I think early next year, a lot of the IVF funding pathways are going to be reviewed, so if I were you, I would go ahead and start looking into it now, just in case things get a little bit worse after the funding has been changed by the government.
As soon as a person becomes pregnant with an embryo and as soon as that birth takes place, the person who’s carrying the pregnancy becomes the legal parent; that’s just automatic in law. Now, if you’re married or in a civil partnership, you automatically also become the second parent; however, if you’re not, you must fill in those forms just to ensure that your legal parenthood is recognized. I did describe the WP and the PP form earlier on in the presentation, and what you’ll need to do is assess that against your actual situation. Some people decide that they want to get married or into a civil partnership to avoid filling out all these forms, but I would suggest that you focus on your treatment and just fill in the forms accurately and, as I said, before you have any treatment. If you can get a donor embryo in the UK, that’s fantastic because embryo donation is quite unusual, so I wish you luck.
As you’ll be carrying the embryo yourself, you’ll automatically become the birth parent and, therefore, the legal parent, so you won’t need to fill in those forms. It’s, however, important to make sure, if you’re using donated embryos, that you get as much information as you possibly can beforehand and that your clinic will have the donor appropriately registered. This would involve the registration of both the male and the female who created the embryo in the first place. It doesn’t matter if you’re single.
As part of the consenting process, you fill in the form, and there’s a section that talks about what to do with your embryos after your death when you no longer need them; there is the option to donate your embryos to either research or another patient or to someone known to yourself. So, yes, you can do that, but what you need to bear in mind is that you will need to have several additional screening tests to ensure that you are suitable as a donor. For example, you’ll be screened as a donor would be screened, so additional blood testing, genetic testing, all these things that you wouldn’t have for your own treatment. If you then want to donate it to someone you know, they would then be treated as your recipient, or you can donate it to an embryo bank which will then find a recipient for you. It’s also important to remember that you, too, would be on the donation register, and so, therefore, any child created from those embryos would then have the right to your identifying information when they reach the age of 18.
The testing that you can get for all these different disorders is slightly different to PGD because what PGD do is only test for one particular disorder and that would be the disorder that’s relevant for your family. So, common things are like haemophilia, Huntington’s, and also cystic fibrosis; they’re the most common, and they don’t do a whole spectrum of testing. That’s not how embryo testing works. It would only be covered in the NHS, this kind of testing, if you had proof that within your family you had this genetic problem and, generally, you would already have an affected child.
If you want to use a donor, in this case, your sister’s eggs, and she lives abroad, there are two different ways you can do it. If you want to make an anonymous donation, she wouldn’t be anonymous to you, though, because she’s your sister. You would need to go to the Czech Republic and have your transfer. The issue surrounding this is if you then wanted to have subsequent treatment, you wouldn’t be able to bring any embryos over from the Czech Republic to be used in the UK.
The alternative is that your sister comes to the UK and donates her eggs here, she would then have to be on the register as a donor, so it would make her non-anonymous, but I guess known donation can be very, very complicated and it would be unusual for the donor to be anonymous if it’s a family member, but there are lots of clinics that have different locations so work from London and Prague as in this example, but also London and Spain are quite a common one. I’m not sure. Unless you’re not intending to tell your child, in that case, it could be safer for you to have your treatment abroad because there’s no chance that your child would find out; however, we don’t encourage that in the UK because it’s felt that children benefit from knowing where they come from genetically. This is kind of a thing that you really would discuss during your implications counselling because you want to make sure you’re going with your eyes open for any treatment that you have.
The HFEA has done a lot of regulation around surrogacy; to be honest, I probably should have included that in my presentation. The important thing to note is that because you’ll be given particular forms that ensure that the surrogate is signing over her right to you as the intended parents, that starts the ball rolling. Unfortunately, that doesn’t automatically mean that you are the parent. Six months after the birth, generally, you would then get to court to get full parental rights and full legal rights.
The way you do this is by making an application before the child reaches the age of six months to the courts and generally, as long as you haven’t paid your surrogate too much money because expenses are kept in the UK, there’s no problem at all. It’s also very rare for a surrogate to decide to keep the baby and also, as long as you’ve got all the paperwork in place, the clinics generally insist that the surrogate the intended parents and the partner of the surrogate, if they have one, go through extensive counselling to ensure that all parties are on the same page when it comes to the treatment. If there’s any doubt that your surrogate may decide to keep the baby, then that’s not the surrogate for you. I know it’s really difficult to find surrogates, but I can assure you that there are lots of protections in place to ensure that the intended parents receive the child as they should. But again, forms must be filled out before treatment. It’s crucial.
At the beginning of 2020, the HFEA closed clinics for a period of three to four months in most cases. This means that the recruitment of donors was also stopped. Some clinics decided they wanted to stop the recruitment of donors for longer than that, but in reality, the majority of people, whether they’re a recruitment site or if they’re a donor bank, do have enough donors still in storage to ensure that supply is available. As I mentioned previously, you can also import donor sperm from overseas. The most common places are the European Sperm Bank and Cryos.
Both of these understand the HFEA regulation very clearly, and they get their donors to fill in the same forms, so even if you can’t find a donor in the UK, you can get these from abroad. If you really want to get a UK donor, and generally there are donors available, if you’re from a background that isn’t Caucasian, things can be a bit more difficult. For example, it’s particularly difficult to recruit black donors and donors of oriental descent, but if you’re Caucasian, it’s generally very easy to find a donor that’s suitable for you.
The difficulty is there’s been a lot of discussions surrounding this because there was one period when the HFEA discussed the option of perhaps making baby photos available; this is still in discussion. The discussion surrounding adult photos is rather different because with technology as it is today it’s very easy to then identify the person, which completely goes beyond what’s expected by law in terms of the identification of those donors. So, for the time being, I suspect that no, the law isn’t going to change to let photos be available. It may be that baby photos are available, but I think it’s unlikely. Something very interesting to you and something very important, a lot of the American sperm and egg banks do provide that information and you can import those gametes to the UK, you get the infamous additional information like the photographs, etc., separately and the clinic would then only get the information about screening, etc., and consent. So yes, that would mean you could have a photograph of a donor if you wanted to do so.
I think the way things are set up in the UK is to ensure that children have the choice of whether they find out who their donor is. This is instead of the parents who are selecting the donor, I guess it’s a personal decision whether you feel that’s appropriate, whether you think that parents should be able to see what the donor looks like, but I guess it’s all about the law in the UK allows that control to be handed to the child and surrogates are sightly different case because the surrogate will generally be known to the intended parents. So, therefore, photos aren’t necessary. What would be the advantage in the UK?
I’m not sure there would be an advantage. I think it’s really important to consider other things when you’re choosing your donor rather than just physical characteristics because if you’re using your own eggs or if you’re using your partner’s sperm, then that will mean that they will have an input into how the child is going to look in the end. Furthermore, I also think that some people feel that education, occupation, interests, those kinds of things are more important, but again, you don’t know if those are genetically inherited, so I’m kind of on the fence about photos. At this stage, I don’t think they’re necessary in the UK because you can get them elsewhere.
I think it’s less of a case of treatments being more advanced, I think it’s more of a case of us getting better at the treatments that we offer. So, all the time we’re getting better at culturing embryos, the better embryos we create the higher chances of pregnancy, but also getting better at understanding the reason for the inability to become pregnant as well.
The assessments of the females and the males are getting much better, so we can identify things that are stopping you from getting pregnant. Also, the availability of donors is making things a lot easier, particularly for older women who want to have treatment. They get the opportunity to use eggs from a much younger person, and then you can think about the epigenetic episode, so how the person carrying the pregnancy then has an impact on how the child turns out in the end. A lot of work is going into improving our processes, and I think that’s the way we should think about improving: what we can do well already and then seeing what happens in the future. I suspect most things will become more genetically related than they are at the moment.
We don’t offer that at our particular clinic, I know some clinics do that. There are also particular ways that you can organize the cost of your IVF through organizations, I’ve completely lost the name of the particular one I was thinking of, but there are organizations that you can approach that do offer that live birth guarantee. The problem is the amount of money that you have to pay up front. It’s generally quite hefty because the expectation is that you’ll have a lot of treatment, and then if you get pregnant, excellent, but then you would’ve spent a huge amount of money when you could have perhaps been just as successful by going through a pay-as-you-go type situation.
Sometimes, some clinics do offer three-cycle packages, for example, where you pay for two and you get one free, but again that isn’t a live birth guarantee, that’s more about spreading the cost a little bit and making things a bit cheaper for you. Where I work do a lot of NHS-funded treatments as well, and that’s the case of you being offered a certain number of treatments until you have a child rather than a live birth guarantee.
