Human Fertilisation and Embryology (Amendment) Regulations 2024
(1 month ago)
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Baroness Merron
That the Grand Committee do consider the Human Fertilisation and Embryology (Amendment) Regulations 2024
Relevant document: 1st Report from the Secondary Legislation Scrutiny Committee
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Merron) (Lab)
My Lords, these important regulations were laid before the House on 15 May 2024 by the previous Government, and one of my early tasks in post was to approve that this change in legislation be put before Parliament. I am pleased that we have secured this time today and grateful for stakeholders’ patience.
This legislation brings us one step closer to extending the chance to start a family. The Human Fertilisation and Embryology Act 1990 provides the legislative framework for regulating fertility treatments and the use of gametes and embryos in the UK. These draft regulations amend two aspects of Schedule 3A to the 1990 Act, which were inherited from the European Union’s tissues and cells directive 2006/17/EC.
The first issue we are seeking to address in these regulations is where “partner donation” is defined as being between a man and a woman who are in an intimate physical relationship, which excludes female same-sex couples. We are in an age where social attitudes to same-sex couples and family formation are very different and, alongside this advancement in attitudes, assisted reproduction techniques have developed that now allow both female partners to take part in the creation of a child. This is through reciprocal IVF where one partner donates her egg to make an embryo with donor sperm, forming a biological link to their child; then the other partner undergoes IVF, becomes pregnant and delivers their child.
Legislation has not kept pace at all with these advances. Currently, female same-sex couples who undergo reciprocal IVF as a non-partner donation are required to have additional screening for infectious and genetic diseases. This leads to an additional financial burden for female same-sex couples undergoing this treatment. It can cost more than £1,000 when compared to opposite-sex couples undergoing IVF using their own gametes, where there is no clinical reason for the screening.
The second issue we seek to address under the 1990 Act is where a person living with HIV cannot donate their gametes to create a family, unless it is with a partner in an opposite-sex couple. Thankfully, through the advances in the treatment of HIV, such as anti-retroviral therapy, the risk of transmission is now regarded as negligible through unprotected sexual intercourse and by extension, gamete donation.
The proposed regulations would allow people with HIV who meet certain conditions to donate their gametes to known recipients, where certain conditions are met. These are: that they have an undetectable HIV viral load of less than 200 copies per millilitre, shown by two tests prior to donation; that they have been receiving anti-retroviral treatment for at least six months prior to donation; and that the recipient knows of the donor’s HIV diagnosis and provides informed consent.
The proposed regulations will also modify the definition of partner donation to include female same-sex couples, allowing them to undergo the same testing requirements as opposite-sex couples. The regulations also create a new defined term of “partner donated egg” and exempt these donations from the requirement to comply with more stringent screening criteria. These policy changes have been adopted following advice from the Advisory Committee on the Safety of Blood, Tissues and Organs.
Lord Wigley (PC)
My Lords, I am delighted to contribute briefly to this short debate for one specific reason. Back in 1990, when the defining Act was passed, it was at the end of a strenuous five-year battle of attrition, as certain Members in this Committee—in particular, the noble Lord, Lord Winston—will recall. The right honourable Enoch Powell had tried in 1985 to get a Private Member’s Bill, the Unborn Children (Protection) Bill, on to the statute book. It was hugely controversial; if passed, it would have prevented essential research into both infertility and avoiding certain hereditary disabilities, such as cystic fibrosis and muscular dystrophy. I should declare my own interests: we then had two boys who were alive with hereditary conditions.
This led to the establishment of the organisation Progress. Three of us were trustees: the late Jo Richardson, Peter Thurnham and myself. We were immensely indebted to advice and guidance from the medical fraternity, in particular the noble Lord, Lord Winston, people such as Robert Edwards and Michael Laurence, and a number of others. When that Bill was originally put forward by Enoch Powell in February 1985, it was passed in the House of Commons by 238 to 66 votes. By 1990, five years later, there had been such a sea-change in public perception—thanks to much of the work undertaken by the noble Lord, Lord Winston, and his colleagues—that the House of Lords passed what became the 1990 Act by 238 to 80 votes and, at Second Reading in the House of Commons, it was passed by 362 to 189 votes. It was an immense change in the public mood.
I pay tribute to the noble Lord, Lord Winston, and his colleagues for their pioneering work. I also pay tribute to those who have done such great work over the past 35 years at Progress and its successor organisation, PET, which is an independent charity that improves choices for people affected by infertility and genetic conditions.
On these specific regulations, I wish to ask the Minister a couple of questions. First, can she confirm that the devolved regimes—in particular, Senedd Cymru —are fully in support? Although this is not a devolved matter, it obviously overlaps with responsibilities that are devolved. Secondly, can the Minister give some indication of the potential additional costs on clients, to which reference is made in paragraph 9.2 of the Explanatory Memorandum? Might these be punitive, or even prohibitive? Thirdly, is there any likelihood of costs escalating to over £10 million? If so, what would be the mechanism for a statutory review, as mentioned in the regulations?
I welcome this instrument but I would be grateful for answers to those specific questions.
Lord Winston (Lab)
My Lords, I am rather embarrassed after the noble Lord, Lord Wigley, has spoken so volubly and over-kindly about the work we did together. I have to say that when he was Dafydd Wigley MP his amazing attempts to help us subvert Enoch Powell’s Unborn Children (Protection) Bill meant sitting all night several nights running to prevent that legislation going through, even though there was a big majority in the House of Commons. It is a remarkable story that has never really properly been told, but perhaps it should not be told. I cannot divert the Committee now, but one of the extraordinary things was that by the end of that I had remarkable respect for Enoch Powell, which I never expected. He behaved in an extraordinary way and with great dignity, even when he was losing. He was not quite as prejudiced as people made out. I think he was intellectually challenged by what he was seeing in front of him.
I return to the amendment, the business in hand today, which is essentially the issue with HIV-positive patients. We were the first people in the world to treat people who were HIV positive back in the 1980s. We had a baby as early as about 1986, possibly 1985—I cannot remember. It was a long time ago. That was before the regulations. We were aware that there was a small risk of transmission, but with caesarean section and so on the risk was so minuscule that we felt it was worthwhile. It got a lot of adverse publicity, until it was copied by a lot of other people, and it went on to be accepted. However, I accept completely that what the Minister is recommending is safer, but there are just a few questions I would like to ask her.
First, what would happen if the recipient was already HIV positive? Is there some regulation? That was something we faced nearly 40 years ago. I should like her to explain because I am sure things have moved on with the legislation, and I am not now clinically in practice, although I am still active in research. Secondly, I am concerned that the Minister should argue that this is just a matter for private practice. That is not acceptable. This should be available under the health service. The fact that somebody has a problem with HIV should in no way discriminate against their getting or giving proper treatment to a friend, relative or other person. I regard that as an essential human right. I suspect that there might be some reason to question that.
Unfortunately, one of the terrible things that has happened in Britain is that at the moment human in vitro fertilisation has become colossally expensive. The Minister gave a figure of £1,000. I regret to say that in London that would be almost impossible. I suspect that most people getting donations of this kind would be spending far more than that, even though it may not be clear. Clinics do not declare what they charge. The Human Fertilisation and Embryology Authority claims that it has no power to deal with the price of IVF. That is important to consider. I hope that the Minister will at least address that issue because undoubtedly—I beg her for obvious reasons because she will have sympathy—there is massive exploitation of women going through in vitro fertilisation. Every week, I get stories by email that suggest that what is happening not other than somewhat under the table, so that is the other issue.
The Minister made no mention of counselling. When the Bill was initiated back in 1990—it was passed first in the House of Lords, of course—there was a clear discussion during that debate about the need for counselling. It was repeated in the House of Commons as well—I see the noble Lord, Lord Wigley, nodding—and it was written into the workings of the Human Fertilisation and Embryology Authority. It is therefore important that proper counselling is part of this, and it should be written in in some way so that there is some understanding that it should be there.
The issues with HIV are always of concern, certainly in IVF. Suppose that somebody who was negative suddenly becomes positive again, which is not impossible, even though they may have had retroviral treatment in between. We ought to be aware of those things with this instrument.
Having spoken at great length on what seems quite a trivial matter, I have probably wasted the Committee’s time a bit. I am completely in agreement with the aim of what is undertaken here. I do not think there is any need to change the wording or anything like that, but what I am talking about must be considered. I thank the Minister, and I thank the noble Lord, Lord Wigley, for his extraordinary work 40 years ago, which is still remembered and greatly appreciated.
Lord Scriven (LD)
My Lords, in following the noble Lord, Lord Winston, I disagree with him: he never wastes the Committee’s time with his knowledge and expertise in helping this field move forward. After listening to the noble Lords, Lord Wigley and Lord Winston, I think that this statutory instrument is not just a one-off regulatory update; it represents a continuation of the journey in the realm of reproductive rights, scientific progress and ethical standards in this part of healthcare. It is important that both noble Lords asked us to look at these amendments in the context of that journey.
The landscape of reproductive rights technology has evolved dramatically—particularly recently—with advancements in IVF, genetic screening and other reproductive technologies. We have the potential to transform countless lives in this field. I note that the noble Lords, Lord Winston and Lord Wigley, say that some people are perhaps debarred because of the lack of provision on the NHS. In a wider debate in a wider context, I am sure the Minister would want to take up the discussion and debate that when we have the time.
However, we must note that progress comes with challenges, especially regarding ethical considerations and access to these technologies. These amendments seek to address some of those concerns so that couples made up of two women and those living with HIV have a better chance, or a more equal chance, of accessing this kind of healthcare and technology. These regulations are a step forward in this area in health provision and help to promote equity so that more people can pursue their dreams of parenthood, notwithstanding the issue of where they get that provision, whether in the private sector or the NHS.
As the Minister said, it is essential that these regulations highlight the importance of supporting diverse family structures in 2024. These amendments recognise that families come in various forms and that reproductive technologies should be accessible to all families on an equal basis.
Over the past couple of days, I discussed what was coming before the House with friends, and some people raised concerns, interestingly, about the implications of the use of gametes from people living with HIV. Therefore, it is crucial to understand that the amendment does not advocate unrestricted access without proper oversight. It promotes a balanced approach that prioritises ethical standards while facilitating innovations in HIV medicine. Advancements in HIV treatment have not only significantly improved health outcomes for individuals living with HIV but have made it safe to include people living with HIV more broadly in these amendments.
These regulations champion access, ethical standards and innovation in reproductive health. Notwithstanding the questions asked by the noble Lords, I have no questions because we support this SI. We believe it not only empowers individuals and families but fosters a reproductive healthcare service that values inclusivity, diversity and ethical progress.
Lord Evans of Rainow (Con)
My Lords, when I came here today, I did not think I would be hearing about Enoch Powell. I think that, if he were here today, he would be very interested in what we have been debating. Enoch Powell’s consistency was Wolverhampton South West. In the 2010 election, a colleague of mine of Asian background, a Sikh, won by the same majority as Enoch won it by in 1950. I am glad to say that Mrs Enoch said that Enoch would have been delighted by my Conservative colleague Paul Uppal winning that seat. It shows that people change over time. I wish he were here to hear what I am about to say.
I welcome these regulations laid before us by His Majesty’s Government. They bring forward the plans from May this year that were established by the Conservative Government. Now, as then, we believe that equality under the law is a long-established principle in this country and any improvement towards this end is to be lauded. I am sure that can receive support from all noble Lords.
These regulations mark a further step towards ensuring equal access to IVF services for people living with HIV and for female same-sex couples. It is another stage in the process of ensuring that as many people as possible can fulfil their dreams of parenthood, and it builds on the incredible work done to reduce the stigma associated with HIV, which has for so long prevented people getting tested and seeking treatment. With these changes, we will make it clear that people with HIV can live happy and fruitful lives.
The conditions in these regulations limit donation to those with an HIV viral load of no more than 200 copies per millilitre, meaning that the infection is undetectable and therefore non-transmittable. This requires the donor and recipient to have a personal relationship with one another and ensuring that safeguards are in place to minimise any risks associated with partner donation from people diagnosed with HIV. This will benefit hundreds of couples who have been trying in vain to become parents, and it will also reduce costs relating to IVF.
I hope that His Majesty’s Government will continue in the steps of the previous Conservative Government with efforts to help those living with HIV to have equal access to healthcare services.
Baroness Merron (Lab)
My Lords, I am glad to sense not just support for this draft statutory instrument but recognition in this debate. Following the comments of the noble Lord, Lord Evans, I acknowledge the contribution of my predecessor as Minister responsible for this area, who pressed on with the SI and ensured that it was laid. I am glad to be speaking to it today, as I know he is. I am also pleased to note that Adam Freedman from the National AIDS Trust is with us today. He is most welcome to the Committee. He has come to see the statutory instrument debated. He and his colleagues have patiently encouraged the previous Government and this Government in the right direction, and I thank him for that.
On the points raised by noble Lords, the noble Lord, Lord Wigley, asked whether the devolved Governments were content. I delighted to tell him that they are. He also asked about additional costs. A de minimis assessment was carried out, and it estimates £46,000 to £92,000 for the impact on the fertility sector. Obviously, as has been evidenced and described in this debate, there is a hugely positive impact from the measures within this draft statutory instrument.
I note what the noble Lord, Lord Wigley, said. I put down that he, along with the noble Lord, Lord Winston, and other parliamentary colleagues past and present, are veterans of change and of the Acts we are talking about. As the noble Lord, Lord Scriven, said, this is a journey—one that I suspect is not at its end, although I am pleased to take us further on that journey today. I also pay tribute to the contribution in this area of the noble Lord, Lord Winston, over many years, and to the contributions of other colleagues, who have given it their support and professionalism.
The noble Lord, Lord Winston, asked what the case would be if a recipient were HIV positive. The answer is that they will be able to get IVF. They are not actually affected by these regulations, which impact donors, not recipients. I assure the noble Lord that he was far from wasting the Committee’s time with his comments. I heard clearly his comments about counselling and the need for support. I will look closely at that with officials, following his remarks. I clarify that the £1,000 I referred to was not for IVF. It was an estimated cost for the additional screening required for female same-sex couples, which we are now seeking to correct.
On funding and the issue of availability on the National Health Service, as noble Lords will know, funding for IVF is devolved to ICBs. I am very well aware of the differential provision to different groups and individuals. I will consider future policy options, having picked up this part of the brief and spoken to a number of people about their concerns.
The noble Lord, Lord Scriven, also asked about access to IVF on the NHS. In addition to the point about consideration of advice that I will be getting about improving the service, I want to share his comment about this being just one more step in a positive direction. It is about supporting the fact that families come in all shapes and sizes. A family or a household is a family or a household, and parents are parents. They are there to support and bring up their child in a positive way, and we want to support that too.
I finish by thanking the noble Lord, Lord Evans, for reminding us that one thing that these regulations will do is take us a step on another journey—that of reducing the stigma for those who live with HIV. There have been so many medical advances, which is why we are able to bring this instrument forward today. But attitudes continue to be something to be challenged at times, and I am glad that noble Lords recognise the contribution of the legislative change we seek to make.
We want to ensure that those who want to start a family do not face barriers where there is no reason for those barriers. I place on record my thanks to the organisations who have pushed for and supported these reforms, particularly the National AIDS Trust, Stonewall, the Elton John AIDS Foundation and the Human Fertilisation and Embryology Authority. As I said earlier to the noble Lord, Lord Wigley, I thank all those parliamentarians and others along the way who have got us to this place today.