Motion to Take Note
My Lords, I open this debate in a spirit of inquiry and concern rather than as an expert with well-established views. I do so because I am a journalist, not a scientist. The field of gene editing is developing so widely across the planet and so deeply in the range of applications that it is time to back the calls of many scientific institutions to extend the debate beyond the medical and scientific fields, where, until recently, any degree of concern has been concentrated. It is time for everyone to know what is going on.
Before I get to the meat of the matter, here for a start is an issue raised by two charities, Genetic Alliance UK and the Progress Educational Trust, once they knew about this debate. In the interests of clarity, they have asked for the phrase “genome editing” to be used consistently in this debate, rather than simply “gene editing”. They warn against too often using the term “CRISPR”, a process of genome editing pioneered since 2012, as if it were the synonym for gene editing in general when there are several other techniques. Having explained that to your Lordships, for the purposes of this debate, and because it was used in its title, I shall refer to gene editing.
Last December, a Chinese scientist was convicted of practising a medical procedure without a licence to do so. He was sentenced to three years in prison and fined 3 million yuan. He is He Jiankui, a name now familiar throughout the world of gene editing. He had researched and produced, through the use of CRISPR, the genomes of what have since become two little girls. What is more, he declared that he had done so at an international genome editing conference in 2018. The world of biogenetics was appalled and flew into an explosion of panic and outrage. The welfare of the little girls is not a matter of public record—not yet.
Last November, I was invited by the Royal Society to chair a debate called “The Quest for the Perfect Human”. Its four panellists were people steeped in the science and application of gene editing and each was familiar with CRISPR. One, Dr Rodger Novak, was co-founder in 2013 of CRISPR Therapeutics. Another was Professor Robin Lovell-Badge of the Crick Institute, where many of its 110 labs are allowing scientists to analyse gene function and disease processes. Professor Lovell-Badge is also a member of the World Health Organization Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing. More of that later.
Intervention in a person’s genes for the sake of medical benefits is a technique that was always on the cards once the human genome project was declared complete in 2003. However, science is a constantly flowing river and, before then, interventions such as IV fertilisation had resulted in the first IVF baby, Louise Brown, being born as long ago as 1978. From the late 1980s, scientists in the UK were developing pre-implementation genetic diagnosis—PGD—a process whereby parents with a serious inherited disease in their family can avoid passing it on to their children. This technique is approved in the UK by the Human Fertilisation and Embryology Authority.
Time moves on, and in June 2013 the UK Government agreed to develop legislation that would legalise three-person IVF as a treatment to eliminate mitochondrial diseases that pass from mother to child—it is called MRT—and the 2015 mitochondrial donation regulations, allowed under the Human Fertilisation and Embryology Act 1990, made this possible with parliamentary consent.
I mention this background to indicate how genetic procedures are becoming more and more common in modern medicine and to place gene editing and its direction in that context. As one of the panellists said at the Royal Society debate, a line drawn in the sand gets washed away by the tide of change. Perhaps prompted by Mr He Jiankui’s extraordinary announcement, in 2018 the UK Nuffield Council on Bioethics published a report which concluded that
“though there may be many individual objections, there exists no categorical ethical objection to planting genome-edited human embryos.”
Given that, as I have outlined, existing UK law already allows limited editing of genomes in human reproduction, the eventual wide acceptability of editing to prevent the transmission of serious diseases and to eliminate them from the germline appears likely in the near future.
That being so, a number of ethical and social issues need to be considered. Before setting them out, let me summarise the present state of law around the world concerning gene editing. No country explicitly allows human germline genome editing, but many have no prohibition on it either. In the UK these matters are, as I have indicated, the concern of the HFEA, which requires all such matters to be done under licence. The August 2017 issue of Nature first reported on the American use of gene editing in humans. In response, George Annas, director of the Center for Health Law, Ethics and Human Rights at Boston University School of Public Health declared that
“the scientists are out of control.”
What makes a big difference to all this is the speed of scientific developments and the availability of editing techniques that are precise, affordable and easy to apply. We know that many are being used successfully under licence in the treatment of rare diseases. Their availability around the world makes their use, official or unofficial, likely to spread. CRISPR is the most well known. When CRISPR was first announced, the acronym received 19 million hits on Google, 5,000 articles were written, 28,000 patents were taken out and, as we know, two babies were born. The prospects for the future of medicine and the human race are huge: 8 million babies are born each year with genetic defects and most will die quite soon. The potential for doing good is enormous. There is talk, for example, of being able to eliminate sickle cell disease entirely, and families blighted by the possible inheritance of Huntington’s can look to gene editing permanently to delete the aberrant gene from their germline. Work is also being done on type 1 diabetes.
In this country, the Government set up the national genomic healthcare strategy last February to improve existing services for those with rare diseases, with the NHS offering genome sequencing as part of its service. One in 17 people in this country—6% of the population —will be affected by a rare disease at some point in their lives. That is 3.5 million people in the UK and 30 million across Europe. It is because so many new techniques are in use or imminent that it is important to confront the broader ethical and social dilemmas.
Is it ethical to change for ever a human germline to eliminate from human history certain patterns of inheritance? There have been calls for a moratorium, or at least a pause. How can and should the world control this? In the wake of Mr He Jiankui’s announcement, the World Health Organization has set up a committee of experts to look at the governance of the process and to create a framework that will consider the risks, benefits and various models of regulation—hard laws, soft laws and so on. How can any regulation be policed? With the techniques cheap and available, who is to stop rogue operators, or even biohackers, seeking to make such changes? How might a political tyrant one day make it serve his or her interests? The WHO report is expected this spring.
Another major consideration arises: what is to be considered an illness and who decides? Is deafness an illness? Should we be seeking to wipe it out? Is autism an illness? Many of those who belong to such communities would not think so. The offspring who result from gene editing have no say in the matter, and the consent of the patient is one of the major principles of medical practice. Who has the authority to rule on such a matter, and what form would any such ruling take? Would it be a total ban or would there be conditional permissions? Who is to write the framework, and should it be universal or local?
Another matter is social justice. To whom will this new facility be made available? Will it be acceptable for rich countries to forge ahead, leaving behind poorer countries that cannot afford such developments? Will rich individuals be able to benefit while the poor cannot? Who will have the right to refuse such treatment and to whom? The project risks widening, in an ever new and devastating way, the differences between rich and poor, and dividing the human race into subsections worthy of some futuristic science fiction. Indeed, such fictions have already been written—Huxley’s Brave New World, Kazuo Ishiguro’s Never Let Me Go and plenty of others. The imagination of our novelists is running ahead of the science.
The debate that I chaired at the Royal Society was called “The Quest for the Perfect Human”. In the course of that evening, the word “eugenics” came up—the science of perfecting the human race. It was used merely as a touchstone of the worst that could be imagined, but it is why I initiated this debate.
I have spoken of what I know and what I have heard. The first is very little; the second I may have oversimplified—I stand to be corrected by experts. However, as these techniques become more widespread, what has emerged—from the considerations of the World Health Organization to those involved in this work at the Francis Crick Institute and in university research institutions across the world—is the belief that the public must be brought on board. I hope that the Government are taking to heart the concerns that exist about this exciting but fundamental change in how science is about to shape, irreversibly, the human race. I beg to move.
My Lords, I thank the noble Baroness for initiating this debate. Although I agree with much of what she has said, I have a different viewpoint of how the science might develop. It is right and proper that society decides what science output to control and whether it is right for society to benefit from it if it harms society.
Perhaps I may start from a different angle. This is a story of another time—of a plausible future 20 or 30 years from now—in which the human experience of life and health, and perhaps even who we are, will unfold unlike anything we have known hitherto. In future, citizens will learn early in life, through a combination of intelligence gathered from their smart accessories, embedded devices and more accurate information from genetic testing, their predisposition to disease—whether they are heading towards disease, depression, dementia or any other condition.
More importantly, they will have a choice of an exit strategy. They will be able to choose a familiar route of medication, behavioural change or lifestyle change, or they might choose novel treatment paths. Those predisposed to disease will be able to have their risky DNA removed or altered. Those with neurological conditions might be treated with brain implants, and even cognitive function might be restored by a cling-film-like membrane or hair-like wires inserted into the brain to restore neuronal connections.
Brain implants are already in use in tens of thousands of patients with epilepsy, tremors, seizures, Parkinson’s disease and even some conditions related to mental health. If such treatments were effective and safe, who would not choose them to divert the course of their illness? Yet our genes and neurons are more than origins of our illness; they are also part of our substrate, our being, our humanity. Would manipulating them risk altering who we are?
Yet we cannot stop science and scientific developments that may make people’s lives better. As humans, we have been shaped by our discoveries: stone tools, fire and its control, eye glasses, electricity, antibiotics, nuclear physics, organ transplants, in vitro fertilisation and the internet, to name but a few.
Yet there is something different—some may say exciting—about gaining mastery over our DNA and brains. Our complete set of DNA, its molecular code and how it is expressed give rise in each and every one of us to a singular life. In modifying DNA in human cells, we turn them into living drugs. Since 2003, over a dozen gene therapy treatments have been approved to treat cancers and other disorders, of the eyes, blood and neuromuscular systems. The technology holds promise for countless cures.
Jennifer Doudna, who is known for her work on CRISPR-Cas9, says that, in less than 30 years,
“it will … be possible to make … any kind of change to any kind of genome”.
Because of the power of the technology, she and many others have called for a moratorium on germline editing of the human genome.
Developments in somatic editing of the human genome are quite different. This is not germline editing. Genome editing and somatic editing hold out great promise for the treatment of diseases caused by genetic mutations. There are over 75,000 genetic mutations that cause inherited diseases. Unlike in germline editing, the changes made in somatic editing are not passed on to future generations.
Several CRISPR-related therapies are in early phase trials for somatic genomic editing: editing patients’ T cells for treating cancers; boosting foetal haemoglobin in sickle cell disease; editing donor cells to treat non-Hodgkin’s lymphoma; editing photoreceptor cells to treat inherited blindness. Even in the UK, there are trials related to somatic genome editing; the CRUK-AstraZeneca Functional Genomics Centre does much of the work. The UK was the first in Europe to make CAR-T therapy, as it is today, available to cancer patients.
There is still a lot of science to be done to make these treatments safer and more effective. This will happen as more new technologies develop. CRISPR-Cas9 is not now likely to be used; it will be replaced by more accurate baseline and intermediate editing, which target a single nucleotide. ACGT nucleotides make up the amino acids of DNA. The transfer of one A instead of a C may cause a mutation and a disease; editing that into a normal sequence would cure the disease permanently.
Newer technology for base editing and prime editing, as I mentioned, holds much more promise. Germline genome editing in embryos to create genetically modified people is different, and ethically fraught. In my view, there should be a global moratorium on this for at least five years; it would not include a moratorium on research, because we can learn a lot of science from research into germline editing which may help in other areas.
There is a need for better regulation. We are lucky in the United Kingdom that we have a regulatory authority that can exercise this function to regulate practices that might be unethical, including research on embryos. The authority has granted one licence for research on genetically modified embryos. It may grant others if it is satisfied that they are necessary. But there are gaps that need to be filled. Hence, I ask the Minister to address this.
When the Human Fertilisation and Embryology Act was enacted, it was in the context of the science then, but now things have changed because the technology and the science have advanced to a point where it is not just human embryos that we can modify. It could be done on gametes produced outside the body or in vivo to gametes, so there is a need to change the Act so that it meets those changed circumstances. The definition of a woman has also changed, with trans women and other issues, so we need to look at the legislation so that it meets the current status.
The second aspect is that, as the noble Baroness has already mentioned, we need to have a wider consultation with the public such as the Government had before mitochondrial transfer was legalised. That took three years of experts and patients’ panels looking at the evidence. I hope the Government will do that with genomic editing.
My Lords, I warmly congratulate the noble Baroness on introducing this debate of great importance. I admired her for suggesting that it was in the spirit of inquiry and concern, not as an expert; I echo her comment. The joy of this place is that we have many distinguished scientists and clinicians as well as many distinguished ethicists among the Lords Spiritual and many others, so this is the right place to discuss this critical subject.
I shall quickly declare an interest as a member of the international advisory council of Chugai, a research-intensive Japanese pharmaceutical company involved in a pioneering genomics analysis programme. I have not discussed this debate with the company, incidentally.
All are aware that nearly every human ailment has some basis in our genes. The recent advancements in genomics are among the most impactful and exciting developments in medical research. Research using genome editing is enabling significantly improved diagnostics and treatment of a range of diseases including cancers, diabetes and cardiovascular disease.
I want to go back 40 years to when I published a paper in the Journal of Child Psychology and Psychiatry on the management of families with Huntington’s Chorea— now called Huntington’s disease—an incurable inherited neurological disorder that severely damages co-ordination and mental abilities, often resulting in psychosis. At that time there was no way to predict who carried the gene until it was manifest in deteriorating symptoms and, inevitably, a prolonged and deeply distressing death. It was a family secret, a taboo subject. However, as life-changing genetic medicine has developed, remarkable progress has been made, as has just been suggested, such that we can now perform genetic testing on high-risk individuals before the onset of symptoms. Pre-implementation genetic diagnosis now allows us to test embryos produced using IVF in order to prevent those with HD genes being implanted and, consequently, prevent the offspring inheriting the disease. Just last year uniQure announced a clinical trial for a gene therapy solution, AMT-130, which aims to utilise a harmless virus to add extra genetic code to patients’ neurons to make them produce a chemical that lowers the mutant Huntington protein. This is the first AAV to enter clinical testing for the treatment of Huntington’s disease—a wonderful example, but just one of many, of the benefit that genome editing may bring.
My second phase in this topic was as a member of the Medical Research Council under the distinguished leadership of a former Leader of this place, Earl Jellicoe. Some 35 years ago there was great excitement about the work at Cambridge—involving Sir Keith Peters, the Regis Professor at Cambridge, a man who I have recommended for a place in this House more times than I have had lunch but, I am afraid, without success—that led to the establishment of the Sanger centre, which in 1992 became the Wellcome Sanger Institute. Those were early days. Never then did I anticipate the phenomenal scientific progress that the next 30 years would bring.
Part of my purpose, and a prime concern during my National Health Service work, was to bring our great research universities together with the great teaching hospitals to protect, enhance and develop our scientific and medical research—a great strength in the UK where we see ourselves as a global leader. As we leave the EU, it is all the more important that we protect and enhance our competitive strength, in which biomedical sciences are a leader.
There has been great leadership at the Department of Health and Social Care. Jeremy Hunt launched Genomics England. Given its vast potential, it is vital to see the UK in a leadership position. I pay great tribute to Sir John Chisholm, Jon Symonds and many others who have served there. The House will be aware of the excellent work the organisation has undertaken through the landmark 100,000 Genomes Project since the organisation was launched in 2013. The project, which saw the full genome sequencing of 100,000 patients with cancer or rare, infectious diseases, places the UK at the cutting edge of genomic science.
Similarly, I pay tribute to the last Chief Medical Officer, Dame Sally Davies, a wonderful woman who I know really well. I am delighted to say that she is now the first female master of Trinity College, Cambridge. She worked on many causes—antimicrobial resistance, obesity and much else—but showed real leadership on genome sequencing. She has earned vast admiration. One of her research areas was sickle cell disease, so she really knew the patient cost of that. As CMO, she called for a gene-testing revolution in the hope that whole genome sequencing would become as common as blood tests and biopsies. It may cost around £700 a patient, but it can improve diagnosis and care for a majority of patients, allowing doctors to tailor treatments to each patient’s needs.
While the patients who participated in the 100,000 Genomes Project all gave full consent for their biological data to be sequenced, there are still some who are troubled by the implications of this technology for their privacy. Dame Sally has always said that the data can be stored securely and anonymised, but I well appreciate this point. One of my greatest battles in my health role was a fight with the insurance industry, which would weight clients, if they had an HIV test, as though they were HIV positive. I felt passionately that this was so counter to public health, and I am pleased to say that it changed its policy in the end. However, anxiety about what will become of patient information is real and genuine.
The NHS Genomic Medicine Service continues to develop. The leadership shown by Jeremy Hunt has been taken up by Matt Hancock and there is a great deal of potential. Like others, my concern is regulation. The first Bill that I took through the House of Commons in my own right when I became Minister of Health was what became the Human Fertilisation and Embryology Act. Coming back to the points made by the noble Baroness, Lady Bakewell, public debate on that was so important. Hysteria and misinformation are quite different from rational, evidence-based logic and the problem is always how to communicate that, so I was delighted to hear about her recent conference. At that stage, we were trying to spread information. The noble Lord, Lord Winston, who is in his place, was very much part of the campaign at that time, as were many others.
There was a real danger that we would not get the Bill through the House of Commons. I think the noble Lord, Lord Alton, was also there at that time. The Bill got a bit hijacked by the abortion debate. As ever, debates in the Lords were critically helpful and important. I remember drawing frequently on many of the Lords’ comments to take the work forward. Subsequently, I invited the noble Baroness, Lady Deech, to chair the Human Fertilisation and Embryology Authority, which she did magnificently. It has been said by the noble Lord, Lord Patel, and others that there have been light years of change since then, including MRT and much else.
The difficulties that we now need to consider are profound. I ask the Minister: how will we show leadership in regulation, nationally and internationally? It is complex and confused. It was 12 years from Louise Brown to the Human Fertilisation and Embryology Authority. How does he see the future?
My Lords, I add my own congratulations and gratitude to the noble Baroness, Lady Bakewell, on securing this timely and important debate. Unlike my noble friend Lord Patel and other noble Lords yet to speak, I am not a scientist. However, I have vivid memories of following the Human Genome Project with a mixture of excitement and awe as I realised its huge potential for good. I have been equally impressed by the many recent developments in gene editing, including the 100,000 Genomes Project and CRISPR-Cas9, which we have heard about, and their implications for the prevention or treatment of diseases such as cystic fibrosis, muscular dystrophy and cancer.
As our Library briefing makes clear, the benefits for personalised, precision human healthcare in particular could be enormous. The Church of England is supportive of what is going on, especially in the UK, which is leading the way. But, as always with progress of this kind, as we have already been reminded several times, several ethical considerations need to be taken very seriously and have already been mentioned. It is to those that I will now refer, given the generally accepted need of an ethical framework for all this work.
First, there is clearly a need to distinguish between research and its clinical application. Just because we have discovered that we can do something does not necessarily mean that we should do it, for a variety of reasons. In both research and application, it is essential to establish margins of risk for the participants. In the case of research the participants are of course embryos which, according to the HFEA code of practice, need to be granted “proper respect”. That respect is not easy to define but it means that they should never be viewed simply as commodities for experimentation or a means to an end. The 14-day limit for research on early embryos plays an important role here, since that is when the so-called primitive streak begins to appear.
Where clinical procedures are concerned, the participants will include donors, prospective parents and, above all, prospective children, as well as their eventual offspring. We need to consider every aspect of their well-being, including the psychological and social. At the moment, it really is not possible to know how subsequent generations of children might be affected by gene editing in their parents and grandparents. Interactions between genes might not come to light for several generations, so we need further research into the interrelatedness of genes before the clinical application of genome editing is likely to prove universally efficacious or safe.
Also, as we were reminded by the noble Lord, Lord Patel, there is a further distinction to be drawn between somatic or non-reproductive cells and germ or reproductive cells, as the Medical Research Council and others have made clear in the past. Human somatic gene editing does not present any novel ethical dilemmas but human germline genome editing has been aptly described as the bioethical equivalent of splitting the atom. This means its clinical application requires a very nuanced ethical approach. In particular, we need to be aware of unexpected outcomes and unintended consequences, such as deleterious changes in social attitudes; for instance, in our approach to disability and the stigmatisation of individuals.
As our Library briefing points out, there is also the danger—the noble Baroness, Lady Bakewell, referred to this—of facilitating eugenics or designer babies. The current consensus is clearly that such practices are ethically unacceptable. This raises the further ethical issue of human enhancement. The borders between treating illness, enhancing health and enhancing human performance and attractiveness are fairly porous, as we already know from periodic scandals in the world of sport. That needs more exploration before genome editing becomes a widespread clinical reality. So too does the question of social disparity, especially if clinical genome editing is to become primarily available through the private sector, as with IVF. This certainly needs to be adequately analysed and addressed. It was of course one of the two principles which the Nuffield Council on Bioethics insisted upon when commenting on the ethical acceptability of gene editing.
I remarked in opening on the huge potential for good that gene editing has, especially in the early prediction and diagnosis of certain diseases. I certainly believe that to be the case despite the ethical whirlpools which need to be negotiated along the way. Perhaps we also need to be wary of exaggeration and its attendant danger, genetic determinism. For instance, it has recently been proposed that all newborn children should be offered genomic testing. That in itself is fraught with ethical difficulties, from consent—who gives it?—through to subsequent applications for life insurance, although there is a current agreement on that.
Even more perplexing is the fact that many illnesses, such as cancer, dementia and heart disease, are not due to just one factor. As a recent article by Dr Phil Whitaker in the New Statesman points out:
“Numerous genes contribute to susceptibility and all interact in fiendishly complex ways with environmental and lifestyle factors. The risk estimates achieved by commercial genomics tests are no better (and may even be worse) than our current clinical judgements.”
That has been stated also by the British Society for Genetic Medicine. Even if the predictions are accurate, there may not be a lot that we can do about them apart from feel anxious, and we have more than enough anxiety around already.
We are asked in this debate to take note of recent developments in the field of gene editing. I for one am glad to do exactly that, with admiration for all the work that is going on, and enthusiasm, but not entirely without some ethical reservation.
My Lords, I declare an interest as a founder president of Progress. I take some objection to its attempts to change the nomenclature, as it did at the time of embryo research when it called the embryo the pre-embryo. I do not think that is particularly helpful; it will not really make much difference to how we handle the actual biology and the science.
I am an unashamed gene editor. I have been involved with gene editing in embryos for nearly 30 years and have a company, Atazoa, which has looked at different methods of modifying embryos. We have done that both in mice and in pigs, and not only in embryos but in sperm, so I feel that I have something worth contributing to this debate.
I am grateful to so many people for mentioning preimplantation genetic diagnosis, or PGD, which was invented in my own laboratory. Alan Handyside and I published that first paper, and the first patients are now aged 30, so there is already a technique for preventing genetic disease that has been pretty reliable. It is not absolutely reliable—mistakes have occasionally been made—but the advantage of embryo biopsy is that one is not fundamentally changing the embryo and any risk taken is therefore simply a failure of that patient to get pregnant. As far as we know, there are no epigenetic consequences; we do not think that it causes long-term ill-health.
As the Human Fertilisation and Embryology Authority has been mentioned, I should say that it admitted this week in answer to a Written Question that it has no follow-up on any of the issues currently important in embryology in IVF. So we do not know what happens to babies in the long term after egg freezing, and we have no follow-up on PGD or on a whole range of issues. Such issues are far more important than regulation of IVF, which is done quite inaccurately much of the time. Due to the finances, many private clinics are doing things that most of us in this House would regard as utterly disreputable, such as selling research treatments that have no basis. It is clear that there will always be that risk, just as there was with He Jiankui in Shenzhen University. We also have to say that any medical procedure can be misused; I do not think in vitro fertilisation, or even gene editing, are any worse. Of course, it is terrible for the child born irreparably damaged, who carries that gene editing through their lifetime and passes it on to the next generation—of course, it cannot be controlled in the future. The risk of gene editing in the embryo is of massive importance and it is therefore extremely valuable that we have this debate at least to put this online today.
A recent headline in the Times suggested that we can now eliminate genetic disease by gene editing. That is complete nonsense. We cannot eliminate hereditary disease because so many of these genetic defects will not be expressed in the genome of the parents being screened. In fact, many of these defects occur between the generations, at the time when the egg or the sperm is formed, during meiosis or at other times. The idea that we can eliminate hereditary disease is rather like the Tower of Babel: it is trying to be so ambitious that we lose sense of what our humanity is. That is really important and I will come back to it.
I have to say that we were criticised, in this House as well as elsewhere, when we produced the first pre-implantation genetic diagnosis and it was said that we were undertaking eugenics. If you go to YouTube, you can hear a recording of Anne Sofie von Otter singing “Wiegala”, a lullaby that includes the words “Schlaf mein Kindelein”—sleep, my child. It was sung by its composer, Ilse Weber, as she entered the gas chamber at Auschwitz carrying her child. She wanted to comfort the child, who was frightened, and she died in that gas chamber. We know that this happened, because there were eyewitnesses, and we have the score of the poem she wrote. That is eugenics, because her only fault was that she was Jewish—a 41 year-old woman with two children. There was nothing else and the science was misused. Science is always capable of being misused: it is not just Nazis, anyone can do it. This was done in China and it can be done in this country, as it can in Europe. Let us not forget that.
Regulation is not really the answer here. I shall come back to that, if I may. We have to differentiate between eugenics and reasonable medical intervention. It seems to me that eugenics is where you involve a population. When you are dealing with an individual, you think of the best solution for that family; therefore, sometimes you decide to put back an embryo that has had some mitochondrial change—which, incidentally, is not gene editing, but simply changing the spindle, and therefore rather a different process. Gene editing has not been done in this country. We gave approval for that, but gene editing is banned and should remain banned, in my view, because the risks are appalling.
CRISPR is not an accurate technique. It is the best technique we have yet devised, and far better than the techniques we were using, introducing viruses into embryonic cells, but it carries the risks of off-target mutations, of epigenetic effects, of possibly producing cancer, of misdiagnoses and of producing, as the right reverend Prelate pointed out, completely unpredictable effects. I greatly valued and admired his speech, which was an important intervention in this debate.
One of the concerns we must understand has to do with our humanity. If we went through enhancement, we might end up with the basic principle of ethics being completely confounded. We believe in ethics because, whether we are religious, scientific or humanist, we believe in the notion of the sanctity of human life. If we make a superhuman, what value has human life? Playing God is something we should do; it is not wrong to do that. Imitating God, making use of our intelligence to provide the best solution to things, is what we are empowered to do and should be doing. However, to try to imitate God in the way they did, for example, at the Tower of Babel, if that parable or lesson is right, is utterly inappropriate, in my view.
We have to recognise that regulation will not work; it did not work in China and it would not work in this country. You could not prevent somebody doing this out of hand. We must recognise that we have to collaborate. International law will not work, but having more scientists working together and understanding the ethical issues will. I bet that if Dr He had worked in our laboratory, he would not have done that experiment in China. He worked somewhere in the United States. He was not an embryologist, which was not very helpful, because he did not understand the ethical issues raised. That understanding is something we have to grasp more and more.
My Lords, it is impossible to follow that outstanding speech by the noble Lord, Lord Winston. I hope the House will forgive me if I focus on this subject as it applies to international sport.
It is interesting to reflect that 100 years ago in competitive sport the distinction was between the amateur and professional ranks. Today the focus is on the drug cheats who knowingly take banned performance-enhancing drugs to gain a competitive advantage. London was supposed to be the cleanest Games in history; statistically, they turned into the dirtiest. There were 116 failed tests at the London Olympics in 2012, beating the mark of 86 set in Beijing. Of those 116 athletes, 69 have subsequently been disqualified—more than triple the number caught doping at the 2004 Athens Olympics and, as your Lordships will know, only the dopey dopers are foolish enough to get caught during the height of the competitive season.
Thanks to the noble Baroness, Lady Bakewell, we have the opportunity in this debate to look to the future and focus on the next major challenge to clean competitive sport. The outlook is bleak, for the battle between sports cheats and testers is poised to enter a whole new era. The consequences of gene editing for performance enhancement in sport are real. That is why the World Anti-Doping Agency has extended its 2003 ban on gene doping to include all forms of gene editing. It already bans the use of genetically modified cells and gene therapy if they have
“the potential to enhance sport performance”.
The list also includes
“gene editing agents designed to alter genome sequences and/or the transcriptional or epigenetic regulation of gene expression”,
although, interestingly, the responsibility lies with the athlete, which is impossible if their gene editing eventually one day becomes somatic.
The field is advancing incredibly fast, in part due to the discovery in the Olympic year of London 2012 of an easier editing method, CRISPR, which has been referred to, and its subsequent sons and daughters. The challenge in global sport for the remaining years of the 21st century will move on to the consequences of fast-moving developments derived from gene editing, where genetically engineered athletes will be set against the untainted natural skills of the fastest, highest and strongest competitors on earth. At the heart of the debate will be therapeutic use, as opposed to performance enhancement, among athletes, as rightly referred to by the right reverend Prelate.
There will always be huge ethical hurdles to consider, as evidenced by the rogue Chinese scientist Dr He Jiankui, but for sure there will be others seeking to fill his research shoes and the possibility of hidden funding to attempt to create the perfect athlete, which, as the noble Lord, Lord Winston, noted, will be impossible. However, it will not be impossible to create enhanced athletic performance.
My call for an outright ban on the application of this science in the world of competitive sport does not mean that I am blind to the potential of gene editing outside sport. However, I caution on the reality of further laboratory work in this context. Genes have a significant role to play in sporting performance, but they will never deliver sporting glory on their own. Without the balance of genetic advantage, environment, coaching and training, there will never be gold medal outcomes.
Take the example of the benefit of altitude training. As elite athletes acclimatise to high altitude, they acquire more red blood cells, which allow them to carry more oxygen. When they compete at lower altitudes, they get a natural boost to the muscles when additional oxygen is available. This blood-expanding effect can enhance performance by up to 2%. While that sounds like a tiny improvement, it can be the difference between missing selection and a gold-medal performance.
As evidenced by David Epstein in his seminal book The Sports Gene, the celebrated Mäntyranta—the multi-gold medallist in cross-country skiing in Finland—had a genetic trait which led to an extraordinary blood cell count, measured at up to 65% higher than that of the average man. It demonstrated that even trace quantities of EPO could bring major performance advantages. Subsequently, in all, 97 members of his family were examined, 29 of whom had remarkably high haemoglobin —many were champions in cross-country skiing. The geneticist Albert de la Chapelle discovered that, of the 7,138 pairs of bases that make up the EPO receptor gene, a single base was different in the 29 family members who had unusually high levels of haemoglobin. Each family member, like all human beings, had two copies of the EPOR gene. But at position 6,002 in only one copy of each affected family member’s two EPOR genes, there was an adenine molecule instead of a genuine molecule—a minuscule alteration, but the impact was immense. The production of red blood cells ran amok. Here was a mutation beneficial for an athlete, but otherwise of little consequence.
Of course, natural examples such as this are extremely rare, and applying that science in the laboratory and finding the athleticism genes is extraordinarily complex and difficult. However, it is attractive to those who wish to cheat in international sport to achieve glory. This is the road that will be travelled by rogue sports geneticists to cheat the system, which we must block through effective regulation and legislation, both domestically and through international co-operation, however great the challenge. David Epstein went on to say:
“A persistent inability to pinpoint most sports genes doesn’t mean they don’t exist, and scientists will, slowly, find more of them.”
One conclusion we can all reach is that, despite the uncertainty surrounding the potential application of gene editing to competitive sport, its potential is real. It should have no place in competitive sport. As I have made clear, in the 21st century, cheating by means of performance-enhancing drugs is an issue of today, and it is an issue of tomorrow for those geneticists who will go to any lengths to corrupt the athlete, and, sadly, many nation states in search of glory, in one of the few sectors where some countries can gain national pride. Gene editing clearly has huge benefits, such as relieving the burden of heritable diseases. However, it has no place in the sports arms race if we are to protect the integrity of competitive sport between clean athletes and rejoice in fair competition between young sports men and women worldwide.
My Lords, the whole House will want to thank the noble Baroness, Lady Bakewell, for giving us the opportunity to discuss this hugely important topical but also morally important question, which raises grave issues regarding the science and ethics of what we might do, especially regarding eugenics, to which the noble Baroness referred. I particularly endorse the remarks that were made by the right reverend Prelate the Bishop of Carlisle and the noble Lord, Lord Winston, who made an incredibly important speech in our debate today, asking us to consider the wider issues that are at stake here.
The noble Baroness will have seen the response of the British Society for Genetic Medicine to Matt Hancock and his ambition to conduct genomic sequencing of healthy newborns. It says that that could be “problematic”, because the genetic code of a healthy newborn
“will only rarely predict future disease accurately”—
a point the noble Lord, Lord Winston, reminded us about. The society says that it is important that
“children are not tested for adult onset conditions if there is no effective preventative intervention or treatment in childhood. Issues such as sample and data storage, access and retrieval also require detailed scrutiny”.
“Such a venture therefore needs to be carefully researched, and the ethical and societal aspects require careful consideration before roll-out to the general population.”
However, other forces are at work. This morning, I sent a letter to the Minister, the noble Lord, Lord Bethell, from the Royal Academy of Engineering, as well as my response. I was dismayed to see the phraseology it used in talking about gene editing, citing factors such as
“economic activity and sustainable and resource-efficient solutions to the societal challenges faced in food, chemicals, materials, water, energy … and environmental protection.”
If applied to humans—which has yet to be excluded—I admit that the language employed in the academy’s letter sounds rather disturbing. For example, it uses words such as “exploiting”, “explosive”, “market pull” and “technology push” and “commercialisation and industrialisation”. The Royal Academy of Engineering’s report also focuses on commercialisation to the apparent exclusion of ethical discussion, apart from a glancing reference to consumer choices in clothing.
Reference has been made in your Lordships’ House to earlier debates on the 1990 legislation, the establishment of the Human Fertilisation and Embryology Authority and the use of mitochondria. It is important to say in the context of such debates that we should not tantalise or raise expectations unduly. During our debates in your Lordships’ House on mitochondrial replacement, we were told that there would be cures and that they would be imminent. What progress has been made on clinical use since the licences were granted by the HFEA? It is an interesting precedent in the context of today’s debate.
One of my last contributions as a Member in another place before standing down was in a debate on genetics and embryology. I said:
“Legislation cannot be value-free or ethically neutral. A dirigiste or disinterested approach—marketplace genetics—simply would not do.”—[Official Report, Commons, 19/7/1996; col. 1444.]
So I cheered when, in December 2018, the World Health Organization established an expert panel to develop global standards for the governance and oversight of human genome editing. Its consultation closes on 7 February.
A year ago, in an article in Nature magazine, 18 scientists and ethicists from seven different countries called for
“a global moratorium on all clinical uses of human germline editing—that is, changing heritable DNA (in sperm, eggs or embryos) to make genetically modified children.”
My noble friend Lord Patel referred to this point earlier; I endorse entirely his call for a global moratorium for at least a five-year period. The scientists warned against using tantalising arguments to justify the risks and pointed to unknown dangers, including attempts to correct or modify susceptibility to one disease and unwittingly opening the way to another. They said:
“It will be much harder to predict the effects of completely new genetic instructions—let alone how multiple modifications will interact when they co-occur in future generations. Attempting to reshape the species on the basis of our current state of knowledge would be hubris.”
They warned of
“marketing pressure to enhance their children.”
“Genetic enhancement could even divide humans into subspecies.”
They said that implications for
“future generations could have permanent and possibly harmful effects on the species.”
Very significantly, Jennifer Doudna, one of the two scientists jointly responsible for CRISPR-Cas9 gene editing technology, is cautious about its use in humans and calls for prudence. Her co-discoverer and co-inventor, Emmanuelle Charpentier, has far stronger reservations. She urges us to look for alternative approaches and, along with her colleagues, says that
“germline editing is not yet safe or effective enough to justify any use in the clinic.”
She says that, even with experience, study and future research,
“substantial uncertainty would probably remain.”
Against this background, around 30 countries currently have legislation that directly or indirectly bars all clinical uses of germline editing. Although a regulatory approach, which has been referred to, and an international treaty—perhaps mirroring those on chemical and biological weapons—is what I prefer, I recognise the challenge of securing such international agreement. Of course, UNESCO signally failed to create a legally binding convention outlawing human cloning.
However, we should at least attempt to secure voluntary pledges to prohibit the clinical use of human germline editing while a moratorium is in place. I like others’ suggestion of a global genome editing observatory to track developments and foster widespread debate. I welcome the Minister’s response to that proposal.
The urgency of tackling the wild west of marketplace genetics was illustrated by the way in which, in late 2018, the Chinese biophysicist. He Jiankui ignored ethical and scientific norms in creating the twins Lulu and Nana, who were referred to earlier. His use of gene editing on embryos was not a correction of any existing disorder but an attempt to immunise the twins against HIV—an attempt at enhancement that appears to have introduced novel mutations. On 4 December, the Guardian warned:
“China gene-edited baby experiment ‘may have created unintended mutations’.”
Initial approbation turned to condemnation; as we know, He Jiankui is now in jail.
The Chinese Academy of Sciences is to be commended for its robust and unequivocal condemnation of He’s activities, which, it said, represent
“a gross violation of both the Chinese regulations and the consensus reached by the international science community. We strongly condemn their actions as extremely irresponsible, both scientifically and ethically.”
I hope that the logic of that argument will be extended when we look at issues such as DNA profiling and, although it is wider than today’s debate, when we think about the million Uighurs incarcerated in Xinjiang, all of whom have had their DNA profiled. I wrote to the Minister about this; although it is outside the scope of today’s debate, I hope that he will reply to my points and place a copy of that correspondence in the Library.
As the noble Lord, Lord Winston, reminded us, this is a week in which we commemorate terrible events. In December 1946, the so-called Doctors Trial opened the eyes of the world to the way in which medics and scientists had committed appalling and vile crimes against humanity. It must always be our objective to ensure that good science and good ethics march hand in hand and always go together.
My Lords, like other noble Lords, I will talk mainly about gene editing as it relates to human reproduction, which is a highly contentious issue at present.
The UK recently completed a project to map the genomes of 100,000 individuals. When an individual’s genome has been mapped, therapies can be tailored to address their personal ailments, including cancers. An individual’s genetic information can serve to identify the precise nature of the cancer, then the cancer can be treated by means that are more subtle and less invasive than the surgery, chemotherapy and radiotherapy on which we have depended hitherto. In mapping an individual genome, one can also discover whether an individual is a carrier of a pathological recessive gene, such as those that give rise to cystic fibrosis, muscular dystrophy or sickle cell anaemia.
There is detailed genetic knowledge of many monogenic disorders. In such cases, gene editing might serve to alleviate the disease and prevent it being transmitted to future generations. Genetic editing, which is the topic of this debate, denotes the introduction of new genetic elements into organisms. It has been pursued in the laboratory since the 1970s, with plants and animals as the subjects. Hitherto, the major drawback of this technology has been the random way in which the DNA is inserted into the host’s genome. This can impair or alter other genes within the organism, which has disbarred its widespread use in humans.
Recent advances have meant that gene therapy can now be targeted more precisely. Among the novel techniques is CRISPR gene editing, which is based on a modified version of a bacterial antiviral defence system. This method allows DNA to be cut at a specific location, which is identified by the code incorporated in the Cas9 enzyme, which does the cutting. Then, the repair mechanisms of the cell can be relied on to mend the break and, at the same time, incorporate a DNA snippet or plasmid that has been introduced in the company of the Cas9 enzyme.
As we have heard, there are two types of gene therapy. In somatic cell gene therapy, the therapeutic genes are transferred into any cell other than a germ cell, which excludes sperm and egg cells. Such modifications affect the individual patient only, and are not inherited by offspring. In germline gene therapy, germ cells are modified by introducing functional genes into their DNA. The change will be passed on to subsequent generations.
Australia, Canada, Germany, Israel, Switzerland and the Netherlands prohibit human germline gene therapy. The techniques are regarded as unsafe and it is maintained that there is insufficient knowledge of the risks to future generations. The US, by contrast, has no controls regarding human genetic modification beyond the regulations that apply to therapies in general.
We need to consider whether the denial of germline therapy is a significant impediment to the application of genetic technology for the betterment of human welfare. For this, we need to look at some examples. We may begin by considering the case of a recessive gene such as sickle cell anaemia. Genetic editing might be used to eliminate the genes from the germline of a procreating couple, each of which contains a single copy of the gene. In normal circumstances, there would be a one in four chance that any offspring would inherit two copies of the faulty gene from the parents. This is a consideration that might encourage the couple to remain childless. However, there are several other recourses that are more obvious and familiar than gene therapy.
The parents might, for example, use in vitro fertilization to produce several embryos. After a few rounds of cell division, the cells of the embryos could be subjected to a biopsy. If any of them were found to be free of the faulty gene, it could be implanted in the mother. This recourse is described, as we have heard, as pre-implantation genetic diagnosis. Another recourse would be to use the sperm of a donor who has been shown to be free of the pathological gene. This would ensure that the offspring could not be afflicted by the disease, and that at most, they would inherit only a single copy of the recessive gene. Another possibility is an embryo donation to the mother using the ovum of a third party. The final recourse, which seems eminently practical and desirable, would be the adoption of a child.
Gene editing could in principle be used to the same end as pre-implantation genetic diagnosis. It would be possible to use techniques to correct, within the human embryos, the mutant beta-globin gene associated with sickle cell anaemia. The treated embryos would be grown in vitro and subjected to genetic sequencing to allow the selection of those in which the desired modification had been achieved, and one or more of them could be implanted. However, there seems to be no advantage in such a rigmarole in the case that we are considering.
A stronger case could be made for gene-edited conception where both parents have two copies of the recessive mutant gene. Another instance in which gene editing might be justifiable is where one of the parents contains two copies of a dominant pathological gene which is bound to be inherited, with ill effects, by any offspring. Sometimes, the affliction will be so severe that the individual is unlikely to procreate. However, some genetic diseases such as Huntington’s disease are not manifested soon enough to become obstacles to procreation.
Another theoretical possibility is to apply gene-editing techniques to the gametes—that is, the egg and sperm cells—instead of to the already-formed embryos. To my uncertain knowledge, albeit that I have been informed by the noble Viscount, Lord Ridley, on this matter, this is not part of the current repertory. However, there could be no avoidance of the need for a biopsy of the resulting embryos.
I have now learned something. However, we must now ask where this leaves us. The first point to be made is that the existing methods of gene editing are of insufficient accuracy to be used in human reproduction without the accompaniment of a rigorous pre-implantation genetic diagnosis. In such circumstances, they have no advantage over the existing methods of embryo cultivation and implantation, provided that there is a possibility of selecting a disease-free embryo.
A word should also be said about the eugenic fantasies that have accompanied the publicity surrounding recent advances in gene editing, notably the CRISPR technique. It has been suggested that they have created the prospect of breeding humans endowed with superior qualities of athleticism, brain power or other desirable traits. I believe that such fantasies can be dismissed. Notwithstanding the example given to us by the noble Lord, Lord Moynihan, the human qualities in question are the consequence of multiple genetic endowments. They are also affected by environmental and epigenetic influences, and such determinants are way beyond the reach of gene-editing techniques.
Finally, one is struck by the thought that the Cas-9 enzyme could be devoted to its original purpose, which is to defeat vital infections. Also, the bacteriophages against which it is naturally directed could be employed as substitutes for the human antibiotics whose efficacy is very rapidly declining.
My Lords, I thank the noble Baroness, Lady Bakewell, for introducing this debate with her usual clarity and for the extraordinarily powerful speeches that we have heard from noble Lords on all Benches, to which I have listened with great attention and interest.
In the past, I have had the huge privilege of being a member of both the HFEA and the Nuffield Council on Bioethics, and any contribution that I can possibly make to this debate is almost entirely indebted to that experience and what I learnt when I was a member of them. What first came out of my membership of the HFEA was a huge admiration for those working in the field of medical research. It is painstaking and exacting work, which I am sure the noble Lord, Lord Winston, can emphasise much better than me that for long periods can yield only disappointing results. Of course the results in recent years have been quite startling, as many of your Lordships have pointed out, so I will not repeat them.
The creative intelligence of the human mind in its capacity to discover and develop new forms of treatment for illness is a truly remarkable feature of what it is to be a human being, and a gift from the giver of all good things. Moreover, the Bible, if I am allowed to mention it, makes it clear that illness and disease are contrary to the will of the creator. They may for the moment be an inescapable part of being alive at all, but we are called on to alleviate pain and to cure illness whenever it is in our power to do so. It is remarkable how much in the Gospels is given over to stories of Jesus healing people. Using all our human ingenuity to overcome disease is not just what we want to do in our own interests as decent human beings, but from a Christian point of view it is co-operating with the work of a good creator.
All this may seem very obvious but it needs to be said because as we know, sometimes we hear accusations, particularly in the field of genome editing, that human beings have started to “play God”. It is not playing God, as the noble Lord, Lord Winston, emphasised, rather it is using our God-given gifts in the way they are meant to be used. According to the three great monotheistic religions of the world, we are made in the image of God. We are rational, creative beings able, within limits, to shape our human lives for betterment of our health and well-being.
That said, as all noble Lords have made quite clear, the cutting edge work now being done needs to be set firmly within an ethical framework. Every country in the world recognises this, including China, which recently took dramatic action to jail that maverick scientist. Within the overall framework of UK and European law, every research proposal now has to be approved by the appropriate research ethics committee. Furthermore, as we know, if it involves gametes, it needs to be licensed by the HFEA.
In relation specifically to genome editing, the Nuffield Council of Bioethics report of 2016 set out some important ethical considerations which it would be well worth continuing to take into account. That report was followed by another in 2018 that was specifically concerned with editing the genome of embryos, eggs or sperm; in other words, changing the genome not just of a particular individual, but for the benefit of future generations. This is allowed for research purposes if it is properly licensed by the HFEA, but it is not allowed in the UK for clinical application.
The Nuffield committee argued that it could perhaps be morally permissible on a case-by-case basis, provided that certain measures were first put in place. These are that there has been a sufficient opportunity for broad and inclusive public debate about its use and possible implications; that further research has already been carried out or needs to be carried out to establish standards of clinical safety; that the risks of adverse effects for individuals, groups and society as a whole have been appropriately assessed, and that measures are in place to monitor and review these. It adds that if it were ever to be permitted, it should be strictly regulated by the HFEA in the UK, introduced only in the context of a clinical study with monitoring of the long-term effects on individuals and groups, and that it should be licensed on a case-by-case basis. The two key ethical principles which have emerged time and again in this debate are that, first, they must be intended to secure and be consistent with the welfare of the future person; and secondly, that they should not increase disadvantage, discrimination or division in society as a whole. As we know, Huntington’s disease—with its devastating effects—is just one very obvious example where such a treatment would, if successful, be of immense benefit.
As we have heard, in principle it might prove possible not just to prevent a particular disease but for parents to have the genome of their offspring edited to enhance certain qualities. Suppose parents wanted their children to grow up muscular, clever, with blue eyes or whatever. That would potentially put those who pay for such editing in a position that might increase disadvantage, discrimination and division in society generally. The scientific community is quite rightly very cautious about the possibility of genes being used to enhance certain qualities.
In the light of these concerns, the council recommended, first, that there should be a widespread public debate—perhaps initiated by a government body—and, secondly, that without waiting for the report of such a debate, the Secretary of State for Health and Social Care should give consideration to bringing within the scope of licensing any heritable genome-editing interventions that currently fall outside its scope.
In the light of this debate, is there scope for a new House of Lords Select Committee—or, as I believe we are now meant to call them, an ad hoc committee—to deal with some of these issues? Some years ago we had a Select Committee for embryo research, which I had the privilege of chairing, with many distinguished scientists and philosophers who remain Members of the House.
I have two questions. First, in relation to somatic genome editing, is the present regulatory framework adequate or do we need something more overarching? Secondly, in relation to germline genome editing, should there be a moratorium or should it be licensed and strictly regulated? In this House there is clearly the strong view that there should be an absolute moratorium. The point is that this debate is not going away, and it would be very useful to have an authoritative body—a Select Committee from this House—to look at it very seriously and come up with a recommendation, either that there should be a moratorium or perhaps that it might be licensed by the HFEA on a case-by-case basis. I hope the Minister and his department will think seriously about the possibility of an appropriate committee.
My Lords, it is an honour to follow such a clear and persuasive speech by the noble and right reverend Lord, Lord Harries, with whom I fully agree. Like others, I congratulate the noble Baroness, Lady Bakewell, on securing this debate. Its title does not include the word “human”, so I will focus my remarks on genome editing in agriculture and the environment. I had a hunch that greater medical and ethical minds than mine would have addressed the human aspect by the time I stood up.
In contrast to the human case, it is absolutely vital that the UK Government signal their encouragement of genome editing in agriculture this afternoon. There is no clearer case of a technology in which we could and should take the lead, but in which we are and will be held back if we do not break free from the EU approach. That would be not a race to the bottom but the very opposite: a race to the top. For example, if we allowed the genome-edited blight-resistant potatoes developed at the Sainsbury Laboratory to be grown here in the UK, we would be able to greatly reduce the spraying of fungicides on potato fields, which happens up to 15 times a year, harming biodiversity and causing lots of emissions from tractors. That would be an improvement, not a regression, in environmental terms.
Although we have heard the Prime Minister champion this technology, we have not heard nearly enough from other Ministers so far. The technology has enormous potential to do good and less possibility of doing harm than the existing technologies it would replace.
The private sector is not in a position to champion genome editing in agriculture, because the private sector effectively does not exist in this space. Twenty years ago there were 480 full-time equivalent PhD-level jobs in agricultural biotechnology in the private sector in this country. Today there are 10. That is what has happened to that whole sector in this country. Until politicians signal a sea change, the private sector will shun the UK’s wonderful labs and the breakthroughs will be applied overseas, if at all.
In that context, let us not forget that—as others have suggested—Britain has a truly extraordinary record in biology, far above any other country’s and far more dramatic than in physics and chemistry. Here is a short list of the things that were discovered, invented or developed first on these damp little islands with 1% of the world population: the circulation of the blood, evolution by natural selection, antibiotics, the structure of DNA, DNA sequencing, the first test-tube baby, DNA fingerprinting, the first cloned mammal. I could go on.
Genome editing is an alarming exception. The early work is the result of work done in Spain, France, Japan, Holland, Finland and America, with not a Brit in sight. We are playing catch-up, but are well placed to get back in the lead if we only have the right encouragement. Here is another shocking statistic: last year three French scientists reviewed the patenting of CRISPR products in agriculture and found that, whereas America had taken out 872 patent families and China 858, the EU had taken out only 194. The gap is growing.
The July 2018 ruling by the European Court of Justice, in defiance of clear advice from its Advocate-General, was a disaster. It meant that genome-edited plants and animals are subject to the draconian, interminable and reputation-poisoning regulations that have killed genetic modification in Europe, despite its manifest environmental benefits. It also made no sense. The objection to GMOs was always that they include foreign genetic material. That is not true of genome editing. In many cases, it is impossible to distinguish a genome-edited variety from a conventionally bred variety with the same trait. Stefan Jansson from Umeå University in Sweden put it like this:
“Common sense and scientific logic says that it is impossible to have two identical plants where growth of one is, in reality, forbidden while the other can be grown with no restrictions; how would a court be able to decide if the cultivation was a crime or not?”
America sensibly went the other way, regulating the technology not by the method used but by the trait expressed. If you can make a potato resistant to blight, what matters is: is the potato safe, whether it was made by conventional breeding, gamma-ray mutagenesis or genome editing? In the EU, if you made this potato by gamma-ray mutagenesis, scrambling its DNA at random in a nuclear reactor, the regulations would say: “No problem. Go ahead and plant it; no regulations.” If you made it by the far more precise method of genome editing, in which you know exactly what you have done and have confined your activities to one tiny bit of DNA, you are plunged into a Kafkaesque maze of regulatory indecision and expense from which you will likely never emerge.
We need to hear from the Government that they will switch to regulating biotechnology by trait, not by method. The Science and Technology Committee, on which I sit, recommended this a few years back. It is a matter not just of environmental benefits but of animal welfare. In 2017, scientists at the Roslin Institute near Edinburgh announced that they had genome-edited pigs to protect them against a virus called porcine reproductive and respiratory syndrome, PRRS. They used CRISPR to cut out a short section from the gene that made the protein which gave the virus access to the cell, thus denying the virus entry. They did this without altering the function of the protein, so the animal grew up to be normal in every way except that it was immune to the disease. This means less vaccination, medication and suffering. What is not to like? But commercialising that animal in the UK is currently all but impossible.
Looking further ahead, the same scientists at the Roslin are now looking into how to control grey squirrels not by killing them, as we do now, but by using genome editing to spread infertility infectiously through the population, so that the population slowly declines while squirrels live happily into old age. This technique, called gene drive, will transform the practice of conservation all around the world, especially the control of invasive alien species—the single greatest cause of extinction among birds and mammals today. For those who worry that gene drive might run riot, it will be designed to last for a certain number of generations, not forever.
Looking even further into the future, genome editing will one day allow the de-extinction of the great auk and the passenger pigeon. To achieve this, we need to take four steps: to sequence the DNA of an extinct species, which we have done in the case of the great auk; to edit the genome of a closely related species in the lab, which is not yet possible but will not be far off with genome editing techniques; to turn a cell into an adult animal, which is difficult, but possible through primordial germ cell transfer, again pioneered at the Roslin Institute; and to train the adults for living in the wild, which is hard but possible.
If we do gene editing in Britain we will cure some cancers, improve animal welfare, encourage biodiversity and bring back the red squirrel. If we do not, then China and America, Japan and Argentina will still push ahead with this technology and will follow their own priorities, leaving us as supplicants to get the technology second-hand.
My Lords, I join many others in thanking the noble Baroness, Lady Bakewell, for initiating this important debate and for her very clear and informative introduction. I apologise for missing the first few seconds of it.
I also want to focus not on the medical issues but on the use of gene editing in crops, domestic animals and wild populations. In this I am indeed following the lead of the noble Viscount, Lord Ridley, although he might take it as given that my views are 180 degrees opposite from virtually everything he just said.
I will address this subject from three aspects. The first concerns the very sad fact that we will be leaving the EU on Friday night. We have seen the collective efforts of the European Union, together struggling for 30 years with this fast-moving field of endeavour. We saw 10 years of uncertainty until the European Court of Justice ruled in 2018 that directed mutagenesis techniques such as CRISPR, which we have been discussing, are to be considered GMOs under the EU’s GMO directive. However, it is important to point out some misinformation. The EU does not have a ban on GMOs. Around 70 authorised food and animal feed products come into the EU. That means thousands of tonnes of animal feed, soybean, rapeseed and maize. For the EU and for us, a safety assessment needs to be updated regarding the latest understanding of these imports, particularly on stacked events, where we might see interaction between the genetic modifications.
In the EU we currently have mandatory labelling and tracing that enables the public to know what they are eating and what they are getting. There is very strong evidence that that is what the public want and it is something we very much want to keep. Research is also allowed in the EU—I expect it will continue in the UK—provided there is no risk of contamination in the outside environment. We had a long debate about dynamic alignment. It is worth thinking about the fact that, from Saturday morning, we will share a land border with the EU. It will be very interested in what we are doing, because our decisions about genetic editing will almost inevitably end up affecting the EU.
The second area I want to address is the fact that gene editing can have unintended effects—and intended effects—that go much further than anyone thought they would: gene combinations, results and biological ramifications that were not intended. They can be significantly different from those produced by conventional breeding, including random mutagenesis. We need to have clear, close and tight oversight.
The noble Lords, Lord Alton and Lord Winston, made very powerful speeches reflecting on the interaction of science, politics, economics and society, and how those interactions can be deeply and horrendously toxic. On a perhaps lesser scale, the noble Viscount, Lord Ridley, spoke about ensuring that pigs do not catch a particular disease. Maybe that means that people will think they can house pigs much more closely together, in far more crowded conditions. What will be the animal welfare ramifications of that?
The noble Viscount also referred to gene drives—possibly some of the most frightening aspects of potential gene editing, and which are being widely explored in the laboratory at the moment. They are intended to achieve permanent genetic changes to the make-up of wild populations of animals and plants. It means that you release something that you cannot then call back. I guess I should declare my Australian origins here and say that we have very close and intimate understanding of what the release of the cane toad did and continues to do to Australian ecological systems. It was released and cannot be controlled.
For noble Lords who are interested in this area, I make specific reference to a recent report known as RAGES—Risk Assessment of Genetically Engineered Organisms in the EU and Switzerland—which came out last year. Although the noble Viscount suggested that EU regulations were far too tight, the report concludes that they are not nearly tight enough. It concludes that the European Food Safety Authority’s GMO panel’s
“implicit and unaccountable risk assessment policies … indicate that those assessments are far more likely to underestimate the range and severity of possible adverse effects, rather than to overestimate them.”
My third point is the question of how we approach the world and our management of it. Genetic editing, pretty well by definition, involves a silver-bullet solution: you address one aspect of one thing. That ignores the complexity. People say that if we modify just this one gene in wheat, it will become more drought resistant and then we will solve hunger. Problems of hunger, food security and the unhealthiness of our diet are not innately biological problems, but ones of society, poverty and our food system. The idea that you can take one step with one gene and make a huge difference to that is, I argue, entirely false.
I am very pleased to say to the Minister that we are now hearing from the Government about agri-ecological approaches in the Agriculture Bill. This is the alternative way to look at how we solve the huge problems we face with food security and hunger. The Government are focusing on the health of soils. These are the kinds of approaches we need to take, rather than simple silver-bullet solutions.
We also know that a huge percentage of the world’s food is produced by small farmers. Patented and costly tools produced by gene-editing technology are not the solutions to their problems. We know how fragile these apparent solutions can be when we look at the spread of herbicide resistance in weeds around genetically modified crops.
I conclude by reflecting on how complex human health and biology are. I have a personal interest in the human microbiome, some recent research into which has been looking at bacteriophages that live—I apologise to any noble Lord who is about to eat lunch—in your gut. The bacteria in your gut mostly exist as inactive prophages. Depending on the food you eat for lunch, they might be activated and that will change your microbiome.
This is complex and we have to tread very carefully. I stress that this is not an argument for doing nothing; it is an argument very much for science, research and caution. Things can be done, as we have recently seen with mitochondrial donation. We can make progress, but very cautiously.
My Lords, I congratulate the noble Baroness, Lady Bakewell, on securing this important and timely debate on developments in gene editing. She set the scene to allow the widest of debates. I think we can all agree that we have had an extraordinary, wide debate.
The noble Lord, Lord Patel, said that our genes are part of our humanity, yet we cannot stop science. There is much to be done to make it safe and effective. The noble Baroness, Lady Bakewell, the right reverend Prelate the Bishop of Carlisle, the noble Lord, Lord Alton, and the noble and right reverend Lord, Lord Harries, talked about the ethical and social justice issues that must be considered alongside scientific advance if we are not to slip into eugenics. I always learn so much from the contributions of the noble Lord, Lord Winston, and his outstanding speech summed up the dilemma very well as eugenics versus “a reasonable individual intervention”, which encapsulates the moral dilemma we have been discussing. The noble Viscount, Lord Hanworth, reinforced the need for a careful public debate and for clear regulation. The excellent speech by the noble Lord, Lord Moynihan, reminded us that athletes are always under pressure to find that extra advantage. I think many of us agreed that there is no place for gene editing in competitive sport. The noble Viscount, Lord Ridley, and the noble Baroness, Lady Bennett, rightly reminded us that we need to include agriculture and the environment in our debate—equally thorny issues to get right. Current parameters and frameworks should be reviewed and updated as science improves and takes us forward.
From the Liberal Democrat Benches, we echo many of the concerns about social and health injustices—for example, developing genetic techniques that might improve an embryo so that the child has enhanced intelligence, a longer life and so on. If that is available only to the wealthy, or in wealthy countries, how do we ensure that those not so enhanced are not at a permanent disadvantage that cannot be rectified? This is not fantasy. We know that when in vitro fertilisation became available, some communities used it to choose the gender of their child. We must guard against that.
I want to talk about genome editing and children with rare diseases. I thank the Library, the Francis Crick Institute, the Progress Educational Trust and, especially, Together for Short Lives and Great Ormond Street Hospital, for their excellent briefings.
Over 70% of rare diseases have an underlying genetic cause, and most, including all childhood cancers, present in childhood. Inevitably, our children and young people are disproportionately affected. These diseases are serious: one-third of children with a rare disease will not live to see their fifth birthday.
Treating rare diseases has been extraordinarily tough. It has been about the management of symptoms, often with severe side-effects that are hard for small children to understand and tolerate. There are some curative treatments, such as bone marrow transplants, but they rely on donors, and children must live with the risk of tissue rejection. As these children grow older, their symptoms may worsen, with many not surviving. The exceptional developments in genome editing and research, which noble Lords have already spoken about with such eloquence, can transform the lives of children with rare diseases. Genetic diagnosis can be achieved before symptoms begin to show. Early intervention to correct the genetic error could provide a long-term barrier to disease, sparing children from developing debilitating symptoms and suffering cumulative, irreversible damage to their bodies. Unlike treatments such as bone marrow transplants, the patient’s own cells can be modified, making the treatment perfectly matched, with no risk of rejection.
However, rare diseases that individually affect very small numbers, but collectively might affect millions, can struggle to attract research funding. Genome-editing technologies can be applied across a broad range of diseases and may therefore be more likely to attract funding. They can be adapted and applied to benefit isolated patient populations, but there is still a risk. The 100,000 Genomes project, delivered by Genomics England, a company owned and funded by the Department of Health and Social Care, was established in 2012 to sequence the 100,000 genomes from NHS patients affected by a rare disease or cancer. In December 2018, the project ended when the 100,000th sequence was achieved. The Health and Social Care Secretary, Matt Hancock, announced
“an ambition to sequence five million genomes in the UK over the next five years.”
In November 2019, Mr Hancock also confirmed his ambition to see all children receive whole genome sequencing at birth, saying that tests would be routinely offered to map out the risk of genetic diseases and offer predictive, personalised care. Today we have heard concerns about how this would operate without a clear moral and legalistic framework. What progress have the Government have made in achieving the Secretary of State’s ambition that all children should receive whole genome sequencing at birth? What assessment has the Minister made of the extent to which mapping genetic diseases can offer personalised palliative care for children with life-limiting and life-threatening conditions?
In July 2018, the noble Baroness, Lady Blackwood, spoke at the British Paediatric Surveillance Unit’s rare disease summer tea party. She said that
“seriously ill children who are likely to have a rare genetic disorder will be offered whole genome sequencing under the GMS.”
To continue cementing the UK as a world leader in genomics, in February 2019 she announced that the Government were
“developing a UK genomics healthcare strategy. I’m very pleased to say that the work is well underway, and the strategy will provide a clear, national vision, setting out how the genomics community can work together to make the UK the global leader in genomic healthcare.”
She went on:
“The strategy will be ready for publication this autumn, so watch this space.”
That is now last autumn. Can the Minister tell us how many seriously ill children who are likely to have a rare genetic disorder have been offered whole genome sequencing under the NHS Genomics Medicine Service? When does she expect the Government to complete the UK genomics healthcare strategy?
For rare diseases, genetic understanding is the key to getting this right. Our scientists and clinicians need infrastructure, technologies and collaboration. To develop effective gene-editing approaches, the UK must advance understanding of what, how and when genetic changes occur in a child’s development and how they cause disease. This will help to diagnose problems more quickly and accurately, and to understand which treatments are most likely to work for each child. Clinicians will be better able to predict the risk of genetic diseases and their progression, and to develop treatments such as genome editing, to eradicate these diseases.
Two years ago, Great Ormond Street Hospital became one of seven genomic laboratory hubs commissioned by the NHS to deliver the nation’s genomic sequencing. The initiative builds on the 100,000 Genomes project, in which the hospital played a leading role, as well as rapid genome sequencing techniques developed there that read an entire genetic sequence in a matter of days. This approach will underpin the development of gene-editing approaches.
The Zayed Centre for Research into Rare Disease in Children, based in Great Ormond Street, opened last year. It is the world’s first purpose-built centre dedicated to paediatric research into rare diseases. It has a six-room suite that adheres to strict requirements to manufacture therapeutic, gene-edited cells which can then be returned to patients. Facilities with this capability are extremely rare; there are no comparable labs elsewhere in the UK at present.
None of this will be achieved without proper long-term funding of research. The UK’s leading role in the European Union’s Horizon 2020 project must necessarily come to an end tomorrow, as we leave the EU. It is worth noting that in Horizon 2020, we contributed £3 billion and received £5 billion back in research grants. Because we lead research in many areas, we have been net beneficiaries. Can the Minister confirm that funding and research for genome sequencing will continue at least at the same level, to ensure that we continue to lead the world in genome research?
I close with a personal example. A family I have been working with for the last five years had a child with a rare disease that was undiagnosed. He died 18 months ago, aged 10, having been treated at Great Ormond Street Hospital. Just after he was born, he had his first gene test, but the cause of his multiple and profound problems could not be found. Just before he died, the hospital asked his mother if it could take another sample, as genetic testing had clearly moved on a great deal. This week, it identified the disease, which is extremely rare. Most children, if they survive the first three months, die within three years. Their son is an example to look at in the future, when caring for children born with this disease. The family are very proud.
My Lords, like all other noble Lords, I thank my noble friend Lady Bakewell for securing this debate. From listening to today’s thoughtful contributions and my own preparation, it is clear that the 2020s and beyond could be touted as the decade for genome editing.
When I was studying for my O-level in biology at the Ardrossan Academy in the mid-1980s, I remember thinking whether I would ever in later life need to know about deoxyribonucleic acid and the building blocks of adenine, cytosine, guanine and thiamine and how their pairing created a double helix of DNA. I now know that it was of great use.
This year’s Wolf Prize in Medicine was awarded to, as we heard earlier, Professors Jennifer Doudna and Emmanuelle Charpentier for their discovery of the gene-editing tool CRISPR-Cas9. The Wolf Foundation stated:
“This transformative technology has the potential to … revolutionize the fields of genetics, molecular biology and medicine.”
By acting as molecular scissors, CRISPR allows scientists to tweak, change or remove genes at a specific location. Doudna said:
“Over the next decade, researchers will continue to advance the use of CRISPR … to treat and in some cases cure diseases, develop more nutritious crops, and eradicate infectious disease.”
Obviously, this is an exciting time for those working in this field but, as noble Lords have mentioned, consideration must be given to the oversight of this science to protect people and society from any possible negative and unintended consequences. As Doudna stressed:
“We must work to ensure that the technology is responsibly applied to allow it to reach its potential and benefit millions”.
The process of genome editing can, as we have heard, lead to biological, medical and environmental benefits. This technology has the potential to help, treat and prevent human diseases. Illnesses such as heart disease and Alzheimer’s could be cured through genome editing. It also has the potential to deal with hereditary diseases.
This technology has also been trialled on food to determine whether it can help farming and crop resilience. Genome editing can, potentially, significantly improve the UK’s environmental footprint. The Commons Health Select Committee stated that the Government should
“require UK Research and Innovation to closely monitor the development of genome editing for potential obstacles to innovation”.
Can the Minister explain what steps the UKRI has taken to follow these recommendations?
In agriculture, genetic editing is seen by some as the answer to farming sustainability and crop resilience. The World Resources Institute has said that genetic modification is the key to feeding a growing global population in the face of warmer weather and scarcer water supplies. However, the effects of human interventions are not always predictable and food standards could be threatened. Like many other noble Lords who received it, I found that the National Pig Association’s briefing raised some interesting points in relation to this issue. It stated:
“We do not see this technology being the sole solution to the efficiency of pig production in the UK, but we recognise that it will be an important part of the solution.”
We all know that the US has a more relaxed approach to GM food and, although on a slightly different track, Professors Erik Millstone and Tim Lang have said that accepting products such as hormone-treated beef would be an “unnecessary and unacceptable risk” just to secure a future trade deal. Can the Minister outline the Government’s thinking on GM food in relation to any future trade deals?
The Prime Minister has called for the bioscience sector to be liberated from the rules against GMOs, as we heard from the noble Viscount, Lord Ridley, and the Conservative Party’s manifesto stated that it would implement science-led policy to improve the quality of food, agriculture and land management. Science-led, yes, but where do ethics and moral issues sit within that?
Clearly, this is one area in which the Government want to go it alone after Brexit, but it is not enough just to give the green light from No 10. We need a strong regulatory framework for this science to be ethically and commercially available. I agree with my noble friend Lord Winston that regulation alone is not enough; scientific co-operation will also be necessary.
So, as much as the benefits of genome editing could be of great help to many of us, the Government need to ensure they do not get ahead of themselves and consider all factors in genome editing before they continue moving on these medical practices. As the noble Baroness, Lady Brinton, and the noble Lord, Lord Alton, mentioned, in 2019 the Secretary of State for Health and Social Care announced ambitions to see all children receive whole genome sequencing at birth. I agree with the right reverend Prelate the Bishop of Carlisle and the comments of the British Society for Genetic Medicine, who advised that this could prove to be problematic as
“the genetic code of a healthy newborn will only rarely predict future disease accurately”—
again, an issue touched on by my noble friend Lord Winston. The BSGM later stated:
“Such a venture therefore needs to be carefully researched, and the ethical and societal aspects require careful consideration before roll-out to the general population.”
As my noble friend Lady Bakewell mentioned in her introductory remarks, in July 2018 the Nuffield Council on Bioethics published findings from an independent inquiry on the social and ethical use of genomic editing in human reproduction. This inquiry concluded that genome editing could only be deemed ethically acceptable on humans if two principles are satisfied. The first principle is that the interventions are intended to secure, and are consistent with, the welfare of the newborn child who may be born consequently to this practice. The second principle is that these interventions would uphold the principle of social justice and should not provoke social division, or marginalise or disadvantage groups within society. Do the Government agree with these principles? If so, what have they done so far, and what will they continue to do, to ensure that these two vital principles are consistently met?
So, like my warning to my children when they were younger—do not run while holding scissors—I encourage the Government to do the same, even if those scissors are molecular scissors rather than tangible ones.
My Lords, like other noble Lords I start by thanking the noble Baroness, Lady Bakewell, for calling this important debate and for instigating a broad discussion of complex themes around genome editing that deserve detailed analysis. I have followed her written and spoken career and note her important debate at the Royal Society and her excellent Radio 4 “Inside the Ethics Committee” programmes around this subject. I also thank my noble friends who have spoken here with great passion and experience today for their contributions. They say that in the other place the Minister is the person who knows the most about any subject, but in this place the Minister knows the least about the subject. I have never felt that aphorism to be more true than today, and I commend noble Lords on their remarkable experience and wisdom. My noble friend Lady Bottomley put it very well: this Chamber is filled with experts who have had a part in every aspect of this debate over many decades, and for that I thank them.
I am not immersed in this subject, as some noble Lords are, but I declare an interest as I know something of the ambitions for genome editing through my work as a trustee of the Scar Free Foundation, a medical research charity, where we hope a breakthrough will improve those blighted by unsightly or painful scars. I pay tribute to my noble friend Lady Blackwood in the Department for Health and Social Care and my noble friend Lord Gardiner in the Department for Environment, Food and Rural Affairs and to all those across Whitehall, Westminster, academia and industry who engage in this fascinating and broad subject.
It would be incorrect for any of us to consider the use of genome editing as heralding some sort of panacea. None the less, the opportunities posed to us by genome editing are quite incredible, and the Government are committed to seizing the opportunity but, as several noble Lords made clear, our work must be rooted in ethics and controlled by regulation, and that is where I will begin.
The noble Baroness, Lady Bakewell, and the right reverend Prelate the Bishop of Carlisle set the scene very well. I recognise the deep concerns of several noble Lords. My purpose is to reassure the Chamber that the UK has a robust, evidence-based regulation regime that is under rolling review to adjust to developments as they happen. It is true that UK regulators have adopted a pro-innovation regulatory approach but, as noble Lords have made crystal clear, it must be strongly rooted in public dialogue and ethical discourse. The Government’s efforts have created a safe space for UK innovators to develop cutting-edge, disruptive products that will transform the lives of people in the UK. This regime must be committed to upholding ethical values, personal safety and public acceptability. We rigorously test public attitudes to polarising issues such as human enhancement and social justice, which were mentioned in this debate, through engagement with the public because it is not just the science that matters but what we as a society want to do with it.
To find the right balance, we have committed to engaging world-class academics and expert groups such as the Progress Educational Trust, the Nuffield Council on Bioethics, and the Wellcome Trust, which were mentioned by a number of noble Lords including the noble and right reverend Lord, Lord Harries, the noble Baronesses, Lady Bakewell and Lady Brinton, the right reverend Prelate the Bishop of Carlisle, and the self-confessed and unashamed gene editor, the noble Lord, Lord Winston.
We are fully aware of the challenges presented by this technology and the anxieties it raises among some people. In response to the question about leadership asked by my noble friend Lady Bottomley, I say that we embrace our leadership role where necessary in the EU, the World Health Organization and the numerous emerging forums on this hot subject. For instance, in the wake of the revelations of germline editing mentioned by several noble Lords, the UK joined our counterparts from the US national academies to bring together a consortium on ethics at the World Health Organization. This consortium is currently accepting evidence on this issue. The deadline is 6 February, so I urge all noble Lords who can contribute to hit that cut-off date.
In response to the noble Lord, Lord Alton, and others who asked about a global observatory, I can tell them that we look forward to the World Health Organization report and the prospect that it may lead to the rollout of a global observatory.
As a number of noble Lords, including the noble Baroness, Lady Bakewell, mentioned, what happened in China is completely illegal in the UK, but globally standards and regulations differ, which is a challenge when it comes to the pursuit of ethical science, so Britain must have a clear and definitive voice. That is why we have set up the Centre for Data Ethics and Innovation to get the balance right. As a result of this leadership, a safe place has been made in the UK to turn our country into a renowned hub for genome editing, allowing us to attract and nurture businesses.
The noble Lord, Lord Patel, spoke persuasively for a commission based on the consultation on mitochondrial disease and regulations amending the Human Fertilisation and Embryology Act 1990. The noble and right reverend Lord, Lord Harries, suggested a House of Lords Select Committee. These ideas are worthy of consideration by the Government, and we will look closely at them. However, I emphasise that the issues brought up by genome editing are very broad, not specific, and we are already engaged in considerable public and expert consultation.
If we get the ethical framework right, the opportunities are enormous. The noble Baroness, Lady Bakewell, mentioned Louise Brown, the first IVF baby. I have Elizabeth and Rosalie, my two IVF babies, and very beautiful and bouncing they are too. Their embryos were screened. I remember the moment well, and I remember the ethical conversation I had with my wife before we went ahead with that. I take seriously the comments of the noble Lord, Lord Winston, about the need for follow-up research. It is on the mind of parents such as me around the world.
As a number of noble Lords mentioned, there are opportunities for genome editing to create new types of medicines for tackling a range of conditions and improving the lives of patients. Who could not be moved by the story of David Sanchez in last week’s “Storyville” on the BBC? He is a charismatic young boy with sickle cell disease who described his wait for advances in genome editing that could mend the single-digit mistake in his DNA and save him from a painful affliction and an early death. The noble Viscount, Lord Hanworth, my noble friend Lady Bottomley and the noble Baroness, Lady Bakewell, mentioned rare diseases, and I was struck that up to 17% of the UK population may be affected by diseases such as Huntingdon’s. That is why we are so excited by advanced therapies. An example is CAR-T treatments. They are new, personalised, precision medicines that work by taking immune cells from a patient, reprogramming and using them to target cancers within the body. That excitement is why the NHS moved fast. It is the first health system in Europe to agree full access to CAR-T treatments. That was achieved through the fastest product approval in the NHS’s 70-year history.
We are ensuring that it is not only laboratory research to which the NHS has access. There are six licensed gene therapy products, including Kymriah, a cancer therapy, and Strimvelis, the bubble-baby therapy. More than 70 companies are developing advanced therapy medicinal products in the UK, such as Autolus, which looks at T-cell immunotherapy, and Oxford Biomedica, which looks at Parkinson’s disease. The noble Lord, Lord Patel, gave us an expert read-out on the progress of these sorts of initiatives. These businesses which productise research are exciting evidence of the success of our life sciences industrial strategy.
The noble Baroness, Lady Brinton, asked about the genetic screening of children. This is a huge subject, and I do not have time to delve into it in huge detail, but I reassure the House that the Government are starting with those with severe illnesses. Yesterday the Government announced that a pilot of exome sequencing would be extended to whole-gene screening and that we are hoping to process hundreds of cases a year, starting this year. The department is looking at ways of extending these trials dramatically.
The noble Baroness, Lady Brinton, also asked about palliative care. I reassure the House that the focus is very much on diagnostic and preventive opportunities, although there might be opportunities in pharmaco- genetics. She also asked about the genomics healthcare strategy. I reassure noble Lords that the aim is to have this published by the end of the year.
A number of noble Lords mentioned the economic opportunity presented by these medical advances. Advanced therapy companies already employ 3,000 people and that number is set to more than double by the end of 2024. Estimates are that this sector could be worth £10 billion a year to the UK by 2035.
A number of noble Lords mentioned government interventions. Since 2009, over £300 million of government investment has been committed to support commercial research and innovation in cell and gene therapies. Initiatives include the Cell and Gene Therapy Catapult and advanced therapy treatment centres. I shall give an example. As several noble Lords mentioned, the Medical Research Council is funding research into the earliest stages of human development. The team working on this research is based at the impressive Francis Crick Institute in King’s Cross—the first globally to embark on this sort of research. The work, which is ongoing, might help us better understand the development of embryos during pregnancy, and it is hoped that it will help to explain and prevent miscarriages.
An important point was raised by the noble Lords, Lord Patel and Lord Alton, and my noble friend Lord Moynihan. They suggested that it might be time for a moratorium on germline editing. I reassure the House that at present the researchers, the regulators and the Government are satisfied by the regulations as they are. However, the Government totally acknowledge that the Crick team’s research, and that of others in the future, might make suggestions for future reviews or a moratorium should the position change. The Government also acknowledge that those suggestions should be debated in Parliament and that they might lead to future regulation or legislation.
The tools of the fourth industrial revolution touch many sectors—too many to cover in this debate—but a number of noble Lords, including my noble friend Lord Ridley and the noble Baroness, Lady Bennett, mentioned agriculture. If the House will indulge me, I will take a brief moment to praise our fantastic British produce. It includes Welsh lamb and fantastic English wines that rival French champagne, and I need not remind the noble Lord, Lord McNicol, of spirits such as Scotch whisky which are renowned the world over.
As our climate changes, we may need to take steps to protect our food industry from warming temperatures or new pests and diseases. It is important that, should a time come where we need them, we have tools at our disposal and are sure that they will work. Genome editing and other technological advances can enable higher-yield varieties of staple crops so that we can feed our growing population or help our native varieties to withstand future conditions as our climate continues to warm.
As described by my noble friend Lord Ridley, the European Court of Justice has, regretfully, ruled that all genome-edited organisms should be treated as genetically modified. That is a shame. The Government feel that this ruling is neither scientific nor justified. As I have said previously, we would prefer a science-based, evidence-driven approach to regulation in this space, and we will revisit what regulations it might be appropriate to consider as the future landscape and our relations with the EU evolve in the coming years.
The Government are supportive of new applications for genome editing in other emerging fields that are too numerous to mention. However, I should like to refer to synthetic biology, which might allow us to make new medicines, fuels or other substances faster and more efficiently than ever before. For instance, we have seen the collaborative approach taken by government and industry in the development of the life sciences sector deals and the bioeconomy strategy. We have also seen groups such as the Synthetic Biology Leadership Council and a host of partnership programmes. The UK’s academic facilities in this exciting area of science are second to none, and they include the noble Baroness, Lady Bakewell’s very own BRIDGE Lab for genomic research at Birkbeck University.
The Government are proving their passion for science, having recently committed to double the science budget. I reassure the noble Baroness, Lady Brinton, that the manifesto at the last general election and the Prime Minister’s statement after his successful leadership election made very clear the Government’s long-standing commitment to budgets in this area. These will enable the best research to take place in the UK, create new jobs across the country and support sectors that are crucial to the UK economy.
By way of closing, I again thank the noble Baroness for proposing this debate. It has not been possible to answer all the questions, so I will endeavour to write. I am reminded that that includes writing to the noble Lord, Lord McNicol, on GM food and trade deals, and on UKTI’s work on identifying investments in innovation.
The noble Lord, Lord Alton, is entirely right. I shall be glad to write to him on DNA profiling. It is felt to be a little outside the scope of this debate but I will be glad to place such a letter in the Library, as requested. I thank each and every noble Lord who has spoken today for their contributions, and I look forward to this important subject being revisited in the future.
My Lords, when I proposed this debate, I knew that it would be a good one because, as the noble Baroness, Lady Bottomley, said, people in this House know stuff. It has been great to hear so many different points of view.
Speaking personally, it is rare to find myself in agreement with two bishops—an agreement that I wholly endorse. I have learned a great deal not only from the medical people here but about sport—perhaps, for me, the most surprising entry to this field of knowledge. I very much enjoyed and found interesting what turned out to be a spat about EU regulations between two of the speakers, but I suppose that we are all getting a little twitchy as we get towards the end of tomorrow.
It has also become clear that the dilemmas are proliferating—the moral dilemmas about children born with genetic diseases, the sport issues, which have not surfaced in my knowledge, and the Government’s ambitious plans for the genome sequencing of children. I think that there is a big issue around that that will be problematic.
Finally, I thank the Minister for his answers. He did not propose a strategy for making these issues more possible and more widely acknowledged by the public at large. I hope that that will happen some time soon. In the meantime, I thank him and all noble Lords for taking part.