Genetic Technology (Precision Breeding) Bill

Lord Winston Excerpts

2nd reading
Monday 21st November 2022 Lords Chamber

[Lord Winston (Lab)]

Well, it was a real pleasure to hear the Minister open this interesting debate, and we are very grateful for the way he has done it. This is a Bill whose importance we should not underestimate. Although the amounts of money the Minister declared were quite small, the actual commercial value of these technologies in the longer term is massive. He has carefully, and very reasonably, understated the potential advantages to the environment: in a world that is increasingly suffering from crop pests and drought, this is a very serious issue. It has been estimated that, across the world, one-fifth of all cereal crops is lost by processes during storage, so this is massive in terms of starvation. Anything that can be done to make plants resistant will therefore be very important. Clearly, plants and animals have different consequences, and that is one thing we will need to discuss in Committee.

In addition to drought resistance, I have listed a few other things I think are important. The fact that you can make better flowers and improve the appearance of plants sounds trivial, but it is none the less part of the marketing. Certainly, for economies such as Ecuador’s, it is probably one of the most important money-spinning exports. In addition, pathogen resistance generally will be very important. Making plants that have greater nutritional value or bigger fruit will certainly be hugely valuable to a lot of people. There is a whole range of other things we might come to during this debate, which I will not go into in great detail now.

The challenges, however, are quite considerable, and before I come to that I will mention my own experience with gene insertion, transfer and modification of various sorts in animals. My experience goes back as far as when I first visited Jon Gordon in New York, about 40 years ago, and saw the giant mice he was trying to make. At the time, that was almost one of the first possible mutations, and he was very proud of the fact that he had done this. I was amazed to see what he was doing down his microscope and thought, “I have to get into this technology myself”. I did not, really, because by that time I was already involved in in vitro fertilisation, which uses some of those technologies but not all.

What was surprising and horrifying was going down to the animal house with him afterwards and seeing the mutations he had not talked about, which had occurred as a result of the manipulation of gametes and embryos. There was no doubt that some of the animals were unexpectedly blind and had limb defects and a whole range of other things—skeletal defects of different sorts—as result of whatever it was: whether it was the DNA being inserted or the method of manipulation was not at all clear.

That has been a constant problem. In the early days, raw DNA was injected, and gametes and embryos have been soaked in DNA, from whatever source. We have made DNA, of course, using instruments, and various ways of incorporating DNA have been used, with greater efficiency. Until recently, the main way of doing this was using viruses that were piggybacked as a kind of Trojan horse into the nuclear DNA of the organism. Now, of course, we have CRISPR-Cas9. I wonder whether the Minister, when he sums up, might apply himself to how often that will be used, or whether it is involved in this legislation. To my mind, it is not entirely clear from the Bill what techniques will not be permitted. The idea of natural sources seems to be a bit blurred.

I know from our own experience of all kinds of gene expression, we get lots of surprises—it is variable. Certainly with CRISPR, although that is probably the most accurate targeting at the moment, we often do not get any kind of gene expression at all and sometimes we do not get insertion. It is well-known, as I am sure the Minister knows, that you occasionally get off-target mutations, which may cause problems to the organism, added to other abnormalities that are completely unexpected.

With any gene insertion or any kind of gene manipulation, there is a risk that in some species there will be different attitudes. There is an issue of whether or not the genetic modification that you want will be maintained and continue to be expressed in the way that you want. I see that multiple repeats will be allowed in the Bill, which may help to increase the amount of gene expression—I imagine that is why that was considered—but all these unfortunately quite technical issues are things that we will need to discuss in Committee.

Without going further, one of the clear issues as a result is that a lot of people will be concerned about the welfare of the animals. One might make large animals. The biggest animals that we have been involved with in my own laboratory have been pigs, which are pretty big, but some people have modified cattle as well, and that may be something that we need to discuss. We do not always treat our farm animals as well as we should, and in many parts of Europe there are very heavy-bred animals that I would have thought suffer considerably because of the breeding or interbreeding that is dictated. When I do any kind of animal research myself—I did it in the past but do not do much of it now, although my team still does—we have to have strict animal licences from the Home Office. I do not see anything of quite that calibre in the Bill, so maybe we need to look at that in Committee.

The issues for a lot of people will be, for both plants and animals, those of diversity. I remember clearly Dolly the sheep, which was a very different issue but there were some similarities. When that paper was produced in Nature, I was surprised to see Dr Ian Wilmut justifying the procedure of cloning on the basis, he said, that we would be able to make better farm animals that would be used for herds. That may be true, but if you reduce diversity in a herd then you may increase the risk of that herd suffering from unexpected organisms or different traits that you have not yet identified. That is an issue that we need to look at in detail when we examine the Bill in detail.

I suggest that, apart from diversity, we have to look at how reliable the technique is. I am quite concerned by the use, in the Title of the Bill, of the phrase “precision breeding”. I know it is coming into the literature—I see it increasingly in scientific papers—but in biology there is no such thing as precision. We do not know what is precise or entirely predictable. One of the reasons for being interested in genetics is that it is not completely predictable. It is that issue that may cause concern, along with animal usage, which is something that we need to look at. I ask the Minister to address that issue.

Without going into a huge amount of detail, I am still not clear what we do when there is a high abnormality rate in any animals as a result of these techniques. Do we just cull the animals? Do we treat them in a different way? What kind of disposal of livestock will be used? That will be important. With plants, as everyone knows, one of the great issues that have dogged this technology from the very beginning is changes in the surrounding habitat: changing the environment for both insects and other plants, and the risk of plants overgrowing areas. With an unstable environment in some countries, the real question is: might you then end up destroying crops that you really need or reducing the value of crops that you already have?

These are some of the issues I am quite concerned about. The Bill continuously deals with the issue of marketing and profit. I remind the House that that was one factor in sinking Monsanto when it produced its initial modification, which was then marketed. The marketing was so aggressive. I think the marketed seeds would not reproduce so farmers could not then use them as their own technology in countries which were developing economies. That is one issue we need to look at.

All these technologies are controversial, as the Minister and the Government have certainly accepted. They should not be controversial, but no doubt the controversies will be raised in this debate. We have to be absolutely clear, as the Minister said from the Front Bench, that everything we do with these organisms has clarity and proper accountability. We must be absolutely sure that we are not causing harm but trying to do good.

That brings in the issue of how you manage to run the regulation of this technology, which is focused on a considerable amount in this Bill. However, I am not sure it is adequate. In particular, perhaps we ought to be looking at the long-term effects—particularly in animals when looking at epigenetic effects which will not be expected at the time of the modifications or changes in DNA we are looking at—to the fate of the animal.

That will be very relevant because one of the great advantages of these plants is that they are not only good for nutrition but for making chemicals and medicines we want to use in human care. To some extent, this information will be valuable to human medicine as well when it comes to animals.

There is a great deal to be discussed, but we need some clarity over some of the terms used, particularly “precision” because I do not believe anything in life is really precise. Certainly, my expectation from biology is that it is imprecise, which is one of the reasons I probably got so interested in embryos.

--- Later in debate ---

[Lord Winston (Lab)]

I apologise for interrupting at this late stage of the debate, which has been really thoughtful and helpful.

The Minister might want to consider the difference between DNA that is naturally produced and is what the Bill is talking about and DNA that is produced in a gene sequencer, completely chemically. An issue here is that there is not really any difference at all. We must consider that very carefully.

Do not forget, too, in spite of your spelling, that if three base pairs are missing, for example, you end up with cystic fibrosis, which is a killer. One base pair will do with many diseases, so there is a real problem with these definitions. I hope the Minister will forgive me for interrupting; I do not expect an answer, but it is something we will need to consider during the next stage of the Bill.

[Lord Benyon (Con)]

I am not going to debate with the noble Lord, because he knows much more about this than me, and I know that I would sound even weaker if I just read out a line that has been written. But I value his contribution and I hope to tease out some of these matters as we go through the remaining stages of the Bill.

In response to a point made by the noble Lord, Lord Krebs—I hope I have got this right—in some cases, transgenic organisms will be used as an intermediate step in the development of precision-bred organisms. However, for the end product to be classed as a precision-bred organism, genomic features that could not have occurred naturally or resulted from traditional breeding must be removed from these organisms. For example, this would include removing CRISPR-Cas9 genes from gene-edited organisms.

DNA fragments from sexually incompatible species are naturally present in many organisms. This is in line with what could occur naturally—and I hope the noble Lord, Lord Winston, is on board on this. Therefore, we are allowing for foreign DNA to be present in precision-bred organisms only so long as this DNA does not serve any function and is within the range achievable through natural processes.

The noble Lord, Lord Krebs, also asked why companion animals are in the Bill, and a number of other noble Lords referred to this. Independent scientific experts advise that precision-bred organisms pose no greater risk to the environment or health than traditionally bred organisms. This applies to companion animals, as well as farmed animals. We are aware of precision breeding research that is already taking place on animals that could lead to positive welfare outcomes, such as increased disease resistance. Although there is less research taking place on companion animals, there is early research on the use of precision breeding—for example, in improving hip dysplasia in dogs. We do not want to restrict the potential benefits that can be achieved to improve the health and welfare of these species. That is why they are included in this Bill. I would say that that is not a priority, but it is definitely important that we future-proof the Bill.

We are not aware of the specific project to which my noble friend Lord Jopling referred and I would be interested to hear about it. A project that may be relevant was recently authorised by the Secretary of State for a field trial of GM and gene-edited barley. This is related to the concept about which my noble friend spoke. It is being undertaken by the Cambridge Crop Science Centre and is investigating the potential to increase yields by altering the interaction between the plant’s roots and the soil micro-organisms with which they are associated. We are not aware that any research group has yet succeeded in developing wheat plants in the laboratory that can fix nitrogen like legumes can.

I agree with the noble Lord, Lord Trees, that disease is a welfare issue. I cannot put it better than he did. The Government are committed to maintaining our already high standards in animal welfare, and we want to improve and build on that record. I assure noble Lords that this Bill will not lower the standards set by current legislation. He refers to zoonotic diseases and there is a human health element to this. This Government are very much signed up to the “one health” concept, so there is a wider benefit from this.

I will address the questions about why we are including provisions for animals in this Bill. Precision-breeding technologies such as gene editing have the potential to improve the health and welfare of animals, and improve the sustainability and resilience of farming systems. Such technologies can enable new traits to be developed more precisely and more efficiently than traditional breeding. The noble Lord, Lord Winston, made a really interesting point about genetic diversity. I cannot remember what percentage it is, but many of our dairy cows are descended from a very small number of bulls. It could be that in the future, because of recent trends, something occurs that endangers the health of many of them—I am not saying the whole dairy herd—because of their genetic uniformity. We want to be able to correct circumstances such as those as quickly as possible, and this legislation should allow us to de-risk that situation.

Research in farmed animals is already leading to the development of animals that have increased resistance against some devastating diseases. A number of noble Lords have spoken about the great organisations we have in this country: for example, the Roslin Institute and others such as Genus have developed gene-edited pigs with resistance to porcine reproductive and respiratory syndrome, or PRRS. It is a disease that causes mortality and major welfare issues in pig populations globally. This has been referred to by a number of noble Lords.

Whilst there is great potential for increasing innovation, we recognise that there is a need to safeguard animal welfare in the new regulatory framework. That is why, as I have already said, we are taking a step-by-step approach, facilitating use of precision-breeding technologies in relation to plants first followed by animals later. The measures in the Bill are designed to ensure that the health and welfare of relevant animals will not be adversely affected by any trait that results from precision breeding. To provide some further reassurance, I would also like to take this opportunity to expand on what the system for protecting animal welfare will look like. I am mindful of the time, but I will be as brief as I can.

Before marketing a precision-bred vertebrate animal, developers will need to provide assurances to confirm that the health and welfare of the animal will not be adversely affected by any trait resulting from precision breeding. This will be in the form of an animal welfare declaration and accompanying evidence. The Secretary of State will need to be satisfied with the declaration before issuing a precision-bred animal marketing authorisation, after which point a precision-bred animal can be marketed. This process will also involve an independent scientific assessment of the declaration by a welfare advisory body. We have also commissioned a research project to help us design the animal welfare declaration process and will work closely with a wide range of stakeholders as this work progresses.

I hope my words, the ongoing research project and engagement on these issues will provide noble Lords with some assurance that we fully acknowledge the importance of animal welfare, and we will continue to protect the high standards that we are proud to uphold.

I turn to labelling and the issues raised by the noble Lord, Lord Rooker, and others. The Bill will provide the Food Standards Agency with the ability, through regulations to be made by the Secretary of State, to introduce a new proportionate and science-based food and feed authorisation process. This will include a pre-market risk assessment for food and feed products developed using precision-bred organisms. The FSA’s role is not being diminished but enhanced—we could not be doing this without it—and it has produced some really interesting work in support of what we are doing.

I will address the points on traceability made by the noble Lord, Lord Rooker, and others. To ensure transparency, there will also be a public register of authorised precision-bred organisms for food and feed uses. This will provide consumers, industry and enforcement authorities with information on the precision-bred organism authorisation date, product, developer, characteristics, and food or feed uses. This will give clarity on food business operators involved in the supply of precision-bred organism food and feed products and enable traceability back to source.

A number of noble Lords have raised concerns about the delegated powers. Let me assure them that this is not a skeleton Bill. The powers supplement the principal policy measures which are set out on the face of the Bill and are quite specific and technical in how they are intended to be used. Your Lordships will know that delegated powers serve a valuable purpose, and it is always important to assess them in context. Simply counting up the number of powers in a given Bill is not necessarily meaningful. There are Henry VIII powers, which I know that your Lordships are quite rightly keen to scrutinise. They exist in Clause1(8), Clause 10(2) and Clause 42(1). I am sure that we will discuss those if noble Lords give this Bill the boost that it needs to get into Committee. I will hopefully be able to satisfy your Lordships about the need for them and the proportionality with which they have been put in the Bill.

I am coming to the end of my remarks, but I must address the points made by the noble Baroness, Lady Parminter, the noble Earls, Lord Caithness and Lord Devon, and the noble Lord, Lord Carrington, about trade. They quite rightly want to ensure that trade will not be negatively affected by this Bill. The international regulatory regime for precision-bred products is rapidly evolving. Many countries, as has already been said, have already amended their equivalent regulations, including the United States, Canada, Japan, and Argentina. Our proposed approach would help facilitate greater trade with those countries that have already adopted a similar approach to the regulation of precision-bred organisms.

With regard to the EU, this summer it conducted a consultation on legislation for plants produced by certain new genomic techniques, which is the term it uses for techniques such as gene editing. Some 80% of the respondents agreed that the existing GMO legislation was not adequate for plants, and more than 65% mentioned negative consequences if the regulations were not amended. These consequences included the loss of tools to tackle climate change, to develop more resilient crop varieties and to reduce the use of phytosanitary products. In response to the point made by my noble friend Lord Lansley, we will continue to monitor the position of the EU on precision-bred products and on UK/EU trade implications for products developed using precision breeding.

As things stand, the noble Baroness, Lady Parminter, is absolutely right. If we pass this Bill, some material produced through precision breeding and sold into Europe would be treated as a GMO there, but they are moving fast and we want to make sure that we are too. The global market value for gene editing is estimated at £2.7 billion in 2020 and expected to rise to more than £7 billion by 2026. I therefore ask noble Lords to consider the impacts and missed opportunity that would be caused by not supporting this important transition and the scientific basis for it.

Concerns have been raised about the impact assessment. I reassure noble Lords that this red rating is not a reflection on the quality or the ambition of the Bill. The Government are committed to proportionate, science-based regulations and have carefully considered all views and evidence in establishing our approach. The main criticism of the RPC is that the description of the policy differed between the initial review notice and the final submission. It felt that the impact assessment had not adequately accounted for the potential impacts arising from this policy change.

We are clear that at no point has the policy changed. The final submission had small changes in terminology such as changing the title of the Bill from “gene editing” to “precision breeding”. In our engagement and evidence-gathering, researchers and developers were made aware of the policy intention, and that the name had not been finalised, and so our expectation is that the change of the name to precision breeding will be of no impact on researchers or developers.

In response to the RPC’s comments, work is under way to gather further evidence from stakeholders and additional consumer insight data to provide more detail on the impacts to businesses and to bolster the cost-benefit analysis. We are also seeking to provide information to give more clarity on the policy intention, the Bill’s objectives and the options appraisal. Defra is working closely with the RPC and will submit an enactment impact assessment which will address its comments, and this will reflect any amendments made to the Bill as it progresses through Parliament.

On the point made by the noble Baroness, Lady Jones, about pausing the Bill, the policy has not changed. His Majesty’s Government are absolutely committed to supporting proportionate, science-based regulation. Our engagement and evidence-gathering will, I hope, address her concerns.

We recognise that the devolved Administrations’ positions regarding this legislation differ. My department has had very good conversations with a number of people. I have meetings next week with the devolved Administration in Wales and we will be talking to the Scottish Government as well. The noble Earl, Lord Stair, raised the point that this is a devolved issue. The Scottish Government have declined to join the Bill but the Welsh Government remain open to discussions via the common frameworks. We also engage with leading research organisations: with the Roslin Institute and the James Hutton Institute in Scotland, and with Aberystwyth University and Bangor University in Wales. These are world-leading organisations and they are calling for this kind of legislation. The electoral dynamic will, of course, differ in different parts of these islands and we want to make sure that we are talking to and working with the devolved Governments, and that we come to the right conclusions. I hope that we can persuade them to come along with us.

The noble Earl, Lord Devon, talked about the IP implications and whether precision-bred crops and organisms can be patented. The patent system exists to encourage inventions by offering time-limited exclusive rights in exchange for making the invention public, allowing others to further develop it. I am preaching to the choir; he is, of course, an expert on this. Patent rights are available in the UK in the area of gene editing, including plants and animals modified by such techniques. A number of patent applications have been filed and patents granted that relate to the genome-editing tool CRISPR.

The noble Earl and others also raised issues relating to the World Trade Organization. In 2018, a joint statement issued to the World Trade Organization signed by 13 countries stated that Governments should

“avoid arbitrary and unjustifiable distinctions”

between those crops developed through precision breeding and those developed through conventional breeding. The signatories included Canada, Argentina, Australia, Brazil and the USA. We are moving in that direction.

I have not had time to answer everyone’s points, even though I have been rather lengthy in my reply. It is important that we have open conversations. This has been an incredibly fascinating debate. I am encouraged by the level of support for the Bill. I hope we can progress it through the House. I beg to move.

Genetic Technology (Precision Breeding) Bill

Lord Winston Excerpts

Committee stage
Monday 12th December 2022 Lords Chamber

Moved by

[Lord Winston]

1: Clause 1, page 1, leave lines 4 to 6 and insert—
“(1) In this Act “directed bred organism” means a directed bred plant or a directed bred animal.(2) For the purposes of this Act an organism is “directed bred” if—”Member’s explanatory statement
This amendment is to probe the appropriateness of the term “precision bred”.

[Lord Winston (Lab)]

My Lords, when this Bill was considered by the various powers that be in the House, including the Constitution Committee and the committee on the Bill itself, there was widespread concern from everybody who looked at it. They clearly saw that it was imprecise, not entirely intelligible and of a particular, difficult and complex scientific nature; I agree with that.

One of the problems I have in speaking to my amendments is that, to some extent, they must be probing, because my real problem is that the scope of this Bill is seen as one of the release of organisms into the environment. However, inevitably, the science behind that is of an essential aspect. I am very glad that the noble Lord, Lord Benyon, is answering for the Government, because I felt that his response to me at Second Reading was very helpful; it would have been good to discuss some aspects of this Bill, which we may still have time to do before Report.

To start, one of the really big issues, which I dealt with to some extent in my Second Reading speech, is the nature of precision breeding. As I explained, there is no such thing as precision in biology. Biology is not like physics, and it is certainly not like chemistry. It is a constant response to the environment in a way that does not apply to the other aspects of science. One of the issues here concerns the definitions that we are dealing with in this Bill and, to some extent, in my various amendments—forgive me for my very poor sight but I need to read the numbers; I cannot see otherwise—including Amendments 10, 11, 13 and 14.

One of my problems—it is a problem that many scientists have—is the nature of what is seen as gene editing and a genetically modified organism. There are many different ways of modifying an organism, be it animal or plant. I mentioned in my Second Reading speech that the first time this was done was by the injection of DNA into the egg by Jon Gordon. As we know, that resulted in many mutations and abnormalities in the animals, which were quite horrific to see; to some extent, that is one of the reasons for one of the later amendments that I have tabled for discussion. Moreover, with all the other methods that have been used since—whether it is gene insertion using electro-poration or gene insertion via various other methods, such as using viral vectors and other vectors to carry the DNA into the nucleus—you get very big disruption of the genome.

It is perhaps not fully recognised that gene editing is not, as the noble Lord, Lord Benyon, kindly suggested, like taking a large paragraph of text and just replacing it with three or four different letters to make a new word. In fact, it is calculated that there are some 6.4 billion letters in the human genome—it is vast—and what is extraordinary is that the mutation of one single letter in that genome can result in a horrific disease.

The commonest genetic mutation affecting humans is probably cystic fibrosis, which until recently was a deadly disease. All you need to get cystic fibrosis is a deletion of three base pairs in the delta F508 part of the protein. That leads to a mutation that results in children being very severely handicapped, sometimes not growing or not able to digest their food and, in particular, having serious problems with their lungs. Consequently, not many of these children have a full life; they certainly do not have a full length of life and are often severely handicapped—even today, with modern so-called precision medicine trying to affect the genes, which is not nearly as successful as we would like.

That is just three base pairs out of those billions, and it is a good example of a very common genetic mutation that affects perhaps one in 20 of the British population. That means a one in 400 chance of a child’s father and mother both having it, in a family who would not suspect that they had that genetic disorder. Most genetic disorders are not anything like that common; some of them are extremely rare. None the less, they generally cause pretty devastating disease.

I am not suggesting for a moment that this necessarily applies directly to the Bill, but it is a very good model for trying to understand that, even with CRISPR-Cas9, for example, which is probably the main technology we are currently using for this kind of genetic modification, the so-called genetic editing is not exactly free of the chance of causing mutations. It is much less likely—for example, with Cas9 in plants, which is widely used, it undoubtedly causes mutations occasionally in the plant, and sometimes we do not know what the results of this mutation may be. Most of them will be completely harmless but some of them may change the way a gene affects, often quite severely, and its expression. By the word “expression”, we mean how a gene works. For example, a gene which expresses growth means that the organism will grow, and so on.

With regard to animals, we know that different species are very different in how they respond to even minor changes in their genes. Although CRISPR-Cas9 does not actually introduce DNA into the cells, it facilitates the introduction of DNA through the process of changing the RNA. That is the difference, but it is not entirely free of mutations. Mutations can occur occasionally at the point where the DNA is cut—that is, with a double-stranded cut in the DNA—or it can occur remotely across the vast genome that animals and plants have. They can be anywhere. Most of the time, that disruption will not necessarily be in a coding protein, but that does not mean to say that it will be free of any effect on the organism.

That is one of the serious issues that we did not really get to in our Second Reading discussion, and nor was it properly discussed in the House of Commons. I read the Hansard report of the debate, and it was quite deficient in many ways; it was not a very good debate in terms of the science.

The fundamental problem is the uncertainty that you may cause genetic modification—genetic mutation—that is unwanted and unreliable, and is not uncommon in plants with Cas9, which is part of the CRISPR process, in most cases. There are other ways of doing this: there is a process called TALENs and there is a process using nucleases, but we do not need to go into the detailed science. They all present problems in different ways of getting the DNA into a cell.

--- Later in debate ---

[Baroness Bennett of Manor Castle (GP)]

My Lords, it is a great pleasure to follow the noble Lord, Lord Winston, and, indeed, our very acute Committee chair. I will speak to my Amendments 11 and 86 in this group. It is a great pleasure to follow the House’s acknowledged expert, who set out very clearly the major problems with this Bill and, indirectly, made the arguments for the two amendments I am presenting here. It is perhaps worth starting with my Amendment 86, which amends the Short Title of the Bill, leaving out “Precision Breeding” and inserting “Genome Editing”. I am very happy to debate whether that should be “gene editing” or whatever, but I think the noble Lord, Lord Winston, clearly set out the reasons why we should not be debating a Bill called “Precision Breeding”. As he said, there is no such thing as precision in biology.

There are many areas of science in which “precision” is appropriate and extremely useful. We think about elements of physics and mechanical engineering, say, and talk about going down to millimetres, micrometres, nanometres. We can look at how those might change when the temperature changes, for example. All of those things will be eminently, entirely predictable. That is true of physical properties, but it is not true of biological properties, as the noble Lord, Lord Winston, clearly set out.

I covered this issue extensively at Second Reading, so I am not going to go into it at great length, but essentially, precision breeding is an advertising slogan; it is not a legal description. I do not believe that an advertising slogan should have a place in the title of a Bill. Interestingly, when it was put to me that I should seek to amend the Short Title, a technical expert said to me, “You will never get that through the Clerks”. In fact, it went through without a murmur. I think there is a real awareness that this Bill is not properly titled.

[Lord Winston (Lab)]

On a point of information, the noble Baroness was a great deal luckier with the Clerks than I was, as I tried the same tactic and was told quite firmly that I could not do that.

[Baroness Bennett of Manor Castle (GP)]

I thank the noble Lord for his intervention. I do not know how that happened, but I think I might take that as a seconding of my Amendment 86. Noble Lords might say that it is only the title and it does not matter, but it is how people will identify the Bill.

I am going to refer a number of times to a Defra press release, dated 29 September 2021, which, all the way through, refers to “gene editing”. That is what it is telling people the Bill is about, drawing a very clear distinction, as it sees it, between gene editing and genetically modified organisms, an issue I will return to shortly. That is the case for amending the Short Title of the Bill. What we are talking about is not precision; it is not marked by exactness, and there are real problems if the Bill is not named clearly.

I come to something that is arguably very significant and considerably more impactful in the nature of the Bill. This is my Amendment 11, which would exclude the use of exogenous genetic material in the creation of, or remaining in, so-called precision-bred organisms. Here I need to venture into the depths of this a little, I am afraid; I apologise to the Committee for that. If we look at many of the definitions that describe gene editing, we see that they say this is simply removing genes from an organism or adding genes from a different variety of the same organism.

That is different from genetically modified organisms. The noble Lord, Lord Winston, suggested that, 30 years ago, when GMOs were being debated, they got an undeserved bad name. But look at some of the things that have been done with GMOs: for example, a salmon that combines the genes from three different types of fish and grows unnaturally fast, reaching adult size twice as fast as its wild relative, to be released into the environment with obvious and potentially massive impacts; or, perhaps even more indefensible, the transgenic zebrafish, bred with genes from jellyfish or coral, which give them a glowing effect under certain light conditions. These genetically engineered animals were popular in aquariums and have now escaped into the natural environment, with effects we have yet to understand.

We are being reassured that gene editing is not like that; that it is a different kind of thing. Certainly, that is what the Defra press release of 29 September, which I referred to earlier, said in the name of George Eustice, the Minister:

“Gene editing is different from genetic modification, because it does not result in the introduction of DNA from other species”.


That is what the public is being told by the department.

We are going to hear in this debate a great deal about CRISPR, and I shall say this only once: CRISPR stands for “clustered regularly interspaced short palindromic repeats”. This is the hallmark of a bacterial defence system which forms the basis of genome editing technology. It was first discovered in archaea, a branch of the tree of life that was itself discovered only in 1977—we are talking about very recent science here. The clue is in the description. This is using the bacterial system. The key element of gene editing is the insertion of genetic material from bacteria. That material may or may not be fully removed at some point in the organism’s development, and, as the noble Lord, Lord Winston, set out very clearly, once we put something in, we do not necessarily understand what impact there might be in the current generation, or potentially in future generations.

I am going to borrow and excellent phrase from the joint Soil Association, Friends of the Earth and GM Freeze briefing on the Bill: it says that the genome is

“more like an ecosystem than a codebook.”

Personally, I tend to say that DNA is not a machine blueprint, because that is the metaphor—the idea of animals as machines—that dates back to the philosopher René Descartes, who has a lot to answer for and still dominates far too much of our discussion. We do not have the understanding of how biology and biological systems work. We think about them as machines and they are absolutely, definitively not.

This matters because mixing species, which is what we are doing here with gene editing, is not something that generally happens in nature. Certainly, there is horizontal gene transfer—which is of great concern in the area of antimicrobial resistance, an issue that I do a great deal of work on—but that is a far more limited occurrence and occurs mostly within kingdoms of living things rather than across different kingdoms of living things, which is what we are doing here. My Amendment 11, saying that we cannot introduce genetic material from other species, is doing only what the Government, in their own information about the Bill, say they want to do. That is why I believe we should have Amendment 11.

--- Later in debate ---

[Lord Benyon (Con)]

The amount of time we spent in the department working with real experts in this field to get the terminology right means that I hope we can persuade other countries to adopt our definitions. I know that I am not going to find total agreement on this legislation with the noble Baroness, but I can try. As I explained at some length—and I apologise to noble Lords, but I think this is a really important part of this Bill—we have arrived at this definition in a coherent way. Of course, we are constantly looking at how other countries are doing this. We do not want to be left behind, but we want to keep this safe; we want to see what is happening in the EU, but we want to make sure we are giving our scientists and our businesses the right guidelines around which to develop a really exciting new area of technology.

[Lord Winston (Lab)]

I am very grateful to the Minister for his consideration of what I think are difficult areas in this Bill, which I think remain—we have not solved the problem yet. One of the things I really loathe in Committee is people who move an amendment then take a very long time making a long speech, which bores everybody because they have already heard it, but I feel I have to address a few points specifically. I will not do it again later in this Bill. I think I have views on every single amendment, but I will be careful not to mention them.

The noble Baroness, Lady McIntosh of Pickering, mentioned Dolly the sheep. I think Dolly the sheep is a particularly interesting issue, because one thing which will not have escaped your Lordships’ attention is that Dolly the sheep had exactly the same DNA as wherever else she was cloned. Yet animals with the same DNA do not always express the same genes. For example, identical twins in humans are often quite different in many subtle ways, including their fingertips, brain functions, thought processes and so on.

We have to accept that there are many characteristics which are not necessarily demanded, essentially, by the DNA itself but by other things as well. In particular, one of the things we have not yet discussed is the problem of epigenetics; it does come into the Bill. We know that genes can express in different ways under different environmental conditions. That expression can be altered from the very beginning of conception—that is what we are talking about here—which could be, for example, in vitro fertilisation. Of course, that is mentioned in the Bill.

One of the concerns I have about IVF, having been involved with it since its very beginning, is that we still have no long-term follow up on what it means in terms of epigenetics—that is, how genes will express in the future. There are many examples where the progeny of a species—for example, a mouse—may show complete changes with regard to obesity, for instance, due to an insult four generations earlier. One has to accept that these changes occur very early; the mothers are fed with fats at the very earliest stages of pregnancy, and four generations later, we see a sex-determined link with obesity in the progeny. These sorts of issues are not teased out here.

Clearly, a great deal of doubt is encompassed in the Bill and in the science of it. As the noble Lord rightly said, we must all have a degree of humility in trying to work out what is best. He and I, and I think most people in this Chamber, would agree that we are mostly concerned about one thing: the environment. We are concerned about climate change and how we might adversely affect our environment. As we will come to later with the release of organisms, one thing that is very clear is that sometimes in the past—with natural causes—organisms have been released into the environment. We can think of the hornet in Britain, the Bufo toad in Australia, or the fungus which causes elm disease in England. Those things have all been produced by simply being involved in our environment, with colossal difficulties. Of course, we do not ultimately know whether this is a problem with modified organisms.

There is one thing which is not discussed here but which we need to consider. What we have forgotten, partly, is evolution. We are trying to evolve a species in one step, and that is a difficulty. If you take the human species, since Homo sapiens was first in east Africa 100,000 years ago, there have probably been about 5,000 families of humans—that is all. We have not evolved very much; the human brain remains very much the same. It takes a very long time for it to change even small amounts. What we are doing here is expecting rapid change for the benefit of ourselves and, we hope, of the planet too, but the problem is that we are dealing with an environment that is constantly balanced and balancing. We are at risk of damaging that balance with so many things that we do, and I regret to say that this is one of the reasons we have to be very careful when we come at the end of the discussion to the problem of balance and, therefore, how we release these organisms into the environment and control that. That is why the Bill is so important.

Without any further ado—I have already spoken for too long—I simply ask permission to withdraw my amendment.

Amendment 1 withdrawn.

--- Later in debate ---

[Lord Winston (Lab)]

Does the Minister see this extending to non-food crops?

[Lord Benyon (Con)]

As I said, I can see this finding a use in forestry and in some ornamental crops. I think the early work will be done in areas that I outlined, including drought resistance and reducing the requirement for input such as fertilisers and sprays, but we want to include the ornamental sector in time. There are 30 million gardeners in this country, and we want to unlock their potential to be part of a great green revolution, but I do not think that that will be the priority here. The priority will be food.

[Lord Winston (Lab)]

Then why not restrict the Bill to agriculture and horticulture? There are, of course, mechanical engineering reasons for wanting some plants or indeed animals for non-food purposes.

[Lord Benyon (Con)]

With respect, I would not want to do that. In the same way that we are insisting that these measures can be achieved over a longer period of time through traditional plant-breeding techniques, if they are safe, it can be applied for food crops and in protection of our trees and woodlands, and it may have applications in other areas which will help our economy, particularly our green economy. I would not want to restrict it from those sectors.

--- Later in debate ---

In conclusion, I support the inclusion of animals, and I note the timetable would delay the introduction until a number of the safeguards in the Bill have been addressed for animals.

[Lord Winston (Lab)]

Would the noble Lord be kind enough to answer one question? Does he not consider the possibility that the genetic modification of a herd of animals might make them more likely to be predisposed to a particular disease or infection that we did not expect?

[Lord Trees (CB)]

With respect, I say that that could be screened out in the development process. There may be indications, were such a risk likely from genetic linkages and so on, and that could be looked for by whole genome sequencing in the screening process and then perhaps by in vivo challenge experiments. But it could occur in natural breeding processes, too.

--- Later in debate ---

[Lord Krebs (CB)]

My Lords, I join my noble friend Lord Trees in welcoming the inclusion of animals in this Bill, but I have added my name to Amendment 6, which would restrict the animals in question in the first instance to those involved in agriculture. My main reason for proceeding cautiously relates to the point just raised by the noble Baroness, Lady Jones of Whitchurch, of public acceptance. There is a risk that, if the net is cast too wide with the inclusion of animals, there could be a backlash, which would undermine the whole endeavour.

As the noble Baroness, Lady Bennett of Manor Castle, has said, Amendment 5, which excludes companion animals, is a helpful start. I agree with her that many people would be horrified at the thought that we might breed dogs with further flattened noses through gene editing and that they would suffer the consequences of that.

One can also ask: would the public be happy to see gene-edited wild animals? We discussed that in relation to plants a few minutes ago. One could conjure up examples where the answer might be yes. For instance, if we could gene-edit herring gulls to stop them stealing ice creams and chips at the seaside, that might perhaps be a popular move; but I suspect that, on the whole, people would not be happy to see our native animals gene edited outside the context of agriculture. As it is most likely that the early applications of gene editing in animals will be for agriculture, why not acknowledge this, start here and progress step-wise to widen the range of animals at a later stage if that is deemed advantageous?

The advantage of Amendment 6 over Amendment 8, which refers to farmed animals, is that Amendment 6 would allow for the gene editing of, for instance, a pest or parasite of an agricultural species while Amendment 8 would not. I defer to the noble Lord, Lord Trees, for his expertise on this, but it may in some circumstances be easier to reduce the burden of disease on farm animals by altering the genome of the disease-causing organism rather than the genome of the farmed animal itself.

So, while I am in favour of including animals in the Bill, I think there is a case for proceeding cautiously and, in the first instance, restricting that to agricultural contexts.

[Lord Winston (Lab)]

My Lords, Amendment 9 is in my name. I will be very brief about that, but I agree that we should be extremely cautious generally about animals at this stage. There is a lot of concern. From the example of dealing with pigs in a genome environment, I know that they are very different from some of the other mammals that we have been experimenting with. We may come to that issue later on when it comes to licensing.

With regard to Amendment 9, there is a strong case as well for limiting this to farm animals, if we go ahead at all—and if we do I would like to see equines excluded, for pretty obvious reasons. Some time ago, when I was working with an anaesthetist who was looking at equine metabolism, it was amazing how suspiciously the horse-breeding industry looked at our work—so much so that we could not share our data on their metabolism. It was very clear that we would have great difficulty with the restrictions that are proposed on that industry.

With regard to the great apes, it would be wrong to consider them in the same way as other mammals. It seems to me that these sapient creatures are so close to humans that they ought not to be included in the Bill. There are restrictions, of course, on the use of rhesus monkeys in research. I have worked with rhesus monkeys, not in Britain but in the United States. As a research worker, I always found that extremely distressing because I saw their response to even just a visit from us, when they knew we were going to do something which they thought would be unpleasant. I feel strongly that there has to be a very strong case for modifying sapient creatures, perhaps even to make them less sapient—so I propose Amendment 9 on that basis.

[Lord Cameron of Dillington (CB)]

My Lords, I realise that these are mostly probing amendments and, as ever, we await the Minister’s remarks with bated breath. But I cannot let the proposal to exclude all animals pass without comment because, like my noble friend Lord Trees, I believe that if we were to exclude all animals from the Bill, it would be an opportunity wasted to enable us to remove a lot of suffering on their behalf. My noble friend and I both mentioned the disease PRRS in pigs at Second Reading. It is a devastating disease for any herd, outdoors or indoors, organic or whatever. As a farmer, you just have to cull drastically to eliminate as much suffering as possible, and killing your herd is not a very pleasant thing to have to do. Breeding resistance to the disease is therefore a much more humane approach.

One of the great positives of the Bill is that if you alter the genes of one animal, say, to make them resistant to a particular disease, and succeed in making this a hereditary and stable characteristic—not always a given—you can get huge benefits for animals and even humans, because you will be taking more antibiotics out of our environment. Breeding resistance into future generations is so much more sensible than the ongoing use of antibiotics, medicines and even vaccines as a way to help animals live pain-free and disease-free lives.

The key to making the Bill work fairly and humanely for animals is to ensure that we continue to have the strictest monitoring and regulation every step of the way: in the laboratory and on the farm, and for plants and particularly with animals. We will obviously come to the tightening of some of these regulations later in our deliberations.

On the companion animal debate, I fear I disagree with my noble friend Lord Krebs, who I very rarely disagree with. I realise that they seem to present a slightly more unregulated environment than that of farm animals; people keeping pets are not subject to the strict regulations that exist on our farms—regulations that are, in theory, enforced by a variety of inspectors, not least those who come from the supermarkets, on which the farmers depend for their livelihoods. However, we are not debating how the pets are being kept: it is the ability of breeders to get the relevant licence and approval from the Home Office, and now from the welfare advisory body. If we had some form of guarantee that the welfare advisory body will have a remit—nay, a duty—to investigate in the home and on the farm the future quality of life of any relevant animal and its progeny, along the lines of my later amendments, I do not see it as necessary to exclude companion animals in total from this Bill.

--- Later in debate ---

[Lord Benyon (Con)]

My Lords, when I was in another place, there was a free vote on the smoking ban. I remember a panicked Back-Bencher coming towards the Lobbies and saying that he did not know how to vote, because he hated smoking but loved freedom—what was he to do? Someone just said to him, “That way for freedom from smoke; that way for freedom to smoke.” I mention that because it shows that you can look down two ends of a telescope and come at this from two directions. I entirely understand that people who want to oppose the Bill in its entirety will find hooks on which to hang that belief, and that others who see merit in this will try to see a path down which to go.

I will try to address the points raised. First, for clarity, I say to the noble Baroness, Lady Bennett, that fungi are out of the scope of the Bill. I am sure she will be pleased to hear that. I say to the noble Baroness, Lady Jones, that animals were not a late inclusion into the Bill. There was a consultation in March 2021 which included animals, and a response to that was published in September 2021, so I do not think the idea that this was a late entry into the Bill stacks up.

I am grateful for the opportunity to further build on the Government’s position on why we think it is vital that animals remain part of the Bill. There are many potential benefits of enabling precision breeding in animals, including, as we have heard, to improve the health, welfare and resilience of animals. We have a real opportunity to harness the great research that is already taking place in the UK. Noble Lords highlighted some of this great potential during Second Reading, but to reiterate, our leading scientists are already using precision breeding to develop resistance to a range of diseases that impact animals across the country.

We have already mentioned at Second Reading research focused on resistance to bird flu in chickens, resistance to sea lice in farmed salmon and resistance to porcine reproductive and respiratory syndrome, which was mentioned by the noble Lord, Lord Trees—

[Lord Winston (Lab)]

I have been looking very carefully at the literature on gene editing for this debate, to remind myself. Although the Minister praises British research—of course we like to promote British research and British universities, being at one myself—I have to say that what I see is that the papers describing the risks of gene editing in detail largely come from other countries, including Asia and America. I do not think we can ignore the fact that there is a wide body of opinion that recognises that this is still a relatively dodgy technique, particularly so in animals, and therefore we need to go carefully before we start to implement it as a sort of service that we might be able to sell.

[Lord Benyon (Con)]

I am grateful to the noble Lord and will cover that point in a moment.

I was making a point about PRRS, but there are also developments abroad in producing cattle that are more heat tolerant and resistant to climate change. As was pointed out at Second Reading, there is potential to reduce methane emissions from cattle, which is vital for more sustainable agricultural systems.

I agree with the noble Lord, Lord Trees, that there are many examples that demonstrate the potential to bring significant health and welfare benefits to our animal populations and economic benefits to our farming industries. That is why we are looking at this down one end of the telescope. I hope I can persuade noble Lords that this a way that offers great potential, particularly in the area of animal welfare.

It is vital that we create an enabling regulatory environment to translate this research into practical, tangible benefits. This is a key objective of the Bill, and removing animals from the Bill would hinder us from realising any benefits of these technologies for animals. Ensuring that these technologies are used responsibly and enhance animal health and welfare is vital; I think we are all agreed on that. That is why we intend to take a stepwise approach in implementing the Bill, with regulatory changes to the regime for plants first, followed by that for animals. We want to make sure that the framework for animal welfare set out in the Bill is effective, and we will not bring the measures on precision breeding into effect for animals until this system is in place.

It is important we get this right, and that is why we have commissioned Scotland’s Rural College to carry out research to help us develop the application process for animal marketing authorisations. This will focus on the welfare assessment that notifiers will have to carry out to support their welfare declaration. This research will help us determine an appropriate welfare assessment for precision-bred animals and identify the evidence and information that must be submitted to the welfare advisory body along with the notifier’s welfare declaration. The research will involve experts from the Animal Welfare Committee and a wide range of organisations with expertise in animal welfare, genetics and industry practice.

As the noble Lord, Lord Trees has noted, the Bill introduces additional animal welfare standards, over and above existing animal welfare legislation. We are clear that these additional safeguards will complement our existing animal welfare regulatory framework for protecting animals. This includes the Animal Welfare Act 2006, the Welfare of Farmed Animals (England) Regulations 2007 and the Animals (Scientific Procedures) Act 1986. A suite of legislation exists. I absolutely refute the points that have been rightly raised that this can be seen as a fast passage towards higher density occupation of buildings because birds are somehow resistant to diseases caused by tight accommodation. There is already legislation that controls the densities and other animal welfare provisions. The idea that this is somehow going to allow producers to get round existing legislation is not the case, and there are additional animal welfare safeguards within the legislation.

If we want to drive investment in new research and realise the potential benefits for animals, we need to include them in the Bill. By doing so, we are providing a clear signal that the UK is the best place to conduct research and bring products to market.

I move now to the topic of limiting the scope of the Bill to certain animals. As we have already discussed, we know that there are benefits from enabling precision breeding. This technology has the potential to improve the health and welfare of animals. This applies to a range of animal species. I hope that the points I am coming to now will address the points made in the amendments and the remarks of the noble Lord, Lord Winston, the noble Baroness, Lady Bennett, and others.

The definition of animals in this Bill is broad so that the legislation remains durable for future years and to encourage beneficial research and innovation. Much of current research is on animals used in food production. We want to ensure that the potential benefits, such as improved welfare, can be realised across different species in a responsible way as research advances. This includes species that are kept only in this country as companion animals. Independent scientific advice that precision-bred organisms pose no greater risk than traditionally bred organisms applies to farm and companion animals.

To quote one example, hip dysplasia in certain breeds of dog is a devastating condition; it causes a lot of misery for the dog and its owners, and results in the dog’s early death. I do not say that there is some quick and easy path to resolving this, but there is a lot of research going on to traditionally breed out that condition. I want to see this sort of work speeded up. It seems right to include the ability to tackle these sorts of conditions in companion animals in this legislation, with adequate safeguards.

It is important to note that this is just the beginning. We intend to take a step-by-step approach with animals. We will not bring the measures set out in this Bill into effect in relation to any animal until the system to safeguard animal welfare is fully developed and operational. This system is intended to ensure that, before a vertebrate animal or its qualifying progeny can be marketed, their health and welfare will not be adversely affected by any trait that results from precision breeding. As I said, we have started by commissioning Scotland’s Rural College to conduct research that will help develop this application process.

I acknowledge the amendments tabled by noble Lords in relation to the range of animals covered in the Bill. The suggestion from the noble Lord, Lord Krebs, to pursue and build up the step-by-step approach is the right way forward. I hope that noble Lords will be reassured to know that the Bill, as currently drafted, already allows us to take this step-by-step approach through commencement regulations; for instance, by commencing the relevant provisions of the Bill in relation to some animal species before dealing with others. I hope this offers some reassurance to the noble Lord, Lord Winston. I hope that the points I have made will enable noble Lords to not press their amendments.

--- Later in debate ---

[Lord Benyon (Con)]

All I can do is assure noble Lords that nothing will happen before we are in the right position to do it. That is why we have commissioned the work with Scotland’s Rural College, and we are working with important stakeholders such as veterinary colleges and others to make sure that we get this right.

The priority will be to try to do this for farmed animals first, and we want to make sure that we are operating a step-by-step approach. If we put it in the Bill, it may be too prescriptive, because we are in a fast-moving area of science, and it may constrain the ability of the scientific community to progress this if we do it in the wrong way. We want to give as much freedom as possible, and that is why we are adopting this process.

[Lord Winston (Lab)]

I hope the Minister will forgive me—I have been a complete pest to him this afternoon and will probably continue to be one—but it is nothing to do with the scientific community. That community can take as long as it wants to get the right answers; it is the marketing of these animals that concerns us. We have no problem with the science, providing it is done humanely, and we recognise that that is the Government’s intention because we already have very good legislation to do that, but we have to accept that the science is still uncertain. That is why we are concerned that we might make mistakes.

[Lord Benyon (Con)]

That is precisely why we want to have the proper regulatory framework in place, and that requires consultation. We also have a flowchart, available on the Bill webpage, that sets out very clearly the process for applying for an animal marketing authorisation. I will not delay noble Lords by going through each of the six steps in the process, but it is very extensive and exhaustive and clearly sets out how we propose to do this.

It gives the kind of reassurance that a lot of noble Lords talked about regarding the public’s acceptance. To address that point, it is a matter of how you put the question: if you do so in the way in which the noble Lord, Lord Trees, just did, mentioning the benefits of the legislation, I think a huge majority of people will support it. If you ask it in a different way, you will get a different answer—that was the problem 25 to 30 years ago.

The noble Lord is right, of course: the scientific community will move at the pace that the money allows it to, and the market will create demand for the research. But we want to make sure that we have a good, proper regulatory process that reassures the public and is clear to developers of these products, so that they can see how they will be required to sit within that sort of framework.

[Baroness Bennett of Manor Castle (GP)]

I thank the Minister for his answer and thank everyone who contributed to what has been a very rich, full and very informed debate. I am going to deal first with the structural questions just raised by the noble Baronesses, Lady Hayman of Ullock and Lady Jones of Whitchurch.

We again have this problem that we have to wait for the regulations and trust the Government. I appreciate that the Minister was doing his best to persuade us, and I felt that he really wanted the opportunity to have a PowerPoint presentation here to show us a slide of his flowchart. But this is all about taking it on trust. Almost certainly, in the timeframe the Minister referred to, we are talking of not the same Government implementing this—I am not casting any aspersions on who the next Government might be—and the noble Lord not being in a position to guarantee what will happen in the future. We are left with this uncertainty and it not being clear. We know that tomorrow will test your Lordships’ House on just how much it is prepared to stand up against regulations. We shall see what happens then.

The Minister responded to me on the standards of what I call factory farming. He said that there is already legislation on this, but I say that that legislation is grossly inadequate and that we have huge disease problems because of that. Tightening up animal welfare regulations and regulations for housing animals in this country would greatly reduce the need to deal with problems of disease.

It is interesting that the Minister also said, perhaps a couple of times, that including animals is about making the UK the best place to conduct research. I come back to the point I made on an earlier group about whether this Bill is for animal welfare, food security for farmers, or for our biotechnology industry. It appears that we are hearing that it is for the biotechnology industry.

I am not going to run through all the contributions, because the noble Baronesses, Lady Parminter and Lady Hayman, have already provided us with a good summary, but I will draw together the responses from the Minister and a number of others, including the noble Lords, Lord Trees and Lord Cameron of Dillington. There have been suggestions about tackling disease, but we are talking about ecological niches here. Let us say you produce pigs that are entirely resistant to a particular disease; you are producing resistance to one species or one threat. You are very unlikely to produce widespread resistance, so you are opening up an ecological niche for another disease to come in, if you keep animals in conditions that allow that to happen.

We can take a practical example from what is happening in human society at this moment. Over many centuries, human societies have had conditions that have allowed the spread of a wide range of respiratory diseases.

[Lord Winston (Lab)]

I am grateful to the noble Baroness for giving way. Does she not agree with me that we have been somewhat dismissive in this debate of the use of vaccines? Surely one of the ways to look at this with more intensity, and perhaps more money, is to look at more vaccines not just for human health but for animal health. At the moment, the research there is nothing like as much as it is for humans.

[Baroness Bennett of Manor Castle (GP)]

I thank the noble Lord for his intervention and agree, although we know that animals kept in good conditions of husbandry are much less susceptible to disease. My first approach is to keep animals in conditions where they are not susceptible to disease, and then you do not need to go to the expense and effort of developing vaccines or using antibiotics, which have the issues with resistance that were raised by the noble Lord, Lord Cameron.

I was talking about respiratory viruses. Our population is threatened now by not just Covid-19 but a number of other coronaviruses that have long been causing respiratory diseases in humans. We are threatened by rhinoviruses and by flus, all because of conditions that make us prone to respiratory illnesses spreading. Tackling just one of those, as we have done with the Covid-19 vaccine that the noble Lord just referred to, with great effect, does not mean that we will stop all those other forms of respiratory illness.

That has covered the main points. I want to come back to the amendment from the noble Lord, Lord Winston, which raises some interesting points on great apes. I would extend this to all simians or monkeys. I ask your Lordships’ House to consider whether we actually want to be gene editing great apes or monkeys.

The point about equines is also very interesting when we think about horseracing and the enormous amount of money and the possibly shady characters involved in it. Whether we really want to see gene-editing in racehorses leads us into the companion animals question. It is a real area of concern. On that, the noble Lord, Lord Trees, referred to brachycephalic breeds that are identified as a problem area. If the breed societies were to say that they were going to create really rigid rules and change their definition of what those breeds are supposed to look like, that would be another way, a kind of husbandry way, of tackling the issue.

I will of course withdraw the amendment at this stage, but before I do that, I want to ask the Minister a question. Following on from the noble Lord, Lord Winston, does he think we should leave open the possibility of gene-editing great apes?

--- Later in debate ---

[Lord Benyon (Con)]

I apologise to the noble Lord if I am sending him to sleep, but this is a complex area. Patent lawyers will dance on the head of a pin on some of these issues. As I said, we have worked with the Intellectual Property Office to get this exactly right and to address precisely the point he made earlier about some of the difficulties that were faced, with large international companies owning the rights to seed entitlements. That caused great difficulty in the past.

I shall just read one bit to him again, and if the noble Lord could try to stay awake, it will be an achievement that I will rejoice in. The Bill does not make any changes to laws associated with obtaining a patent; nor does it alter the process by which an applicant would apply for patent protections. Breeders wishing to patent their precision-bred plant or animal should therefore undertake this process in the same manner as for all other inventions and under the guidance of the Intellectual Property Office.

The Bill is also an attempt to provide precisely the balance that the noble Baroness, Lady Wilcox, stressed. We want to secure the rights of those who are investing enormous amounts of money in the development of these technologies, while also not making it impossible for farmers—precisely the people we want to have access to these technologies—to have access. That is the balance we are seeking to achieve.

I can work only on the best legal advice I am given. There are noble Lords in this Committee whose speciality is intellectual property law, and I am sure they could dance much more dextrously on the head of that particular pin than I.

[Lord Winston (Lab)]

I wonder if we could “strictly” stop dancing just for a moment and come back to the question of the noble Lord, Lord Krebs. I have to declare an interest in the register: I have a company called Atazoa, which is responsible for modifying the genes not of embryos but of individual sperm. We have of course also been working with eggs. This is before fertilisation—before the organism is formed. That is subject to a number of patents which have raised a certain amount of money for our research, and the research has been moderately fruitful—not as fruitful as I would have liked it to have been; it has not made any major changes.

There is an issue here. First, what happens if we produce a farm animal as a result of that technique? Does that come under the licence or not? Secondly, during the process of gene editing, it is very probable that people will make new editions to the modification of techniques to find new ways to put together what is quite a complex process; even though it is fairly efficient and simple to do, it remains complex. What happens, for example, with regards to improvement of the technology, rather than the animal husbandry side of it? Does the patent there still stand or not?

[Lord Benyon (Con)]

I have to be honest with the noble Lord and say that I will write to him on this. He makes a very good point. I can think of it only in terms of a standard invention. In intellectual property terms, you secure the creation of whatever it is, with whatever characteristic it has, and others may come along and improve it. The line on intellectual property exists until they change it beyond its original purpose, and I quoted the other criteria earlier. I am going to write to both the noble Lord, Lord Krebs, and the noble Lord, Lord Winston, to give more precise answers to those particular points. With that, I hope the noble Baroness is willing to withdraw her amendment.

--- Later in debate ---

[Baroness Bennett of Manor Castle (GP)]

My Lords, I have the greatest respect for the noble Lord, Lord Cameron of Dillington, but I think the contribution that the noble Lord has just made demonstrates a fundamental difference in approach to, understanding of and belief in systems for—to use the phrase—feeding the world between him and several of us on this side of the House. I am going to take a very practical example of this because, last week, we saw reports emerge in the mainstream media of a new wheat variety called Jabal. The noble Lord spoke about our scientists finding solutions for Africa, and he spoke about leaving it to business. He said that only big companies could now develop new varieties of crops such as wheat. Jabal, which means mountain in Arabic, is a new durum wheat which is extremely tolerant to drought and heat. It was developed for climate resilience through the Crop Trust’s Wild Relatives project. It was developed between 2017 and 2021, so over a period of five years, and by working with farmers on the ground in the communities affected. It is looking to be extremely successful. There is no big business. There are some scientists—I have no doubt that there were some British scientists, but scientists from all round the world were involved in this—but it is grounded in the communities that need these crops and has been done without anyone making huge amounts of money out of it. If we are talking about feeding the world, there is a potential alternative model.

However, I am now going to come back to the detail of these amendments, starting with Amendment 16, already very ably introduced by the noble Baroness, Lady Bakewell of Hardington Mandeville. I do not really think that I need to add much to that, having attached my name to amendment, although I will note that Amendments 76 and 77, both of which appear in my name and which the noble Baroness has also kindly signed, have more or less the same intention of inserting in Clause 43 instead of earlier in the Bill. Amendment 77 looks at impacts on UK exports to the EU, as the earlier amendment did. Amendment 76 is broader and looks at exports around the world and what impacts it might have.

Amendment 78 in my name, which the noble Baronesses, Lady Bakewell and Lady Hayman, have kindly signed, addresses some of the points raised by the noble Lord, Lord Cameron. It says that regulations under this Act must particularly look at the impact on small and medium enterprises. Here, perhaps we are not thinking so much about enterprises that might be producing those so-called precision-bred organisms, but more the farmers using them and small farmers and the kind of impact we were addressing on the debate about intellectual property and the issues of market dynamics and competition which have been such an area of concern with GMOs.

Finally, I come to Amendment 75 in my name; the noble Baroness, Lady Hayman, also kindly signed it. If the noble Baroness, Lady Noakes, were here, she would probably be giving me lessons in the structure of Bills and exactly how a five-year review should be constructed. In her absence, I have done my best to propose that there should be a five-year review of how the Bill is working.

The debate on animals and plants provided some powerful ammunition for the discussion. The Minister acknowledged that the Bill will evolve and change according to events, but we also need to note that this is a fast-moving area of both technology and scientific understanding.

I will not go into great depth on what has been roughly described as the new biology but huge, fundamental debates within the science of biology are going on at the moment about the structure of organisms, of life and of ecosystems. In five years, the scientific framework behind this—not just the technology but scientific understanding—may well have moved on significantly. Surely a Bill this controversial, complex, difficult and technical should have a five-year review built in.

[Lord Winston (Lab)]

I never thought I would be a member of the Green Party, but I clearly am this evening. I must agree with the noble Baroness, because we have to understand that gene editing is a new technique and has been on the books for only about eight or 10 years, which seems a long time but is not at all—in science, that is a very short time.

It was 40 years ago that we genetically modified organisms for the first time. The noble Lord is proposing that we speed this process up when we do not fully understand what is happening with procedures such as CRISPR-Cas9 and other methods. We need much more data before we can be sure about the progeny of these animals. That is one of the problems, and it will not be simple.

Of course, I appreciate that it takes quite a long time to breed an animal. As a human, I understand that quite well—I have dealt with a few humans myself, and no doubt the noble Lord, Lord Cameron, has also had children—but we have to accept that it takes time before you can really work out the status of an animal. It is a complex process.

[Baroness Jones of Whitchurch (Lab)]

My Lords, in one of the earlier debates the Minister sought to categorise some of us as people who are fundamentally opposed to the Bill and trying to find any way we can to derail it. I assure him that I am not in that camp, and I hope that the amendment I will speak to will give some illustration of that.

I will speak to Amendment 88 in my name, which is a very particular amendment about the status of GMOs; this seems a very odd group of amendments that have been put together. It follows on slightly from the comments just made by my noble friend Lord Winston because it recognises that it has been many years since the regulations relating to GMOs have been reviewed. As a result, we appear to be legislating in silos rather than looking at the impact of genetic technology as a whole. We already have the GMO legislation on the statute and now we are looking at GE, but how do those two bits of legislation interrelate?

When the Government announced their plans to roll out gene editing, they also committed to a review of the wider GMO rules, but so far there does not seem to be any sign that the review is taking place—unless I have missed it. Amendment 88 probes whether the impact of Clause 41, which amends the Environmental Protection Act 1990 to exclude precision-bred organisms and differentiates them from GMOs, is likely to require further review.

This is all about the interrelation between genetic engineering and GMOs. Where is that review taking place? Is the wording of the legislation as it stands in Clause 41 how we want it to be? When and how will that wider review of GMOs take place? How will the Minister synchronise any result of that with the provisions of the Bill? It seems rather odd that scientific institutions could be potentially following two different routes for technology that in many ways is very similar.

--- Later in debate ---

The Bill also allows us to take a step-by-step approach with the commencement of the relevant substantive provisions in relation to certain animal groups or species before others. The timing of this approach will be determined by the period it takes to complete the regulatory process and develop the animal welfare safeguards. These will then need to be reflected in secondary legislation under the Bill’s powers setting out the technical details of this process. Additionally, on the basis of promising research on precision-bred crops in the UK—which has already begun—we predict it will be several years before domestically produced precision-bred crops will be on the market for farmers and consumers. Therefore, although there are no dates for these steps in the Bill, there is a clear policy approach for these regulatory changes and for precision-bred products to come to market. I hope my words have provided noble Lords with some reassurance not to press their amendments.

[Lord Winston (Lab)]

I would love to hear from the Minister say “finally” again in just a second. One of the issues I would like him briefly to address—probably in a note, not now—would be how to classify a plant organism, for example, which has been treated not only by gene editing but also by, say, radiation. I mention this is because a recent publication by Amritha and Shah in the last few months shows that, by combining those techniques, the resulting edit is even more successful. It seems that is hardly a natural process, but I do not know whether that is something to discuss now.

The other issue is that we are all obviously agreed about climate change, but what I think concerns a lot of people who are arguing on my side of the Chamber is that modifying plants could make us, the plants or the land more vulnerable to climate change. That is something we need to be thinking about during the course of the Bill.

[Lord Benyon (Con)]

I take the noble Lord’s points. We have to make it clear that we will not allow organisms to come on to the market that would somehow make it harder for us to adapt. There are so many benefits that we can introduce to tackle things such as drought and other issues that plague farmers. We have climate change affecting farmers here and now in this country. It is not something that is happening in Pacific countries alone; it is in our country, and we need to give farmers the tools to deal with it.

On the noble Lord’s other point, as the noble Lord, Lord Krebs, said earlier, irradiation—if I have got the word right—is an established part of plant breeding today. He is right. I can see an overlap in this, but I will write to him and make sure that we give him the facts that he needs. With that, I hope that we can progress.

--- Later in debate ---

[Baroness Bennett of Manor Castle (GP)]

My Lords, I shall speak briefly to Amendment 19, which noble Lords will see already has a full complement of signatures. I thought the signature of the noble Lord, Lord Krebs, was far more useful than mine, so I was pleased to leave that space. If the Minister cannot agree to make some commitment such as that which the noble Baroness, Lady Jones, of Whitchurch, just asked for, it might well be possible to find a Conservative Back-Bencher to make a complete set on Report, should we get to that stage. I would have attached my name to this and I think it has already very been powerfully argued for, but I want to make two additional points.

Both the Environment Act and the Agriculture Act were built around the idea of public money for public good. Here, surely the Conservative Government would embrace the idea of public good for no public money at all. This is the Government able to make the rules, and they can ensure that there is public good without a penny having to be spent. That would be very much in line with the Environment Act and the Agriculture Act.

I want to highlight a couple of the elements in Amendment 19 that I think are particularly important, including sub-paragraph (x),

“supporting or improving human health and well-being”.

I note that the Government, in promoting the Bill, talk a great deal about sugar beet. Given the massive overconsumption of sugar in the UK diet—if we produced by volume only two-thirds of the sugar we produce in the UK, that would be more than enough for a sufficient, healthy level of diet without importing a single gram of sugar—and the fact that sugar beet is associated with massive loss of fertile topsoil from some of the richest lands in the UK, if we could gene-edit sugar beet to be more productive on less land, it would be ideal to combine that with ensuring that we produce only a healthy amount of sugar and free up the land for other purposes.

I also note that the Minister talked about sub-paragraph (ii), mitigating and adapting to climate change—indeed, he talked about the climate emergency quite a lot this afternoon. Of course, when we are talking about animals, we talk about engineering cattle to release less methane; we are looking at a whole-systems approach here, and having fewer cattle would be by far the easiest way to produce less methane. Further, they would not be consuming grains and proteins, such as soya from the Amazon, which we could be consuming as human food instead. It is a complex issue, but what we are getting at here is trying to deliver, as the noble Lord, Lord Krebs, said, what the Minister said is the purpose of the Bill.

The noble Lord, Lord Winston, has not spoken yet, but I will venture to make one comment on his Amendment 21. The wording is not terribly clear, and the noble Lord could answer now or later, or think about this amendment on Report. It says that the genome should be sequenced and the changes recorded and reported to the Secretary of State. My question is whether that should be published and publicly available. We are talking about licensing something that the Government are giving companies the right and the chance to potentially make money out of, so it is perfectly reasonable to demand an increase in public knowledge to make accessible those genomes that would then be available to other researchers for all kinds of possibly very different purposes, not necessarily productivity or seed-producing purposes. The knowledge of all those genome sequences would be a very useful thing. I think that should perhaps be written into the amendment.

[Lord Winston (Lab)]

Seeing as my name has been mentioned, perhaps I ought to speak. I thought we were still on the two previous amendments. The difficulty I have with this is that Amendment 21 is really a continuation of Amendment 20, and Amendments 22 and 23 follow logically.

Let me just deal very quickly with this. Basically, what we are talking about here is the release of organisms into the environment, and the proof that we have done to those organisms what we what we said we were going to do. Of course, that particularly means looking at the phenotype of the animal, whether it is a normal animal and therefore not suffering in any kind of way, and at whether the editing has changed the genome in a way that is unexpected. Of course, the Minister mentioned off-target mutations, but that is only one thing that can occur with gene editing. Once the DNA is on a double-stranded split and there is a gap there, you can actually introduce foreign DNA—even human DNA; whatever is floating around in the laboratory. When we are doing very careful work in the lab with genetic material, we have to be scrupulously clean of the flow hoods and so on. Those things need to be considered, because they would be part of what is seemingly a simple procedure, but in reality there are really quite difficult safeguards. What I am really asking is whether the Government intend that there be some form of sequencing to see whether there have been mistakes, or some form of examining the genome of the animals after we have done the work required.

To my mind, there are two issues here. One, of course, is the need to get better data on the effect of the gene editing, wherever it is done, and, in particular, of gene editing in general. That will help the research. If we really want to promote a market, we need to show that we are what we promised to be: a leading scientific organisation in this country, doing this sort of stuff at the top level. That is important. The other issue, of course, is protecting the environment. Clearly, release of organisms that turn out to be not what we expect, and which would have the ability to produce progeny, is risking things further. That is basically the reason for all these amendments, but Amendment 21 expresses my main concern: to ensure that we have done what we promised to do, and if we have not, to find what went wrong so that we can deal with it.

The primary question of privacy of the information has to be discussed by us, but it is deliberately not in this amendment at the moment. There are pros and cons for doing that. There does not necessarily have to be openness, but there must be a proper register of the information. We may well not get the work done if we do not have complete confidentiality, although science is never done best when it is confidential. On the whole, openness has been described, in the general information about the Bill, to be an issue in it, and transparency is a word mentioned by the Government. In the interest of transparency, this amendment may be required.

[Lord Sentamu (CB)]

My Lords, when I practised law before I started practising law and grace together, I was of the view that any lawyer enshrines into legislation an agreed public policy. Here, the public policy in Amendment 19 to Clause 3 is that really, if you are to develop these organisms, they must be

“for or in connection with one or more of the following purposes”.

The purposes are explained. The Minister has to work out clearly what the public policy is that he is trying to enshrine here, because any general knows that it is no good launching out into a battle when there are no soldiers coming behind you. One of those purposes here is to try to help the public to understand why this is being done. It is not just for money—although that, of course, is important—and it is not just because we think that science has developed and there is no control over it. At the end of the day, it is about the fact that we want to get our purposes to work out and progress. I hope that the Minister will see this as helpful in stating what the public policy is, why this is being done, and what areas may in future be brought into being.

Of course, I regret that the noble Duke, the Duke of Montrose, was stuck in Scotland and therefore could not be here, because, under Clause 3, if all those things that are supposed not to be let out are let out, what will be the sanction?

--- Later in debate ---

[Lord Winston (Lab)]

That was a very complicated statement. I think the noble Lord, Lord Krebs, had a bit of difficulty with it, and so did I, so I shall read it with great interest in Hansard. Perhaps we can discuss one or two issues that the Minister raised. I think he said, though maybe I misheard, that there have been no recorded changes in the genome or in the DNA of animals that have been modified using the CRISPR technology, for example. I should like to get back to the noble Lord in order to share with him my understanding and to present him with some reports from the literature which argues that this actually has happened and that the introduction of stray DNA, as well as off-target mutation, is a real issue. But now is not the time to discuss this. We shall probably have to leave it until Report.

I am sure that we are basically working towards the same thing. However, it seems to me that, if you own a picture—a Rembrandt, for example—you do not automatically sell it as a Rembrandt; you sell it for what you think it is worth, or what its provenance is. So the provenance of what we sell in terms of our animals to other people is just as important. It is part of a proper sale. If in fact it depends on the genome and the nature of the genes—whether they are expressing or not expressing, and whether the progeny is normal—that, I would argue, is important to the person who is going to buy it. It is essential that we try to be honest, open and transparent.

[Lord Benyon (Con)]

That is absolutely right. I would just say to the noble Lord that ACRE assessed the evidence put to it by the scientific community. I repeat what I said. Many recent gene-editing studies on animals have reported no incidences of unintended genomic changes when using CRISPR-Cas9. If the noble Lord has information that ACRE should be considering in relation to this, I would be very happy to connect him with ACRE. But that is also the same scientific opinion that was reached by the European Food Safety Authority, which advises the EU Commission. But the noble Lord is absolutely right that the science on this is moving. There are advances being made, not just here but internationally as well, and we must have the best possible advice to allow Ministers to take the best possible decisions.

Genetic Technology (Precision Breeding) Bill

Lord Winston Excerpts

Report stage
Wednesday 25th January 2023 Lords Chamber

[Baroness McIntosh of Pickering (Con)]

I have nearly finished my remarks. I have some sympathy with the amendments from the Front Bench opposite and would like to hear a very good reason why my noble friend may be minded not to support them.

[Lord Winston (Lab)]

My Lords, I remind my noble friend Lord Krebs—and I call him my friend because I have huge respect for him as a scientist, a Peer and a contributor to the House—that one of the great outliers was Dr Oppenheimer at the time of the Manhattan Project, who afterwards recognised what had been released as a result of that. We know very well that every single piece of technology that humans have ever produced has a downside we do not expect, and do not recognise and predict at the time. I would argue that this is one of those examples of a technology, which we have a duty, as a House in Parliament, to examine extremely carefully. I am not sure we have done that yet, and I am not sure how we can do it very well.

--- Later in debate ---

[Lord Roborough (Con)]

My Lords, I declare an interest as a dairy farmer and as an investor in a number of agriculture-related businesses around the world. I also declare negligible scientific credentials, unlike many noble Lords who have spoken.

However, I believe that it is essential that farmed animals are included in the Bill without undue delay, and I am very much against any amendment which delays or removes these animals. I have previously mentioned in this House that I could raise the output of my herd by 23% were all my cows blessed with the same genetics as my best cow. As noble Lords have already mentioned, there are disease benefits. Another example is the Roslin Institute’s engagement in gene editing of salmon, which improves resistance to infectious pancreatic necrosis viruses. These are meaningful benefits and I agree that they also improve animal welfare.

I would also add that I do not entirely recognise the world that was described by the noble Baroness, Lady Bennett, earlier. Agricultural productivity continues to increase globally, powered largely by ongoing plant and animal selective breeding. I believe that we have an obligation to unleash this technology of precision breeding to further increase production globally and support a growing global population.

[Lord Winston (Lab)]

Before the noble Lord sits down, I wonder if he might be kind enough to comment on this, seeing as he wanted to breed his best cow with all the other cows to reduce genetic diversity. Can he tell me what happens if a virus comes along to which that herd is susceptible? What do you do then? That is the problem.

[Lord Roborough (Con)]

As a non-scientist, I am not sure that I have a good answer to that. I would rely on the vets.

[Lord Taylor of Holbeach (Con)]

I think my noble friend is quite right: we will depend on increasing productivity and will be able to do that only by breeding. The whole point of the Bill is selective breeding; actually, it is precision breeding. The noble Lord may well have this nightmare that we are releasing something ghastly into the world; I do not believe that is true at all. It is done because of objectives in the breeding programme, which is precise. This is just the sort of thing that I do—and I declare my interest as a horticulturalist, as the House well knows—when we are breeding bulbs and daffodils. But this is more serious; this is not about domestic gardening but is about feeding the world and making it possible for the diversity that exists in gene stock to be harnessed for greater productivity.

[Lord Winston (Lab)]

I do not want to argue with the noble Lord about this too much but, actually, I have to say that there is good evidence. For example, with gene editing and the operation called i-GONAD where you can change embryos, most of those animals look perfectly normal and would pass without their gene being changed, but it turns out, of course, that they do not actually fulfil the requirements that you eventually have for the gene. That is one of the problems. That is a serious issue because you change other genes; not as a result of editing them, but by having those other genes edited. That is a big problem.

[Lord Curry of Kirkharle (CB)]

My Lords, I will briefly respond to the noble Lord, Lord Winston, on that point. It is a fair question, which we do need to respond to: what happens if we narrow the gene pool and expose animals to genetic risk? There has been evidence in the past that by narrowing the gene pool in dairy cows, we have had lameness problems; there has been an issue in other species. That is because we have not properly understood; indeed, random breeding, as the noble Lord, Lord Trees, has said, has resulted in that kind of action. Through better understanding of the genes, and through ensuring that we retain as wide a gene pool as possible from which to choose, but being selective and more careful and intelligent about the use of those genes, we should avoid that consequence.

--- Later in debate ---

[Lord Krebs (CB)]

Obviously, I agree that the different parts of the genome serve different functions. As the noble Baroness said in Committee, when we were students, we learned about junk DNA. However, it is not junk DNA; it can play an important part in regulating the expression of other genes. I take the point.

[Lord Winston (Lab)]

I love the idea of the noble Lord’s field of wheat waving gently in the breeze and the sunlight, but does he not agree that certain genes in those wheat seeds are rather well conserved and, in fact, do not change? Indeed, certain genes are protected from mutation. Therefore, there is nothing to prevent us looking at analysis to see the frequency of certain mutations within the genome; perhaps we need to be doing that. The data there could be very useful in all sorts of ways.

[Baroness Bakewell of Hardington Mandeville (LD)]

My Lords, this group of amendments deals with technical scientific issues and moving whole or parts of clauses from the negative procedure to the affirmative. Your Lordships will know that I am not a scientist so I shall, I hope, avoid digging a hole for myself or getting caught in the crossfire.

Amendment 12, in the name of the noble Baroness, Lady Bennett of Manor Castle, would require the details of genome sequencing to be recorded in a publicly available register. If the processes outlined in this Bill are to be carried forward successfully, it will be necessary for farmers, producers and the public especially to have confidence in the process. Ensuring that there is transparency and visibility through a publicly available register can only help this process. The DPRRC was strongly in favour of such a register in its report of 2 December.

Amendment 13, also from the noble Baroness, Lady Bennett, seeks to make the whole regulation in Clause 3 affirmative. Currently, the Bill is silent on whether Clause 3 is affirmative or negative. I suspect that, as it currently stands, Clause 4(6) applies to the whole of the section headed “Release”.

I am grateful to the Minister for his amendments in this group. At Second Reading and in Committee, concerns were raised at the number of negative procedures in the Bill. The Minister has tabled government Amendments 14 and 15 to Clause 4, which would qualify the section on marketing and keep subsection (1)(b) as negative while the rest of this clause will be moved to the affirmative procedure. This is welcome and gives the opportunity for debate on the notification requirements if necessary. Perhaps the Minister can clarify in his response whether Clauses 3 and 4 are covered by his Amendments 14 and 15. If not, can he say what process is applied for Clause 3? I am sorry; I may have misunderstood what this is all about.

Amendment 16, to Clause 6(4), moves regulations on the precision bred confirmation from negative to affirmative. We welcome the Minister’s movement on this point. This is a sensible way forward and, again, gives the opportunity for further debate.

Government Amendments 24 and 25 are somewhat confusing. Amendment 24 indicates that the regulations under Clause 18(1) are to be affirmative, and Amendment 25 deletes “this section” and inserts “subsection (6)”. I think this means that Clause 18(1) is affirmative while the rest of the clause is negative, as Clause 18(7) has not been amended. I would be grateful for the Minister’s clarification. It is important for when we come to debate these things later to know whether it is affirmative or negative. Although these are technical amendments, they are very important and provide transparency in the Bill, which is to be welcomed.

[Lord Benyon (Con)]

My Lords, I thank the noble Baroness, Lady Bennett, for her Amendment 12, which would require details of the specific gene editing event and the whole-genome sequence of a qualifying precision-bred organism to be made publicly available for its release into the environment. The noble Baroness’s Amendment 13 to Clause 3 would require that regulations made under this clause to establish a public register containing this information are subject to the affirmative procedure.

It is not our intention to require breeders to include sequence data as part of their release or marketing notices. I have discussed this previously following an amendment tabled by the noble Lord, Lord Winston, in Committee. We have since had a very useful meeting with the noble Lord and our scientific advisors, ACRE, to explore why whole- genome sequencing information has limited value in most cases, and the noble Lord has not retabled his amendment on Report.

This type of information has limited value because there is a significant degree of genetic variation between individual plants and animals within a species, which is more or less the point that the noble Lord, Lord Krebs, was making. This amount of background noise means that the value in requiring whole-genome sequences is limited in terms of addressing regulatory questions; for example, questions about the precision-bred status of a plant or animal. Additionally, the release notice that researchers are required to submit to Defra will be in line with the requirements of the Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022, which were agreed by the affirmative procedure.

Our intention is that information provided in release notices will be published on the precision breeding register and will include the relevant and necessary information about the precision-bred organism in it. We also intend to require developers to confirm that the organisms that they intend to release in research trials meet the criteria in the Bill. The technical details of this notice will be prescribed by regulations, prepared with input from the advisory committee appointed to advise the Secretary of State on the regulatory status of these organisms and, in accordance with the amendments to Clause 4 that I have tabled, our intention is that such regulations will be scrutinised using the affirmative procedure before they are made.

I hope that this reassures noble Lords and that the noble Baroness, Lady Bennett, is persuaded to withdraw this amendment and not move her additional amendment to Clause 3, which would specify the parliamentary procedure for the delegated power that her substantive amendment would insert.

I always pay particular attention to points raised on secondary legislation by the noble Baroness, Lady Bakewell. As a member of the Secondary Legislation Scrutiny Committee, she is very good at holding me to account on these. I did not quite understand her point about Clause 3 because there are no regulations in Clause 3 and therefore no requirement for it to be affirmative or negative.

We remain of the belief that the matters to be set out in the regulations under the powers in Clauses 4(3) and 6(2) are administrative in nature. However, the Government acknowledge that these provisions are of significant public interest. We have heard this previously in the House and the Delegated Powers and Regulatory Reform Committee has raised this as well. We have considered these matters closely and have decided to change the procedure from negative to affirmative for both powers. These changes will increase the scrutiny when these powers are used to prescribe the information which must be provided to the Secretary of State by a person who wishes to release or market a precision-bred organism. I hope that noble Lords feel that I was serious in Committee when I said that I had listened to them. I hope that they feel that this improves the Bill. Regulations under Clause 4(1)(b) would be administrative in nature, not of significant public interest, and will remain subject to the negative procedure. I hope that this reassures noble Lords.

Amendments 24 and 25 will increase the level of scrutiny when powers are used to prescribe information that must be included in the precision breeding register. The Government acknowledge that these provisions are of significant public interest. We accept noble Lords’ concerns about the level of scrutiny for such provisions. Therefore, we will change the parliamentary procedure from negative to affirmative for the power in Clause 18(1). Regulations under Clause 18(6) regarding the keeping of the register, which is an administrative matter and, again, not of significant public interest, will remain under the negative procedure.

[Lord Winston (Lab)]

My Lords, I thank the Minister for what he has just said, but can he answer this question about whole-genome sequencing?

When we first started genome sequencing, it was laborious, expensive, time-consuming, and so on. It is now a pretty rapid process and can be done without huge expense. Does the Minister not agree that one of the reasons for doing this is not just marketing—because of course there are different issues there, which is how we are addressing this—but the advantage of getting more knowledge about what we are doing? The advantage there would be seeing where things are moving within the organisms that we are trying to edit. That is important as a research tool because, ultimately, we are doing something that—admittedly—we do not fully understand, and this would greatly increase knowledge. Does he feel that this is a relevant point?

[Lord Benyon (Con)]

It is entirely a relevant point, and was much on our minds when we debated some months ago a research measure in secondary legislation to allow the development of plant precision editing but not for it to be taken forward to market. The noble Lord is absolutely right that this is fast-moving and that we therefore need to be clear about how we regulate: that we are regulating a research process and a process to take products to market. Ministers will have to be clear about the intention of the organisation taking that forward. I hope, through the changes that we made, that there will be greater parliamentary scrutiny, that people with real knowledge, particularly in this place, will be able to scrutinise that, and that the Secretary of State of the day will have the best available information about what is being taken forward and why—whether it is just for research. The point made by the noble Lord about the value of research of products that will never go to market, that it is just to understand a particular aspect of genomic sequencing, is crucial.