Genetic Technology (Precision Breeding) Bill

(Limited Text - Ministerial Extracts only)

Committee stage
Monday 12th December 2022 Lords Chamber

[Baroness Hayman of Ullock (Lab)]

I thank the noble Lord, Lord Krebs, for his very important point. We need to think about where we want to go with this and how we want those regulations to come in as we go through the Bill. I am sure that we will be having some very interesting debates on that as we move forward. Clearly, the whole purpose of the Bill is about deregulating the law on gene editing so that we can actually move forward beyond the traditional breeding processes.

The purpose of this group is to look at the definitions as to how we move forward; what we mean by that; and whether the Bill has the right definitions in it. The noble Baroness, Lady McIntosh of Pickering, talked about unintended outcomes, for example. The interesting thing for me is whether “precision breeding” is the right terminology. Why have the Government picked that terminology? That is something that a lot of noble Lords raised on Second Reading, and again now.

The noble Baroness, Lady McIntosh, also talked about the EU. One of the things that I have noted is that the EU has quite a different term. I am not aware that the European Union is using the term “precision breeding”, but it is looking at “new genetic techniques”. How does what we are doing in this regulation fit in with what the European Union is doing? We will be talking about trade later on but, clearly, it is going to be very important that it all fits together and works together in the long term. It is going to be very interesting to look at how we develop as we go on.

A lot of the definitions are quite vague as well. It would be helpful if the Minister could, perhaps, explain some of the definitions in Clause 1. For example, in Clause 1(1), the actual definition of “precision bred organism” is very, very broad. Is it deliberately broad? Is it trying to capture something in particular? My noble friend Lord Winston talked about traditional processes and natural transformation, as well as referring to “stable”. Understanding what these actually mean and their implications for the Bill going forward are important.

Amendment 86, from the noble Baroness, Lady Bennett of Manor Castle, again refers to the title, coming back to what we have just been talking about. She also has Amendment 11 on exogenous genetic materials. There has been some work done by Defra to shed some light on this. The consultation, for example, that was carried out last year, states that

“this proposal does not apply to organisms which introduce genetic material from other species.”

However, that distinction, as we have heard, is not in the Bill. Does it need to be in the Bill?

It is not stated anywhere that precision breeding technologies are technologies that edit a single organism. I refer to Clause 1(7), which refers to

“somatic hybridisation or cell fusion of plant cells of organisms which are capable of exchanging genetic material”.

What does that mean? Does that open the door to transgenic exchange, for example? Some of it is quite weak on definitions, and some of the definitions could be stretched to include pretty much anything—so I do think that some kind of clarification would be very helpful.

The chief scientific adviser to Defra, Professor Henderson, giving evidence to the Commons Select Committee, said that the Bill was designed not to allow exogenous material. He also said, however, that this was something of a grey area. Particularly in the light of what the noble Lord, Lord Krebs, said—and he has a far greater understanding of this than I do—it is very important to get clarification on this area before we move further on into the detail of the debate.

[The Minister of State, Department for Environment, Food and Rural Affairs (Lord Benyon) (Con)]

My Lords, I am very grateful for this interesting debate on this first section. I will start with, I hope, a note of humility: I understand that I am in the presence of people who have proved, in the introductions by the noble Lords, Lord Winston and Lord Krebs, and others, that I sit at the foothills of knowledge compared with them. The noble Baroness, Lady Bennett, quoted Descartes—I think he said, “All I know is that I know nothing”. I hope I know a bit more than that, although my learning curve has been very steep. I am grateful to officials at Defra and others who have helped me through this process.

I am aware that the term “precision breeding” has been controversial in some quarters, although well received in others. I thank noble Lords for this opportunity to explain why we have adopted it. The noble Lord, Lord Winston, suggested “directed bred” as an alternative term to “precision bred”, whereas, on this point, the noble Baroness, Lady Bennett, suggested “genome editing” to replace “precision breeding”. Concerns have been raised about using the term “precision bred” to describe these organisms, because they can result in off-target changes to the organism’s DNA. Although off-target changes can occur using precision breeding technologies, the advice we have received from our Advisory Committee on Releases to the Environment—ACRE—in relation to precision-bred plants is that off-target changes are significantly rarer than those produced during the course of conventional methods of plant breeding. This is also the view of the European Food Safety Authority, which advises the EU Commission.

On animals, ACRE concluded in its advice published in September last year that there is good evidence to suggest that the use of techniques such as CRISPR-Cas9 in animals does not result in a greater number of off-target changes than the background rate for natural mutations—the noble Lord, Lord Krebs, referred to this. Indeed, many recent gene-editing studies on animals have reported no incidences of off-target changes when using CRISPR-Cas9. Therefore, although off-target changes may occur using these technologies, the scientific advice is that they are more precise than traditional breeding, both in terms of making targeted changes to the DNA of a plant or animal and in terms of the number of off-target changes they cause.

In her amendment, the noble Baroness, Lady Bennett, used the term “genome editing” instead of “precision breeding”. The class of plants and animals we intend the term to cover will include some gene-edited organisms. However, it will not cover all gene-edited organisms; it will not include plants and animals that contain genetic features produced by modern biotechnology that could not have occurred naturally or by traditional processes. For example, plants or animals developed using gene-editing techniques to contain engineered gene drives would not be included in this new class of organism; they will still be regulated as GMOs. In addition, there are techniques of modern biotechnology other than gene editing that could produce plants and animals in this new class—for example, cisgenesis. It is important to note that the EU is also considering cisgenic, as well as gene-edited, plants in its plans for regulatory reform.

We considered using the term “gene edited” in the Bill but, for the reasons I have explained, we concluded that this would be more misleading and confusing. The purpose of the Bill is to more closely align the regulation of this class of animals and plants with those produced by traditional breeding, recognising that the genetic changes they contain will have arisen in a more targeted and precise manner.

The noble Lord, Lord Winston, makes a very good point about the very important need to engage the public more on this case. The Government have tried very hard to do this, and the Food Standards Agency and wider organisations are doing some very good work. There is a big social science job to do to get the message out about what we are talking about—and, perhaps as importantly, what we are not—and the wider benefits, which we will come to in this and other clauses, about how we can improve the life of us here on this planet, protect animal health and make us more resistant to such factors as climate change. These are factors that we need to hold in our minds as we rightly debate this important Bill, line by line.

Amendment 10 would, in effect, remove the requirement that every feature of an organism’s genome must have been capable of resulting from traditional processes or natural transformation in order for the organism to qualify as precision bred. I understand that the noble Lord’s intention in tabling this amendment was to explore the meanings of the concepts of “traditional processes” and “natural transformation” that are used in this Bill. I hope to address his concerns around the terminology that we have used in this Bill and why it is appropriate. I will begin by defining what we mean by “traditional processes” and “natural transformation”.

For the purposes of this Bill, traditional processes refer to a number of methods listed in Clause 1(7). The noble Baroness, Lady Hayman, also referred to these. They are well known conventional breeding methods, some of which have been utilised for over 10,000 years, and therefore have a long history of safe use. The methods outlined in Clause 1(7) were not chosen to represent an exhaustive list of traditional breeding processes. Instead, they were chosen because they represent the full range of genetic changes known to occur naturally between sexually compatible plants and animals.

Scientific advice is that genetic changes that could have been achieved through traditional processes, as outlined, do not pose a greater risk as a result of being introduced by modern biotechnology. This is why we have included

“could have resulted from traditional processes”

as a criterion for obtaining “precision bred” status.

“Natural transformation” refers to the process by which DNA from a sexually incompatible organism may be inserted into an organism. In plants and animals, this is almost always the result of infection with a bacterium or virus. Often, the fragments of genetic material left behind after infection no longer serve a purpose or function. The material is non-functional and does not affect the physical characteristics, also referred to as the phenotype, of the plant or animal.

The effect of Clause 1(2)(c)(ii) and Clause 1(6) taken together is to ensure that, for the purposes of this Bill, DNA from a sexually incompatible species which is similar to that which occurs through natural transformation is allowed in a precision-bred organism. This is so long as it does not affect the physical characteristics of the precision-bred organism. This is supported by scientific advice that genetic features produced through modern biotechnology but which could have arisen in nature do not pose a risk as a result of the method of production.

DNA from a sexually incompatible species is critical in the intermediate stages of development of many precision-bred plants and animals. They enable the subsequent precise genetic changes to be made to these organisms. For example, CRISPR-Cas9 often involves insertion of the Cas9 editing machinery to enable the intended precise genetic edits. The Cas9 gene would need to be removed for the resulting plant or animal to be classed as precision bred. Clause 1(6) comes into play where, in some cases, small non-functional fragments of DNA from the Cas9 gene may be left behind. This would be allowed, provided the genetic changes created could have been introduced through natural transformation.

Taken together, the terms “traditional processes” and “natural transformation” ensure that precision-bred organisms are able to contain, in principle, changes that could develop in nature. It is this characteristic that makes precision-bred organisms and GMOs fundamentally different, and we believe that regulating them as such is a proportionate response to the growing body of scientific evidence supporting the safe use of precision-bred organisms.

--- Later in debate ---

[Baroness Bennett of Manor Castle (GP)]

The noble Baroness, Lady Hayman, raised the issue of international compatibility of terminology. I am sure the Minister is aware that the International Organization for Standardization, more commonly known as ISO—and many noble Lords are familiar with ISO numbers applied to all sorts of technical and practical procedures—earlier this year produced a genome-editing vocabulary. It provides a list of internationally agreed terms that will

“improve confidence in and clarity of scientific communication, data reporting and data interpretation in the genome editing field.”

There is no mention of precision breeding in that internationally agreed ISO dictionary of terminology. Picking up the point from the noble Baroness, Lady Hayman: would it not be better if we used internationally acknowledged terminology?

[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.

--- Later in debate ---

[Lord Benyon (Con)]

My Lords, I am grateful to the noble Baroness, Lady Jones of Whitchurch, for reminding me that I have not referred noble Lords to my entry in the register or stated that I have farming interests. I thank her for being on the board of Rothamsted, one of the great institutions of this country. Many of the scientists there have been enormously helpful to us in the development of this legislation, and I am grateful to them for that.

I thank the noble Baroness for Amendment 2. The focus of our discussion has been on crop plants, but there is potential for precision breeding to be used in the breeding of other plant species, such as in forestry and ornamentals. I entirely agree with that. There would have to be a market for them, and I do not think they would be a priority for plant breeders in ornamentals, but there are huge possibilities for this in areas such as forestry.

The noble Baroness, Lady Wilcox, who I welcome to her post in the team, mentioned ash dieback. She is entirely right that it is a scourge on our environment and anything that can help to protect our forestry, ecosystems and woodland environments is important, which is why there may be a future for precision breeding in some of these areas.

Precision breeding could be particularly beneficial to speed up the breeding process in species that take a long time to mature—for example, to introduce disease resistance and drought tolerance traits in trees. This could have benefits for the forestry sector and for trees that are particularly susceptible to disease. As such, the definition of plants in the Bill is necessarily broad to allow for precision breeding and for the benefits to be realised in a range of species.

Our scientific advisory committee, ACRE, advised that precision-bred plants pose no greater risk to the environment than traditionally bred counterparts. It also advised that crosses between precision-bred crop plants and any sexually compatible wild relatives are extremely unlikely to result in weedier wild populations. Precision-bred plants are unlikely to be more invasive or persistent in non-agricultural settings compared to traditionally bred equivalents. This is because precision breeding relies on the creation of the same type of genetic variation as is selected for in traditional breeding.

The Bill introduces two notification systems. They require developers to provide information about precision-bred plants before they are released into the environment. Our intention is that this information would be published on a public register before the plants are released. I assure the noble Baroness that this will be closely monitored by the Government and, we anticipate, by stakeholders.

This Government have a strong commitment to protect and improve the environment, and we are clear that environmental protections are not being reduced in this Bill. Existing regulations such as the Wildlife and Countryside Act 1981 and the Natural Environment and Rural Communities Act 2006 will continued to apply to protect the environment from the introduction of non-native and invasive species.

I hope that reassures the noble Baroness that precision-bred plants pose no greater risk to the environment than traditionally bred plants, and that the Bill provides for proportionate systems to monitor developments in how these technologies are applied. I hope that she will feel able to withdraw her amendment.

The noble Lord, Lord Cameron, raised some interesting points. If he will forgive me, I will keep my powder dry until we get to the group beginning with Amendment 19, later in today’s proceedings, because that is where I can best address his concerns.

I turn to Amendment 31, which probes how the use of a precision-bred organism may impact on agricultural processes and systems. As I have previously outlined, we see precision breeding as an essential part of our toolkit to improve our food system. We are already seeing promising research in which precision breeding could positively impact agricultural processes, such as by reducing the need for pesticides and fertilisers and reducing water use.

In countries such as Argentina, where the use of precision breeding has already been regulated in a more proportionate and cost-effective manner, there has been an increase in the variety of beneficial traits being researched. We hope to see a similar outcome in England. This would enable our farming system to benefit from new varieties and breeds that have improved climate and disease resilience and pest tolerance, among other things. We do not expect one trait, product or company to dominate the market and shape agricultural processes in England.

Existing regulations related to plant variety registration, seed certification and seed marketing already deliver an assurance of quality and stability for most agricultural crops. For some agricultural crops, this also includes additional testing for value for cultivation or use. If such crops were to be developed by precision breeding, they would also fall under these regulations.

Precision breeding has the potential to bring positive impacts for farmers and the environment, and we want to encourage that. To encourage this innovation and investment, we need to create a more proportionate and science-based regulatory regime. That is what we are trying to achieve in the Bill. I hope that provides the reassurance that noble Lords require.

[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.

[Baroness Jones of Whitchurch (Lab)]

My Lords, I thank the Minister for that response. I accept, as several noble Lords have said, that there is a role for gene-editing techniques in breeding disease-resistant trees. My noble friend Lady Wilcox gave the good example of ash dieback and we can think of other examples of such applications.

The Minister seems to be going gung-ho for all markets, if I could put it like that. I caution against that. As I said earlier, we need to do this step by step. We all understand the pressure to feed the nation more productively, but I am not sure that it is a priority to go beyond that to things that are more decorative, for example, even if there is a market at this time. I would have liked the Government to have had a more balanced view to this, but I will study what the Minister said more carefully in Hansard.

Moving on to Amendment 31, I do not think the Minister actually answered the fundamental question, which is whether the advisory committee will be asked to look at the wider implications for agriculture of these particular techniques. Will it be looking purely at whether the individual genome is safe or at how it might impact on the wider landscape, if it is planted in the wider landscape? All we were asking is whether the advisory committee will be given that role. The noble Lord mentioned other pieces of legislation, but we should not have to rely on them to make sure that the environment is protected. It would be nice to see that written into the Bill.

[Lord Benyon (Con)]

I will just answer that precise point. That is very much what ACRE does. It would not just be restricted to looking at a narrow area of science but the wider implications of the release into the environment and any impacts that that could have.

--- Later in debate ---

The Minister has talked about the need to future-proof. I absolutely understand that, but we need to have those timescales—those restrictions, if you like—about when things can happen laid out clearly in the Bill. We will come to group 5 on implementation shortly, and I am sure we can look at this further then. There will also be more debate around animal welfare in group 8. However, I am concerned that we are moving forward without the information and the right regulation in place at this stage.

[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.

[Lord Trees (CB)]

On companion animals, I can understand that this is a difficult and quite controversial issue. There is an irony and a paradox—for example, around short-nosed dogs; the so-called brachycephalic breeds—and we can look at it with either a glass half full or a glass half empty approach. The irony is that, through natural, traditional breeding, we have bred animals that are deformed. Brachycephalic breeds have a markedly reduced life expectancy than breeds with long noses. They have not only problems with obstructive airway disease but delivery by Caesarean section is much more frequent, and they have ocular and skinfold problems. Genetic manipulation and editing could help reverse these trends much more quickly than might happen through traditional breeding. We need to be open minded about the potential for good, as well as the potential for less good outturns.

[Lord Benyon (Con)]

I totally agree with the noble Lord: there are opportunities here. With the balanced approach that we have taken and the step-by-step approach with which we will implement the legislation, I hope that we can quickly get to the place that the noble Lord described, where we start to reverse some of the terrible things that we have seen in traditional breeding processes. I hope that the Bill can be seen as paving the way for higher standards in animal welfare for all kinds of animals.

I am about to sit down, but I can see various noble Lords poised to step in and I am very happy to take more points.

--- 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.

[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?

[Lord Benyon (Con)]

I do not think that any conversation I have had has considered what our priorities would be. Our priorities would be to look at farmed animals and possibly the benefits for companion animals. We are not a range state when it comes to those sorts of animals, and I cannot see that being a priority.

[Baroness Bennett of Manor Castle (GP)]

I thank the Minister for his answer, but I note that the Bill allows that to happen. There is nothing in it to say that it would not. I have no doubt that this is an issue that we will return to on Report, probably at some length, with a number of choices before us. I beg leave to withdraw the amendment.

--- Later in debate ---

[Baroness Wilcox of Newport (Lab)]

I am grateful to the noble Baroness, Lady Bennett of Manor Castle, for tabling Amendment 12, and to the noble Lord, Lord Krebs, for tabling Amendment 74, which my noble friend Lady Hayman of Ullock was pleased to sign. Issues around intellectual property were not explored in any detail in another place; nor did the topic feature heavily in the Hansard report of Second Reading. Some may argue that such matters are pushing the scope of this legislation, but we believe it is vital that all interested parties understand the regimes that will apply once the Bill is passed and enacted.

For a product to make it to market, it will have been subject to research, testing, scaling up and the release and marketing processes laid out in the Bill. This will involve significant costs for those who develop the technologies and associated products. We understand that they will want to protect that work and the underlying financial investments to the best of their abilities. On the other hand, for this process to be successful, we need to see fair prices for the farmers who will utilise these technologies or the new plant and animal varieties that arise from them. At present, it is not clear what IP regimes will apply. We can make assumptions, but there is no certainty. As a result, we do not know how many players will bring these new products to market, nor how many farmers will be able to afford them. Amendment 74 offers a way forward, requiring the Secretary of State to publish guidance on these matters prior to bringing the bulk of the Bill’s provisions into force.

These matters are incredibly complex and perhaps not best dealt with through additions to the final version of the Bill. However, this is Committee, and we hope that the Minister will be able to provide an indication that this work is not only in progress, but that appropriate guidance will be in place at the earliest opportunity.

[Lord Benyon (Con)]

I thank noble Lords for their amendments regarding intellectual property laws. I will first take the probing amendment in the name of the noble Baroness, Lady Bennett of Manor Castle, which would prevent an organism from qualifying for precision-bred status if it was subject to a patent, either on the product itself or on the process used to produce it. This provides an opportunity for us to explore how a precision-bred organism can be patentable, and what it means for such an organism to be capable of having

“resulted from traditional processes or natural transformation”.

As I am sure she is aware from previous debates in Committee, it is the final genetic composition of an organism that we are considering when assessing whether a plant or animal meets the criteria for being “precision bred” as set out in the Bill. This is in line with the scientific advice we have received: that it is the final genetic and phenotypic characteristics of an organism that are important and not the technology or process used to produce it.

This approach differs fundamentally from the current principles used to determine whether patents are available for plants and animals whose DNA has been altered using modern biotechnology. Unlike the definition employed in the Bill to determine whether an organism is precision-bred—which, as I have said, focuses on the end result—patent principles focus on the technology or processes used to produce these plants and animals.

The definition of a “precision bred organism” should continue to be based on scientific evidence and advice. In continuation of this logic, it would be disproportionate and unscientific to prevent a qualifying precision-bred organism from having precision-bred status on the basis of the granting or not of a patent. To prevent precision-bred organisms from obtaining patent protections would go against the core principles on which the Bill is based: that regulation should be proportionate, robust and driven by the evidence.

An invention must meet a number of legal requirements if a patent is to be granted. The granting of a patent is determined not only by the nature of the invention but by other legal requirements, including whether the invention is new or non-obvious. This is not the same as asking whether an invention that did not exist previously could, in principle, have been produced through a different method. As such, the presence or absence of patent protection cannot be used to determine if a particular DNA sequence could have resulted from traditional processes or natural transformation.

Patents represent an important mechanism for innovators to gain return on their investments. As a result, preventing organisms from being classed as “precision bred” if those organisms or the processes used to create them are subject to patent protection, would likely deter uptake of the technologies that the Bill wishes to facilitate. Ultimately, the UK would lose the significant benefits that implementation of the Bill could bring.

Amendment 74 would require the Defra Secretary of State to review and publish guidance on the implications of the genetic technology Bill for intellectual property law. As I am sure that noble Lords are aware, in the UK the Intellectual Property Office is responsible for patents. I assure noble Lords that we have worked closely with the Intellectual Property Office in this area. UK patent law does not specifically exclude patents from being granted on precision-bred plants and animals. Indeed, a patent may be granted if all the requirements for a particular invention are met—novelty, utility, and non-obviousness.

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.

Most interest in this area has revolved around the use of patents that protect precision-bred organisms. However, it is important to note that other protections for intellectual property are available. For example, a plant breeder may want to obtain protection using plant variety rights. In animals, breeders generally gain protections through contracts with buyers, which stipulate terms to ensure their trait of value is protected. Engagements with industry stakeholders have highlighted that fair access and value gains for farmers must balance with restrictions on the use of protected material in order to enable a return on investment. In plant breeding, licensing platforms which facilitate access to patented material have been borne out of the need to create this equilibrium. We envisage that a similar situation would arise should breeders decide to protect their precision-bred organisms. Ultimately, patent law strikes a balance between incentivising innovation and allowing access for farmers and breeders, precisely the point that the noble Baroness, Lady Wilcox, was making.

[Lord Krebs (CB)]

I do not know who drafted this response but it is a masterpiece of obscurantism, in my view. I do not blame the Minister; he is simply reading out what his civil servants have given him. I could not understand—maybe because I am falling asleep or something, but I do not think I am—whether the answer is that PBOs are equivalent to the plants or animals that could be produced by conventional breeding, and therefore enjoy the same protections, or whether they are different. Will he just nail that point down, with a very simple yes or no? Is his answer that precision-bred organisms are treated as equivalent to those that could be produced by conventional breeding, and therefore they enjoy the same patent protections?

[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.

[Baroness Bennett of Manor Castle (GP)]

My Lords, I thank the Minister for his answer and everyone who has contributed to this short but very dense—I think that is the appropriate adjective here—debate. I cannot help feeling that, should we revisit this on Report, as I suspect we may, we will need a couple of IP KC specialists to hand it over to, rather than leaving it to be tangled with by those who are not legal specialists in this area. The noble Baroness, Lady Wilcox of Newport, nailed it: it feels like this has not been properly worked through, and it certainly has not been explained to the Committee. That is exactly where we have arrived at.

I will put some more questions to the Minister, because I am wrestling with this. I freely acknowledge that I am not an IP law specialist, by any means, but how can something that is patented be natural and traditional? Those two things are simply incompatible in law, and certainly in public understanding. That is what my amendment addresses, and I do not believe the Minister has dealt with that issue.

More specifically and concretely, and perhaps easier to answer—although I understand if the Minister wants to write to me—he referred to some of the tangles that had occurred previously with GMO technology. Seeds had blown from one field to another, and a farmer who had not even planted the patented crop found themselves in legal difficulty with its owner because they were illegally growing the seeds, even though they did not want them. Some of them may even have been organic farmers, who definitely did not want those seeds. Can the Minister assure me that we will not see this situation arising with so-called precision-bred organisms in the UK, particularly plants in this case—I am not sure we are talking about animals as much? Also, what happens if a genetic trait cross-breeds with or appears in a weed? Who is responsible for that? Is the owner of the intellectual property responsible for what happens with the weed?

[Lord Benyon (Con)]

That last point would have been dealt with in the process for ACRE’s analysis of its worthiness as a precision-bred organism that can be taken to market, as it clearly does not sit within the intent of the applicant.

All I can say to the noble Baroness, as I said earlier, is that we want to achieve a balance in encouraging the development of this. She was wrong earlier to say that this is just for commercial activity. It is very much not. There are other benefits, public goods, that the Bill achieves in animal welfare, tackling climate change, improving our environment, and reducing the requirement for pesticides and fertilisers. Just as there is a balance between those public goods and encouraging commerce and the ability of organisations to take products to market to be of advantage to the UK economy, the Bill also tries to achieve a balance between securing the intellectual property rights of those who have invested large amounts of money in the development of precision-bred organisms and the importance of making those organisms available to precisely the people who we want to have them. In most cases, that will be producers of food.

[Baroness Bennett of Manor Castle (GP)]

I thank the Minister for tackling those questions. I feel that it might be best for me to write to the Minister to spell out the details of the questions that I am not sure I am sufficiently equipped in the IP area to formulate now. We are going to revisit this at Report, and I do not think we have heard any kind of argument against Amendment 74 and the idea of a review. In the meantime, however, I beg leave to withdraw the amendment.

--- Later in debate ---

[Baroness Hayman of Ullock (Lab)]

My Lords, I thank the noble Baroness, Lady Bakewell, for introducing her Amendment 16. As we have heard, there are a few amendments in this group around trade, particularly in relation to the EU and individual member states. Amendment 16 specifically refers to this. It is an important consideration for the Bill and its implications

The noble Baroness, Lady Bennett of Manor Castle, has tabled a number of amendments in this group. I also thank her for her introduction. I have added my name to her Amendments 75 and 78. As Amendment 75 says, it is really important to review the effectiveness and implementation of the Act once it is passed. The Minister has talked about a step-by-step process. I shall come to that as well in my amendment. As I mentioned on the previous group, there are still a lot of unknowns and a lot of SIs to come into play before we know exactly what the legislation will look like. A commitment to a review is pretty important to make sure that everything is happening as the Government intend and to see whether anything needs to be picked up that is perhaps not moving as they would wish. My noble friend Lord Winston made the important point that we need more data on animals. A review would help to look at where we were.

Amendment 78, to which I have also added my name, requires the Secretary of State to have regard to the impact on SMEs, for example. The noble Lord, Lord Cameron, mentioned the importance of supporting small businesses. From reading the Committee evidence in the Commons, I recall that there was quite a lot of debate around the importance of small businesses also being able to benefit from this legislation and not being pushed out by the larger companies. I would be interested to hear from the Minister how the Government intend to ensure that small businesses are allowed to play a full part in any legislation that comes from the Bill when it is enacted.

On a different topic, my noble friend Lady Jones of Whitchurch probed concerning Section 41 in the Environmental Protection Act. Again, this is a really important point. There are different pieces of legislation covering very similar areas. How do they interact? She asked an important question about when the review on wider GMO rules would take place. Once this review has reported, how will the outcomes be managed in relation to the new legislation that is coming forward? Not all legislation sits in its own little place. Lots of legislation interacts, at the Minister well knows. It would be good to know that the Government are looking at this, thinking about it and to know when they were likely to do a review.

I will come on to my Amendment 89 in a minute, as it is a little different. But briefly, on the trade implications which we touched on previously, the Food and Drink Federation has said, for example, that there could be barriers to exporting English farmed food from gene-edited crops. Again, it would be interesting to hear the Minister’s thoughts on this. We also talked earlier about what the impact of a difference in definition would be, and that comes into play here as well. At the end of the day, any commercial cultivation of plants or food products that are derived from gene-edited crops will still fall within existing rules. We know that the EU is reviewing where it is, but it is important that we do not end up with negative impacts on our farmers and exporters in food products because we have not thought this through properly.

Perhaps the Government could reassure us that that they are looking at the trade implications and whether they are considering any mitigating factors to ensure that there are no problems. The impact assessment says that it could

“have a relatively significant impact on UK producers”

if there are problems with exporting to the EU, because

“UK crop-related food exporters are heavily dependent on EU consumers’ demand”.

Again, it is important that we have those assurances. I know that the noble Lord, Lord Krebs, is concerned about the word “risk”, but there are risks to exports which the Government need to recognise.

In looking at whether products are going to be accepted, I want to ask about Scotland. I am concerned that the Minister in Scotland said that they would not have any food products forced on them because of easing regulations around gene editing. That concerns me because, if we are not careful, we will have a constitutional flashpoint. Our single market rules say that any produce approved in England is automatically then allowed into Scotland, so what ongoing discussions are the Government having with Scotland on this and what mitigating circumstances can be brought in? That is a worry.

Finally, my Amendment 89, which I have left to the end because it is different from the others, brings me back to where I was on the step-by-step approach. I asked the Minister whether he would consider that; I know he has reassured us, over and again, that precision-breeding technologies will be used first in relation to plants, followed by animals later. But not to put too fine a point on it, we have only his word for that—and while I trust his word, we do not know who the future Ministers or Secretaries of State will be. My amendment makes a suggestion that he could pick up, so that we genuinely would have a step-by-step approach in the Bill. It would be plants first, then farm animals, and then other animals could be looked at. Again, I am only trying to be helpful to the Minister in supporting his step-by-step approach.

[Lord Benyon (Con)]

I appreciate that, as keen as I am to get this right and get something sensible on the statute book. I have a throwaway line before I get into the meat of it. The noble Baroness, Lady Bennett, talked about this being controversial legislation. Actually, in some of the surveys I have seen, a very small number of people are either very opposed or very in favour, and a large number do not know what this is all about. They want to know more, and we have to tell them more. We have to explain it in an unbiased, unpolitical, factual way, and that is what we are seeking to do. In the other place, the Bill passed by a majority way in excess of the Government’s majority, and I want to reassure many noble Lords here, so that we can pass it with equal fervour.

Smarting from the earlier comment from the noble Lord, Lord Krebs—

[Baroness Bennett of Manor Castle (GP)]

I think the Minister tried to suggest that the legislation was uncontroversial. We were before discussing the inclusion of animals in the Bill, and 13 of what I think would be universally agreed to be the premier animal welfare organisations in the UK have said animals should not be in it. That surely is controversy from people who are very informed about its nature.

[Lord Benyon (Con)]

I accept the point the noble Baroness makes, and of course, there are others who fervently want measures brought in as quickly as possible that deal with animal disease, animal welfare and those sorts of things.

As the noble Lord, Lord Krebs, quite rightly upbraided me earlier for boring the House, I will try to be as quick as I can, but there is a lot in this section, and I want to be open with the Committee in my comments.

I will respond first to Amendment 16, which would require the Secretary of State to consult, first, representatives of a number of interested groups and then European partners including but not limited to the EU and its member states. This is to agree on a definition of precision breeding and, if a definition is agreed, to amend the definition of a precision-bred organism in the Bill accordingly, using a Henry VIII power. The amendment could be used to change the key concepts that form the basis on which this legislation has been drafted and debated in both Houses of Parliament.

This summer, the EU conducted a consultation in which 80% of participants agreed that the existing provisions of the EU GMO legislation are not adequate for plants produced by certain new genomic techniques, which largely aligns with our view of precision breeding. As I have previously mentioned, the definition of a precision-bred organism in the Bill aims to cover all plants and animals produced by modern biotechnology that could have occurred through traditional processes or natural transformation. This approach to carving out precision-bred plants and animals from GMO legislation is in line with scientific evidence and advice, because it focuses on the end product rather than the technology used to produce it.

Furthermore, we have continuously engaged with national and international stakeholders and regulators to develop a definition that reflects the key principle of this legislation. Our approach is based on the science. With regulations on precision-bred plants and animals changing around the world, we believe the measures in this Bill will facilitate greater trade.

On the topic of trade, I am grateful for the opportunity to discuss how differences in regulation and public perception in other countries will impact on our trade with them. Noble Lords have referred to genetically modified organisms in the amendment we are dealing with, and I want to be clear that there is a scientific distinction between GMOs and precision-bred organisms. Many countries recognise this and have changed, or are in the process of changing, their regulations to reflect it. As the international regulatory landscape evolves, our approach could help facilitate greater trade with countries that have already adopted a similar approach to the regulation of precision-bred organisms, with trading partners such as the USA, Canada, Japan and Argentina.

Currently, there are only a few precision-bred products on the market globally, and none of those are traded internationally. Many of them are still in the early development stage, allowing time to monitor and understand the international regulatory framework as it develops. Britain is an exporter of quality products, and one of the reasons for introducing this new, proportionate regulatory approach is to enable the development of more nutritious, higher-quality products that have been grown more sustainably.

Turning to Amendment 77 and the remarks made by the noble Baroness, Lady Bakewell, I would like to outline developments that are likely to change the requirements for companies exporting precision-bred products specifically into the EU; we have been following these developments with interest.

As our legislation on genetically modified organisms mirrors the EU’s, it is not surprising that we have the same drivers for change. The timing of the EU’s reform plans means that we are unlikely to be able to consider any new EU legislation while we are drafting our regulations under this Bill. However, we will continue to monitor developments closely and work with the EU, and other countries we trade with, to enable innovation and trade. I hope I have reassured noble Lords on this.

--- Later in debate ---

[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.

[Baroness Bakewell of Hardington Mandeville (LD)]

My Lords, although I thank the Minister for his response, I am obviously somewhat disappointed by it. I understand the desire of the noble Lord, Lord Cameron, to speed up the process, but I fail to understand how consulting with the EU would affect that. It certainly would delay it a little bit, but not by the years and years that the noble Lord indicated. I believe that a Bill introducing a process which alters the genome of crops and animals ought to have a review every five years. I accept that the Minister feels that there are sufficient reviews in place—I just do not necessarily agree with him.

The Minister spoke about a consultation that took place—he did not say exactly when it was, but I think it might have been last year—and said that 80% of those consulted said that the EU definition of precision engineering was not adequate, and that the end product, rather than the process, was more important. The Minister can write to me, given the hour, but I would like to know who was consulted—who were these 80% of people who said that the EU’s process was not fit for purpose? The Minister also said that the UK’s regulations mirrored the EU’s regulations and monitors; that conflicts with this figure of 80% saying that they were not fit for purpose. For me, it is smaller businesses that benefit most from trade with the EU rather than with Argentina, although I accept that some will trade with the latter.

--- Later in debate ---

[Lord Benyon (Con)]

My Lords, I am grateful for Amendment 19, which raises the importance of ensuring that what we do has a public benefit. Across government we are undertaking a range of what I believe is really exciting work to deliver public good and we want to see precision-breeding technologies complement this work to improve our food system and the environment.

On my phone I keep some crucial lines from the Agriculture Act, because when I meet farmers and they say that this Government no longer mind about food production I remind them that right at the front of the Agriculture Act, in Clause 1, it says:

“In framing any financial assistance scheme, the Secretary of State must have regard to the need to encourage the production of food by producers in England and its production by them in an environmentally sustainable way.”


That is a declaratory statement right at the front of the Act. What we are seeking to do in terms of environmental land management goes through the heart of that piece of legislation and this piece of legislation fits very firmly within that.

As noble Lords are aware, the UK is privileged in its scientific position and researchers across the country are already delivering exciting research that contributes towards public good in the field of precision breeding. In the other place, the John Innes Centre gave evidence about the vitamin D tomatoes that its research group is developing, striving towards improving the food we eat for the benefit of our health. Another notable example is from researchers at Rothamsted who are exploring ways to increase the lipid content of grasses. This could help improve the quality of animal feed and has the potential to reduce methane emissions in livestock. I think we are all proud of the work taking place in this country and I am sure that the noble Baroness, Lady Jones, is particularly proud of Rothamsted.

This amendment, I fear, might hinder the important research in this area by placing restrictions on and creating significant uncertainty for critical field trials for researchers and breeders attempting to make new varieties of precision-bred crops. While I understand the intention of this amendment—and it is an intention I applaud—it would not be appropriate to restrict technologies used in breeding, nor do we have any evidence that suggests developers are doing anything other than creating better and improved varieties or breeds.

Of course, it is important to note that these technologies are not a silver bullet, and we want them to be part of our innovation toolkit to improve our food system. Delivering public good is what I did say earlier, and I am very glad I did—and it has been underlined by other noble Lords. It is what we strive for across government and we are fully committed to developing a more sustainable, resilient and productive food system.

Noble Lords quite rightly referenced the Government’s food strategy and, building on Henry Dimbleby’s extraordinary, in-depth piece of work, we have set out a plan to transform our food system and ensure that it is fit for the future. The noble Baroness, Lady Bennett, mentioned sugar beet. This is a crop where there is an application which might be of huge benefit, and not just in terms of the food that we produce. Being able to develop a strain resistant to virus yellows would mean that we would not have to seek noble Lords’ permission through secondary legislation for a derogation to allow the use of neonicotinoids to control virus yellows. More importantly, we could have a crop that was not only able to produce more sugar for our producers here but would require us to import less sugar from abroad, thereby lowering the carbon impact of that crop.

There are counterfactuals in everything. Trying to improve the home-grown element of our food, while reducing the impact that failing to produce it at home would create by having to import that food, sometimes from far away, needs to be factored in. It is fundamental to our food strategy.

I thank the noble Lord, Lord Winston, for his Amendment 21, which would require the genomes of precision-bred organisms to be sequenced before they can be released into the environment, regardless of whether or not an organism with the same genetic changes had previously been assessed and classified as precision bred. It also stipulates that the genomic changes resulting from the use of modern biotechnology have to be recorded, that no unprecedented changes can be present in the plant or animal, and that this must be reported to the Secretary of State.

I assure noble Lords that the criteria for defining a precision-bred organism, as set out in Clause 1, consider both intended and unintended changes to the genome. This means that any changes resulting from the use of modern biotechnology, whether intended or unintended, must be able to occur through traditional breeding or natural transformation for a plant or animal to be considered precision bred. It also means that unintended changes will already need to be assessed as meeting these criteria before any precision-bred organism is released.

The noble Lord’s amendment would mean that plants and animals could not be classed as precision bred if they contain unintended genomic changes. Unintended genetic changes occur during the traditional breeding process. Some of these may be removed during that process and others not, as will be the case with precision-bred organisms. As I expect the noble Lord is aware, many recent gene-editing studies about animals have reported no incidences of unintended genomic changes when using CRISPR-Cas9. Having assessed this evidence our expert advisory committee, ACRE, has also advised that unintended genomic changes occur significantly more often during the course of traditional breeding than they do as a result of precision breeding. This is also the view of the European Food Safety Authority, which advises the EU. Consequently, while we expect developers to ensure that any unintended changes are within the range of what can occur naturally, the scientific advice we have received suggests that it is not appropriate to prevent plants or animals with unintended genetic changes from being classed as precision-bred organisms.

We are committed to taking a proportionate approach, requiring only the information that fulfils the regulatory requirement at the appropriate time. It is for this reason that the Bill distinguishes between requirements for research trials and marketing applications of precision-bred organisms. This amendment is likely to add regulatory burden, without adding value to the process. For example, developers would be required to submit a release notice to Defra, confirming that the founder organism they intend to release for research trials meets the criteria in the Bill. They would have generated genomic data to confirm that this is the case.

However, requiring whole-genome sequencing would be disproportionate, given the specific, targeted nature of changes being made. I assure the noble Lord that breeders who release an organism modified using modern biotechnology that does not meet the criteria outlined would be subjected to sanctions under existing GMO legislation. This is a strong deterrent against releasing organisms that do not qualify as precision bred. That also goes some way to answering the point that the noble and right reverend Lord tried to pick up from the previous group, which was not moved. However, we are clear about the sanctions that we want implemented.

Developers will have to submit an additional notification to Defra should they wish to market their precision-bred organism. Breeders will need to provide fit-for-purpose information to demonstrate that they have met the requirements that I have outlined. The technical details will be developed with the advisory committee appointed to advise the Secretary of State on the regulatory status of these organisms.

For marketing approvals, assessments will be carried out on a case-by-case basis. The full genomic sequence of an organism may not be required in addition to information on intended and unintended genomic changes to determine similarity to traditional breeding or natural transformation. As a result, we do not feel it necessary to include a provision that specifically requires whole-genome sequencing.

Finally, to address the noble Lord’s point that the DNA of all progeny of a precision-bred organism should be sequenced before release, if a “founder” organism has met the criteria laid out in the Bill—specifically, that the genetic changes made by modern biotechnology are stable and could have arisen naturally or through traditional breeding—we have been advised that the regulatory status of its progeny does not have to be assessed. This is because the changes made are stable and in line with those that occur naturally.

To address the noble and right reverend Lord’s point about this being a public good, I hope I have set out why the Bill fits in with the Government’s food strategy and how environmental sustainability will be enhanced by it if we get it right. Perhaps the greatest public good will be if we are able to adapt to and tackle elements of climate change that affect not just these islands but countries all around the world. It could benefit some very challenged environments, so we owe it to them to make sure that we are regulating this correctly, making it accessible not just to large multinational companies but to smaller businesses and—to use the rather pompous word I used earlier—democratising it, ensuring that its benefits can be felt far and wide. I hope this provides the assurance that noble Lords need not to press their amendments.

[Lord Krebs (CB)]

I thank the Minister, but I have one question of clarification, just to check that I have understood what he said—namely, while accepting that it is important that public goods are delivered by precision breeding, that it would in some way stifle innovation if one defined too precisely what one meant by “public goods”. Can the Minister give an example of where saying what one means stifles innovation?

--- Later in debate ---

[Lord Benyon (Con)]

Whether I can give the noble Lord an example or not, I do not know, but he is absolutely right. That is why crafting this legislation has been such a monumental task. MPs in the other place and noble Lords in this place very often—and quite rightly—want to see as much as possible on the face of a Bill, because it holds current and future Governments to account. Very often, not having things on the face of a Bill can be exploited. However, putting too much on the face of this Bill, or being too prescriptive, could create a feeding frenzy for lawyers, be a burden on producers and have a stifling effect on innovation. I hope noble Lords will feel that we have got the balance right and are allowing enough flexibility.

I can see that there are elements of the regulatory framework that support this legislation that are yet to be developed in detail. I am very happy to give noble Lords as much information as I can on the process of developing that, not just now but, for example, as we get information from the Scottish colleges that will inform us on some aspects of the Bill, including this one. That will give the wider consumer and the concerned individual the information they need to know that we are being proportionate and are very focused on this key point of trying to make sure that we are providing a public good.

[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.

[Baroness Hayman of Ullock (Lab)]

My Lords, I thank my noble friend Lord Winston for his amendment and for the discussion, but I do not feel qualified to comment on it any further than that. We are having an important debate in these areas, and his knowledge is really helpful and useful as we continue to debate the Bill.

On my Amendment 19, I thank all noble Lords for their support, particularly my noble friend Lady Jones of Whitchurch, the noble Baroness, Lady Parminter, and the noble Lord, Lord Krebs, for adding their names to it and supporting me strongly on this—I appreciate it. I am sure that noble Lords and the Minister will not be surprised that I am extremely disappointed in his response. As the noble Baroness, Lady Parminter, and my noble friend Lady Jones said, the amendment fits so well with the Agriculture Act and, as the Minister himself said, with what the Government are trying to achieve through the food strategy. I genuinely do not understand why it cannot be part of the Bill. The Minister said that the amendment was too restrictive, and the noble Lord, Lord Krebs, raised a question about this and asked for an example, which I am not sure we got. I ask the Minister again: how is it too restrictive?

I am not sure whether all noble Lords have seen the amendment, but it lists 11 different purposes—I tried to keep it broad. One of the 11 is

“protecting or improving the health of plants”,

and another is

“protecting or improving the health or welfare of animals”.

My amendment says that it has to be only “in connection with one” of the 11. In discussing the animal part of the Bill, everyone said the reason for having it is to improve health and welfare; I do not see how the amendment would not fit in with this. The same is true of some of the other areas around plants. I genuinely do not understand why it is too restrictive, and I would appreciate it if the Minister could perhaps think about that before Report, because we will come back to this.

Earlier, I said that, when making legislation, we have to ensure that, as well as welcoming those who are undoubtedly trying to do good, we must guard against those who are not. I think the Minister is looking through rather rose-tinted spectacles. On that note, I beg leave to withdraw the amendment.