Genetic Technology (Precision Breeding) Bill

Lord Winston Excerpts

2nd reading
Monday 21st November 2022 Lords Chamber

[Lord Winston (Lab)]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

--- Later in debate ---

[Lord Winston (Lab)]

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

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

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

[Lord Benyon (Con)]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

“avoid arbitrary and unjustifiable distinctions”

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

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