I have a few reminders. Please switch off electronic devices or turn them to silent. Tea and coffee are not allowed during sittings. Hansard colleagues would be grateful if Members could email their speaking notes to hansardnotes@parliament.uk. Jackets can be removed if Members are feeling the heat.

I understand that the Government wish to amend the programme order agreed by the Committee on Tuesday 28 June in order to hear again from Professor Gideon Henderson, chief scientific adviser at the Department for Environment, Food and Rural Affairs, who experienced some technical issues when contributing on Tuesday. Because the motion has not been agreed by the Programming Sub-Committee, it can proceed only if everyone is content. Does anyone have an objection to the motion being considered?

Ordered,

That, the Order of the Committee of 28 June 2022 be varied so as to omit the eleventh and twelfth rows in the table and substitute the following—

Examination of Witness

Professor Gideon Henderson gave evidence.

We will now hear oral evidence from Professor Gideon Henderson, chief scientific adviser at DEFRA, who is with us today in person. Before calling the first Members to ask a question and before allowing the professor to introduce himself, I remind all Members that questions should be limited to matters within the scope of the Bill, and that we must stick to the timings of the programme motion that the Committee has agreed. That means that for this first session we have until 11.45 am. Professor, would you like to introduce yourself briefly? Then we will start with questions from the Minister.

Professor Henderson: Hello. My name is Professor Gideon Henderson and I am chief scientific adviser at DEFRA.

Q135 Welcome, Professor Henderson. I would like to start with a broad question. Are you content that this Bill is based on the best available science? I would like to understand from your point of view why you think this legislation is necessary now, and why we should not wait for some of the more technical details, which have been asked for, to be developed.

Professor Henderson: I am content that this Bill is scientifically sound. I have given it a great deal of attention and have called on a great many expert witnesses through informal and formal processes. I have interacted with a large number of stakeholder groups over the past 18 months, and I am content that there has been due scientific scrutiny and that this Bill is based on sound science and agreed science.

It is important to move forward with this Bill for several reasons. There are very significant benefits to the environment, human health and resilience to climate change that can accrue from precision bred organisms. The technologies that we can harness to derive those benefits are now sufficiently mature that we are ready to capitalise on them. The UK is well positioned to do that. Many other countries have already made the use of such technologies easier, and it is time for the UK to catch up and it is safe to do so.

Q Can you say how you work across the four nations? Can you talk about the involvement of the whole of the UK in the evidence gathering that you have been doing?

Professor Henderson: There are two sides to my answer, one of which is the scientific side. The scientific body of knowledge is, of course, shared across the world and certainly across the four nations, and there is strong expertise in gene editing and the technologies we are talking about today in the devolved nations, as well as in England—certainly, those strengths are quite considerable in Scotland and Wales. The UK as a whole is very strong in this area, scientifically.

At a governmental level, there have also been significant discussions between Government scientists. I talk to my counterparts in Scotland, Wales and Northern Ireland, and I have been sharing information with other officials and sometimes with Ministers in the devolved nations as well. I think there is agreement about the science across the four nations, but not always about the policy direction.

Q Good morning and welcome, Professor Henderson; it is very good to see you in the flesh. Can I start by saying on behalf of my hon. Friend the Member for Newport West that she has unfortunately tested positive for covid? She was engaged with dialogue with you when the video link went down the other day, Professor, so I will possibly be slightly greedier with questions today.

I will not be repeating the questions we went through last time, but go on to some other things. I was particularly struck by the written evidence from the Nuffield Council on Bioethics, members of which we will be hearing from later, and I want to put to you a couple of the questions that were raised in their evidence. They talked about something that I do not think we were aware of, which is that the Department is looking at its advisory frameworks in general. In reference to the Bill, obviously the Advisory Committee on Releases to the Environment looks like it will play a significant part, so could you say a little bit about what discussions have been had as to whether that is really the appropriate body, or whether some new body should be formed to oversee these complicated trade-offs and issues?

Professor Henderson: There are a number of things that that might refer to. There is a periodic review of how we get advice—scientific and otherwise—into DEFRA, and such a review is ongoing at the moment. I think it is entirely safe to say that that will not impinge on ACRE’s activity. It serves a critical function already, and has an expanded role through this Bill to identify when things are precision bred organisms and when they are not. To me, that body seems to be the right place to attend to that type of decision about whether something is a PBO or not. There are also questions about animal welfare, and it may be that other bodies are required to adjudicate in that area, but that is for further down the line.

Q But you would agree that, as it stands, the Bill is fairly thin in that area. It sets up a structure, but it does not really talk about what the right body might be.

Professor Henderson: Again, I will divide that into two. I believe there is clarity about the role of ACRE, and ACRE has published guidance about the definition of a PBO, which has been scrutinised and, I think, generally found to be appropriate. As for, “What is a PBO?”, the advisory system is in a good place. On the animal welfare aspects, there is perhaps some more thinking to be done.

Q Of course, the advice came out after the statutory instrument, but we will not go into that. That was a debate in the past.

I would like to pick up on a point that the Nuffield group has made about the release of precision bred organisms. It said:

“On our reading of the Bill, this means that precision bred animals that are not transgenic organisms may be released without further authorisation, without even a ‘precision bred confirmation’. Such releases could have significant effects on existing ecosystems (for example, if they should have a reproductive advantage over wild organisms of the same species). This may be a matter of significant concern to other UK and wider jurisdictions as such animals may travel freely across jurisdictional boundaries.”

Is that something that you have considered? What would be your response to that concern?

Professor Henderson: There is a notification requirement and the necessity for permission from the Secretary of State before things can be released. There are some appropriate mechanisms to scrutinise things as they pass through the process, but in general, the scientific evidence is that if something is mimicking traditional breeding and therefore is a precision bred organism according to the definition, the risks of release are no greater than those of a traditionally bred organism, and may be lesser.

Q Okay, thank you. I am conscious of time, Ms McVey, so I will do one more, but I do have some further questions if there is time. Clause 1(6)—this is at the beginning of the Bill, where there is the quite complicated list of definitions—says:

“In determining whether a feature of an organism’s genome could have resulted from natural transformation, no account is to be taken of genetic material which does not result in a functional protein.”

The Nuffield group says:

“The intention of this provision is unclear to us.”

It is unclear to me as well. Could you explain it?

Professor Henderson: I can explain it. Actually, it is related to the questions you asked me last time. During traditional breeding, in nature and during precision breeding, it is commonplace for some transgenic—some exogenous material—to cross into the genome, but most of that has no functional role at all and does not impact on the phenotype. This clause is pointing to the fact that if there is some such material, it does not matter, as long as it does not create any function. This clause is seeking to say that if it creates a function and it is exogenous, then this thing will fall outside the definition of a PBO.

That is helpful. I am sure you are aware that there are other views on that. Thank you, Chair.

Q You spoke about discussions with the devolved Administrations about this. I heard this morning that the discussions around this did not go through the common framework procedure. Are you able to tell me why that was?

Professor Henderson: I am afraid I am not. As a chief scientific adviser I am here to talk about the science. I spoke to my scientific counterparts and officials in the devolved Administrations who have a scientific interest, but I am not aware of the process you are talking about.

Q I am told that it is only being offered retrospectively, which seems odd. Obviously, Scotland has said that it will wait until the consultation with the EU is completed. What will happen if the EU goes down a different route with gene editing and genetically modified organisms? We are trying to export products to the EU but the EU Commission’s first question, probably quite rightly, will be, “How do you prove whether the product is non-gene edited or gene edited?” Once it is in the environment, as I understand it, it is very difficult to remove, particularly in the case of crops. How will we do that without labelling and proper traceability schemes?

Professor Henderson: This is a double-edged sword because it is genuinely scientifically impossible to tell precision bred organisms from traditionally bred organisms in some cases, and therefore this will become a problem, regardless of the legislative environment that we work under, and it will be harder and harder to trace these types of organisms through systems globally, not just in the EU.

In terms of this legislation, all varieties that are approved for growth will be on a seed varieties listing and will be designated. It will clear that they are PBOs, as per their listing. So if you are shipping tomatoes or something, it will be possible for that to be a discrete product that can be traced to the extent that is required through that process.

It becomes more problematic with products where things may be blended, and then it will be up to the producers or those selling to make sure that they have a supply chain that will satisfy the people they are selling to.

Right, fine.

Order. I just want to say there are two minutes left.

Q I have one question left. If a gene edited animal breeds with a non-gene edited animal and produces offspring, how would they be described? What label could be used to describe those products?

Professor Henderson: Just to make sure I understand you correctly, are you talking about a precision bred organism breeding with a non-precision bred organism?

Yes.

Professor Henderson: You might be better placed asking this question to animal breeders later today, but I imagine this is to do with the way in which you describe the varieties and the strains of livestock when you are sending it to market.

Q Yes. Are you saying you cannot answer that and that I am better off speaking to animal breeders?

Professor Henderson: From a scientific point of view, I will again come back to the point that a precision bred organism and precision bred livestock is scientifically equivalent to something that could have been produced with traditional breeding approaches, so scientifically that coupling would not create a concern.

We have just under a minute. Do you have a question, Daniel Zeichner?

Q Hopefully we can get this in in 30 seconds. The precautionary principle in general has been much discussed and Lords Committees are querying the current Government’s current interpretation. What impact does this Bill have in terms of the precautionary principle? Does it abide by the traditional interpretation of the precautionary principle going back to 1992, for instance?

Professor Henderson: I will avoid getting into a discussion about the precautionary principle because that would be long, and there are even multiple definitions of the traditional interpretation of the Bill. I believe that the Bill we are putting forward now is precautionary—it follows the guidelines of the precautionary principle. We are not leaping in with both feet, but we are moving in stepwise motion.

Order. We have come to the end of the time allocated for the Committee to ask questions. I thank Professor Henderson on behalf of the Committee.

Examination of Witnesses

Professor John Hammond, Professor Bruce Whitelaw, Dr Craig Lewis and Dr Elena Rice gave evidence.

We will now hear evidence from Professor John Hammond, group leader of genetics, genomics and immunology at the Pirbright Institute. He will be appearing via Zoom. We will also hear from: Professor Bruce Whitelaw, director at the Roslin Institute, who is with us in person; Dr Craig Lewis, genetic services manager Europe and chair for the European Forum of Farm Animal Breeders at Genus, also with us in person; and Dr Elena Rice, chief scientific officer at Genus, who is appearing via Zoom. The session will run until 12.25 pm. Starting with Professor John Hammond, will you all briefly introduce yourselves, before we go to questions?

Professor Hammond: I am Professor John Hammond and I work at the Pirbright Institute. I look after the science responsible for improving post-livestock genetics to increase disease resistance and resilience.

Professor Whitelaw: Hello, I am Professor Bruce Whitelaw. I hold the chair of animal biotechnology at the University of Edinburgh. I am also the director of the Roslin Institute and have led projects there that have generated genome edited livestock.

Dr Lewis: I am Craig Lewis. In my current role I oversee the implementation, design and execution of practical animal breeding programmes for a subunit of Genus called PIC. Prior to that, I hold advanced degrees in animal genetics, from Roslin, and animal welfare.

Dr Rice: Good morning. I am Elena Rice and I am the chief scientific officer for Genus. I am overseeing the research programme across our business units, PIC and ABS. We are a world leading animal genetics company.

Q Thank you, lady and gentlemen, for appearing this morning. To Professor Hammond first, I would like to understand your broad thoughts on precision breeding in animals. How do you think the technologies that we are talking about can support research into bringing disease resistance forward in animals?

Professor Hammond: Where we have got to with the precision breeding methodologies in the Bill now supports decades of primary research in the UK and other countries. We understand the complex genetics underlying health traits and, in particular, disease resistance, which is a complex biological process. Because of those advances, and the work that we and others are doing, we are identifying genetic variants that may exist naturally, which, in combination or isolation, can dramatically increase disease resistance and resilience in farm animals.

The ability to undertake precision breeding, which would be the equivalent to the natural variation that we find in those populations, is an almost transformative technology to improve animal welfare and production—for example, there would be a lack of wasted carbon caused by disease. I think it has a really important potential for planetary health in terms of climate change.

Q Thank you. Professor Whitelaw, can you tell us a little about the work that Roslin has already done in this area, how you consider animal welfare, and how that work might or might not help in mitigating external stresses that farm and other animals have from external diseases?

Professor Whitelaw: Roslin has been involved in a number of species: pigs, cattle, small ruminants and poultry, primarily chickens. We are also now looking at research to do with aquatic species. The main driver of that research has been to reduce stress impact on the animals, and we have focused on disease, partly because it is one of the main stresses imposed on animals around the world, but also because we have a lot of knowledge. As my colleague John just indicated, we have a lot of genetic knowledge and a lot of knowledge around the actual pathogens themselves.

There are two projects that have the highest profile. One is to do with pigs and relates to a disease called porcine reproductive and respiratory syndrome, and we have done that in collaboration with Genus PIC. The other area we have been looking at extensively is around influenza—primarily in chickens and poultry, but also in pigs—and there are other diseases behind that. From a research perspective, disease is a very challenging topic, but we have a lot of knowledge. There are other stresses that we are looking at, such as heat tolerance. We are looking at the impact of reproductive issues on animals, and these can all be addressed by using genetic technologies, including genome editing.

Q Where do you think UK science sits in this area globally?

Professor Whitelaw: We are very fortunate that we punch above the size of our island and have been leading in the area of livestock for some considerable time. We all know the reason why Roslin has a high profile: it is because of a certain sheep called Dolly, which was 26 years ago. That whole project was around genetic engineering, and the same exists in the plant community. We have some really strong players in the academic arena. We do not have the numbers that exist globally, but we do sit very well within that. I will quite happily say we are leading, and I will quite happily say that Roslin is a leading player in that too.

Q My final question is to Dr Rice and Dr Lewis. Can you talk a little about your work on PRRS, and where does that collaboration with the university go next? Is this something that you will be optimising globally, given that we do not yet have the right regulatory framework in this country?

Dr Lewis: To put it into some context, I grew up on a pig farm in Herefordshire, so I have seen PRRS, or what was called blue ear disease here in the UK, at first hand with my father. The focus of my PhD work at Roslin was actually looking for natural variants in terms of PRRS resistance. Are there pigs out there—even today—that we could selectively breed so that we would not have to deal with this problem or could at least make the animals more robust? After three years at Roslin, the bottom line was that although we do a great job at creating genetic improvement to make more robust pigs generally—we can increase feed conversion, growth rate and so on—specific disease resistance is obviously a very complicated trait. This is an opportunity where we can almost create a natural variant, and therefore the mutation in the particular genome that confers the resistance; it would be wonderful if that just happened in the next generation completely naturally, but this is not a fairy tale—it is practical animal breeding. The ability to be able to create that variant so that we can actually implement this in a practical breeding programme, as John said at the beginning, is game-changing technology.

In terms of how that could impact globally, PRRS is endemic in multiple markets around the world. I have worked across the United States, which is very impacted by this particular disease. Right now, Spain is going through a very nasty strain of the PRRS virus. Here in the UK, whether it is indoor intensive units or the outdoor pig units in Norfolk, East Anglia, which we see when we drive around, we have PRRS outbreaks. That is a difficult scenario, for the pigs, obviously, in terms of morbidity and mortality, but there is also a human element. People like my father are deeply impacted when their animals are sick. Fundamentally, that is why I got into science. The scope of delivering truly disease-resistant animals impacts so much, as we look at this technology.

To get into the science, I will hand over to my colleague, Elena.

Dr Rice: The question was where are we today with the development of PRRS-resistant pigs. Today, we have quite a large population of animals that are not the first generation. We did the edits and already bred animals that carry the resistance to the virus. Those animals have been tested in disease challenges and we showed that they are completely 100% resistant to the virus. Because of this small edit in one gene, those animals do not see the virus and cannot get sick, which means that they do not require extensive application of antibiotics on the farm. In our process, we are building a commercial herd now. We are going through the accrual process with the US Food and Drug Administration. The process is very successful. We are moving forward and are actually accelerating our studies. We hope to see approvals in late 2023 or the beginning of 2024. So this is real and it is here.

We are also working with regulatory agencies in other countries, such as Japan, Canada and South Korea, and we are expanding our interaction with many other countries. What we see today is that there is a very clear path in all those countries to get approval for the animals and bring them to the market.

Lovely, thank you very much. A clear path is what we are aiming for.

A number of Members have signalled that they want to speak. I remind Members that this session goes to 12.25 pm. I will start with Daniel Zeichner.

Q I will try to be quick, Ms McVey. First, I think we need some clarity on what is being done where. The purpose of the Bill is to allow research to take place in the UK, and we have just been told the UK is a world leader. There seems to be some contradictions there. If that could be drawn out and explained, that would be helpful.

My second question is for Genus. These opportunities are fantastic. If we can deal with influenza and PRRS, that is a fantastic opportunity, but can you explain to me how the intellectual property rights will work? Who owns this? How does it get transferred from country to country? That is quite a big question, but if you could do it fairly briefly, that would help everybody.

Professor Whitelaw: Good question. I will start off and then pass over to Genus colleagues. The first question was about how we can be world leaders and need the Bill. All the work that goes on at the Roslin Institute is contained use under the Animals (Scientific Procedures) Act 1986. It is an experiment that is done in our labs or on our farms. We, the university, are the inventors and we are the owners of that. Our commercialisation organisation at Edinburgh University is Edinburgh Innovations, which negotiates with a third party to get access and a licence to that IP. In this case, we have negotiated a commercialisation licence with Genus to take it forward into the market. All the work at Roslin is done there under ASPA contained use. That is the research base. That is where we lead with the development of intellectual property and develop the projects.

Dr Rice: I had a small problem hearing the question, so maybe Craig can start.

Dr Lewis: I will leave all the IP pieces to Elena, because I am a breeder, not an IP lawyer—full disclosure. In terms of development, I think that one of the things we need to understand here, which Bruce hit on quite effectively, is that there is a big difference between the research stage and what I would call the scaling phase before implementation. It is not a matter of simply saying, “Okay, we have done great work at Roslin and have created a precision bred animal, which is going to impact on commercial animals here in the UK.” There is a different step, because we need to be able to scale it. That comes back down to basic animal breeding and the structure of a breeding pyramid. We need to scale those animals to have enough of a population to be able to serve the commercial producers. That would happen.

I think there are opportunities for the UK. If we try to do the scaling step without a market, basically you will have major farms where 100% of the offspring cannot enter the food chain. That becomes a huge barrier to further innovation. We can do the very early stuff, but we would miss out that scaling step in the UK. A Bill that would allow us to access a marketplace would have the benefit of significantly reducing the cost of the scaling piece.

Q I suppose my question is to Elena. I get that point, but does this not put enormous power in the hands of one group of people who own the intellectual property around this particular form of the animal?

Did you hear that question, Dr Rice?

Dr Rice: Yes, I think the question is about IP and how it is placed in the market. As Bruce just said, the university owns IP. It is possible for any company to license that IP and bring the research to commercial production. We did exactly that. We interacted and worked together for many years with the Roslin Institute. We have the ability to bring that research to the hands of producers and farmers. As Craig said, it actually takes a lot of work over many years. To give you an example, as a company, we have devoted around five to seven years now to actually taking it from the research stage from the Roslin Institute to learning and understanding how we can implement that particular edit in our elite breeding germplasm. Why is that important? Farmers and producers around the world want the best genetics that we can offer, but the best genetics need to be combined with the edit.

I want to quickly give you an overview of how it works. We make an edit in an embryo. Then we take the embryo and put it into an animal who carries the edited heritage. We create exactly the same edit in our founder lines. In this example, we have four founder lines that we created and edited. We select them and do thorough analysis for any potential off-target effects. We select only animals that carry no off-target edits. Then we breed those animals in many generations to provide the elite herd that will be distributed to our customers. I want to make sure that the animals that the farmers get are not touched by any instrument—that they are not edited themselves. They are bred from the initial set of animals that we have created. That is why it takes a long time and a lot of effort to bring it to the market.

I understand that point. Thank you.

Q Professor Whitelaw, I hope to visit you soon at the Roslin Institute, along with your local MP, who has spoken glowingly of you for some time. The Scottish Government want to wait for the EU consultation in this area to be complete before approaching gene editing in the way that the UK Government are. That presents potential problems if the EU decides to stay where it is or just moves marginally, or has a different approach from the UK Government’s approach. If that happens, how do you see that affecting trade with the EU and our export trade there? This is the big concern for the Government. What is your answer to that?

Professor Whitelaw: I am not sure I can comment on export trade. It is not an area that I am knowledgeable about, but maybe I can comment more generally. One of the benefits of the Bill is to give momentum to investment in this area. I do not mean just money, but talent coming into the field, into the universities, and students knocking on my door and saying, “I want to do a PhD on genome-edited animals.” I see that increasing and I see that as a huge benefit for the UK and for Scotland. To me as a researcher, that is one of the major drivers—to see that investment opening up. Yes, it will happen in the commercial world. We have seen how other countries that brought in legislation on genome editing have seen a proliferation of small and medium-sized enterprises and innovative ideas coming through. That is what I want to see come out of the Bill. That is the bit that drives me. I am really not knowledgeable about the impact on exports.

Q Dr Lewis, you were discussing the PRRS—the porcine reproductive and respiratory syndrome—that you are working on. Could you tell me how quickly, once this Bill comes law—if it becomes law—you will be able to scale up and it all becomes commercially available? If you could have a stab at that, it would be helpful.

Dr Lewis: It depends on the timeline and when the Bill would come into effect. Rather than talking about a specific gene edit, one way to also ask the question, even in the current state, is: when I produce an elite animal today, how long is it until it really impacts the whole flow of pigs? I can answer that perfectly today. Based on the structure of the pig industry, you have to have pure line animals, then you have to create crossbred animals that are the mothers of the commercial offspring, and then you use a terminal sire. Basically, if you look at getting the whole pyramid to be 100% influenced by new genetics—you are putting in three different levels, three breeds coming together—that would roughly be about five years.

Q Five years. That is interesting. Thank you. I have asked other witnesses that question just to see how long it would likely take.

Finally, Roslin has got a tremendous reputation for really high quality research. Do you think the Bill guarantees the absolute traceability of gene edited products and also the strictest possible monitoring of what science is doing in this area, or is there more that could be included in the Bill to ensure that?

Professor Whitelaw: I will answer the science question, then touch on the traceability. Our science is very well scrutinised through current legislation, because it is under the contained use. We have to go through a variety of permissions before we do an experiment with animals, and that is visible. Therefore, I do not think the Bill will necessarily affect the regulation of what we are doing; but as I said, I hope it increases the volume of what we do.

When it comes to traceability, which was mentioned earlier, genome-editing technology generates the equivalent of what is naturally found. Every animal born carries 40 de novo mutations, and genome editing adds another one to that list. Without having an audit trail of individual animals, you will not be able to identify one genetic change from another. It is impossible to categorically say, “That is caused by genome-editing technology rather than a natural mutation.” Therefore, the audit trail of an animal or product will not be based on the molecular analysis of that animal; it must be based on something else.

Q Which might be?

Professor Whitelaw: Craig might be able to answer this more clearly, but depending on the species, that might be breed books or production systems, which would be embedded within the companies or with different nations.

Dr Lewis: We should be very aware here that there is a species component to that. When we start thinking of cattle, for historical reasons, there is a very strong traceability element through the cattle chain. However, if we look at the pig industry in the UK, it is more done on a—shall we say—lot basis. For example, normal practice in the UK pig industry is to use pulled semen at a commercial level for a terminal sire, so even within a litter, you might have three or sires represented. That is today, so an individual animal traceability in the UK pig industry today does not really exist. When we answer the question on traceability and what exists today, that is very species-specific, rather than “This is the livestock sector.”

Professor Whitelaw: This is the basis of all of my thinking. We are using these tools to create precision changes to the genome—changes that can happen naturally. There is no difference between those two. There is a difference in how they arise; one is because we choose to target a specific DNA sequence and change it, and the other is just a random lottery that evolution throws up. However, from the animal’s perspective, and I would argue from our perspective, in how we look at these animals, it is just a genetic variation that exists. There is no difference. Going to the traceability question, why and what are you tracing?

Q I know you do not deal with IP, but if it is a natural occurrence, why is IP applicable? Surely, it is not invention; it is a genetic coding. I am just keen to know why you feel you then have the right to impose intellectual property rights on something that, as you are arguing to us, is naturally occurring. Yet, you will impose intellectual property, I would imagine, to be able to make a profit. I am finding a logical failing there. That is just to put that one out there, and maybe you can come back on to that.

We have been dealing with crops so far, and we have now moved on to animals. I must admit that I am now beginning to struggle with this slightly. We are not talking about plants but about sentient animals, and about genetic modifications to them.

The thing I have been reading about PRDC—porcine respiratory disease complex—is that part of it comes down to environmental and conditioning factors. There are obviously some pig farmers, for example, who keep their animals in better conditions than others, but many do not. Even when you keep your animals in optimal condition, there are certain conditions that they are kept in that will encourage that disease.

My question is on behalf of the millions of people who are increasingly becoming vegan or vegetarian. We are now introducing genetic editing to enable us to keep those animals in sometimes quite horrific conditions. It is for this disease at the moment, but what is to say that exploitation of these animals is not going to only deepen? Now we can keep these animals knee deep in their own crap—sorry, Ms McVey—and we can edit their genes so they can survive in those conditions. That is how some people will see this and that is how much of the public will see it. Can you give me some reassurance that that is not going to happen? When profit is the bottom line, I see these animals becoming more robust and able to live in ever-more extreme and difficult conditions.

Dr Rice: Perhaps I can jump in. If you have read about PRRS virus, you will probably know that it is actually not dependent on conditions. Animals in the wild, as well as animals in production, all get sick. What actually happens on farms today is that farmers have to install multimillion filtration systems—because viruses are airborne—to filtrate outside air through very complicated filtration systems so that viruses cannot get into the farm. So it actually has nothing to do with the conditions.

I disagree with that. I am reading a peer review paper here—

Allow the witness to finish.

Dr Rice: It is a reality today and you are welcome to visit those farm centres. I visited one two weeks ago, and I just want to tell you that when we are talking about conditions, I was at the farm and the animals looked beautiful. At the same farm, the owner was telling me that two months ago, he was walking into a room full of dead piglets. Why did that happen? It was because the mother got PRRS virus and it killed all her not-yet-born piglets and they were born dead. So when you walk into this room and see all the crates covered with dead bodies, it is actually very impactful on people’s minds and everything. People suffer mentally seeing those pictures. We have an ability to prevent that. It seems a little strange that we would say no, that they would have to continue to suffer like that, even though we have a tool to give them to completely avoid those types of situations for those poor animals. No, they are not maintained in very bad conditions; they are properly farmed. There are rights on those farms, I would say, but again, all the pigs are getting that and the main biosecurity precaution today is to prevent air from outside from bringing the virus to the farm.

Dr Lewis: I appreciate your questions and concerns, Mr Lewis. Let us just step back. First and foremost, I have the privilege of travelling the world and working with pig farmers all over the world. First and foremost, the UK should be very proud of its tradition of animal welfare and the UK farming sector’s animal welfare standards. If I look at the most extensive and intensive systems here in the UK, both equally get PRRS virus. I struggle with that in many conversations with vets all over the UK. Really, the system does not dictate whether—

Q Can I make one point on that? I have to speak on behalf of many people in this country who would make the point that if you did not have animals as foodstuffs or even believe that we can keep them as pets—there are many people who think that; maybe not millions, but plenty—the fact that you are keeping them for the sole purpose of benefiting human beings, either as foodstuffs or for other products that they can create, is in itself part of the problem. I am just putting that down there. There is obviously a growing number of people who are becoming vegetarian and vegan with the climate crisis and so on who increasingly believe that. Now we are moving into a new phase of gene editing and all that comes with that.

Dr Lewis: I was just coming to that point. This is a conversation that I have actively had. I have had the privilege of being in a couple of public dialogues with Peter Nuffield. There is a great debate about where animal welfare, farming systems and the food system are in the UK today, but I do not think it is directly relevant to this Bill. If we say that animal welfare needs to change, we already have robust legislation and codes of practice for the UK on what animal welfare should look like and what the standards are. The debate about whether they should move or not is about the animal welfare legislation, and I believe it should be part of a public consultation.

Considering that that legislation is already in place, whether we have genome edited animals or not does not change how many animals we put in the pen; that is dictated by a separate piece of legislation. Just saying that we are going to have gene editing so that we can put more animals in the pen—

But here is my question—

Mr Lewis, we are straying from the topic. I have to stop you because I have three other Members who want to remain on topic—Kerry, Andrew Bowie and Katherine Fletcher. We will move on because we have strayed off the topic. I have been very patient and I did let it go on for a little while.

Q On a similar point to Clive’s, I note what Dr Rice said about the virus coming from outside, but from my reading of the syndrome, it spreads by direct contact between animals, as well as by natural breeding, artificial insemination and a variety of other things. There is the concern that the more animals you have in one place, the more likely it is that the disease will spread.

I note that the syndrome was first identified in the States in the late 1980s, and now it has spread worldwide in most swine-producing countries. I would be interested to know your take as to why it has spread to that extent. Is it because there is more intensive farming, in the same way that we saw with things such as bovine TB? I get what you are saying about the farm animal welfare codes, although they are not very well adhered to—there is a separate debate about that. If this would permit more animals to be kept in intensive situations because the virus would not spread, does that not leave the door open to people to argue that that is the path we should be going down?

Dr Lewis: I appreciate the question. We can look at this in a couple of ways. Just as pure history—as I say, it was my pet project with my PhD—the PRRS virus was originally identified in two separate locations at the same time. One was in North America—Minnesota—and one in Lelystad in the Netherlands. It was pretty much simultaneously defined in Europe and the United States. Did the movement of animals globally—breeding stock and so on—facilitate the global spread? I think that is probably fair, but that needs to continue to happen as we move the geneplasm around the world and connect populations.

The number of stock is an interesting question. PRRS is very infectious, so once you have got it into a farm, it does not matter if there are 10 pigs or 100 pigs in the farm; the whole farm is probably going to get it. The way that you look at it is that the barrier to entry into the farm is more important than how many pigs are in the farm. That is why we continue to refine biosecurity practices.

I was talking more about proximity than about numbers.

Professor Hammond might be interesting on this, because he deals with avian flu, and obviously that might broaden it to the wild community.

If you want to do that, you have less than a moment. It is for all Members to direct the questions to who they would like to hear answer them.

Q It is not so much numbers, but if you have a smaller number of pigs, they tend not to be kept in such close proximity.

Dr Lewis: My final point would be that if we look at gene editing, or genome precision breeding on the other extreme, one of the reasons why we keep animals inside is to protect them from disease, whether it is flu or PRRS. One different way of looking at it is that the use of precision breeding technology could facilitate the extensification of agriculture.

Professor Whitelaw: You have to remember that a virus does not choose which animal it is going to infect. It will infect an animal in whichever farming system it is in. This technology, equally, can benefit all farming systems.

This session has been busy with lots of speakers and questions. I apologise that we did not get on to other Members. I want to thank Professor John Hammond, Professor Bruce Whitelaw, Dr Craig Lewis and Dr Elena Rice. Thank you very much for your time.

Examination of Witnesses

Dr Peter Mills, Dr Madeleine Campbell and Peter Stevenson OBE gave evidence.

We will now hear oral evidence from Dr Peter Mills, assistant director at the Nuffield Council on Bioethics, who is with us in person; Dr Madeleine Campbell, British Veterinary Association member, RCVS recognised specialist in veterinary reproduction and European diplomate in animal welfare science, ethics and law, who is appearing via Zoom; and Peter Stevenson OBE, chief policy adviser at Compassion in World Farming. This session lasts until five minutes past 1. Again, if everybody could be mindful of that and direct their question to the witness they would like to answer it. Could each of the witnesses introduce themselves for the record, starting with Dr Peter Mills?

Dr Mills: Good afternoon. I am Dr Pete Mills. I am assistant director at Nuffield Council on Bioethics.

Dr Campbell: Good afternoon. I am Dr Madeleine Campbell. I am the current chair of the British Veterinary Association’s ethics and welfare advisory panel. If I may briefly correct something you just said, I am actually an RCVS recognised specialist in animal welfare science, ethics and law and a European diplomate in animal reproduction.

Peter Stevenson: I am Peter Stevenson. I am chief policy adviser at Compassion in World Farming. I am a solicitor by background, although I do not do all that much legal work nowadays.

Q Good afternoon and welcome. I would like to address my first question to Madeleine. I believe you have argued that it is an ethical imperative that we make use of precision breeding. Do you believe this is a tool that could be used to maintain and potentially improve standards of animal welfare?

Dr Campbell: To clarify, I did indeed argue that at a recent Animal Welfare Foundation event in the course of a debate. I was slightly making an argument, but yes, we do feel that genetic editing of animals could play an important role in enhancing animal welfare and in the broader context of enabling agriculture to develop in a sustainable way, which would minimise the impacts of animal agriculture on the climate and the environment. Yes, it has great potential to do good, but it also has great potential to do harm from an animal welfare point of view. As I say, it needs to be thought about very carefully.

Q Lovely, thank you. Moving on to Dr Mills, what are your thoughts on the potential opportunities to transform the food and farming system? Given that caveat from Dr Campbell, what do you think are the big questions we should be asking?

Dr Mills: The Bill is a very welcome initiative. The Nuffield Council does not believe that the retained EU regulatory regime is fit for purpose. One of the shortcomings of that regime was the way in which it was relatively indifferent between plants and animals. We believe that the potential power of genome editing as a technology merits some control, so we are pleased that the Government have brought forward this Bill to do that.

The Bill addresses a number of potential mischiefs that could occur as a result of the use of those new technologies. It is perhaps a little bit unambitious in the sense that it leaves a vacuum at the heart of the governance system that applies to breeding technologies. You heard evidence in the previous session about the Animals (Scientific Procedures) Act 1986, which is primarily focused on experiments on animals. The Animal Welfare Act 2006 was also mentioned, which is to do with the treatment of animals in different settings. There is nothing at present that controls the production of animals of particular kinds.

The precision breeding Bill—despite the title—does not, in a sense, control precision breeding or genetic technologies, except indirectly by causing breeders to anticipate the conditions under which they will be able to market the products of their breeding. What is missing is some more positive statement or principle about the purposes for which precision breeding—and breeding more generally—might be used. As we argued in the Nuffield Council report, breeding of all kinds should be directed towards securing a just, healthy and sustainable food and farming system. Having something like that in the Bill as a framework, within which standards can be elaborated through regulations and by the relevant authorities, would be extremely helpful.

Q I think we will put that in work in progress for discussion. As we have just heard, there is a broad spectrum as to what one might be working with. My final question is to our final panellist, Mr Stevenson. We have heard evidence about the Bill’s potential for good, given the common goals of tackling climate change, reducing disease and so on. While being aware of further discussions, what is the evidence that we should not move forward with the legislation to the benefit of animal welfare, broader animal disease, enhancing food security and tackling climate change?

Peter Stevenson: I am afraid that I have serious misgivings about gene editing. I think it is going to do a great deal of harm, both during the creation of gene edited animals and then when it is used on farms. Having said that, I recognise that there will be certain cases where it can be beneficial. For example, Compassion in World Farming is working quite closely with a company that is trying to gene edit hens to not produce male chicks. That would prevent millions of male chicks being killed at a day old every year. We are not totally against it.

For me, at the root of the problem is that the Bill argues that gene editing is just a more precise form of traditional breeding, such as selective breeding. If you look at the last 50 years, selective breeding has caused immense health and welfare problems for farmed animals. Meat chickens have been bred to grow so quickly that millions suffer from painful leg disorders each year, while others succumb to heart disease. We have bred dairy cows to produce such high milk yields that many are suffering from lameness, mastitis and reproductive disorders, and the cows live with these welfare problems for a large part of their lives. We have bred hens to produce 300 eggs a year. As a result, many suffer from osteoporosis, making them highly susceptible to bone fractures.

The idea that we will push all this further through gene editing is really worrying, but if we are going ahead with this, which is the clear intention, I think—I am now speaking as a solicitor—that the animal welfare protections in the Bill are drawn in very broad language. They are imprecise and unclear, and they need to be given more focus and strength, so I would love the Government to revisit those provisions.

Q Thank you very much. Professor Whitelaw, who is still in the room, laid out in previous evidence that gene editing is akin to traditional breeding, but you do not believe in the science as it has been put forward to us—that this is akin to traditional breeding. In the answer, there was both, “Yes, we agree that it can be positive” and “No, we don’t think it can be positive.” Can you clarify that? Professor Whitelaw was quite definitive about the benefits.

Peter Stevenson: In 30 years of working in this field, I have never tried to assert anything that is not supported by the science. I have tried to say that gene editing could be helpful in certain and very limited circumstances, but that it will be harmful overall. The science about the detrimental impact of selective breeding on just about every main farm species is utterly clear. There is a huge amount of science on the subject, some of which comes from the Farm Animal Welfare Council, which is now called the Animal Welfare Committee. I totally reject any suggestion that what I have said about the damage done by selective breeding is not based on the science. As I say, the idea that we will push this further and drive animals to even higher yields, faster growth and larger litters through gene editing is really disturbing.

Okay. I will leave it there.

Q Dr Campbell, may I ask you about the potential future risks, the extent to which we know or do not know the impact on animals, and how we might monitor or check that in the future? Are there sufficient provisions in the Bill to deal with those issues, based on your professional experience?

Dr Campbell: That is a key question. When we talk about whether gene editing will be beneficial or detrimental from an animal welfare point of view, as we have just been discussing, we need the evidence to look at that. I do not feel that the Bill as drafted will provide a mechanism for doing that.

At the moment, the Bill has a mechanism specifically for applications for marketing authorisations to be referred to the animal welfare advisory body. It is somewhat open in Bill as to exactly what that body is, as I understand it; it could be an existing body, or a new one. What will be crucial is that we have a proper mechanism in place to have oversight not only of the marketing and the release of any genetically edited animal organisms, but of the actual processes that are going on with the so-called precision breeding, so the animal welfare advisory body needs to have oversight of those processes as well, and that needs to be an obligatory oversight. It needs to have an obligatory reporting role too.

This needs to be an independent body, with suitable expertise to understand and interrogate both the basic science and the animal welfare science, and to understand and explain the ethics around that. It must be independent of Government and of scientists, and it must be independent of any lobbying—around trade, for example. Then it needs to be able to look both proactively and retrospectively at data about the health and welfare of animals that are produced using so-called precision breeding techniques. It would be an independent oversight body—in my mind’s eye, very analogous to the Human Fertilisation and Embryology Authority—that can take an independent look at the data and then make recommendations for policy changes in light of that data, as the science develops.

Q Could you say a little more about that final point—the potential benefits that you would see coming from something like that authority?

Dr Campbell: I am sure you heard in the previous evidence—I was not in the meeting to hear that—that there is still some uncertainty about the effects of genetic editing, in particular the so-called off-target effects. Exactly because of the nature of the techniques, those can be effects not only on one generation of animals, but on many future generations of animals. One could approve something now, but a generation or more down the line, the evidence could become available that would cause you to reconsider that opinion. That is exactly what this independent body would be doing. It would be gathering data about the health and welfare of the animals produced using precision breeding techniques and independently analysing that data, and then making recommendations about whether policy and/or legislation needed to be updated in the light of the developing scientific evidence about health and welfare effects.

Q Finally, do you see anything in the Bill as it is currently drafted that allows that to happen?

Dr Campbell: No. As I understand the Bill, at the moment there is within the regulations some kind of optional reporting function for that animal welfare advisory body—which, as I say, is not very well specified—but there is no obligatory function. I think it absolutely has to be an obligatory reporting and oversight, data collection and analysis function, and that animal welfare body—whatever it is—needs to be better defined and specified within the Bill, and it needs to be constituted specifically for this purpose, with the relevant expertise within it.

Q Thank you. Dr Mills, I have already said that I have been very influenced in my thinking by your larger reports and the evidence to the Committee. Very briefly, what are the key things that you think could be done to improve the Bill?

Dr Mills: I am very grateful for the recommendation for our report.

I have said already that I think that what is perhaps lacking is a framework that sets out positive purposes for precision breeding—a framework in which a body of the sort that Dr Campbell referred to could elaborate standards that could then be applied independently to precision breeding.

The thing about breeding is that we are talking not about one animal, but about a lot of animals. We are talking not about simply the next animal, but about the potential trajectory that is followed by a practice that results in future conditions in the food and farming system. Some attention should be given to those things.

The other thing that struck me coming off the page of the draft legislation was the fact that there was a focus on the individual traits being modified, but of course welfare is not about one trait. The welfare of the animal is about the interaction of a range of traits at the molecular level and the phenotypic level, and it is about the interaction of that set of characteristics of that animal with the environment. What breeding is doing is trying to develop animals and fit them to particular environments, and consideration needs to be given to that as a more general theme.

I am extremely pleased that the Government have taken note of the fact that welfare is an important ethical issue affecting animal breeding, but it is not the only one. A range of other considerations need to be taken into account when one is directing a breeding programme, and those are a range of considerations that are of public interest, and therefore properly, I think, the subject of public policy.

I am conscious of time, Ms McVey, so I will come back to Peter if I have time.

If we could all be conscious of time, please.

Q Nuffield Council has obviously welcomed aspects of the Bill, but there will be a lot of detail required in legislation that we have yet to see. A lot of it seems to subject to the negative procedure as well. If the Bill is amended as it goes forward, what are the main areas that you want strengthened in regulation?

Dr Mills: I concur with Dr Campbell. In the first place, there is quite a lot that is opaque or simply missing, because it is subject to further regulations. It is unfortunate in some respects that you will have to debate the Bill with those uncertainties in front of you. It would be nice to see the constitution and membership of the animal welfare advisory body, for example, specified. The powers, resources, reporting lines and enforcement functions will be really important in thinking about how well whatever government system we end up with for precision breeding functions.

Q Would you speak a little about the point you make in your document about the release of precision bred organisms, and about the reassurance you are seeking on the inclusion in primary legislation of a minimum prescribed period for those proposed releases? How might that be published? What time would be needed to examine that? What are your thoughts on the current shortcomings on those issues in the Bill?

Dr Mills: This may be a minor and easily remedied technical point, but certainly from my reading of the Bill, it struck me that in order to release a precision bred organism one had to comply with part 2 obligations and notify the Secretary of State. If that organism was not being made available, however, or marketed, I do not think there is any further obligation to secure prior permission. If that is the case, at the very least the power to make regulations to provide a period during which that release can be examined, representations made, decisions reached and possibly enforcement powers brought to bear should be given effect. That power should be exercised mandatorily rather than at the discretion of the Secretary of State.

Did you want to say something, Mr Stevenson?

Peter Stevenson: Yes, if I may. As I said earlier, I think the animal protection provisions in the Bill need to be clarified and strengthened. For example, clause 11, requires an applicant for a marketing authorisation to assess and identify the welfare risks, and clause 12 says the welfare advisory body must then make a report on whether the applicant has properly identified and assessed the welfare risks. To some degree, the way it is written puts the applicant in the driving seat—playing the lead role in determining which welfare risks will receive primary consideration. The Bill needs to be amended to make it clear that it is the welfare advisory body that is in the lead. Of course it will look at the information supplied by the applicant, but the Bill must require the advisory body to carry out its own independent, far-reaching investigation into the possible welfare risks. It should not be fettered by just what the applicant has said.

Thank you.

Q Mr Stevenson, if you could change the Bill, what are the key changes you would make? For example, do you agree ethically with the plant component of the Bill, in terms of gene editing plants, but not the animal side? You have talked about some of the changes that will need to be made on welfare and about putting the farmer, or whoever it is, in the driving seat with the changes you talked about just now. I am keen to know if you make a distinction between plant gene editing and animal gene editing. Does the Bill go far enough in the revisions that it makes to deal with gene editing of animals, or do you want to throw it out completely?

Dr Mills, on gene edited exports, one presumes that once this biotechnology is achieved, it does not make a difference what welfare rights we have in this country for animals. A big part of the Bill is giving British biotechnology the ability to get out in front on this, and we could then sell that technology to other countries that have much lower animal welfare standards. Is that a concern?

Peter Stevenson: I do not know enough about plants to give a proper opinion. When it comes to the animal side, as I said earlier, there are a few cases in which I think gene editing could be beneficial, but ideally I would like to see animals removed from the Bill and much more thought given to how gene editing is going to be used and what protections should be there before legislation is introduced.

For example, the arguments that gene editing can be beneficial in terms of disease resistance have been overstated. Yes of course, if you are looking at diseases that have nothing to do with the way animals are being kept, gene editing for disease resistance can be helpful, but the science is absolutely clear that many diseases stem from keeping animals in intensive conditions. Very specifically, the crowded, stressful conditions in intensive livestock production can lead to the emergence, the spread and the amplification of pathogens. Gene editing should not be used to tackle such diseases. These diseases should be addressed by keeping animals in better conditions. There is a very real danger that if you gene edit for resistance to diseases that primarily result from keeping animals in poor conditions, that could lead to animals being kept in even more crowded, stressful conditions, because they may be resistant to the diseases that are inherent in such conditions.

Having said all that, I suspect Government isn’t about to drop animals from the Bill. I have talked about how the Bill should be strengthened in terms of giving a stronger central role to the welfare advisory body, but it also needs to be strengthened in setting out what that body should be looking at. The Bill is very unusual. Usually primary legislation provides more definition.

For example, the welfare advisory body should be looking for things like a piece of gene editing aimed at animals growing faster or providing higher yields, and asking, “Has this caused a problem for animals that have been selectively bred for such purposes?” If it has, it should be very careful and look at whether that is likely to happen with gene edited animals. It should also be asked to look at whether the desired objective of the gene editing could have been achieved in less intrusive ways. An awful lot more thought needs to be given to the use of gene editing in animals.

I will add one point. It is more than 50 years since Ruth Harrison’s book “Animal Machines” first alerted us to the dangers of intensive livestock farming, yet gene editing is doing exactly that: treating animals as machines that can be fine-tuned to make them a bit more convenient for us. The Bill sits at considerable odds with the recent Animal Welfare (Sentience) Act 2022 that regards animals as sentient beings. The two do not mesh.

Dr Mills: To pick up on what Mr Stevenson said and to clarify, the Nuffield Council certainly sees many benefits in genome editing as applied to animals. Unlike perhaps a number of other commentators on the issue, we does not see genome editing as necessarily being the last resort. We recognise that, in some cases, there are social conditions that are every bit as intractable as the biology of animals; indeed, given the technologies that are becoming available to us, the biology of animals is perhaps more tractable. Our way of approaching this is to treat those things symmetrically and to consider in what way different interventions might promote a just, healthy and sustainable food and farming system, taking into account the interests of the people and animals that are dependent on that system.

You asked about the technology being sold to countries that have lower animal welfare standards than the UK. I am very happy to live in the UK, a country that does respect animal welfare. Of course, the science and the technology are very easily translated across national and jurisdictional boundaries, but that really is an argument for the governance of breeding according to purposes. It should be consistent with the purpose of securing safe, just and sustainable food and farming systems. A technology can be applied in any number of contexts, and one cannot necessarily control them all. However, if you set out in the right direction, you have a much better chance of arriving at a desirable destination.

Dr Campbell: Chair, may I comment on that?

Yes, you can. The question was not directed to you—again, I am mindful of time—but of course, please do come in.

Dr Campbell: I will be very brief. I just wanted to pick up on one thing said by Mr Stevenson and one by Dr Mills. Mr Stevenson mentioned the scope of the animal welfare advisory body as it is written into the Bill, and I think he is absolutely right. It needs to be increased so that it has a more proactive function and looks at the actual process of precision breeding, not just looking at marketing authorisation applications. I know you talked before I joined the meeting about the interaction between the ASPA and this piece of legislation. I think it is going to be very important to understand that and whether the Bill is proposing to bring some genetic precision breeding out of the ASPA and into a non-ASPA realm. The advisory body will be important there.

That brings me on to the point about the international aspects of this legislation. I am very aware that one can go online now, already, and buy a genetic editing kit for frogs, including live frogs. You have to purchase it in the States—I checked this morning before I joined. We must be careful of having a system in place that carefully regulates professional scientists, but somehow allows others to undertake genetic editing of animals outside of it. That will be very important to protect animal welfare, as well.

Q I am a huge supporter of higher welfare standards for animals—it is really vital. Having lived and worked in Africa, I agree with Dr Mills that we are fortunate in the UK to value the fellow mammals that we share the planet with—we can forgive the odd chicken and not get offended. However, to my mind, the Bill is about enabling science and making sure that we can go forward and use the tools and techniques in institutes such as Roslin. I am not sure why animal welfare would need to go in the Bill if precision breeding is the same as traditional breeding and, in fact, lots of the deficits in traditional breeding techniques are what has produced some of the deleterious conditions that current stock animals find themselves in. I will start with Dr Campbell, but I would welcome anyone else coming in. Dr Campbell, in your practice as a vet, if you identify poor animal welfare, what current legislation would you be using to ensure that that was taken up and prevented? I do not see the link between a different breeding technique and animal welfare standards falling over. Do you see what I am getting at?

Dr Campbell: I think I see what you are getting at. Obviously, in normal, non-experimental areas, one would be looking either at the Animal Welfare Act 2006 or at the Veterinary Surgeons Act 1966. I think what is different here is the potential for off-target effects, which at the moment are not very well understood and not predictable. We need to have a mechanism for keeping a very close eye on those.

I have one more point. There is—carried over from the consultation on this Bill, I think—an idea that a mutation, effectively, that could occur in the wild is really no different from what we are trying to achieve by genetic editing. And while it is true that a mutation might occur in the wild, that does not necessarily mean that it is not a bad thing. And anyway, when we are doing the genetic editing, we are very deliberately trying to cause something at a very high incidence, and that probably would not be the incidence of the mutation in the wild. So I do think there is a difference between employing these technologies and just more general selective breeding, and so-called traditional breeding is currently ill defined in this Bill.

Q There are a couple of points there. Could I just come back to the question that I asked, which was about having animal welfare standards in this Bill, because for me the Bill is about enabling science? Then I would like to ask a brief follow-up question on your point about the techniques.

Be mindful that we have under three minutes left of the whole sitting.

Okay, I will ask this in one sentence. Current animal welfare standards are not in this Bill, but we have animal welfare standards—is that right?

Dr Campbell: We have animal welfare standards under the Animal Welfare Act 2006, certainly. A noticeable thing about this Bill—I think someone else mentioned the Animal Welfare (Sentience) Act 2022—is that, as I understand it, the Bill is relying on the definition of animal in the Animal Welfare Act and that of course is less comprehensive than the definition in this year’s Animal Welfare (Sentience) Act. It does not include cephalopods or decapods, and I am unclear on why that is.

In the interests of time, perhaps we can pick this back up and explore it later. I am conscious that others want to come in, Ms McVey.

Okay, with two minutes left, is it possible to get Kerry McCarthy and Andrew Bowie in?

Q This will possibly have a one-word answer. We have heard quite a few witnesses say that the farm animal welfare codes are sufficient in terms of regulating some of our concerns bout welfare. This question is particularly for Professor Campbell and Mr Stevenson. Do you think they are adequate?

Peter Stevenson: No, the codes do not address breeding issues in any very clear way, other than sometimes through a broad principle to say, “Yes, be careful how you breed in order not to harm animal welfare.” We have a huge amount of legislation in this country, but just one or perhaps two provisions that deal with breeding, and they are so broadly worded that they have never had any impact on the harms done by selective breeding. To go back to Katherine Fletcher’s point, I think it is vital that there is something in this Bill to protect animal welfare, because the current legislation, as I said, has really very little on breeding, which is why we have all these problems. If this Bill is going ahead—I know it is—let us at least have some good, well-crafted animal welfare protections.

Is not the implication of that that you would be telling the scientists what to do?

Sorry, but we have only 30 seconds left. Can you do a quick question, Andrew Bowie?

Yes; this is just to Peter Stevenson. We all agree that intensive farming and seeing animals held in situations that we would not have in this country engender disease and all the rest of it. We see that around the world. Is not it better that we use the technology and science being developed in the UK, at places such as Roslin, to try to edit out those diseases, because practically, these animals are being held in conditions that would not be acceptable in this country? We can export that technology overseas.

Order. I am afraid that brings us to the end of the time allotted for this sitting, but I want to say thank you very much indeed to Dr Peter Mills, Dr Madeleine Campbell and Peter Stevenson for being with us here today.

Ordered, That further consideration be now adjourned. —(Gareth Johnson.)

Before we begin, I have a few preliminary reminders for the Committee. Please switch all electronic devices to silent mode. No food or drink, except for the water provided, is permitted during Committee sittings. Hansard colleagues would be grateful if hon. Members emailed their speaking notes to hansardnotes@ parliament.uk. It is a little muggy, so I am happy for hon. Gentlemen to remove their jackets, if they so wish.

Clause 7

Combined county authorities and their areas

I beg to move amendment 46, in clause 7, page 7, line 5, at end insert—

“(3A) Condition C is that the public in the area have been consulted.”

This amendment would require public consultation to take place before the establishment of a CCA.

With this it will be convenient to discuss the following:

Amendment 48, in clause 22, page 18, line 33, at end insert—

“(c) the public have been consulted.”

This amendment would require public consultation to take place before the amendment of a CCA area.

Amendment 49, in clause 23, page 19, line 35, at end insert—

“(c) the public have been consulted.”

This amendment would require public consultation to take place before the dissolution of a CCA.

It is a pleasure to serve with you in the Chair, Mrs Murray. We had a very good first day of line-by-line consideration on Tuesday. We had interesting debates, held in good spirits, and where we differed, we were able to do so well. I am sure that we will do similarly today. I hope that we may have a little more luck moving the Minister, and even if we do not in substance, we may at least establish some agreements in principle.

Today we start our consideration of part 2, the final half of the levelling-up provisions in the levelling-up Bill. There is a certain oddness to the fact that we will be considering the Bill well into September but will finish the levelling-up bits shortly. That pushes me back to the point I made at the beginning on Tuesday: this is not wholly a levelling-up Bill anymore. Nevertheless, the bits that we have in front of us are very important.

Clauses 7 to 70 establish combined county authorities, which will be the essential building blocks of sub-regional devolution. If done well, they will be the foundations of local place-shaping architecture that will drive forward levelling-up across our nations and regions. We do not have an issue with the establishment of CCAs—indeed, we support their development—but we think there are various ways of improving them, and those are covered by these amendments and amendments to come.

Some basic principles govern the amendments. First, we want to see greater public involvement. Secondly, we want to see strengthened local leadership. Thirdly, we want to see access for all communities to the highest level of powers. Fourthly, we want the Government to be non-prescriptive on the governance model. I might add as an addendum that I hope to hear from the Minister that the Government really intend to let go; they do not want to devolve powers but then still keep their hand in to guide communities when they do not get from them the answers they want. Where the Government can meet those tests, we will support them, and when they do not, we will seek to enhance the provisions.

Clause 7 establishes new bodies corporate, the combined county authorities. I will say a little on the distinction between CCAs and their sister organisations, combined authorities—as established by part 6 of the Local Democracy, Economic Development and Construction Act 2009—when we debate amendment 15. At this stage, it is important to understand our amendments by understanding what these new regional, or presumably sub-regional, structures will do. They will be at the heart of the levelling-up agenda when it comes to leadership. These bodies will receive power and money from the centre and use them to drive forward the development of their communities. If it turns out that levelling-up has succeeded, as we all hope it will, it will be because these bodies have succeeded. We have already seen the success of those rather similar, although in law distinct, bodies in parts of the country. Examples are the Greater Manchester Combined Authority and the West Midlands Combined Authority. We could list them all, but I will not do so. However, we can see that success across the country.

That said, we have to be clear that these bodies must be structures that work for communities. They are not conveniences for central Government or regional leaders. They must be bodies that drive collaboration across the public, private and voluntary sectors and, critically—this is the spirit of our amendments—that connect the public to the process of levelling up and improving their communities, getting the public involved in the decisions that shape their communities and lives. Amendments 46, 48 and 49 would start that process. If we fail to connect the public to the process then, despite the promises made in the White Paper on communities shaping their own futures, that just will not happen. We will be stuck in the progress paradox, whereby things get better but people feel worse, because change in their community happened to them rather than in partnership with them.

I put it to the Minister that one of the biggest risks of this entire programme is that, the Government having told local communities that levelling up will mean a shift of power from the centre to communities—from Whitehall to town hall—some power moves instead from the centre to the sub-region. That sub-region, which is currently an alien concept to most people, will be a new tier of politicians and public figures who are at a level even further away from people than their local council and who are harder for them to engage with, and certainly harder for them to remove. I do not think that will meet the public expectation test. It is really important that we demonstrate that the public are equal partners in the process and that it is done with their consent and commitment; otherwise, the new bodies will sit in isolation and will not deliver what they are supposed to deliver.

Amendment 46 makes a simple but important point. If the Minister wishes to secure for the Secretary of State, as in clause 7(1), the power to establish the new bodies, we really ought to establish whether the public want them, understand their value and understand their role in them. Currently, clause 7 allows for the formation of combined county authorities should two tests be met: condition A is that the area consists of

“the whole of the area of a two-tier county council”

combined with either

“a unitary county council, or…a unitary district council”;

and condition B is that the area is not already part of another CCA, an integrated transport area or a combined authority. The amendment would add condition C, which is that

“the public in the area have been consulted.”

That is a low bar—indeed, I have lightly prescribed it and would recommend then tightening the mechanisms in the guidance that follows the legislation—but it is nevertheless a crucial test to ensure that the body is set up in the public interest and is actually what people want.

My own local community is a pertinent example. It is no secret—it is in the White Paper—that the Minister and the Secretary of State hope to form county deals that lead to CCAs for Nottingham and Nottinghamshire and for Derby and Derbyshire. From all the coverage, I understand that those two deals are likely to come together. As a Nottinghamian I have doubts about that as a natural geography, but it is not necessarily about my views, or indeed the view of my constituency neighbour, the hon. Member for Broxtowe, who I am sure has his own views, or indeed the views of the Minister, as the initiator from the centre; it is about the views of the million-plus people who live in our community and whose future will be shaped by such deals. It is important that it happens with their consent and understanding, that the case is made for that geography, and that their views are properly and meaningfully tested and given due prominence in the discussion. That is a reasonable thing to ask and, if we are to get the bodies off on a good footing, a good idea and a good place to start.

Amendment 48 is a counterpart to amendment 46 and would amend clause 22, under which the area of a CCA might be amended in future. It mandates public consultation on a non-prescribed basis. It is even easier than the requirement for public consultation under amendment 46, because currently that would mean talking to people in the abstract: “You currently have a central Government, a local government, and you may have town and parish councils, a county council, two-tier local government or a unitary authority, as in the city of Nottingham. We are going to create this new body about which you do not know yet because you do not have a combined authority yet.” That will involve a certain amount of explanation and high-quality information. With amendment 48 it would be a bit easier, because at the relevant stage CCAs will already be established so it will be easier to ask the public whether they wish to enter or leave an established one.

Similarly, amendment 49 would amend clause 23, under which a CCA might be dissolved. Again, that is rather easy to explain to the public or for them to understand: “You have a CCA; do you wish to still have one? Here might be the reasons either way.” I have a lot of confidence that the public are more than capable of properly engaging in those decisions. In fact, I think there is significant public expectation of that engagement. As leaders in this place, we should look with some concern at the polling every couple of months on public trust and confidence in Parliament as a whole, and in our ability to enact the changes that they want. There is a high degree of scepticism. People are actually more confident in local government.

The strand that comes through all that polling is that people want to have a say. If we establish such important bodies, which will have a significant say on levelling up, we need to ensure that the public have been engaged at the earliest point.

It is great pleasure, Mrs Murray, to serve under your guidance. I will say a brief few words, broadly in support of what the hon. Gentleman said about consultation.

Devolution is not devolution if it is done on the terms of central Government, by definition; nor is it really devolution if it involves hoovering up the functions of lower-tier councils. It is not devolution if it is done for the convenience of people in Whitehall and does not involve listening to the people in the communities directly affected. Setting up combined council authorities may indeed be an important building block in delivering what the Government see as levelling up, and I can see the merits in it, but although consultation needs to happen—it is right that it is written into the Bill—it also needs to be meaningful.

Twelve months ago, the Government had not settled on any kind of reorganisation for Cumbria—I speak from not bitter, but rich, personal experience—and we are now two months into a new authority, which was elected at the beginning of May and on which, I am pleased to say, the Liberal Democrats have a majority. Westmorland and Furness Council was but a twinkle in the Secretary of State’s eye only a year ago, however. There was a consultation, but less than 1% of the population of Cumbria responded to it. Generally, most people were of the view that the proposals were meddling top-down reorganisation for national, rather than local, purposes.

Remember that Cumbria itself was established in the early 1970s, when the historic counties of Westmorland, Cumberland, Lancashire over the sands, and the West Riding of Yorkshire were put together. That county kind of worked, but someone who went to Sedbergh would have to talk about cricket in a very different way from if they went to Grange. The reality of local identity is hugely significant. A consultation in which a few engaged people fill in a form on the internet is not consultation. It is a consultation in name, but the majority of people are not actually listened to.

If consultation is to be formally included in the Bill, that is fine, but I want it to be deeply embedded so that communities actually get a say about the boundaries that may be formed by any new combined council authorities. I am fortunate that every single blade of grass in my constituency is parished, but not every part of the Westmorland and Furness Council area is parished. It is important that voices in each part of the new authorities are able to express the views of those communities.

Consultation is vital, but it should be more than just a word. Arguably, as a society, we have never been more consulted but less listened to. Let us make sure not just that consultation is included in the Bill, but that it is ingrained in the practice of developing the new authorities, so that communities’ cultural identities are reflected and the wishes of the people on the ground go towards building those authorities, which should be built not for the convenience of Whitehall, but for the empowerment of communities in Cumbria and across the rest of the country.

I, too, will speak in favour of the amendments. Consultation is so fundamental to the Bill because it is important that the power of our communities and the public be on a level with that of Government. The public bring the expertise and know the nuances of their communities so well that they can advise Government on what is best for them. That expertise can be overlooked in a top-down approach. It is essential that there is proper consultation—not just information—because being able to participate will give people agency in the democratic structures that will be developed.

I appreciate that we are just on clause 7, but has the hon. Lady considered clauses 42, 44 and 45, which provide the means for public consultation?

I am grateful to the hon. Gentleman for highlighting why it is so important to sew that principle right through the Bill to ensure public consultation—including in clause 7. It is an important principle which is why I hope that the Government will accept the amendments.

With respect to the hon. Member for Keighley, clauses 42, 44 and 45 do not relate to consultation at the initial stage of CCAs, but that is what we debating now, is it not?

My hon. Friend is absolutely right. We want communities to be involved in their own destiny before there is any ink on the paper. That consultation and working through the stage of each process to bring the CCAs together is also important. That is why we want that process to be embedded in the Bill.

We have recently been through a local government reorganisation in North Yorkshire, and that has been quite a painful process for many of the district councils as they have come together to form the new North Yorkshire County Council. York was part of the initial consultation and because we had a voice, we were able to stake our claim not to be brought into that authority. We argued that we had our own identity, going back to King John and the charter that established York as a city. If we had lost that identity, we would have lost a significant place on the global stage. The original proposal was for York to disappear and to be replaced by a North Yorkshire East and North Yorkshire West model. If the identity of such a significant city had disappeared, there would have been no heart to Yorkshire, nor any identity. That is why I am glad that we had proper consultation about that process, and that is why it must be replicated in this legislation.

To Labour, the people’s voice really matters, and we want to see people’s voices coming through so that they are involved. Nothing in a Government agency should be superior to those we represent. I trust that the Government will reconsider the amendments and see the opportunity that they present to them, if not to the people.

It is a pleasure to serve under your chairmanship, Mrs Murray. I echo the comments from those on the Opposition Front Bench about the quality of the debate on the first day of line-by-line scrutiny. I hope to continue that tenor and interesting dialogue.

We completely agree with much of what Opposition Members have said, which is why we have provided for exactly what they want in the Bill. Let me expand on that. In the levelling up White Paper, we announced a new institution that we believe can provide the strong leadership and effective and coherent collaboration needed for a strong devolution deal in certain circumstances. This new institution is the new combined county authority model, referred to in the Bill as a CCA.

As Opposition Members have said, the appropriate circumstances for that model is where a county deal covers an area with two or more upper tier local authorities. Those upper tier local authorities will be the constituent members of the CCA. Although we have not yet of course established any combined county authorities, because we are legislating for them here, we need to look to the future, as Opposition Members have said, and anticipate a scenario where an established CCA wishes to change its boundary. Since there is no benefit in a shell institution existing in perpetuity, it is only right that the legislation provides for such an institution to be abolished.

Wherever a CCA is planned to be established, its boundaries changed, or is to be abolished, we absolutely want to see the local public being consulted on the proposal, but the amendments are unnecessary, because the requirement for a consultation on a proposal to establish, amend or abolish a CCA is already provided for in clauses 42(4)(a) and (b), and 44(3)(a) and (b). Those provide an opportunity for local residents, businesses, organisations and other key stakeholders to have a say on the proposal, exactly as my hon. Friend the Member for Keighley pointed out. A summary of the consultation results must be submitted to the Secretary of State alongside the proposal and have regard taken of it.

There is a further safeguard in clauses 43 and 45, which provide that the Secretary of State has to undertake a consultation before creating, amending the boundary of, or abolishing a CCA, unless there has already been a consultation in the affected areas and further such consultation would be unnecessary. That will ensure that there has been sufficient public involvement in the consideration of whether it is appropriate to establish, change the area of or abolish a CCA. As such, I hope that I have given sufficient reassurance that the amendments would be purely duplicative for the hon. Members to withdraw them.

To touch on a specific point, the hon. Member for Nottingham North talked about initiators of devolution at the centre, we are the initiators of the devolution process in one sense. However, we are not the initiators of devolution deals for particular places. Ahead of the levelling-up White Paper, we called for expressions of interest, and we only move forward—we can only move forward—with a devolution deal if it has the support of locally elected leaders. In that sense, we are not the initiators; it takes two to tango, and that is the nature of devolution. In this Bill, it comes with what I hope for Opposition Members is sufficient requirement to engage in deep public consultation, and for that consultation to be listened to properly, as said by various people.

I am grateful for colleagues’ contributions. They were good ones. Briefly, the example given by the spokesperson for the Liberal Democrats, the hon. Member for Westmorland and Lonsdale, was a salutary tale. Again, there is the idea that something so significant might be engaged in by only 1% of the population; if that is where we end up with these structures in future, it would be really problematic and almost undermine their ability to perform from the outset.

On the points made by my hon. Friend the Member for York Central, I have not quite found the right moment in the debate to talk about integrated care systems, but that is a good example of another very significant body that will have to engage with the county combined authorities in some way. The footprints do not sit elegantly, and they do not in life—I understand that. It is easy in countries such as the US perhaps, where they have defined, existing state borders—okay, everything can fit elegantly around that, but it can still get confusing at the margins.

There is a challenge there, but I think that it gives greater strength to the case for public involvement, rather than saying we ought to sit here with a map and carve things up. The people who know that best and how the sensible natural geographies work are the general public. The answers lie there, and it happens naturally—people know at what point they start to look, say, northwards to the hospitals in the north of the county, rather than to the one in the south, as happens in Nottinghamshire. That is a strong case for greater public involvement.

I am, however, reassured by what the Minister said about the provisions in clause 42(4)(a) and so on—the hon. Member for Keighley mentioned them, too. The reason for the separate amendment was my concern for the process to be one that happened not as an ABC condition right at the beginning, but as a co-equivalent term of engagement. Clearly, from what the Minister said, the intent is not to come alongside a proposal: “Have you brought your consultation with you? Right, that is ticked, therefore it is done.” On that basis, I will not press my amendment to a Division.

I will finish on the point the Minister made about initiating devolution. I am not sure that I quite agree with what he said. First, of course the centre is the initiator, in the sense that we could not have these bodies if we did not have the Bill, and we could not have the Bill if a Minister of the Crown had not presented it—so the centre is the initiator in that sense.

Also, I love the idea that the Government’s view is that local communities of a natural geography would come together to ask for county combined authorities and, most importantly, the powers that come with that, and the Government would respond on the quality of that application, but the White Paper already tells us the 10 areas that the Government are prioritising. That is “initiating” in any sense of the word; those are the areas chosen and the geographies for those areas have been chosen. There is no sense that this is a “come one, come all” process, as the Prime Minister has previously said— come to him or the Minister with ideas and “We will give you the powers you need.” That is not what is in the White Paper—it is very clear who it is who is being called forward. So I challenge the Minister’s point on that, but I am grateful for the comfort he has given on the amendment and I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

I beg to move amendment 15, in clause 7, page 7, line 7, at end insert—

“(4A) “The Secretary of State must commission an independent evaluation of the merits of establishing CCAs as distinct from combined authorities and must lay the report of the evaluation before Parliament within 12 months of this Act coming into force.”

This amendment would require the Secretary of State to conduct an independent evaluation on the merits of the new Combined County Authorities established in Clause 7 and to report the findings to Parliament.

As we have discussed, the clause establishes county combined authorities if conditions A and B are met. The latter is the most pertinent. CCAs are different, though complementary, to combined authorities, which already exist under part 6 of the Local Democracy, Economic Development and Construction Act 2009. The clause essentially rolls out combined authorities so that all communities can have access to devolved powers, which is of course a very good thing.

That raises the question of why we need this clause, as we have the power on the statute book already. We need to be very clear, because this is a significant policy change. The Government feel that there is a need for CCAs alongside combined authorities. The decision to form such a combined authority can be decided at the upper tier, which essentially removes what the Minister termed, in the evidence session, the district council “veto”—we will get into that point more when we reach clause 16. This is a significant moment, a significant distinction and a significant divergence from current policy, which will have a significant impact for all those areas with two tiers of local government. I have no doubt that it will elicit strong feelings about whether district councils should be a formal partner in the process; the powers included here mean that, in the future, they will not be.

Amendment 15 is perhaps slightly less exciting. We will now have essentially two sets of organisations that basically do the same thing, or which will be used largely interchangeably in this place, the media and in public conversation. I expect that Ministers will engage with both types of organisation similarly—there is nothing in the White Paper to suggest otherwise. I understand the value in getting them going, but—I am leaning on the expertise that the Minister has access to—does he have no anxieties that that different legal status may lead to unintended consequences down the line in terms of what the organisations can and cannot do? We might end up with a divergence that we are not seeking. As far as I have had it explained, the only reason for divergence is for the ability and convenience of getting these things going.

The amendment asks that within a year of the Act coming into force, the Secretary of State commissions a report that establishes whether it is desirable to have this technical difference for things that are substantively the same.

I can already hear what the Minister is going to say in response, because we rehearsed some of these arguments on Tuesday. The importance of the independence that the amendment points to should also be drawn out. If we are building confidence between communities and Government and establishing a new tier of power and of democracy, having rigour and independence is also important, to ensure that we can progress proposals on CCAs. Does my hon. Friend agree that that is a vital element of what the amendment proposes?

Yes, that independence and transparency will be the theme of a lot of our discussions. I make no apology for that. In this case “independence” was carefully chosen because we need to be clear that the reason for setting up a new class of combined authorities as distinct from those cited in the 2009 Act is one of convenience, because it means that something will be done. The broad agenda has been stuck, spinning its wheels, and there are no more combined authorities in the works because those who were able to form consensus have done so and the rest, presumably, are unable to do so. The Government of the day have the right to bring forward proposals, as they have done, but the amendment is designed to provoke a clear response from the Minister that there is no danger of separate treatment for those bodies that is not intended at the outset.

This is important because the suspicion of many people is that this is a back-door way of circumventing district councils. We have been through reorganisations in much of the country, and for those places that have escaped somehow, such as Lancashire for instance, the Bill is a way of making sure that they all behave themselves and come under an aegis of an organisation set up by the Government.

In many cases, there is great value in two-tier authorities. If we believe in devolution, it should be knitted together and initiated from the grass roots and not from Whitehall down. If the CCAs are the building blocks through which levelling up is to be delivered, that must be done on the basis of an accurate analysis of the respective needs and desires of the communities involved. Independence in this context applies to the assessment of the value of the boundaries and the nature of the CCA. That is vital, particularly to put at rest those who may fear that CCAs represent a back-door way of scrubbing out the powers and relevance of district councils, even parish councils. I hope that the Government appreciate that fear and seek to address it.

In my earlier comments, I set out the CCA model and talked about the rationale for it. Some areas that we are discussing a devolution deal with are considering adopting that CCA model. But even with those first areas, it is highly unlikely that the deals will be negotiated, announced and implemented via secondary legislation, and CCAs established and up and running within the 12-month period of this Bill receiving Royal Assent. That would render the report’s evaluation no different in 12 months’ time from today.

Opposition Members rightly want to have a debate in Committee about the CCA model. I have said a bit in our previous sessions about why we are doing it, but let us take the discussion a bit further. The purpose of the CCA model is to make devolution practically possible in two-tier areas without requiring unitarisation. The hon. Member for Westmorland and Lonsdale talked about districts coming under the aegis of a CCA, but that is not quite right. It could easily be that only top-tier authority powers are devolved to the top-tier authorities in a CCA. If they do not want to, the districts may choose not to take part. They are not having their powers or responsibilities changed, but the difference is that they are not able to veto their neighbours from getting devolution or making progress.

I am perfectly happy to stand here and make an argument about fairness, because I do not think it is fair that one district can veto progress for a large number of neighbouring districts and boroughs for top-tier authorities, particularly if it is not being forced to do anything, as is the case under the Bill. It is simply unfair for such a district to be able to stop their neighbours going ahead.

The Opposition sort of alluded to the practical reality in that although I would not rule further mayoral combined authorities in the future, in a lot of a country that currently does not have a devolution deal, the CCA model will be the practical way of delivering that. In practice, if we do not have that model, we will just not make progress. I can think of one area that we currently discussing that has a very, very large number of district councils, and it is exceedingly unlikely that we would be able to agree a sensible agreement if every single one of them were given a veto.

In a sense, the amendment is to push us, not unreasonably, to talk about the whether the CCA model is the right one. The proposed evaluation is in one sense called for so that we can now discuss whether this is the right thing or not. I think we have been clear. There is no back door. I am standing here telling Members why we are doing it right now and what it does and does not mean. We will discuss some of the nuances when we consider further clauses, and we absolutely have to get that right. However, the amendment and the evaluation proposed would essentially not add anything to our conversation this morning, whether one believes that the CCA model and the removal of that veto is right or not. That is why I ask the hon. Gentleman to withdraw the amendment.

I share a lot of the views expressed by the hon. Member for Westmorland and Lonsdale about districts, which we will have the opportunity to discuss further in the debates on future amendments. I also agree with what he said about parishes. I hope the Bill is the single biggest step forward for parish and town councils in terms of the community powers that they can exercise, closest to the lowest possible level, to give communities a real say in what happens in their area. The Bill does not currently say that but we will seek to add it in due course.

I have a number of points to make about what the Minister said. I appreciate his candour, which reflects well, as it would be easy for him to obfuscate. I take him at his word, but I am surprised that there is a sense that within a year of the Bill achieving Royal Assent, which itself is some months away and probably nearer to Christmas, we will not have had any future deals agreed under these provisions. That genuinely surprises me, and I suspect it will surprise quite a few people who are currently negotiating such deals. I understand that the Minister has May 2024 in mind for elections; that timescale does not give us an awful lot of time, which poses its own desirability problems.

I disagreed with the Minister’s point that rather than this being about circumventing districts it is about making combined authorities possible without requiring unitarisation; that is not quite right. Deals have been made that involved district councils and they did not require unitarisation; they required consensus and understanding. I do not think it follows that it is either what is in the Bill or unitarisation, which leads to the point about districts not losing power. We will test that later, but I am glad that the Minister has put that on the record because it is important.

The Minister made a point about fairness, which I understand. He alluded to an example in which a deal with perhaps 15, 18 or 20 partners could not go ahead because one partner was able to say no to the whole process; I agree with him that that is probably not a good thing. Possibly, that is a point about fairness, but there would be other ways around it, such as to allow districts to exit a process and others to carry on. Again, there are benefits and disbenefits to that. Rather than a single district being able to veto the whole process, it could be done by a super-majority, given the significant nature of the decision.

The hon. Gentleman has touched on a really important point. He has encapsulated in a very neat way what we are trying to establish here, which is the ability of districts to participate if they want to and not to if they do not want to.

I am grateful to the Minister, but I do not think that will be the effect of the legislation. The reality is that a combined authority area can be formed for the area that includes the district council, whether it wants that or not. Indeed, the district council will have limited say. I do not want to prejudge the discussion we will have when we come to clause 16. It is welcome that the Minister has nailed his colours to the mast, but the reality is other mechanisms could have been chosen. The Government have chosen this mechanism, so it is right that we probe it. We have been able to do that and, as I am at risk of moving ahead of the discussion, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 7 ordered to stand part of the Bill.

Clause 8

Constitutional arrangements

I beg to move amendment 16, in clause 8, page 7, line 24, after “about the” insert “initial”.

This amendment, together with Amendment 17 would give the power to vary the constitutional arrangements of a CCA to the CCA alongside any elected Mayor.

With this it will be convenient to discuss amendment 17, in clause 8, page 7, line 25, at end insert—

“(1A) After regulations containing those initial arrangements have been made, the responsibility for varying the constitution lies with the CCA in conjunction with any elected Mayor.”

See explanatory statement for Amendment 16.

The amendments would alter clause 8, which allows the Secretary of State to establish constitutional arrangements for a county combined authority, which are important and establish the terms of engagement. We Members know as well as anybody else that the basic rules by which a body corporate operates can have a significant impact on decisions and outcomes—although they might not be codified in one place, lots of significant rules and conventions guide our activity—so it is possibly not a surprise that we may be the type of people who get very interested in these sorts of things.

My hon. Friend is making an important point about the autonomy of CCAs to control their destiny. We recognise that we are on a journey of devolution. In her evidence, the West Yorkshire Mayor, Tracy Brabin, spoke about how she sees the intersection between her role and that of overseeing the police and taking a public health approach, which shows how things can evolve. As she does that, other authorities will be looking on and looking to replicate such opportunities. Does my hon. Friend agree that CCAs have to be given latitude so that they can make determinations about their own evolution and, as time goes by, get more powers to fulfil the aspirations and opportunities that need to come to local communities, let alone do anything to address the inequalities?

I share my hon. Friend’s view. That point was made very clearly in Tracy Brabin’s evidence. Having said that we in this place have an interest in constitutions and the rules of the game, my strong belief, as someone who wants to see change happen in my community and to see my community improve in a vast range of areas, is that form should follow function. What are we trying to get out of these bodies? The structures—the bodies and committees that need to be in place—should then flow from that. I strongly believe that the people best able to decide that will be those who operate locally in the combined authorities.

The Government have to set the broader parameters, but I am hoping to hear from the Minister that those are likely to be de minimis involvement and that, instead, they will positively cut the link and allow county combined authorities to drive action forward without worrying about that tap on the shoulder telling them that even though they said they wanted to do that, they cannot.

In our response to this amendment, it is crucial that we hold in our minds the distinction between local standing orders for combined authorities on the one hand and the statutory instrument setting out things such as voting arrangements on the other. It is essential for the stability and the establishment of combined authorities that things such as voting rights can be set out in secondary legislation to ensure a stable institution. Of course, the CCA can set out its own local constitution by itself, but those two things are very different.

We have talked already about the county combined authority model; clause 8 is vital to permit the effective operation of a CCA. Before making regulations under this section, the Secretary of State needs the consent of the constituent councils and, where it already exists, the CCA. In other words, the arrangements cannot be imposed against the local area’s will.

To answer the point made by the hon. Member for Nottingham North, the clause closely mirrors the provision for combined authorities, which has supported the establishment of 10 combined authorities, each approved by Parliament. In this instance, “constitutional arrangements” means the fundamental working mechanisms of the CCA, including things such as its constituent membership and voting powers. It is vital that those things are set out in secondary legislation and approved by Parliament. That ensures that CCAs are stable institutions with good governance, in line with agreed devolution deals. It is only right that the core design and operating model of the CCA, such as the constituent membership and the voting arrangements on key decisions, remain in line with the devolution deal agreed by Government and local partners at the outset, with the secondary legislation establishing the CCA being approved by this Parliament.

A CCA can set out its own local constitution or standing orders with additional local working arrangements. It might, for example, set out meeting procedures, committees, sub-committees and joint committees of the CCA. That is done locally, at the right level consistent with our position on localism, and does not require secondary legislation. The Mayor of West Yorkshire pointed out that they were making changes to go from one to three scrutiny committees, which is quite right.

The amendment is really inappropriate and potentially quite dangerous to the devolution process. It is inappropriate because it would allow a CCA to change elements of its constitution that are rightly approved by Parliament and part of the initial devolution deal agreed by all parties locally. It is unnecessary because all the other elements of a constitution can already be changed by the CCA locally. I hope to have given sufficient explanation for why we will ask Members to withdraw amendments 16 and 17.

I am grateful for that response. I take slight exception to the idea that the constitutions cannot be imposed without will. Yes, of course, all the members of the county combined authority will have had to have signed up to it—I understand that—but it will presumably be an indispensable part of the wider package, so we would be asking for local areas to turn down possibly many millions of pounds’ worth of funding, plus transport powers, extra housing powers and powers on skills, because they do not like the shape of the constitution. Of course they are not going to do that. I would not characterise that as them entering into it with the freest of free wills.

Perhaps it would help if I were to expand a little. If I were a local government leader considering joining a CCA, I would want to know that the key arrangements for it, such as voting arrangements, would be stable over time and could not suddenly be changed by a potentially transient majority of local authority leaders who are members of it. To be honest, if I felt that that could happen to my local authority, I would be wary about signing up to a devolution deal on that basis. That is why certain core functions of these things are rightly set in secondary legislation, while other elements are rightly for local decisions so that they can make arrangements work for them and make things work locally.

I am grateful to the Minister. I understand that, but I would like to know that local authorities will not fall victim to a one-size-fits-all arrangement. One could argue either way, which is fine.

The Minister’s point about local standing orders has addressed most of my concerns. He said that the arrangements remain in line with the original deal, but that cuts both ways. If he is saying no to local variation but yes to the idea of local standing orders, that must also mean that the Secretary of State will not make such changes. If we start to see variation between those deals, that becomes challenging, but I am getting ahead of the amendment before us. I am grateful for the clarification on local standing orders, and I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 8 ordered to stand part of the Bill.

Clause 9

Non-constituent members of a CCA

I beg to move amendment 18, in clause 9, page 9, line 30, at end insert—

“(7) The Secretary of State must publish an annual report on the non-constituent members appointed to each CCA. This report must include:

(a) the age of all non-constituent members,

(b) the gender of all non-constituent members, and

(c) the ethnicity of all non-constituent members.”

This amendment would require the Secretary of State to make the age, gender and ethnicity of non-constituent members of CCAs publicly available.

With this it will be convenient to discuss amendment 19, in clause 10, page 10, line 3, at end insert—

“(5) The Secretary of State must publish an annual report on the associate members appointed to each CCA. This report must include:

(a) the age of all associate members,

(b) the gender of all associate members, and

(c) the ethnicity of all associate members.”

This amendment would require the Secretary of State to make the age, gender and ethnicity of associate members of CCAs publicly available.

Clause 9 allows county combined authorities to designate non-constituent members—presumably other bodies such as integrated care boards, chambers of commerce and others—as nominating bodies. Clause 10 allows CCAs to designate associate members. I presume that those provisions are designed to enhance discussion and collaboration, which is a good thing for which we have argued throughout proceedings. CCAs ought to be partnerships between those sectors, and it is right that that is reflected in the Bill. Good examples abound throughout the country, and it is quite interesting to see the different approaches that combined authorities have taken.

Liverpool city region has a local economic partnership representative and a Merseytravel representative; West Yorkshire has a local economic partnership representative; and West Midlands has a tremendous range of observers or co-opted organisations, such as the Midlands Trades Union Congress, and representation from the young combined authority. In evidence, I asked the Mayor of the West Midlands about how that worked in practice, and it was clear that that combined authority had built an admirable cross-sector culture. I hope we will foster such a culture across the piece.

We are establishing a new tier or class of politician and public figure—especially when adding elected Mayors—and those people will make significant decisions that affect those they serve. They will have their own organisational mandates—elected or otherwise—and will come together to make significant decisions. However, they will be some way away from the public.

It is crucial—I hope there is general agreement among all parties on this—that our democratic organisations and public bodies strive to reflect the communities that they serve, and that we acknowledge the challenges and imbalances when they do not. Poor representation is a bad thing not just for those who are under-represented and suffer the consequences of a decision-making process that does not reflect their needs or interests, but for the institutions themselves. When they do not represent considerable parts of the population, they lose their legitimacy.

I do not think such problems could be amended at the stroke of a pen, but they can be understood, and an understanding of them is what we seek to achieve with amendments 18 and 19. Amendment 18 would add to clause 9 a requirement for an audit on the age, gender and ethnic composition of non-constituent members. Amendment 19 would amend clause 10 so that a similar audit happens for associate members. That information would be updated annually, would be produced by the Secretary of State and would be public and accessible to all.

There are examples of the positive role that legislation can play in empowering us to reveal inequalities and promote change. The Equality Act 2010, one of the final pieces of legislation of the previous Labour Government, is a case in point. It has been transformative, and building on elements of that Act would really enhance our work here. For example, section 106 of that Act requires the publication of diversity data on candidates, but the power has yet to be commenced by the Government, which is a real shame. That weakens our ability as a Parliament to represent the country we serve. Perhaps the Minister can tell us when that power might be turned on.

I am conscious that the most recent census information, which is just coming out, shows a significant change in the demographics of our country. It is important that we not only look at the three protected characteristics mentioned in the amendment, but consider wider protected characteristics—for example, disabled people in positions of authority. As well as reflecting communities, seeing that leadership is often an encouragement.

Yes, that is right. The suggestions in the amendments form a basis—I would be very keen to build that out across the protected characteristics.

That provision has worked with gender pay gap reporting and has driven a public conversation. I envisage the changes we are seeking to introduce working in a similar way; at the moment of publicity, the reports would create reasoned and informed public debate about how to change some of the inequalities that exist. Diversity data is a really good way of doing that. This is about being honest and having the conversation, so that we might change things. We should start this new class of bodies, which are going to be really important in our communities, on the best footing, with best practice.

Of the Mayors who have been elected so far, only one has been a woman and only one has been from a black, Asian or minority ethnic background. We would not want any new arrangements to exacerbate existing gaps in representation. Of course, ultimately it is up to voters to select who they wish to be their Mayor, but when CCAs have the power to choose associate and non-constituent members, I hope that we would say from the outset that we want to see a diversity of representation.

Does my hon. Friend agree that the act of carrying out an equality assessment and looking at the diversity of the people who are appointed focuses the mind to consider who is being appointed to these posts?

I think that is right. That has been the experience of the provisions of the Equality Act, and would be the experience here, too. We want these issues to be at the front of CCAs minds at the outset. We want them to speak and work with legitimacy for their communities. They do that by being representative of the communities they serve.

These changes are not onerous. I dare say the report could be done quite quickly. I hope the Government think this is important, that we will hear from the Minister that he thinks it is important and that he will therefore be minded to add them to the Bill.

This is the third sitting of line-by-line scrutiny and the Minister is yet to accept an amendment, but I have noticed that his tone has been positive and he has engaged with everything that has been put forward, which is very welcome. The tone of debate on all sides has been really positive and constructive. The Government Front Bench has not been dismissive—I am grateful for that; I have been impressed. This amendment seems to be one that he could accept, so I wish he would.

I have a few observations, a couple of which are key. First, it is very important that CCAs, indeed all local authorities, should be engaged and listen to chambers of commerce, trade unions and other community groups. It is vital that they do. There is a slight worry that all this looks a little bit like what happened post the abolition of metropolitan counties in the 1980s, when counties were effectively stitched together afterwards, partly by people who were not elected at all.

The people on the CCAs as non-constituent and associate members may be wonderful people whom we should be listening to, but there is a mechanism for them to become full voting members of the authorities if the elected members choose to give them that right. We are therefore looking at the possibility of having not a version of democratically elected local government, but in essence a quango. I am not sure that we need more quangos; we need more democracy. If devolution is to take place, it needs to take place on the terms of the community to which power has been devolved.

That is part and parcel of the Bill, however, and the Government are quite explicit about this: it is part and parcel of a movement towards devolution and a change in the relationship between Whitehall and the regions, sub-regions and nations of the United Kingdom. It is therefore worth bearing in mind that what we have seen already—the combined authorities, the unitary authorities and potentially now the CCAs—is in effect a scaling up of local government. It might be argued that it is the professionalisation of local government—there are all sorts of ways in which it could be advocated as a positive thing. I have my doubts.

One of the areas I have doubts about is diversity. That is why I think the amendments are important. For example, Cumbria—the centre of the universe, or the centre of the United Kingdom actually: if we draw a line from the Scilly Isles to Shetland, the middle point is at Selside, just north of Kendal, and it is important to say that—had something in the region of 300 to 350 elected members on the two-tier local authorities pre-reorganisation, and roughly 100 post reorganisation. Some people might say, “Good; that’s saving money” or, “Fewer politicians; that’s a good thing,” but what it actually means is that those people who are part-time politicians—most have other lives and other responsibilities—have to do three times more work.

The observation from across the country, not just in Cumbria, is that when we do that, we push out certain groups of people—we limit the number of people who are able to take part in local government. It therefore tends to be older people, with time on their hands, and the men who stay behind. Anecdotally, looking at the people who have chosen not to put themselves forward to the new unitary authority, they are principally people with caring and childcare responsibilities, people in full-time work, and more women than men. They are the ones choosing not to go to the new world of the unitary authority.

That scaling up of local government, making local government less local, in itself has a tendency to be bad for diversity. That is not the Government’s intention—I am 100% sure that it is not—but it will happen, I am certain. That is why the amendment is important and an easy one for the Government to accept.

Let me start by gently taking issue with something the hon. Gentleman said: that this measure is very much like the abolition of the metropolitan county councils. I argue that it is almost diametrically the opposite of that abolition; it is restoring a directly elected and directly sackable leadership for a strategic area.

The reason it reminds me of that is that once those county councils went, there had to be a stitching together of some kind—so Tyne and Wear went for the Passenger Transport Executive to run the Metro, the buses and all the rest of it. The people on that body were not directly elected, whereas the people who ran it when there was a county council were—that was the analogy, but I take the Minister’s point.

I am grateful to the hon. Member for taking the point, because I agree with the tenor of the argument, that we do not want to have major strategic decisions made by a quango. That is what we spent the past eight years fixing—starting in the coalition years, in fairness. We are on the case with his concerns.

Let me take a step back for a moment and set out what the clauses are doing. Clause 9 provides a flexible framework for combined county authorities to appoint non-constituent members, who are representatives of a local organisation or body, such as a district council, a local enterprise partnership or health body. Clause 10 provides for CCAs to appoint associate members, who are individual persons with expertise, such as a local business leader or an expert in a particular policy area.

Combined authorities have appointed commissioners with specific expertise to focus on a challenging local policy area and drive change—for example, the Greater Manchester Combined Authority appointed Dame Sarah Storey as a commissioner on active travel. It is a way of bringing in experts and other institutional stakeholders locally to complement the core of, ideally, directly elected local leadership so that everyone works together as well as possible.

It is only right that those nominations, or appointments, are the decisions of local leaders, who best know their areas. The clauses set out transparent processes for the nomination and appointment of both types of members. For a non-constituent member, the CCA designates the local organisation or body as the “nominating body”, which then selects a person to represent it at the CCA. It is for that nominating body to make that decision. For example, the CCA might designate the district council as a nominating body and then the district council selects its leader, for example, as its non-constituent member representative at CCA meetings—ex officio, as it were.

The clauses provide a way for local experts and key stakeholders to have a seat at the table of a CCA, bringing their local expertise and knowledge to facilitate better action to tackle local challenges. Those are vital public roles and transparency on them is equally vital. That is why clause 11 enables the Secretary of State to make regulations about the process of designating nominating bodies, the nomination of non-constituent members and the process of appointing associate members. We expect that all appointments of associate members will be undertaken through an open and transparent process, of course.

By their very nature those roles will be public roles—for example, a public body such as a district council nominating its leader to a role in another public body. In the Bill’s spirit of localism—a key word—this is a matter to be decided locally by the CCA and nominating bodies. They are independent of central Government and it is right that they make the decisions about how and with whom to collaborate.

The amendments seek annual reporting regarding the persons selected by the nominating bodies to be non-constituent and associate members. The Government do not believe that they should prescribe to CCAs that they should be informing Government of the specific make-up of their non-constituent and associate members. As with all good public bodies, a CCA should promote equality and diversity in the organisation. What is more, non-constituent and associate members are only one part of the membership of the CCA. The amendment calls for a report on one group of members of a CCA and does not reflect the CCA as a whole, including its constituent members, which is slightly odd. It is also slightly concerning that, as the hon. Member for York Central mentioned, the amendment mentions only some but not all of the protected characteristics. That would open up some potential legal questions that I am not really qualified to opine on.

The core point is that non-constituent and associate members of CCAs have an important role to play, but the amendment is unnecessary. It fails to consider the independence of CCAs and nominating bodies and does not reflect the fact that the positions of associate members and non-constituent members will, by their very nature, be public; these are not secret roles. I hope that the hon. Member for Nottingham North will agree to withdraw the amendment.

I am grateful to hon. Members for their contributions. I agree with the hon. Member for Westmorland and Lonsdale, who expressed the hope that we are not establishing a quango. We are definitely establishing a new class of leadership, however, and it is less local and less directly accountable.

I am slightly disappointed by the Minister’s response, because I did not get a sense—

I have to take issue with the hon. Gentleman’s comment about the process being less local. If I think about the devolution of powers over a number of things that are already done through combined authorities, such as the devolution of adult skills spending, if an authority is not in a CA, that decision is made in Whitehall. The decision is made here. In the combined authorities, such a decision is made more locally, for example by the West Midlands Combined Authority, which I visited the other day. Such authorities are making better decisions; because they are more local, they can create the co-ordination between local colleges. I take issue with the idea that decision making is less local as a result of what we are doing for devolution.

The Minister is of course right that such decisions are more local than central Government, but that goes back to my argument on the first set of amendments. Having told people that communities will get the power to shape place, if what comes through the process is devolution to a new level of politics consisting of politicians and public figures who are further way from those people than their local councils, I do not think we will have passed the localism test. That may be a point of difference but that is certainly my view.

I had hoped to hear the Minister offer a slightly stronger commitment from the Government that the new bodies really ought to represent the communities they serve in terms of their make-up. I am surprised that was not said. We were left to believe that the make-up was for local decision making. Just as in the Health and Social Care Act 2014, I fear that we will end up with Schrödinger’s localism: when there is a difficult decision to be made, “That’s a local decision”; and when the decision is something that the Government want to reserve to themselves, “Of course we have to set the rules of the game, because otherwise it is dangerous”—as the Minister argued in response to the debate on the previous set of amendments. The Government are in danger of falling into some cakeism, but I hope that is not the case.

This is an opportunity for me to repeat that, like all good public sector bodies, the CCA should promote equality and diversity within the organisation and it is for the CCA to do that locally. On the point about cakeism, these are two very different things. In the case of the voting arrangements for a combined authority, allowing them to be changed locally by a transient majority might cause a lot of local authorities to simply not join in the first place.

I am grateful to the Minister for clarifying that; I would never want to misrepresent what he has said. On the second point, we are likely to test it considerably over the next however long.

I struggled with the Minister’s criticism that the amendments excluded the constituent members of the CCA. That would be a valid criticism had he put in a provision that included them, but he has chosen not to. Similarly, his criticism that I have not included all the protected characteristics would be valid had he put in a provision covering them all. I do not believe that he wants to do those things, so I think that was slightly unfair. On the question of legality, he has access to more lawyers than I do, but I spoke to the Equalities and Human Rights Commission and it did not have a problem with this, so I do not think legality would be an issue.

I am willing to accept the Minister’s point about non-constituent members, pertaining to amendment 18, in that, as he says, they are appointees of their own organisation. I remember chairing my health and wellbeing board and my discomfort at the fact that it fitted the characteristics the hon. Member for Westmorland and Lonsdale described more than it ought to have in a community that was very diverse, but when it came to trying to do something about that, the point was made to me that the board members were representatives of organisations, including the police, the council, the universities and so on, which themselves had diversity challenges that led to that common challenge, to which there was no elegant solution. On that basis, I will not press amendment 18, but amendment 19 involves choices—direct choices—whereby a county combined authority decides who to put on. I want to know whether we are trying to address inequities or just repeating the same failings. That is an important point of substance, so I will withdraw amendment 18 and press amendment 19 at the appropriate time. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 9 ordered to stand part of the Bill.

Clause 10

Associate members of a CCA

Amendment proposed: 19, in clause 10, page 10, line 3, at end insert—

“(5) “The Secretary of State must publish an annual report on the associate members appointed to each CCA. This report must include:

(a) the age of all associate members,

(b) the gender of all associate members, and

(c) the ethnicity of all associate members.” —(Alex Norris.)

This amendment would require the Secretary of State to make the age, gender and ethnicity of associate members of CCAs publicly available.

Question put, That the amendment be made.

I beg to move amendment 20, in clause 11, page 10, line 37, at end insert—

“(2A) Where provisions made under subsection (2) vary between CCAs, the Secretary of State must publish the reasons for this variation.”

This amendment would require the Secretary of State to explain their reasoning for making regulations about CCA membership that differs between CCAs.

Clause 11 permits the Secretary of State to make regulations relating to constituent members of a CCA, a Mayor’s role in a CCA, the nominating bodies of a CCA, and non-constituent and associate members of a CCA. Furthermore, it allows the Secretary of State to decide all sorts of ways in which a CCA operates: votes, numbers and types of nominating bodies, the appointment and removal of members, maximum numbers of certain types of members, and so on.

That broad range of provisions might lead to a risk of micro-management. I have doubts about how desirable it is to be so involved in the detail; it feels a little as though central Government are not quite willing to let go. The Minister said that there is a risk of divergence, certainly at the outset. Although we have taken that interesting point on board, it seems a little odd that the Government are willing to devolve transport functions—and, presumably, no little sum of money—to a group of people, but are unwilling to let them choose whether to have substitute members in the place of associate members. I hope that amendment 20 will help in that regard.

The clauses we have debated so far have established county combined authorities, and given them constitutions, as a uniform class of organisation with a uniform set of rules to play by—or, at least, a uniform set of circumstances under which regulations will set those rules. I will probe the Minister on how he thinks that will work for individual CCAs. Ten new devolution deals were mooted in the White Paper—happily, Nottingham and Nottinghamshire were in one of them. Will those deals be set up with the same constitution? I cannot see why they would not be.

Amendment 20 would give the process some teeth, so that should the Nottingham and Nottinghamshire deal, for example, be different from the others, the Secretary of State would have to explain why those deals have been set up with different constitutional arrangements. That would not stop any differences, but it would be a recognition that the default position should be alignment and that any divergence should be explained.

The reasoning behind the amendment—I think this is a theme that we will cover in later amendments—lies in the history of combined authorities. I have a real personal discomfort with the idea of asymmetric devolution. I lived the first half of my life in Manchester, where my family still live, and I have lived the second half of my life in Nottingham. At some point during the last decade, a judgment was made in the Department that Greater Manchester could have a greater say over its future than Nottingham could over its own. Of course, that might have formally ended in proposals being submitted and deals being struck, but in reality, there were an awful lot of conversations about Nottingham’s readiness and Greater Manchester’s readiness. Ministers—not this Minister, but his predecessors—made the judgment that we in Nottingham would be unable to wield such powers. Of course, local circumstances can make that challenging, but I think our common personhood means that we ought all to have access to the same powers. We will pursue that theme in our amendments.

That is the basic principle, and although it can look different in different places, it holds firm. Instead, we have been left with a mishmash of different devolution settlements and deals. If we sought to explain to someone from outside the country our 10 current devolution deals—never mind the areas that do not have anything at all—we would struggle to explain them with any kind of criteria other than evolution over time. I do not think that CCAs should perpetuate that. The welcome direction of travel that the Minister and Secretary of State set out in the White Paper was that they did not want it to be that way in future, but that instead there were tiers of power to which everyone had access and that communities sought to take on, so that is a start.

The amendment would provide a check, so that if the governing document that drives the CCA—its constitution —does not start on the same basis, there must be really good reasons why not and a public account of those reasons, whereas what we have now is this rather inexplicable variance.

I will be brief, given the time. Personally, I have no problem with asymmetrical devolution. A contrived central devolution is perhaps why Lord Prescott’s proposals in the ’90s and noughties did not work and were not popular. I have no problem with asymmetrical outcomes, but I have a serious problem with asymmetrical autonomy. Each community should have the same access to powers, even if gained in a different way. This is an important probing amendment, and I am interested to hear what the Minister has to say. For example, a rural community such as Cornwall, Northumberland or Cumbria should not have a Mayor forced on it if it does not want one, yet it should still have the same access to the same levels of power that the Government are offering through devolutions to those communities that do have a Mayor.

The amendment brings us to a series of other amendments bound together by a particular philosophy encapsulated in the statement by the hon. Member for Nottingham North that the default should be alignment. The amendment is a particular and bleak way into this philosophical debate, and amendments to some later clauses—in particular amendment 26—make the Opposition’s position much clearer: that things should move in lockstep and that there should be more one-size-fits-all.

Fundamentally, we pretty profoundly disagree with that philosophy for a number of reasons. Devolution agreements should be different in multiple different ways, because there are different local wants. Simply, the point of devolution is that different people in different places want different things, and devolution makes that possible. Pragmatically, there are also different readiness levels. In some places, a process has been going on— for example, the Healthier Together work in Greater Manchester, which had been going on for a decade before health devolution in Greater Manchester. Also, different places are set up with various partners that they work with at different readiness levels.

On a pragmatic point, my great fear about adopting the one-size-fits-all, lockstep approach of the convoy moving at the speed of the slowest is that we will just not make significant progress. Were the hon. Gentleman to find himself in my place and I in his, he would discover that he could not make much progress in getting Whitehall to devolve powers. That is no small thing—to ask the elected Government of the day to give up control of the things for which they will be held accountable by the electorate to local politicians, who in many cases may be of a different political party. That is no small thing to agree. If it were said that a power could not be offered to a particular place unless it was offered to all—like the most-favoured-nation principle—I promise that devolution would grind to a halt extremely swiftly.

There is a framework. The basics are set out in the levelling-up White Paper, but variation is intended. Variation is a feature, not a bug of our devolution agenda. We believe in localism, in particularism, and in adapting things to the particular needs and particular local politics of different places—I agreed at least partly with what the hon. Member for Westmorland and Lonsdale said, which in some ways chimed with our view of this.

The hon. Member for Nottingham North asked us to explain why that might be so, in particular in relation to the amendment, which is about membership. Simply put, there might well be different numbers of members in different CCAs. We could have one with two members or one with a lot of members. Or we could have ones where the members were relatively similar authorities, or one where one member had radically different characteristics from the others—we might imagine a load of urban authorities and one that was more rural, or something like that. However, this amendment is the start of a series of amendments, so I will not labour the point at this stage.

Something else that the hon. Member for Nottingham North said that chimed with me and stuck out was that the centre should let go. That statement is very much our intention, in practice, with the desire for uniform devolution. We do have to let different places do different things because, fundamentally, they have different priorities. One place might care a lot about housing issues, but another might care about its innovation strategy. These things should be different, reflecting different wants.

To recap why we still want voting arrangements, for example, to be in secondary legislation, it is not primarily us in central Government that that arrangement is protecting; it is protecting local leadership from someone joining something only to find that they have been stitched up and then have their powers taken away due to a particular alignment of local leaders. Some things must be certain for local leaders and should be locked down and made safe for them in order for them to make progress, but in other ways there should be diversity, variation and localism.

This amendment represents just one aspect of that philosophy in practice, and we will talk about it again under other amendments, but the Opposition spokesman called on me to be direct, and I will be. There is just a difference in philosophy here about how we should approach devolution.

There is a difference of philosophy, but the Minister slightly misrepresents the point I am trying to make, or perhaps I am not explaining it well. Our intention is not, as he characterises it, a lockstep, one-size-fits-all movement forward or, as he says, that the convoy must move at the same speed; it is that divergence, where it exists, should be the choice of the local community, not central Government. That is what we have today. The Minister is reserving for himself the ability to pick and choose who the Government feel is able and willing to exercise certain powers in certain ways in certain contexts. I do not agree with that, and that is the difference.

We are not saying that the settlement will be the same in every part of the country. The Minister says that this is a feature rather than a bug. I agree with that, and that is the point that we will be probing in subsequent amendments. We do not need to fight things out on constitutions at this stage. We will need to return to that, but on the principle that we are not saying that one size fits all, rather that the Government should not get to pick the winners. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Ordered, That further consideration be now adjourned. —(Miss Dines.)

The Committee is now sitting in public and the proceedings are being broadcast. We will now hear oral evidence from Penny Hawkins, head of the animals in science department at the Royal Society for the Prevention of Cruelty to Animals, who is now before us on Zoom—welcome. Would you like to introduce yourself? We will then move straight to questions.

Penny Hawkins: Good afternoon. I am Dr Penny Hawkins. I am a biologist by training. I am head of the RSPCA animals in science department, which seeks to implement replacement, reduction and refinement with respect to animal experiments, and to ensure the robust ethical review of animal use.

Thank you. We will be finishing at 2.20 pm, so Members should keep their questions brief, and answers should be as precise and brief as possible.

Q174 Welcome, Penny, to this afternoon’s session. Can you briefly outline what protections are in place for the welfare of animals, more specifically farmed animals, which were the source of concern this morning? Can you elaborate on whether you are reassured that all precision-bred lines for animals will be developed under the Animals (Scientific Procedures) Act 1986 controls assessing the ethics of the approach? In addition, what else would you like to see? Where do you think the Bill does well and where do you perhaps think there are more challenges?

Penny Hawkins: Right, there were quite a few components to that question, so if I start to go off topic, do please bring me back. I will start by saying that my area of expertise is the Animals (Scientific Procedures) Act 1986, so while I am aware that there are various pieces of legislation and codes of practice that regulate how farmed animals are kept and what it is permissible to do to them—of course, the Animal Welfare Act 2006 comes into play if farm animals are cruelly treated—what I really know about is the 1986 Act.

That was a major concern for the RSPCA, because when you look at the draft Bill, there is actually no mention at all of the Animals (Scientific Procedures) Act, which I will call ASPA for short from now on. The drafting team kindly gave us some of their time, so I now understand that every new line—every new precision-bred line that is created and that will then go on to fall under this Bill—will still require licensing under the ASPA for the foreseeable future.

That is absolutely essential, because within the ASPA, you have a framework for minimising the harms to animals, for reducing or avoiding wastage, and for ensuring that gene edited animals are properly characterised or phenotyped, so you understand the physical impact on the animal. There are also proper requirements for welfare assessment and, very importantly, a harm-benefit analysis and ethical review of every line, as you mentioned. In cases of special ethical animal welfare or societal concern, there is the provision to ask the Animals in Science Committee to review the project licence application, which is also critical.

The key reason why the harm-benefit analysis is essential is that at the moment, as drafted—and as previous people who have appeared before the Committee have explained—there is nothing in there about permissible purposes, less permissible purposes or purposes that should be really carefully scrutinised. So I think the ASPA is and will remain an essential safeguard to ensure that there is proper risk minimisation for animals, ethical review, and an element of social licence to use these techniques. People have to remember that the public need to consent to this, and at the moment, there are deep-seated public concerns that have not been properly explored.

Thank you; that is really helpful.

Q Good afternoon and thank you, particularly for your written evidence and for the points that you have just made about ASPA. I want to follow on from that slightly, in relation to laboratory animals. I do not think we have really talked about that at all so far in the evidence sessions and I wonder whether you could say a little about it. Could you also comment on the overall framework of protection and, in particular, where the Animal Sentience Committee might fit in with regard to some of this? We are slightly concerned that it seems that the Bill could be on the statute books before the Animal Sentience Committee is even established.

Penny Hawkins: Indeed. I think some very useful lessons can be learnt from the way in which genetically altered laboratory animals are regulated, but I emphasise that, within a laboratory setting, genetically altered laboratory animals include those in which genes have been inserted from other species. We are very clear that within this Bill we are talking just about gene editing and not about deliberate transgenesis, although there have been some discussions about potential accidental additions of exogenous material.

When genetically altered animals are created under the ASPA, a licence is required for their creation, because, obviously, regulated scientific procedures are required in order to generate these animals—procedures that relate to, for example, administering substances to animals so that they produce large numbers of eggs, or super-ovulation, removing those eggs from animals, preparing other animals to receive the gene edited pregnancies, and so on. All those require licensing, and then, when the line of genetically altered animals has been created, they have to be, as I mentioned, phenotyped. That is a battery of behavioural and biochemical tests to look at what the eventual genetic alteration was and to look at the whole animal that this creates—the phenotype.

There is a system of licensing under which the impact on the animal is categorised as mild, moderate or severe. If a researcher or research team can demonstrate that the gene edit they have done is stable for at least two generations, and if they have phenotyping data and animal welfare assessment data to demonstrate that the animal is not going to suffer as a result of being gene edited—the impact would have to be what is referred to as below threshold; not even mild suffering—then, in those circumstances, they can apply for the breeding of that particular line to be released from the controls of ASPA. That would mean that those animals would still be bred in a laboratory under all the codes of practice that normally apply to laboratory animals, but a licence would not be required in order to breed the animals, because there is no risk to their welfare because of the gene edit.

Those are the safeguards in place for laboratory animals. The issue with farmed animals is that, obviously, if they are released from ASPA and their breeding is then controlled or regulated by this PB legislation, they will not be held in a laboratory setting, with all the controls that that entails; they will join the national herd or flock. That is a very different environment, and it can be far from clear how the genes will express themselves once they are in that environment.

Also, this Bill presumably applies to other animals: companion animals, wild animals and sporting animals. At the moment, for example, projects are under way to look at gene editing grey squirrels to result in fewer females being born or male infertility. Presumably, their breeding will also be covered by the Bill. And when they are released, they really will be released into the wild. Again, that is an extremely different environment. So the safeguards that laboratory animals have will be severely reduced or absent for other types of animal.

Q What would be needed in the Bill to safeguard against the issues that you have just raised?

Penny Hawkins: Well, I was listening to the representations this morning and I can only echo what everybody was saying about the welfare advisory body. At present it is there to report to the Secretary of State on whether the notifier has had regard to the risks to the health and welfare of the animal and their progeny. There does appear to be some provision in clause 15 on the suspension and revocation of marketing authorisation. That provides for the Secretary of State to receive information on the health and welfare of the progeny of those animals, but that is dependent on clause 14 on reporting obligations, which states only that:

“Regulations may make provision for requiring the notifier…to provide the Secretary of State with…information”

about their progeny

“during periods…prescribed by the regulations”.

All those elements that relate to long-term surveillance really need to be tightened up, and they need to be “musts” instead of “mays”. Many of those are subject to the affirmative procedure, which I know is normal for statutory instruments, but that again does not reassure people who are concerned about the long-term welfare effects that an adequate mechanism is in place for picking these up.

Similarly, it is not at all clear what qualifications the inspectors who are going to be active under the Bill need to have, so it would be good to see some reassurance as to how they are going to be qualified and to see it explicitly said that they will have the right to access and inspect animals.

Q Thank you for coming along to speak to us this afternoon. The RSPCA has raised concerns about the safety of gene editing, stating:

“There is no history of safe and reliable use”.

What else could that cover? What are your concerns? Can you expand on that, please?

Penny Hawkins: Just to clarify, when we talk about safety we are talking about the safety of animals. There are two kinds of concerns about gene editing: one from the consumer point of view and one from an animal welfare point of view, and we are talking about the animal welfare point of view. I listened particularly to Professor Henderson when he spoke to you, and I noted that he said there will have to be a two to three-year process of gathering and analysing scientific evidence around both on-farm and off-farm welfare

“before the secondary legislation can be enacted.”––[Official Report, Genetic Technology (Precision Breeding) Public Bill Committee, 28 June 2022; c. 17-18, Q24.]

He said that the process for that was laid out in the Bill, but I have looked at the Bill really carefully and I cannot see any such process either in the Bill or the explanatory notes.

This morning Professor Henderson said that more thinking needed to be done regarding animal welfare advisory bodies and advice on the Bill. Coming from the DEFRA chief scientific adviser, I do not think that that is very reassuring. All of the concerns that I expressed previously about the longitudinal reporting and monitoring of health and welfare also apply here. I am particularly thinking about clause 9, which explains what happens from the bureaucratic aspect if an animal is no longer deemed to be precision bred. Presumably if an animal is no longer deemed to be precision bred, it will either be because they have not been characterised or phenotyped properly or because the genome is no longer stable.

As you heard from the Royal Society of Biology, genes can have effects in multiple tissues, so in these cases there must be a much clearer mechanism for identifying and tracing these animals, and that is also lacking in the Bill. From an animal safety and welfare perspective, there really are some issues that need to be addressed.

Q You mentioned ASPA. What are your thoughts on the potential conflicts between this legislation and the Animal Welfare (Sentience) Act 2022?

Penny Hawkins: That is an extremely important question. Reading the sentience Act, I do not think it will necessarily preclude gene editing per se. What it requires is an examination of whether or to what extent the Government are having or have had all due regard to the ways in which the policy might have an adverse effect on the welfare of animals as sentient beings. At the moment it is simply not possible to say that on the basis of the information in the draft statute.

Clause 12 talks about the welfare advisory body reporting to the Secretary of State on whether the notifier has had regard to the risks to the health or welfare of the animal or their progeny and has taken “reasonable steps” to identify or address them. But we do not know how the welfare advisory body will be constituted or resourced, how independent it will be, what kind of expertise it will have access to, whether it will just confine its assessment to looking at those particular traits that have been identified by the notifier or whether it will think about wider issues relating to the process of gene editing, as Professor Campbell said, looking at purposes or at the global impact of gene editing those animals. So it is not possible to say from the way the statute is drafted at the moment whether all due regard has been paid. We just have to hope that the secondary legislation will address this, but at the moment we just don’t know.

Q I have seen criticism that the Bill is too focused on enabling the commercial opportunities inherent within gene editing, rather than focusing sufficiently on animal welfare, for example. Would you agree with that, looking at the Bill as it is drafted at the moment?

Penny Hawkins: Yes, because even the animal welfare applications are ultimately for human benefit. If you think about the gene edited polled cattle, which are the poster child for the animal welfare applications, clearly polling cattle is extremely painful and distressing for them. A world in which that did not have to happen would certainly be a better world for the cattle, but it is actually possible to keep horned cattle together. It can be done, but it is very expensive. Many farmers would not be able to afford it and many consumers would be unwilling, or probably unable, to pay the prices that would be involved. So, yes, there is a welfare benefit, but it is ultimately an economic benefit.

Q Could I just press a little more about the Animal Sentience Committee side of things? We are now in the position where there is the welfare advisory body under this legislation, the Animal Sentience Committee and all the licensing regimes under the Animals (Scientific Procedures) Act 1986. Do you think it would be better if this was all merged into one organisation? We also heard about the codes that apply in terms of farm animal welfare, some of which is legislative and some of which is guidance. Is it not all a bit messy?

Penny Hawkins: No, I do not think it is messy. The Animal Welfare Centre of Excellence, which will bring all these committees together, will ensure co-ordination. The purpose of the Animal Welfare (Sentience) Act 2022 is to look at policy across all policy areas and see whether due regard has been paid to the effects on the welfare of animals as sentient beings. The welfare advisory body is something that the Animal Sentience Committee would look at when it was making that assessment. I still think it is really important to have this overarching body that will look at policy right across the board. To me, they are all separate entities that complement one another.

Q Do you not worry that things would get lost in the mix, and that something might be seen as the responsibility of one body and then be overlooked by another?

Penny Hawkins: No, I do not believe they would. I think there is a suitable framework in place to ensure co-ordination that I think will work.

Can I thank Dr Hawkins for her time and for the evidence she has given to the Committee, which I am sure we will find very valuable? Thank you very much.

Penny Hawkins: Thank you for the opportunity.

Examination of Witnesses

Lawrence Woodward OBE and Pat Thomas gave evidence.

We have until 2.50 pm for this session, so please could you introduce yourselves very briefly and then we will move straight into questions?

Pat Thomas: Good afternoon, and thank you for having us here today. My name is Pat Thomas. I am the co-founder and co-director of Beyond GM. I come from a journalistic background. I am a former trustee of the Soil Association and the Organic Research Centre, and I currently sit on the board of the Nuffield Council on Bioethics’ dialogues on genetically engineered animals.

Lawrence Woodward: I am Lawrence Woodward. I am co-director of Beyond GM; I am also a director of Whole Health Agriculture. I am an adviser to the Seed Sovereignty UK and Ireland programme. My previous life was as director of the Organic Research Centre, during which time I was involved in setting up an organic seed breeding company, developing a programme of evolutionary plant breeding. I was also a founder and director of the European Consortium for Organic Plant Breeding.

Q Good afternoon. We have heard from witnesses earlier today, and on Tuesday, that this technology is equivalent to traditional breeding—that is the term I will use, just for ease—and carries the same level of risk. I understand that you have a different point of view. I would like to understand what the evidence base for that view is, with specific reference to precision breeding and gene editing, in both plants and animals.

Lawrence Woodward: The first issue is clarity of definition and terminology, which indicates concerns and differences of view regarding areas of risk. We start with this terminology, “precision breeding”, which is found nowhere else in any regulation of any other authority—it does not exist. It is a new term, and the definition of what that is, the description of what that is, only exists in this Bill and nowhere else, so there is a question about where safety issues and issues of regulation and risk assessment come in.

The Bill itself starts off with the premise that all these technologies arise from genetically modified organisms. The definitions in the Bill start off with GMOs as defined in the Genetically Modified Organisms (Deliberate Release) Regulations 2002. Those definitions have given rise over the years to contested science in relation to risk assessment and safety. The Bill goes on to say that any of those techniques under those GMO regulations can be considered to be precision breeding if they could have been achieved by traditional processes, but there is no international clarity about what traditional breeding or traditional processes actually are. The narrative in the UK is, “This is traditional breeding”, but different people mean different things by that. In fact, I noted that several speakers on Tuesday talked about conventional breeding, which is probably more accurate. When we talk about that definition of traditional breeding or conventional breeding in modern times, the methods are very different, and the contention is that the damage within the breeding process—the potential risks within the genome—varies according to the different methods.

The evidence presented by the Advisory Committee on Releases to the Environment and numerous scientific bodies in this country is that risk can be assessed adequately on the basis of the final product, on the phenotype: what it looks like, and how equivalent it is to something that comes from conventional or traditional breeding. That, it has to be said, is the opinion of most research establishments and plant breeders in the UK and in some other countries, but it is not true to say that it is an overwhelming consensus. There is a body of evidence that says, “Actually, there are other risks”, and that looking at and assessing risk in relation to the end product misses disruption within the genome, and the potential health and safety aspects of that.

Disruption in the genome is at the heart of genome editing technologies, because you are going right into the cell—into the organism. I have to say, I think it is unfortunate that this Committee has not taken oral evidence from the number of scientists who work in medical practice and agriculture who have looked at the evidence of the risks of this damage within the genome and what that means, and can talk about it much better than me.

In our view, the extent of the damage and disruption within the genome is a contested area. The question then is: what does that mean for the composition of the final product, and what level of risk assessment is appropriate? That is another critical issue in this scientific debate. A number of witnesses on Tuesday referred to proportionate regulation and proportionate risk assessment. We absolutely agree with that, but it is a question of how you discuss proportionate risk assessment. Other regulatory authorities work on a system of tiered risk assessment and risk safety analysis, with different tiers for different levels of the application of this technology. We think that really should be looked at. To come back to your question, the evidence of safety and the evidence of risk is in our view entirely dependent on that tiered risk assessment.

Q Thank you. With sufficient risk assessment, and defined as conventional breeding, you are not opposed to this technology? Is that what I should take from that?

Lawrence Woodward: We are not opposed to the overall application of biotechnologies. Some aspects of genetic engineering technologies are very interesting, and there is certainly some amazing science happening. We are not opposed per se; it is about the context, the framework, the risk assessment and the wider social utility and environmental impact assessments.

I should just say that it was probably out of scope to call people who are much more based in the world of the human genome, but of course we know what advances have been made there using this technology.

Q Good afternoon and welcome. Can I take you back to your opening point about definitions? It is right at the start of the Bill, and we have already had some discussions. A lot of us are struggling, quite frankly, to make the link between what the Bill was promised to be about and what we think the definitions end up being about. The basic question on which I sought an answer from the Government’s chief scientist this morning is: does the Bill as written exclude transgenic material?

Lawrence Woodward: No, the Bill is vague on definitions. Other regulatory authorities have been presented as basing their approach on end-product analysis and ignoring process, but that is not true. It is only Canada that only looks at the end process; all the other regulatory authorities look at the end product and the process. The scope of this Bill captures not just narrow gene editing, as presented by the famous word processing approach—“We alter a letter here and there and everything is okay”. The scope of the Bill is very wide, and it appears to encompass the possibilities of all new developments in biotechnology, such as RNA information sprays. This encompasses a range of things that are on the cards in the future, yet the clarity of that definition and scope are lacking, as are the assessment and consultation processes to deal with those new technologies coming forward. We have the possibility here of enlarging the scope into the future, ill-defined and without the regulatory framework to deal with that expansion.

Q Thank you. Could I turn to Pat and perhaps explore the wider environmental impacts and the extent to which the Bill provides reassurance and protections?

Pat Thomas: In essence, the Bill does not provide any reassurance about environmental impacts, because the Bill has decided that there are no environmental impacts. You have heard statements from scientists, and I will underscore my colleague’s point that it was a shame that dissenting scientists were not invited to present evidence to the Committee. The Bill itself has made a prejudgment that these technologies present no environmental risk, but it has not, as the Regulatory Policy Committee concluded, presented any evidence to prove that.

Particularly where we are talking about plants, which are the dominant lifeform on this planet, and a very wide scope of which are exempted in this Bill, we need to be very clear about what the environmental impact will be, not just in agricultural nature, but in wider nature. That requires much more comprehensive assessment than is currently being looked at. At the moment, the assessment is really whether it is good for business. That is fine—we all want to see business progress—but these kinds of disruptive technologies that cut across multiple areas of concern need to be assessed on a much broader basis.

One thing that would immeasurably improve the Bill would be to ensure that the assessment board is looking not just at something that is scientifically feasible, but at the impacts across environment and the social scale, from a practical, an ethical and even a vocational level. There are examples of that in the world: the Norwegians have an agricultural biotechnology board, for instance, which assesses genome edited products on all those bases. Science does not outweigh, for instance, ecological or social concerns.

A very interesting example of that was in 2017 when that board rejected a double-stacked maize that was engineered to produce its own insecticide and be resistant to herbicides. While it accepted that the maize was probably safe to eat or to grow, the deciding factor was that there was no social utility. There was no benefit for consumers or for the environment, and those concerns, given equal weight to science, were the concerns on which it was rejected. That is what we need here. We need a much broader consideration of the impacts of these technologies.

Q Following on from that, do you see anything in the Bill that limits the scope for herbicide-resistant edits in plants, or, for instance, pesticide-resistant bees, which I have been reading about? Those are both possibilities that raise some wider issues.

Pat Thomas: They certainly do raise wider issues. Within the scope of this Bill, as my colleague pointed out, there does not appear to be any type of genetic engineering that is truly exempted. If a plant or animal breeder can make a case—that case is not checked, it is simply made; it is a notification, not an assessment—that their plant is herbicide tolerant and that there somewhere exists a plant that is also herbicide tolerant, that plant becomes exempted under these provisions.

Lawrence Woodward: If I may just add to that, I had rather lazily gone along to some extent with the claim that gene editing technology will reduce the amount of herbicides and pesticides being used. I was therefore somewhat upset and surprised to see that Cibus, one of the major gene editing developers, put out its annual report the other day with a press release praising efforts around the world and in the UK to deregulate genome editing, because it saw the possibility of increasing herbicide-tolerant traits for sale, thereby increasing the use of herbicides in agriculture. It saw a way in which genome editing technology could increase the effectiveness of putting in herbicide-tolerant traits. That is an example of the complex nature of this area. The question of utility, sustainability, reduction of herbicides and so on, which people talk about, is really not a given.

Pat Thomas: I just want to add a brief point: within the scope of the Bill, the concept of risk is being used interchangeably with sustainability. Risk assessment and sustainability assessment are two entirely different things. A sustainability assessment will look more across the board at the sorts of effects that we are talking about here. We should not take for granted that risk or safety can be used as a proxy for sustainability.

Q May I return you, Ms Thomas, to the points that you were making about Norway? I think the Norwegians introduced a gene technologies Act fairly recently. When I read about the approach that they took to the issue, it seemed to involve a lot more public consultation and discussion. Will you expand a little on the approach they have taken to this issue? What can we learn from it? What would you like to see included in this Bill?

Pat Thomas: I think we can learn the value of citizen views. I have been a little disturbed, in the first session and this one, by the vague disdain for citizens—“Citizens must not understand the science, therefore they must not have a view.” Citizens are major stakeholders in the food system.

What that board does is to have a high percentage of civil society groups in particular, who are used as a proxy for citizens, but it also seeks out citizen views. What we have learned from citizen engagement in our work and in sharing the work of others is that citizens tend to ask a much wider range of questions of the food system. When they are not asking those questions, it is because some aspect of the food system has been hidden from them. For example, until we understood about battery hens, people did not ask questions about that, but they ask them now. When people began to worry about pesticides in their food, they began to ask questions about organic food.

A concern for me about the Bill and citizen engagement is that the term “precision bred” is not well known. It is in fact a way of sneaking genetically engineered foods into the food system. I can envisage a case in which—even if there was a turnaround on labelling—to label something “precision bred”, for example, is not useful information to people who do not understand what that term means.

To circle back to your question, the importance of including citizens in these kinds of assessments is that we get a much more well-rounded assessment, and something that takes into account questions such as, “Why are we doing this?”, “Is there an alternative?” and, “If there is an alternative, why are we doing this?” Those questions are very important.

Lawrence Woodward: May I add to that? The Norwegian law is one thing. People always think, “Okay, it’s in Scandinavia, they don’t do much GM anyway,” but I remind you that in 2015 the House of Commons Science and Technology Committee—of which I believe you were a member, Chair—recommended in its inquiry into agricultural technology the establishment of a permanent citizens panel to work alongside ACRE in assessing all these other aspects of gene technology, such as its application, its commercial roll-out and so on. That is embedded in the House of Commons proceedings. It did not get very far, obviously. The other point about that is that although that provision did not go into detail as to what would constitute a permanent citizens’ panel, the Norwegian one does, in terms of balance of citizen representation and stakeholder representation.

Q We received a briefing from GeneWatch UK, in which it talked about its concerns about a potentially significant impact on trade. As you perhaps know, the Scottish Government are waiting for the EU to complete its consultation on gene editing and GM, and the difference between those two, and whether or not it may allow them to be permissible within Europe as well.

GeneWatch UK said that if exempt GMOs are not traceable—because they are considered to be, as we have heard from several witnesses, the same as conventionally bred organisms—manufacturers should be required to publish a validated test for each GMO released. It suggests that all countries that require such organisms to be regulated could potentially refuse all imports of food and other products that contain that exempt GMO. Could you just expand a little on that for us? I would be interested to hear your points of view.

Lawrence Woodward: If I have understood GeneWatch UK’s position, it is pointing out one of the aspects of this situation, namely that if England proceeds by itself —isolated, without regulatory alignment—that would raise all kinds of trade transparency marketing issues, which are not really addressed and which the Regulatory Policy Committee identified as not being really addressed in the impact statement. You then have dysfunction in regulation and alignment, which leads to confusion in the marketplace, and I think that GeneWatch UK was pointing out the fact that England might allow non-labelling and non-traceability of some of these products would not carry a weight in other markets.

There are many different ways of dealing with that situation. What is absolutely clear is that there needs to be in this Bill greater consideration of traceability throughout the supply chains so that the market can function, and both farmers and consumers have choice. There are different ways of doing that.

GeneWatch UK pointed to the need to develop specific analytical tests. Those analytical tests are being developed. Robin May at the Food Standards Agency pointed out—I think he made some comment that labelling is useless if it cannot be verified. In theory that is true but, first, analytical tests do exist, they are being developed and they can be developed faster. Secondly, we already have in a lot of areas geographical identification and source of origin identification—in egg marketing, whether they are free range eggs or barn eggs. We already have marketing verification based on provenance and audit trails. There is no reason why traceability cannot be built up on that, if the right kind of mandatory information is put in the Bill.

There is a separate discussion about labelling. Obviously, we are in favour of labelling. How that would be, where it is and so on—we recognise the difficulties.

Pat Thomas: To add to that, we have heard a lot over these sessions about how it is not possible to trace these organisms and that simply is not true, particularly for a patented organism. There must be something in place to trace that, in order to protect the patent. So, alongside the development of these organisms, there is also the development of the tests to trace them. The question is whether we will put those into effect or not. I would assume that if the developers want to protect their patents they would want to ensure that those tests are there and available.

Q There are a number of things that I think we have heard robust evidence on, but you have clearly spent a lot of time looking at this in a global context. Countries such as Canada, Japan and Argentina are forging forward and allowing their scientists to develop new lines and strains to move forward their agriculture. Do you have any comments on how they are doing it? In all candour, I am worried that, to prevent worries and questions such that you are raising, we almost throttle something that has the potential to be genuinely transformative. What assessment have you made of what Canada, Argentina and Japan, who are forging ahead, are doing?

Lawrence Woodward: People often forget in this conversation that European research establishments overall have made an awful lot of research investment into GMO technology and gene editing technology. Some great work is being done in UK research establishments. It is not that we have a block on this. On how much faster would deregulation, in terms of what is envisaged in the Bill, increase that research activity, others can speak more on that. It is not entirely clear to me that that is the case. It might be a benefit in terms of increasing inward investment from multinational companies.

Q I can believe that. It is already happening out there in the world, I just wondered what you thought about what was going on in Canada, Japan or Argentina?

Lawrence Woodward: The impact statement pointed to the development of research in Argentina by pointing to the increase in the number of patents that have been registered in Argentina since it altered its regulation. You might say that is a proxy for research and development activity. It is not necessarily. There is not really that much published information that says how much research is going on, who is funding it and where it is being funded. On the development of traits and the interesting science, it is not clear that it is any greater in Argentina or Japan than it is in Europe and the UK.

Q Sorry, what I meant was, obviously they have stuff in place and they have some sets of regulations in their countries to address your concerns, along with the laws that they have passed to allow gene edited, precision bred products. I wondered whether you have looked at what they have done to protect the safeguards while being able to forge ahead with scientific research.

Pat Thomas: In all those countries, the answer is that it depends. There is a patchwork of regulation throughout the world, with not much in the way of harmonisation. What is very clear is that the media narrative around these countries deregulating gene editing is exaggerated. In some countries such as Argentina there is a much more nuanced type of regulation that looks at things on a case-by-case basis. It is not a wholesale deregulation, which is what we are looking at here. That puts us out of step with those countries. China is the latest one to come on, again, with a much more nuanced approach to regulations. I think you have looked at the Canadian regulations, Lawrence.

Lawrence Woodward: The Canadian regulation is product-based but with a greater analysis of where the end product differs from conventional, so there is a trigger mechanism. I am probably still not understanding what you are asking. In the last five years we have had a lot of discussions with conventional researchers, GMO developers and so on. One of the telling things in our roundtable on the use of genome editing in animals was that the research and development very much depended on the commercial partnerships and roll-out. That very much depended on the markets that those companies could see. That depended on the type of agriculture that they were seeking.

It is not a surprise that most of the development is going into pig disease and those conditions that effect elite breeding lines, because that is where, for the breeding companies, the genetic ownership sees most return. That is not to say there will be no spill-over or benefit to small agroecological farmers and so on, but that is not the thrust. The thrust is about the commercial roll-out.

Pat Thomas: I think what you are asking is whether consumer concerns are being taken into account.

No, I was—

Order. It is 2.50 pm. We have to finish there. I thank both our witnesses for their time and their full answers in this session. I am sure the Committee finds them very helpful.

Pat Thomas: Thank you.

Lawrence Woodward: Thank you for giving us the time.

Examination of Witnesses

Dr Michael Edenborough QC and Professor Sarah Hartley gave evidence.

We now move on to our next witnesses. Before we do, Professor David Rose of Cranfield University was due to give evidence on this panel, but unfortunately he has had to withdraw because he has covid. I welcome Dr Michael Edenborough QC, IP law specialist from Serle Court, and Professor Sarah Hartley from the University of Exeter. We will finish at 3.30 pm. Can you both very briefly introduce yourselves?

Professor Hartley: I have been studying genetic modification of biotech more generally for the past 20 years. I studied GM crops regulation back in the 2000s, and more recently have been looking at gene drive applications in the UK and more widely in Africa and North America.

Dr Edenborough: I originally was a scientist but I then became a lawyer. I am now a barrister specialising in intellectual property law, including such matters as patents, trade secrets, plant varieties and geographical indications.

Thank you for joining us.

Q Thank you for your attendance this afternoon. A question to Dr Edenborough first: what impact has changing regulations on precision breeding had on the patents that are held in countries, with specific reference to small businesses? I am interested in how we can ensure a spread of the benefit of such techniques is felt across different organisations.

Dr Edenborough: The Bill itself does not purport to alter the intellectual property regime at all, so therefore this Bill will not have any effect on the underlying mechanisms whereby you can obtain protection—be that, for example, plant breeders’ rights or a patent. Therefore, it will still be open to small and medium-sized enterprises to secure rights as they would have done. To that extent, this has no effect.

Q That is very useful and similar to the evidence that Mr Angus gave us earlier this week—indeed, it gives an open market. To Professor Hartley, your experience in this area is extensive, including understanding the global impact that this technology could have, or is having. Could this technology allow us to be a good global neighbour to those across the world who are struggling to feed themselves? That is more a food security point of view.

Professor Hartley: The Bill enables science to develop in this area, but it does not enable us to direct the science and technology towards doing any good. That would require a different form of governance. We know that gene editing and genetic modification are used in similar ways because we have not seen them separated out in any great detail yet globally. There have been some successes, but there have also been some failures—I would point to the GM cotton in Africa, particularly in Burkina Faso, where it failed to deliver the benefits and, in fact, had quite a negative impact. The question is whether the Bill can provide any public good; the answer is that it would make no difference to the public good. It may allow gene editing to develop, but whether or not it serves the public good would require a different level of governance.

Q The Bill and Melinda Gates Foundation sponsors work in this area—at the Roslin, I think. Given that degree of altruism in this area, what changes to the governance framework might assist in improving food security? Or is that best left to that philanthropic drive?

Professor Hartley: We could leave it to philanthropists, but the process of governance within the philanthropy organisations is quite closed and run by very few people, often within the United States of America. Social scientists working in this space have shown that we need more people from the area where the problem is based to be engaged and involved in the development of the technology. You would need stakeholders, farmers, conservationists and so on to be involved in the development of the technology early on.

Q Would you say it is the design of how the work progresses more than anything?

Professor Hartley: Indeed. That can happen as early as the funding agencies that fund the research all the way through the development and design process.

Q Good afternoon to both of you. Professor Hartley, in your previous answer, you said there was essentially nothing in this Bill to promote the public good. What would need to be in there to allow that to happen?

Professor Hartley: One of the challenges the Bill faces is that it does not address the results from the consultation that DEFRA held. Some important issues came up through that consultation—around transparency, traceability, labelling and engagement—that do not appear to be addressed at the moment. I also think the focus of the Bill on the consultation has been around agriculture, and yet applications in conservation and environmental management are also possible in the Bill. There are a range of stakeholders in those areas who have not been sufficiently engaged, I believe, in the development of the Bill.

Q You have done work before on public engagement. What would need to be changed to respect the outcomes of the public engagement that has gone on so far?

Professor Hartley: We have known for 20 years some of the issues that the public care about in the space of emerging biotechnology, and that includes labelling, which we know is key. We also know that the public have much more support for technologies that deliver public benefit and are not for profit. Over time, these issues are quite consistent across a lot of emerging technologies, but particularly in biotech.

We could argue that part of the failure of the GM crops was that they did not deliver the public benefit that they promised to start with. They promised to feed the world and contribute to global food security, but in fact the products that were developed ended up serving the farming industry and delivering higher economic profits. We also note it is not reflected in the Bill that animals are much more of a concern to the public than crops. Again, the sensitivities to those issues of concern do not appear to have been addressed in the Bill at this point.

Q Perhaps I could return to Dr Edenborough now. You may well have heard some of the discussions about the definitions at the start of the Bill, and there clearly are different views as to what they mean. As someone who might be called on to interpret the Bill, how confident are you that that will be straightforward?

Dr Edenborough: Well, I am confident that it would not be straightforward.

Q Could you elaborate?

Dr Edenborough: The simple point is that clause 1, as drafted, is quite imprecise. For example, if I may refer to the detail, there is the way in which subsection (2)(c) says,

“every feature of its genome could have resulted from…traditional processes…or…natural transformation.”

First, “could have resulted from” is staggeringly imprecise. Is that “likely”? Is that “very possible”? What level of probability is it? Then “traditional processes” is actually defined further in subsection (7), but it is still incredibly wide. However, “natural transformation” is not defined, so that clearly gives scope for further debate.

Even more fundamentally, “modern biotechnology” is, in subsection (3), defined by reference to the Genetically Modified Organisms (Deliberate Release) Regulations 2002. That is wide. However, subsection (8) says that if those GMO regulations are modified, the knock-on effect, with respect to this Bill, is that the regulations may be modified

“to make corresponding changes (with or without variation)”.

Again, that is incredibly wide.

I hesitate to raise it, but there is also, in essence, a Henry VIII clause tucked away in clause 42, which is incredibly widely drafted. Those clauses always give rise to concern because, basically, you can do what you like, when you like, with very little scrutiny. Does that sufficiently address my concerns?

Q Well, it highlights the concerns that we have. Going on from that, my next question is on the terms “precision bred organism” and—this is not in the Bill, but it is related to it—“qualifying higher plant”. Will those terms be easy to define if a challenge comes as to what would constitute those categories? It is the same question that I asked before, really. From this legislation, would you be able to discern the answer if someone comes to you and says, “Is this or isn’t this one of those categories?”?

Dr Edenborough: No, it would not be easy, for the simple reason that, because of the breadth of the way in which things have been defined—in a cascading way—you have uncertainty built on uncertainty. If a particular set of facts were presented to me and I was asked the simple question, “Is this within or without this particular Bill?” the answer would be simply, “Maybe.” It will depend on a raft of expert evidence that addresses each and every one of those points of cascade.

As soon as you get to a crunch point, whereby you need expert evidence to say whether it is within or without one of the particular points, you introduce uncertainty. If you have several of those, you introduce more uncertainty. Therefore, it would be dependent on a mass of expert evidence to determine each and every one of those points.

Q In your earlier answer to the Minister, you—I think rightly—pointed out that this Bill does not add anything in terms of intellectual property rights. In the absence of the Bill providing certainty, how might the wider gene editing debate develop commercially, and will it further the interests of research and development in the UK?

Dr Edenborough: At the moment, there are no bars within the intellectual property regime to doing this sort of work. So the hesitation comes not from the IP regime but from commercial factors: in essence, whether or not you are going to make money at the end of it. The Bill, though, could introduce greater uncertainty into the commercial field, which would arise because of the unclear way in which “precision bred” is defined. That could lead to people, in some senses, exploiting that uncertainty. Now, there are a number of ways in which that could happen, but one is that you could have a big entity with a lot of muscle, and therefore a lot of money, which might want to push all the boundaries and cause confusion in the marketplace. That could have a dampening effect on other, smaller people who do not have the financial muscle to challenge the legal parameters.

That is a very sobering prospect. Thank you; that was helpful.

Q Thank you to both our witnesses for your evidence so far. I would like to hear your views on the United Kingdom Internal Market Act 2020 and the implications for the future. Scotland and Wales in particular have objected to these measures—until such time that we, in Scotland’s case, have heard from the EU about its consultation on this.

Dr Edenborough: My views will be limited to the legal aspects. The simple consequence is that something may, for example, occur in England that may not be permissible in Scotland. But there is uncertainty with respect to whether, if you grow something in England, you could sell the product in Scotland. That is unclear. I think that is probably as far as I can go legally.

Q In terms of the implications of regulatory divergence from the EU—[Interruption.] Is that a tough one?

Dr Edenborough: I am just trying to make sure that I understand your question.

Okay. Obviously, the problem for Scotland is that we would like to stay aligned with EU regulations as far as is possible and practicable. What are the implications for us and for exporting if the 2020 Act forces us away from alignment with EU regulations? I am thinking in particular about the impact on trade.

Dr Edenborough: There might be ramifications with respect to the rights that have been obtained. Actually, this slightly conflicts with an answer I gave earlier, because if one were to obtain a UK patent, that would extend not only through England and Wales but through to Scotland, so there are certain things that the Scottish people may be able to do, but there are other things that they may not because the Patents Act 1977 covers the whole of the four kingdoms.

With respect to the EU, there may be divergence in the way in which products from such precision bred organisms can be addressed. That may be controlled by plant varieties or by patents, but there might be other food regulations that kick in. The point is that certain paths will have to be unified—or are unified and cannot be changed. This Bill does not purport to change plant varieties or to change the patent law, so that is going to stay the same. But the ramifications of things that result from precision breeding may not be uniformly felt throughout the Union, because of other legislation.

Q People have contacted me about what happened with Monsanto, and I would be interested to hear your thoughts on the potential implications for that of anything in the Bill. I think Monsanto sued farmers because they retained seed from a crop, rather than buying seed again from Monsanto for the following year. Is there anything in the Bill that enables that? You are an expert on this subject and I would be interested to hear your thoughts.

Dr Edenborough: The Bill does not fundamentally affect patent law or plant breeders’ rights, but the deregulation aspect will allow people potentially to secure patent rights or plant breeders’ rights more readily in things that they would not otherwise have been able to secure rights in.

Let us say, for example, that you secure the rights to use—I hope this is a neutral example—a different type of mushroom. Once you have those rights, you can control various things: whether the mushrooms are grown and whether the products from the mushroom are sold. You might then say, “Well, I’m going to give those rights away free,” but you may have engineered the mushroom in such a way that there are other things for which you can then charge—for example, particular types of pesticide.

This is a mechanism whereby you might be able to get rights more readily. I might say up front that the rights I have obtained more readily because of this Bill I am not going to charge for, but that gives me a foot into the market whereby I can charge a higher price for other things that are related to the protected items. If they were unprotected, you could not form that link, but because of the protection that you have secured through this deregulation, you can form that link and therefore get an economic advantage eventually—down the line.

Fascinating. Thank you very much.

Q We spoke in a previous evidence session about the difficulty of codifying the beautiful complexity of biology into law, because biology in and of itself is not in a static state. I think the quote was, “Biology is not physics; it’s not a specific number.” So I am sympathetic to some of the comments that you made earlier. What I want to chase with you is what the consequences of the uncertainty in the drafting are. I cannot understand why someone would want to say that something has been genetically edited when it has not been, and I cannot understand why someone would want to say that something has not been genetically edited when it has been—and that is an expensive process. You have much more experience, so what are the consequences of the uncertainty in the drafting?