Genetic Technology (Precision Breeding) Bill (Third sitting)

Daniel Zeichner Excerpts

Committee stage
Thursday 30th June 2022 Public Bill Committees

[Jo Churchill]

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.

[Daniel Zeichner (Cambridge) (Lab)]

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.

[Daniel Zeichner]

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.

[Daniel Zeichner]

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.

[Daniel Zeichner]

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.

[Daniel Zeichner]

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

[Deidre Brock (Edinburgh North and Leith) (SNP)]

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.

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[The Chair]

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

[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.

[The Chair]

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.

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[The Chair]

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.

[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.

[Daniel Zeichner]

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?

[The Chair]

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.

[Daniel Zeichner]

I understand that point. Thank you.

[Deidre Brock]

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.

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[Jo Churchill]

Okay. I will leave it there.

[Daniel Zeichner]

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.

[Daniel Zeichner]

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.

[Daniel Zeichner]

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.

[Daniel Zeichner]

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.

[Daniel Zeichner]

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

[The Chair]

If we could all be conscious of time, please.