Daniel Zeichner
MP for Cambridge · Labour · United Kingdom
“I recall, as a shadow Minister, visiting a major institution in the country and sending the management into panic when I asked them where the bus stop was to get back to the station.”
“My hon. Friend is absolutely right about the location of bus stops. I am so frustrated when I have taken the train to Cambridge, arrive at the station, see the bus, but have to walk 200 yards around the platform, come out of the station and walk 200 yards back to the bus stop, to find the bus has gone.”
“Devolution and local government reorganisation are different things. To be honest, they should probably be considered separately, but they have become so interlinked and intertwined in this debate that it is impossible to do so. If we are to have a stronger devolution settlement, it is right to spend more time getting it right.”
“I commend the Secretary of State and his team for their determination and resolve in the transfer to renewables. In the extraordinary and unprecedented weather that we are having at the moment I can assure the House that some shade would be really welcome in parts of the east of England.”
“I commend all the hard work that has gone into both the road map and the profitability review by the civil servants, the ministerial team and so many people across the sector, including Baroness Batters.”
“On that point about speculative building, I appreciate that the hon. Gentleman is probably not a fan of big, bold projects of this kind, but does he agree that there is a very good example just down the road in Cambridge?”
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“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.”
“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.”
“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 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?”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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?”
“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.”
“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.”
“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 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 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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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 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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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 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.”
“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.”
“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 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.”
“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 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.”
“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.”
“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.”
“Q This will only take a second. I am trying to conclude this long and interesting discussion about liability. I think what you are saying is that in the end it will require something in law—in the Bill—to actually provide that protection. Is that correct? Dr Edenborough: Yes.”