Genetic Technology (Precision Breeding) Bill (Second sitting)

Clive Lewis Excerpts

Tuesday 28th June 2022 Public Bill Committees

[Deidre Brock]

That is really helpful, thank you.

[Clive Lewis]

Q I am just trying to get my head around some of the comments that have been made so that I can apply them to the legislation. I think Mr Angus felt that intellectual property rights were a potential barrier to entry, whereas you felt that an excessive regulatory framework was a barrier to entry. What would the main barrier be?

Professor Napier: In my opinion, it is regulatory approval that is the barrier.

[Clive Lewis]

Why? What does that do?

Professor Napier: It is mainly the cost and the uncertainty. If you think about the way GM crops are regulated, for example, in the US it will cost you something like $10 million and take several years to get regulatory approval. In Europe, you could spend that money two or three times over, and because the approval process also has a political component, it will never be approved, so you have this uncertainty. From an entrepreneurial point of view and a commercialisation point of view, what you want is certainty. Even if you think, “Okay, the horizon is five years and I know I need to spend $10 million,” at least you know what it is. If there is uncertainty, I am not going to go on “Dragons’ Den” and say, “Here is my pitch. I don’t know how much it’s going to cost. I don’t know how long it’s going to take. Can I have some money, please?” I suspect they will tell me to—

[Clive Lewis]

Q So a stable regulatory framework is necessary. I am not trying to be some kind of QC; I am just trying to get to the bottom of this. I guess that profit maximisation in one form or another is a motivator for having a regulatory framework that enables you to do that. Whatever we think about the reality of the world we live in, that is probably the one golden rule that dominates markets and businesses in the mainstream. There are others—B Corps and others—that have different approaches.

I am interested in your views, as individuals who operate in the private-public sphere. When it comes to food security and the climate crisis, I would have thought that profit maximisation will probably not be the route map to solving those problems. What is going to be needed is a private-public partnership where we get the best of both, but some things may cost more. It is going to cost us to tackle the climate crisis; it is going to cost us to ensure that we can feed the world with a climate crisis in the 21st century, so it is even more important that we get the regulatory framework right and that it is robust. Freedom from regulations for businesses means freedoms against consumers, the public and those who do not have access to those sciences to be able to utilise them.

Professor Halford: Look at what has happened to GM technology in Europe. The last GM crop approved for cultivation in Europe was approved in 2010, I think. Only one GM crop is grown to any extent in Europe, and that got approval before it became difficult in the mid-’90s. So nothing is happening—for climate resilience or anything else.

[Clive Lewis]

That is the extreme version, isn’t it?

Professor Halford: Everyone pats themselves on the back and says, “We’ve got a great regulatory framework,” but nothing is happening. Burkina Faso has more experience—

[Clive Lewis]

Q That is an extreme example. Do you not think that there is a happier halfway house in terms of a regulatory framework for gene edited and gene modified materials?

Professor Halford: The simple answer is that it has to be proportionate to the risk. You can also compare gene editing to what we have already. We already have chemical and radiation mutants; that technology has been going around since the 1950s. They are already on the market, with exactly the same kinds of genetic changes that gene editing introduces, but completely random.

[Clive Lewis]

Q But from our perspective as legislators, the risk is not just the science. History shows us that scientists—Oppenheimer and others—often have brilliant ideas, but it is then about how those ideas are used by corporations, politicians and others. The risk is not just the science, but how those patents and that science are used further on down the line. That is part of the risk, and it is the part of the risk that regulation—

Professor Halford: You could make exactly the same comment about anything in plant breeding. The argument is, “Why should you look at gene editing as being different?” Is it more risky? Is it more likely to be misused? I would say no.

[Clive Lewis]

Q I think a really good case has been made today that gene editing is something that is found in the natural world, and it is something that we are just utilising. I get that. For myself as a legislator, yes, the risk is scientific—there is some—but it is also about how it is then applied outside of the laboratory, what the political implications of that are in the commercial world, and how other powers for whom profit is the bottom line may utilise those technologies in a way that is harmful to the public good.

Professor Napier: I know what you are trying to say. I tried to write an article about this a couple of years ago, taking the example of Golden rice, which was developed to deliver a public good and took decades to get to market. Why? Because it had been demonetarised. Effectively, all the economic drivers had been taken out of it, so the impetus for it to be delivered to market was not there. You could not monetarise it, which on one level is exactly as it should be: why should you be monetarising what is effectively misery—childhood blindness and things like that? But it also basically depowers the way the world works—the way that modern economies work. That is just the way of the world, isn’t it? We all know that.

I understand what you are saying. For us, we really want to see stuff applied and translated. People get far too hung up about intellectual property. I am not an IP lawyer, but I know a lot about IP. People feel it is a hindrance in plant biotechnology, but compared with the costs of getting regulatory approval, IP is not the barrier. The reason why we have all these big corporations dominating the field of plant biotechnology is that they are the only people who can afford regulatory approval.

When we ran GM field trials in 2012 at Rothamsted, there were big demonstrations about it. Most of the people had come from the Occupy London demonstration, so they were anti-globalisation protesters. They were protesting about the globalisation and corporatisation of the world; they were not actually that concerned about GM. That is not to dismiss their concerns, but that is what they were really worried about. You can end up conflating a whole load of things and saying, “These are all the things that people should worry about,” but I am not sure that is what you need to worry about. It sounds like I am telling you what to do, but I am absolutely not. There are other things to think about in the Bill.

Professor Halford: If you are going to say that you should regulate how people use the technology—can you do that?

[Clive Lewis]

Q No—I think there is a discussion that will now take place in Committee about the level and type of regulatory framework that we have for these technologies and what the outcome of that is. There is obviously an argument for a low-regulation framework, and there are those of us who believe that there should be a higher level of regulatory framework. That is the debate, and I am just interested in hearing the points of view.

I am sorry, Mr Angus, that I have not brought you into this conversation very well, but that is not my job. If you would like to come back on anything—

[The Chair]

William Angus, would you like to say a few words on this subject?

William Angus: Yes, and I assure you that I will be brief. First of all, I have some comments about various things. This is not a short-term solution. It has been bandied about by many that this is like, “Oh, well, in three years we can do this and that.” We can develop genetic resources in three years already; we do not need that. I am actually a really big supporter of gene editing. I think it allows us to short-circuit when we have major key traits that will be of significant global benefit. Gene editing comes into that very well.

We already have a very strong regulatory system for national listing of varieties. The Committee may or may not know that currently, before we can put varieties into the marketplace, they have to go through a pretty robust national listing system. They have to be distinct, uniform and stable, and they also have to have a value for cultivation and use, so those mechanisms are already in place. I would feel confident that, by beefing them up a bit, we could cover the regulatory issues without huge quantities of over-regulation in terms of entry to the market.

I want to make the point that this is not the shortcut that people perceive it to be, because once you have your trait of interest, you then have to transfer it into a variety or something that is genetically good; then you have your in-house testing process, which is usually three to four years; then you have two years of statutory tests; then your wheat, for instance, gets a recommended listing, and then you have two or three years of seed modification. The idea that we can somehow wave a magic wand with gene editing and create something within three years is complete nonsense; it would take 10 or 11 years. This is the thing about plant breeding: it is a long-term venture.

I am weird—I admit that I am slightly strange. You are quite right that all the big companies are profit-driven. I have absolutely no interest in money, but as a plant breeder you can make a huge difference, not only globally but domestically. I suspect that if you have had a bit of bread today, you will have had part of a variety that I was involved with. That gives me a huge amount of satisfaction, and I hope you enjoyed the bread. That is what plant breeders do: it is about impact. Now that I work on a more global scale, it is helping so many people whom I have met who live on $2 a day. That is really the important part. I do not necessarily represent the interests of large multinationals, I am afraid.

--- Later in debate ---

[Deidre Brock]

Although it is certainly bound up in the arguments about gene editing and genetic modification.

Dr Harrison: In many ways, among the small and medium-sized enterprises such as Bill’s, in a landscape such as the UK, where there is a lot of innovation happening, there are start-ups starting now that want to do breeding and gene editing, so you may well see the opposite happening: a democratisation of the process and more people entering the market as the barrier to entry is much lower because of the regulation change.

Professor Oldroyd: The food production sector is no different from any other sector in this free market economy. I hear a lot of concerns about a few companies owning most of the seeds, but I do not hear the same about a few companies owning most of the drugs, cars, phones, clothes or any other product. That is a reality of our free market economy. The food production system is just like any other sector; there are major players who have a sizeable part of the market share.

Richard made a very important point. The phenomenal restrictions that are being put on traditional genetic modification have actually meant that only the big players that have deep pockets can use that technology. I feel as though we have ended up in the situation that most people feared, where a few companies have total control of a technology, and that is principally because of the cost of releasing those traits. If we follow the Bill and treat them as equivalent to conventional breeding, we absolutely liberate the technology for SMEs to get in the game. At the moment, they could not afford to do that with GM.

[Clive Lewis (Norwich South) (Lab)]

Q It is good to see you again, Professor Oldroyd and Dr Harrison. Your last comments have thrown my question in many ways. You said that not much is said about pharmaceuticals and other products in the free market, but that is quite a low bar. I have been involved with the trade-related aspects of intellectual property waiver campaign. A big part of the global south is campaigning to have access to the understanding of how to make anti-covid drugs, and they are struggling.

I do not think that is a model that I would want to apply to food. Some of us would like to see something more robust that did not make the mistakes that we have made on pharmaceuticals, for example. Food supply is critical, especially as we move through the 21st century with the climate crisis and a growing population. When I was asking you questions as a BBC journalist a long time ago, I was always struck by your passion for the science and for communicating the science. As currently constructed, does the Bill provide the protections we need? Outside your laboratories, away from the pure science, there are free-market corporations for which the bottom line is the end game and the main driver. Do you feel that this science is beyond abuse and beyond being used in the same way that perhaps big pharma have cornered those markets?

Lastly, I understand the notion that reducing barriers opens up the market to small and medium-sized companies, but the history of any industry shows us that big players begin to hoover up small players over decades, and you end up back in an oligopoly or monopoly situation. That does not necessarily have to happen, but that is what usually happens with new tech. There is a free-for-all when everyone piles in, but ultimately people sell up and move on, and the big companies hoover up. When you get past the science and it reaches the real world, do you feel that there is the opportunity for abuse? Does the Bill protect us from that?

Professor Oldroyd: With the caveat of clause 3, legislating gene editing as equivalent to conventional breeding is the best way to allow small to medium-sized enterprises to become involved in the technology. If you really want to see a break in major corporate ownership, lowering the barriers to how you get a product from that technology is almost certainly going to facilitate that. As I said earlier, the big problem currently with GM is that it is so costly to release a GM variety that only “the big four” can afford to do that. I think that taking this approach will help that ownership of lines.

Certainly from me, as a researcher, the Bill as it currently stands greatly facilitates me to work directly with plant breeders and move products through the conventional plant breeding mechanism into the market and on to the consumer. Some of that plant breeding is in the big four, but quite a bit of it is not. Those are more the medium-sized enterprises, not necessarily BASF or Bayer, although they do have a role in some of that. I think the current Bill will certainly facilitate that broadening of ownership of the technology and a speeding up of the impact to the consumer.

Dr Harrison: If I could add one small point, our public research institutes in the UK have a pivotal role to play here. We do research funded by the Government in this area and we publish that. We can protect it before or we can just publish it so it is free and able to be used by many.

You could really think strategically about how those research organisations are used to direct change in the way that one would want to see, so that varieties come on to the market either nearly complete, so breeders can take them up, which is often what happens, or even release complete varieties, as happens in many other countries, from public funded research organisations. Again, that allows freedom of choice, so varieties come on to the market that have traits that are desirable and do not suffer from the problem you point out, which is that some small companies may become subsumed into larger companies.

Thinking about it more broadly—this is outside the scope of the Bill—there is an absolute opportunity for the UK to lead on bringing those traits to the point at which they can be taken to market, in a variety of different ways that are not just dependent on the big four.

[Kerry McCarthy]

Q You have said that you are funded by the Government for some of your work. To what extent is that related to potentially boosting economic growth by making these crops more profitable for farmers, or to what extent is it about achieving public policy objectives? I am thinking particularly about the drive towards net zero. Is that ever put to you? I am thinking about measures to improve soil quality and, in that way, carbon sequestration. Let us take a potato, which takes an awful lot out of the soil in nutrients and so on. Are you looking at that sort of thing in the broader sense?

Professor Oldroyd: I am probably the best person to answer that, because my research is entirely focused on trying to remove the need for the addition of phosphate and nitrate as inorganic fertilisers for food production. I am absolutely driven by a desire to have sustainable productivity for both rich and poor world farmers. Historically, I got most, if not all, of my money from the British or European Governments, but now, as I said, I get money from the Bill and Melinda Gates Foundation and also from the Foreign, Commonwealth and Development Office. In that regard, it is absolutely policy driven for sustainable productivity for smallholder farmers.

Dr Harrison: I echo that. For the UKRI-funded research that NIAB delivers there are two key components. One is scientific discovery. When you are working in crops, that is about strategic discoveries of things that are important to the strategic objectives of the research councils. Of course, BBSRC is the primary funder of agricultural research in the UK. It is absolutely in that zone of looking at how crop science and net zero intersect and how we can generate more sustainable farming systems. Much of the research, even if it is discovery and frontier bioscience, always has a strategic element to it.