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?
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.
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.
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.
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?
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 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?
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?
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?
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?”?
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?
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.
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.
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?
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.
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.
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.
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?
The long and the short of it is that a single entity can say different things to different people in different contexts and therefore, in essence, confuse and confound people. You can secure rights in a place by saying one thing and then perhaps avoid liability in another place by saying the opposite.
Q But there is no risk to humans, no risk to health. This is about a commercial give and take, in effect. That is the consequence of the uncertainty in the drafting.
No, there might be risk. This is a circular definition, in some senses. You do not need to regulate these matters, because these things can result from a traditional process, or natural transformation. It is because of that that there is a low risk. But that is actually answering the question: you do not actually know whether the thing really could have been—
Q No, it is not—forgive me, Mr Stringer; shout if you want me to stop. The classic example is that Belgian Blue cattle, through a natural genetic mutation, ended up with double-muscle haunches. Everyone thought this was wonderful because you have a cow with a massive bum that is more saleable for the same food. But then there was the discovery of consequences about birthing and ease of birth, and it was dropped out. So I do not think saying, “It could have occurred naturally,” and saying, “It is risk free,” are the same thing.
Perhaps we are talking at cross-purposes. The things that can occur in nature are not always risk free. So that agrees with what you have just said. But one of the underlying justifications, as far as I can ascertain, for this Bill and for removing onerous regulation, is that, because these things are supposed to be potentially capable of resulting from—“could have resulted from”—a natural process, it is likely that they would not be harmful, and that is a fallacy.
Q Biology can make mistakes—some mistakes are positive, and some are deleterious. But gene editing allows us to press fast-forward; it is a speeding up of the opportunity that natures engages in, but within an individual species. That is all true, but it is just happening faster, and with more opportunity and structure behind it, so we can go, “Actually, no, don’t do that—it’s a bad idea.”
It is not just a speeding up, in the sense that the way in which it would occur naturally is probably one step at a time. Here you are allowed to take many steps, so what might have been stopped at step 1, you suddenly get to step 5. Therefore, that could be a fundamentally different thing that you are releasing into nature.
Q That is not my understanding. What you are saying, in effect, is that what we do not want to be doing is creating a plant that is both drought-resistant and has a natural pesticide resistance, and—steps 3 and 4—tastes better and has vitamin D in it. You do not want to do all those in one go. I can see that argument, but surely the regulatory regime in the Bill will allow for people to say, “No, that is just a bit too complicated, when you have to go through the phenotypic analysis at the back of it.” But I want to come back to the core point: what are the consequences of having to accept the biological uncertainty within the way we describe things? What bad is going to happen?
I think it comes back to the point you just mentioned, which is that if you are doing one step at a time, the way in which the Bill will work is that you will probably be allowed to do that, but if many steps are taken, you may not be allowed to do that. The question is on the “may”: who is going to act, in essence, as the gatekeeper on how many steps you are allowed to do at any one go?
Q I presume it would be somewhere between the market and the regulator, and we have heard about the importance of that. If you are going to go far down and take multiple steps, you are going to have to know that you are going to get a commercial return at the end of it, because this is not cheap or easy. So in the other instance you were mentioning earlier, I was thinking, “Okay, that could make it much more expensive to do, but then it is going to get disintermediated by something that is not as expensive.” I hold to the view that law and biology are always going to do this and we have to make sure that we have got ourselves protected against any big negative consequences. That is why I keep pressing you on the “for instance”.
It falls back to the discretionary nature of the way in which the notification process and the control are exercised. If it is discretionary, it could be more or less active. That is the long and the short of it. You are going from a regime that is quite tightly controlled, and therefore every step is controlled, to one where you are allowed to jump through many hoops in one go, because the regulation allows for that in a discretionary sort of way. By having the discretion, you introduce greater uncertainty and therefore greater risk.
Q Okay, but if I flip it the other way and you do not have the discretion, you are effectively closing off avenues to what biology will do naturally. If you want to say, “No, we can only do this, this, this and this”—
Q May I ask about liability? I hope this is within your remit. What happens if an organic farmer finds that there is contamination? Does the Bill provide any mechanisms or safeguards for people who might want to resist going down this path and are affected by it?
Q But if your organic product has an organic trademark, in terms of the badging—there are rules about importing and exporting organic produce—that could potentially harm their ability to apply for organic certification.
Q If you have a field of organic crops that could be contaminated, you would not necessarily know the extent to which the produce had been contaminated. The certification is based on what you have used on the field, how you have farmed and so on, so you would not know if something had affected it. Do you see what I am saying?
I want to take this point about damage and liability a little further. You look alarmed, but actually I want you to simplify it a bit. The way you are describing it to me, I think the onus will really be on the person claiming that they have been damaged to make a claim and go to court. There may then be some difficulty for them. I think you are saying that there would be less difficulty in proving causation, because there would be a marker, but there would be considerable difficulty in proving the extent and the fact of the damage that had occurred. Is that correct?Q
Q What could offer better protection than this reliance on what looks, from the point of view of the organic farmer, to be a very unsafe means of obtaining redress?
You could introduce some form of strict liability, whereby there is a presumption, in essence, against the person who is doing the contamination, but that is very rare. There are examples in patent law, but the exception is very narrow. The long and the short of it is that people do not like reversing the burden of proof. It does happen, but it is very rare.
Q This may not be a question for you; it might be one for Professor Hartley. Is there the potential for a real inequality of arms in this—that we are going to see, not invariably but typically, smaller organic producers against potentially global or large commercial entities in court?
One example of this arose in Canada in the early 2000s with GM wheat. I do not know whether this might illustrate the market concern about contamination. Europe had just banned GM foods, and the Canadian wheat market exported largely to Europe. Monsanto had an application with the Canadian regulatory system to develop and test GM wheat, and there was no way in that regulatory process to stop that application, and yet the wheat market in Canada was threatened. In the end, there was a careful behind-doors negotiation and Monsanto withdrew its application. There was the potential for Canadian farmers to take a significant economic hit if the GM wheat was developed there, and there was nothing within that regulatory system to stop it. I think that is maybe part of the concern you are raising here. The market, in that case, did decide, in the sense that Monsanto negotiated with the wheat board in Canada to try to solve the problem.
Can I add a further point? We are talking a lot about farming here, but the Bill is not just about farming. It is also about conservation and environmental management. There is more structure to the farming community than there is to the conservation community, and so there is the potential for this kind of conflict within the conservation sector as well, particularly between the devolved nations.
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?
That was certainly under 90 seconds. I think that is a good place to finish. I thank both our witnesses for the time spent with us and their detailed answers.