Oral evidence: GM foods and application of the precautionary principle in Europe, HC 328Wednesday 5 November 2014

Oral evidence, 5 November 2014.

Witnesses

Dr Mike Bushell, Principal Scientific Advisor, Syngenta, Dr Julian Little, Chair, Agricultural Biotechnology Council, and Dr Geoff Mackey, Sustainable Development and Communications Director, BASF Europe North, gave evidence.

Chair

Good morning, gentlemen, thank you very much for coming in. I would be grateful if you would be kind enough to introduce yourselves.

Dr Little

My name is Julian Little. I am chair of the Agricultural Biotechnology Council, which represents the main companies involved in bringing GM crops to market around the world. My pay and rations, for the record, are from Bayer CropScience.

Dr Bushell

I am Mike Bushell. I am from Syngenta, based at Jealott’s Hill international research station. I have spent 34 years in research and development.

Dr Mackey

I am Geoff Mackey. I am director of BASF in the UK and on the management team in northern Europe.

Chair

For the record and for total transparency, I cross paths with Dr Mackey from time to time as I chair an innovation board at the University of Chester’s science park on which Dr Mackey also serves. Welcome, gentlemen. First, can I ask how you would describe the current state of agricultural biotechnology in the UK?

Dr Little

Agricultural biotechnology in the UK is a very good example of a country that does some fantastic fundamental work. You already heard in the previous session that when it comes down to fundamental work in terms of plant science and, in some cases, how that might be commercialised at a later date, we are punching well above our weight. Unfortunately, we are not in a position to be able to commercialise a lot of the work done either through UK universities and research institutes or via the companies represented here today. That is pretty much entirely due to the issue around European legislation, which essentially has brought in a de facto moratorium on the commercialisation of new products. You may be aware that a small amount of GM crops are being grown around Europe, mainly in Spain and Portugal, but that work has essentially come out of research done in the 1990s. Since 2000 there have been no new agricultural crops available to farmers anywhere in Europe.

Dr Bushell

You heard from the previous panellists that it is a very exciting time to be a plant scientist. There has never been a time when plant scientists were able to do stuff in terms of unlocking how plants work in practice. A massive amount of good work is going on in universities. We use things like GM as a tool in our own research laboratories at Jealott’s Hill. What we do not do there is any work towards the development of GM crops, but we do use some advanced plant science—genetics and genomics—in our traditional plant breeding approaches, including for wheat.

Dr Mackey

From a BASF perspective, we have no research, or employees of our plant science business, either in the UK any more, or indeed in northern Europe, unfortunately.

Chair

Do any of you have any R and D operations? I know BASF withdrew from Europe. Are the same pressures on other people?

Dr Bushell

Yes. Our plant biotechnology targeted towards GM crops closed in the mid-2000s. All of those jobs moved to North Carolina and subsequently to a new research laboratory opened in China. The investment made in that area continues to pour in, and we have fabulous facilities elsewhere. We have fabulous facilities in the UK, but we are not working on GM crops.

Chair

Are British people going out there and taking some of those jobs?

Dr Bushell

About 30 people went out there, and in many cases are still working in the North Carolina area. Our current research director was one of those people, but she has come back to sit in Basle now.

Dr Little

More generally, pretty much all of our members have moved out of Europe when it comes to research, with the exception of the company I work for, Bayer CropScience, whose main facilities are in Ghent, in Belgium. However, and very disappointing from our perspective, the vast majority, if not all, of that work is targeted on GM applications outside Europe. Probably all our members still do work with universities, research institutes and SMEs, both in the UK and elsewhere in Europe, because we will always look for the best science wherever it may be.

Chair

A significant amount of that is here.

Dr Little

Absolutely. When you are looking for good science you will always go to the best countries. I can give you an example from Bayer CropScience; we are currently running 40 projects in 25 universities on agricultural subjects. Some of those will be GM, some of them will not.

Chair

There is all sorts of speculation about what is likely to emerge from the current round of transatlantic trade talks. Is there any input from the agricultural biotechnology sector in the context of those talks and, if so, what are you hoping to get out of it?

Dr Little

The TTIP negotiations are essentially trying to find a way of getting good trade between North America and Europe. Agriculture is such a big topic that inevitably it is going to be part of those discussions. I sat in a discussion—I believe you were present as well—led by Ken Clarke where the agricultural interests of the UK were discussed in the area of TTIP. In the end, what we would be looking for are good, solid regulatory discussions around how things can be regulated in a more science-based and maybe a little less politically-based way. As to whether we believe that is likely to succeed in the early stages of TTIP, we have already heard this morning that changing a European legislation system is not a trivial issue.

Dr Bushell

I would agree with that. The UK, and Europe more widely, is a massive importer of food, and of course an exporter of certain commodities too, so it is very important that artificial trade barriers are not erected in this area, particularly where regulatory issues are causing safe food that has been grown in other countries to be rejected at the borders of Europe for entirely spurious reasons. That would be a really bad thing to happen. Unfortunately, that is a big risk with our current regulatory system and the way it is operated.

Dr Mackey

One of the realities with TTIP and some of the other negotiations going on between Europe and other countries is simply to align the regulatory environments, so no additional costs are created and we can get good safe standards, not just in this area but across all technologies. That is part of the reason for having them in the first place.

Chair

In the context of these technologies, that would mean a regulatory environment led by the science.

Dr Mackey

Absolutely.

Dr Little

Absolutely.

Stephen Mosley

We have received evidence from GM Freeze suggesting that the promotion of GM crops by industry has led to a silver bullet mentality. In your view, does genetic engineering potentially represent a universal remedy for food security issues?

Dr Little

No, and it is very important that we put on record that we do not believe GM will be the silver bullet for all problems out there. When you look at issues of food security around the world, it is not just about whether you have enough food but whether you can get food to the right people at the right time in the right circumstances. It is about weather. GM can do a lot, but it cannot deal with political issues to do with food security. However, we believe that this is a technology that you would not ignore. If we have such a big issue around feeding so many more people on the planet and wanting to use fewer resources, such as water, nutrients and fertilisers, we have to be in a position to use all the available tools. You heard in the previous session that GM is not used just as the end product; it can be used so well in identifying genes in a plant that need to be either up-regulated or down-regulated, or something. Once you’ve got that, you may use GM; on other occasions you may not. It will always be about the best way of dealing with the issue. Our members are equally strong in non-GM seeds and in GM seeds, and in many cases stronger. It will always be horses for courses.

Dr Bushell

I absolutely agree with what Julian said. I do not think we have ever said that GM is a silver bullet or a magic bullet of any sort; it is just a very important part of the farmer’s toolkit. If you look at traditional breeding, that is also being massively advanced by our current plant science, our knowledge of genetics and genomics, and our ability to sequence plant genomes very quickly now in order to breed in new varieties. When you are dealing with complex multigenic traits—for example, drought tolerance—it is much more likely to be an approach that will be successful through traditional breeding rather than GM approaches, but in most cases we will use both technologies to bring the best possible technology to bear, depending on what is available via the regulatory frameworks. For corn in America, we have a range of Agrisure Artesian drought-tolerant traits, but we will be stacking those alongside the other traits that farmers want, in terms of insect control and herbicide tolerance. In Europe—if we are ever going to bring those traits into Europe—we will not have the GM components.

Dr Mackey

As a business, from our side of things we talk long and hard about sustainability. We take that right back to the three aims of sustainability, which are economics, environment and how to move it forward as regards protection. Building on what Julian said, the reality is that there is no one answer; it is all about having the tools and allowing people to choose what is right for their situation. That is what businesses like ours provide.

Stephen Mosley

From an industry point of view, you see no attempt to lock out any alternatives.

Dr Little

On the contrary, we absolutely see bringing all the tools to bear, because the problems we have are too big to say, “We’ll only do it this way.” As Mike said, there will be situations where GM does not make sense. Why would you do it that way? There may be a much better alternative way of doing it. Some of the decisions will be based on pure science; in some cases it will be politics. If we are bringing something new to Europe, it will take a very brave person in any of our companies to say, “Do you know what? I think the best way of doing this would be a GM way.” The chances of bringing it to the market are so slim that it is almost inconceivable that you would go in that direction.

Graham Stringer

Are you inherently opposed to the precautionary principle?

Dr Little

No.

Dr Bushell

We are inherently opposed to abuse of the precautionary principle, and in many cases that is where Europe is getting into trouble. You heard from the previous panellists that precaution is very important. When you are talking about agricultural technologies, or technologies associated with our food, of course we should take a precautionary approach, but existing regulatory frameworks are highly precautionary already. What we are seeing in many cases is not the application of the precautionary principle as defined in the Commission’s own documents, but actually a smokescreen of uncertainty being put around technology to stop it happening for politically motivated reasons.

Dr Little

Can I give you an example? One of our members has been trying to introduce a new GM maize. It is not dissimilar from the GM maize currently being grown in a few countries in Europe. They submitted it for approval 12 years ago. It went through the safety approval system under the European Food Safety Authority, and it was sent back to be re-reviewed, and re-reviewed. To date, it has had seven positive EFSA safety opinions, so it has been demonstrated by EFSA to be entirely appropriate from a science-based perspective; yet again this year, we saw prevarication and people mentioning the precautionary principle as a way of stopping this getting to the market. In the end, the precautionary principle is about needing to be careful if you do not know enough about a subject. How long do you need to be careful, and how many times does a product need to be demonstrated to be safe before you give up and say, “This is not a precautionary issue; this is a political issue”?

Graham Stringer

The agricultural biotechnology sector has called for the use of an innovation principle to be used alongside the precautionary principle. Can you explain how that would work? I am not quite sure what it means.

Dr Bushell

I can provide for the panel a link to the European Risk Forum definition of the innovation principle. It is pretty simple, really. All it is asking for is that, as part of the impact assessment when you are applying a precautionary approach, you must take into account the knock‑on impacts on innovation. When I talk about the abuse of the precautionary principle, it is often the case that the impact assessment that should be part of applying a precautionary principle is not done in any meaningful or broad way. You can see that in things like the neonicotinoid issues of last year, when no meaningful impact assessment was done about what it would mean for farmers, or indeed what the alternative approaches would mean for the environment. I think that in GM we have this in spades. It is absolutely vital for Europe that we have a regulatory framework that encourages innovation and investment, because that is where jobs, growth and economic prosperity are going to come from in Europe.

Graham Stringer

You heard the previous session when the witnesses said they were basically in favour of moving to a trait-based regulatory system. Would you agree with them?

Dr Little

I explained the issue we had with a particular product: it spent 12 years in the approval system. More and more things go into the system than ever come out of it, even for things like import and food use. The reason for that is that there are a number of countries out there that are attempting systematically to stop this happening in Europe. Our issue is always that new regulations come in, and we have tried—sorry, politicians have tried—to find a better way of dealing with this issue. Each and every time it gets slightly more political and slightly less science based, but nevertheless there is a process. Each and every time they bring in these new rules, they are broken; they are ignored; there are prevarications. We have two main concerns. First, if you decide that you are going to change the rules at European level, it will take a number of years, and in the meantime countries that are opposed to GM will say, “While this is going on we must not allow anything else to happen,” so essentially you have a de facto moratorium. Secondly, even if in many ways the idea of moving to a different way of doing things sounds as though as a result things will happen, there will undoubtedly be political pressure by a number of countries to make sure it does not happen. Our concern is that you change one set of rules that currently are not working for a new set of rules that, for all their potential, do not work either. We would say, why do we not try to make the rules we have work in the first instance? Make them more science based in terms of risk assessment, and then allow the marketplace to decide. Farmers will grow only what they can sell to retailers and consumers, and companies will sell only those GM products that farmers are prepared to buy.

Dr Mackey

As an example which may help, it took us 13 years to get a high-starch potato through the regulatory environment into the marketplace. The reality was that the goals were rapidly changed again, so that product is no longer on the market. However serious we are about the technology, or however seriously we believe it can add value, our investment is not exactly giving much of a return over 10 or 12 years. Therefore, from a business perspective it simply does not stack up. That is one of the realities in Europe today.

Graham Stringer

Have your businesses done any assessment or analysis of what the cost to the European GDP has been of these regulations and the inability to authorise the use of GM crops?

Dr Little

Some work has been done, not by us, but by other more independent groups. The Swedish Government did a report looking into this sort of area. We put some figures in our submission. If I may move the question slightly to give a slightly more tangential answer, it has had a massive impact, along with European legislation, on all our areas of business. As an industry we put about $6.5 billion into research and development in agriculture. If you go back not that long ago, when I came into the industry, something like a third of that amount of money was invested in products for Europe in general. It is now on average about 8%. It used to be nearly a third of all the money we put in; it is now 8%, and going down. That tells you that, as a result, when it comes to new innovations coming through, farmers are living off what works for them and also works somewhere else in the world. They are getting things that are working somewhere else in the world. We are investing in that area and it might work in Europe, so they will get the opportunity to use some of those things. When it comes to GM, of course, they are shut out of that process. We find ourselves in a really difficult situation. We are absolutely committed to Europe when it comes to agriculture, but when it comes to GM it is a no brainer; we do not see a way of even starting.

Dr Bushell

The Graham Brookes report, of which you are probably aware, quotes a cumulative figure in excess of $116 billion for the net benefit of growing GM crops since they were first planted in 1996. All of those benefits are being denied to European growers. On top of that, there is a substantial reduction in the field footprint of agriculture because of the ability to take on a lot more no-till agriculture, where people are growing intensive corn and soya using GM crops, so not only economic benefits but also environmental benefits are being denied.

Graham Stringer

What impact do you think the deliberate release directive will have if it is implemented in its current form?

Dr Little

This is the concept of individual member states being able to have a little more choice as to whether they can access it. I would like to make a general statement before we go into that. We absolutely understand the frustrations of many member states, of which the UK is one. They can see the potential of GM to work in some cases in some member states, but the current legislation does not work. Therefore, they do not see a route to market within those member states. A number of countries have tried to look at whether, if they had maybe a little more independence once they have an EFSA okay, if you like, on the safety side of things, individual member states should have a bit more choice. We absolutely understand that and have a lot of sympathy for those countries. Our concern, however, is that the way it is currently shaping up in the European Parliament—and that we are even discussing it at a European level as this—means that this is going to be more a licence to ban than a licence to operate. Our concern is that it will give cover for countries that want to ban the use of these products, but very little for countries that want to move forward. Again, given the way the Parliament seems to be putting through its amendments, I doubt that this piece of legislation will allow UK farmers to access GM. I really doubt that.

Dr Bushell

There is uncertainty anyway about the ability to unblock the regulatory process with this. We are grateful for the large amount of scientific analysis that has gone on in DEFRA in looking at these issues, and the leadership that the Department has shown in this area in Europe. It is a beacon of enlightenment in this area in many respects, but we are being asked to speculate about something that is still going through the Parliament. We will just have to wait and see. There are some advantages. If the market changes, we may react to that, but it rather risks damaging the principles of a single market and bringing in all sorts of intra‑common market trade issues.

Chair

That was clearly to make your question softer, David.

Mr Heath

It follows on directly from what Dr Little and Dr Bushell have been saying. Without wishing to ask you to give a general critique of the structure of the European Union, is it not the case that the more we have co‑decision making and the involvement of the Parliament, the more difficult it is to have science-based policy? Whereas you can talk directly to the Commission and to member states at Government level, talking to the membership of Parliament, who are swayed in this country by the Daily Mail, which makes reference to “Frankenstein crops” every couple of seconds, and equally in other countries by their press and public environment, makes it much more difficult to make advances.

Dr Little

With power comes responsibility, and the European Parliament really does have to sit back and say, “What does this mean?” We talked before about impact assessments before and the need to understand not just the consequences of going forward but the consequences of not going forward. We see the issue around innovation in Europe; we see companies withdrawing innovation. Apparently the European Union is set up to try to push innovation, jobs and everything else, yet it seems to be adopting essentially a more museum agriculture approach to the whole issue of food security. It is almost as if they believe, “Don’t worry. If we can’t produce enough food, somebody else can do it for us.” One of the things we talk to MEPs about is the concept that just a 1% increase in overall agricultural productivity in Europe feeds 10 million more people, but the reverse is also true. It is absolutely critical that as Europe we understand that for every 1% reduction in productivity—because that is the way European legislation is targeting at the moment—we need to import enough food to feed another 10 million people in Europe. That is totally mad, because we know we can do it in Europe. We know that farmers, given the tools and, most importantly, the policies, can feed more people in Europe and be less reliant on imports of food. That is the sort of message the European Parliament has to understand when it is making some of the more mad amendments to this legislation.

Dr Mackey

We are continually talking about food. Let’s be very clear about where primary agricultural production goes. It’s not just food; we’ve also got fibre, fuel and feedstock becoming more and more important within this conversation. How this links up with a green economy, bio-economy and possibly decarbonising our industry may well be part of this conversation going forward. What we are doing in Europe is ensuring that we cannot play a part, because one of the tools has been removed.

Sarah Newton

On that very salutary segue to my questions, I go back to what I was asking about before; I appreciate that you were listening. I am interested in the whole area of intellectual property and patenting. From what you said, there is very little GM crop production that is going to need patents or intellectual property protection, but obviously you are still very engaged with the techniques and the science for producing it. I would like to ask Dr Mackey and Dr Bushell in particular about the policies of their organisations regarding intellectual property. Perhaps you would start, Dr Mackey.

Dr Mackey

As an innovation business, BASF registers over 1,000 patents a year. Fewer than 40 of those were plant biotechnology patents. The reality of what we do is outside Europe. We are working extensively with our partners. Our strategy is not to bring the products to market, but to bring the traits to a partner who will then market them for us. We have a number of partnerships in various parts of the world. Sometimes we compete with those partners in other parts of the world as well, but that’s business. The reality of the situation you are describing is that we also have the research principle, which means that people can use our products for research, and from our side of things that is something that goes on. As was touched on during the last session, anything that evaluates and gives us more data and information has to be a good thing, because at the end of the day good science is what holds our business together.

Dr Bushell

Let’s be clear: intellectual property is something society gives people because there is a benefit to society for doing it that way. The reason it gives a royalty or competition-free period to operate your invention, once your patent is granted, is that you as an inventor need to make a full and frank disclosure of what that invention is, and other people can then springboard on top of your ideas. Eventually, that is how scientific innovation and progress happens. Particularly in an area where you have a very long regulatory time frame and large costs are involved, if there was no competition-free period to exploit the inventions, nobody would make the investments. In bringing a GM crop to market, we are talking of an investment in excess of $100 million. Perhaps up to $10 million of that might be for the regulatory part of it, but the rest of it is all the work that is needed to create the variety and breed it up in sufficient bulk for sale. For a crop protection chemical, it is in excess of $250 million, so patents are an important part of protecting the investors who make those investment decisions, allowing them to get a fair return on those investments, but of course society benefits enormously from having those products available. If you did not have intellectual property protection, you would not have investment on the scale Julian has already said our companies are putting in.

Sarah Newton

Julian, would you like to comment about other members of your organisation?

Dr Little

There are a couple of things that go back to the previous session as well. We often get the impression that as a result, farmers somehow miss out as well, but if you are buying a genetically modified seed, it may have two or three genetically modified attributes. Frequently, those will come from a different company. Geoff has already mentioned that BASF will license one of their traits. It might, for example, be a Syngenta seed containing one Monsanto trait; there might be a Bayer trait and there may be a BASF trait as well. As a farmer, you end up with the best sort of seed with the best traits, irrespective of which company it came from. That cross-licensing of patents is absolutely endemic in agriculture. You are always sharing patents or cross‑licensing patents to make sure that the end product is the best one out there. There was also some discussion about whether we encourage publication. One thing about publication that is always really important is that it demonstrates that the scientists doing it are doing good science. From our perspective, we only want to be working with the best scientists. How do we know they are the best scientists? Because they publish in good journals, do good work and everything else. Not encouraging publication would be mad, because that is a licence to do bad work, not good work. On the patent side of things, I give one example about the idea that it is the multinational companies that do all the patenting. Abiotic stress patents are for heat tolerance, cold tolerance or about water—being able to survive in drought conditions. There have been about 1,000 patents to date in that area, and 50% have been filed by Chinese operations, mainly from universities. You will not be surprised that 41% of them are in rice, so there is a big connection. Eleven per cent are from multinational companies, and 39% would be universities, research institutes and other SMEs around the world, so only 11% of patents in that area are from our members. If you exclude China, that is still only 25% of the patents out there. It is always worth remembering that patents work not just for multinationals, but for all sorts of different people. As Mike says, what you end up with are great new products coming into the market.

Sarah Newton

I understand the need to have a commercially protected period to secure the potential return on investment for the investors. Apart from researchers publishing their findings in well-respected journals, in what other ways—anybody can answer this—do you enable independent researchers, not those you have sponsored yourselves to undertake research, to examine the findings of the research? I understand that it could be after a period of time.

Dr Bushell

If you take a GM crop submission in Europe, these are all basically in the public domain. We were talking yesterday about this. Are they secret? No, they are not. Between 95% and 99% of the information in those submissions would be available for public scrutiny. The only little bits that are left would be perhaps things which were redacted for personal information reasons or, in one or two cases, for commercial sensitivity, because it might relate to some sort of commercial agreement that we would not be able to make more open. In the end, we want growers to know how great our technologies are. As things are going through the pipeline, we are working with third parties who will be growing these materials and showcasing them to farmers alongside other varieties, so that farmers can choose the best possible varieties for use in their fields.

Dr Mackey

If I may be a little practical about the market, the reality of the products we bring to market is that they have to work and give benefit. I am left with a slightly wry smile: I do not see any farmers queuing up at our doors demanding our products unless they work, unless they are getting more benefit and they are better than what they already have. That is one of the key drivers for us. When we talk about a sustainable business, it is all about providing value that we can share. Therefore, the market will drive some of the answers to your questions; they just won’t buy our products if they don’t work.

Dr Little

I reiterate my colleagues’ view on patents. A patent is one way of getting information out there; publication is another. There will always be issues that allow us to protect the $130 million worth of investment that is going into getting a product to the market. We live and die in the marketplace. There will always be people out there who will look at our products, compare them with others and determine which ones are the best. We find that the ones who are most difficult to please are the farmers, our ultimate customers.

Chair

To summarise your answers to Sarah, you are essentially saying that the regulatory structure should examine the quality of the science and regulate on the basis of the scientific validity of the claims you are making, and then the market will determine whether the products work, because it has to work in terms of results and price.

Dr Little

Yes. The disappointing thing about all of this is that we have the most robust safety assessment in Europe and anywhere in the world, yet despite the fact that our products pass with flying colours through the science bit, there is no belief by some countries in Europe that we should work in the marketplace.

Pamela Nash

Dr Bushell, could you share with us the policies of your company when it comes to publishing research? I am particularly interested to know what proportion of the research you have to provide for regulation purposes is published.

Dr Bushell

If we are talking about the sort of journals that academics see as their top impact journals, we occasionally publish in those; for example, we were the first company involved in sequencing a crop plant genome—the rice genome—and that would have made the front cover of Scientific American and Nature, I am sure. There are relatively few of those, because our goal is not to publish papers; our goal is to bring technology and products to farmers. A lot of the information associated with our research and development is very much applied R and D. Often, if you were to submit that to high impact journals they would say, “We know all about this, because we would have to know about it in order to be able to apply it,” so the standards for publication are rather different. We publish a bit of our work, and we do not hide the rest because it is shameful and difficult; it is because we have different things to do in terms of getting on with developing the technology so that it can be deployed in practice. The percentage is quite small, in total.

Pamela Nash

Do you know what it is?

Dr Bushell

No, because we do not count it up.

Pamela Nash

You appreciate why I am asking this. It does not come as a bolt out of the blue that we would be interested to know this. There is criticism from others that without complete transparency on research that is done, the companies working in this area control what is published. People are interested to know about the research that is not published.

Dr Bushell

On any research we have in conjunction with academics, there will always be something written into the agreement that says publication will not be unduly delayed. We have already heard from previous speakers that sometimes it is delayed, perhaps for six months, maximum about a year, so that patents can be properly filed to protect the inventions for the benefit of both parties, but that is really the limit of it. We screen 100,000 chemicals at the start of our screening processes. Nobody would be interested in 99,000 negative results. Actually, we are interested in them; we stick them in our databases, and we will go back to them and look at them over time. That is part of our intellectual property, our know-how. In that case it is not very useful know-how; it is knowing that something does not work, but sometimes we go back to those chemicals and investigate them for other applications. We would not want to destroy the novelty associated with those by publishing them at too early a stage.

Pamela Nash

But that is about timing rather than publishing at all. You have given reasons why you would publish in a peer-reviewed publication only if something was noteworthy. Is that fair?

Dr Bushell

It is often published in different ways. Some people might call this the grey literature, but you see Syngenta technology being talked about in the farm trade press every week, and you see our applied R and D guys working on all sorts of aspects.

Pamela Nash

Is there any reason not to make the information in the studies publicly available, even if they are not in peer-reviewed journals?

Dr Bushell

When you are talking about regulatory submissions, a large portion of this material is already available in the open area, and of course we follow the rules—

Pamela Nash

That is not what I asked you. I asked if there was any reason not to make all of it available.

Dr Bushell

We simply do not have time. I will give you one example. All the field studies associated with the regulatory phase of our neonicotinoid insecticide in Europe were put into two papers and submitted for publication. It took more than a year and a significant rewrite and combination, forced by the journal, to get that material into the public domain. While it is important to do it in that particular case, there are many other cases where we just do not have the time to massage the data and work on it in the way that would be needed.

Chair

Is that true of all field trials?

Dr Bushell

Let’s be clear: in any regulatory studies we cannot hide anything. If you were to do a study and get a result, that has to be submitted to the authorities. There is no hiding there.

Chair

But all the requirements by the regulator that are covered by both laboratory and field trials will go into the public domain.

Dr Bushell

They will go into the regulatory agencies. How people can access the data will depend on the rules of the agencies. In many cases they are published.

Pamela Nash

I am going to come on to that in my next question. I was hoping Dr Mackey could fill us in on his company’s internal policies on publication.

Dr Mackey

I am not a specialist in this area, but if I can talk generally, for our business we spend a substantial proportion of our turnover on research. Along the continuum from research to commercialisation there are a number of phase gates in the process. Products, not just in this area but in any other of our sectors, can fall at any phase gate for all sorts of reasons. Is all of that research published? No, it is not. Why not? The answer is that there is little value in it, I would think, but the reality of where that research then goes is that it starts again or takes a different path to go forward. Certainly, at the pure R and D end, yes, it is published.

Pamela Nash

To be clear, when I am talking about what is published, I am specifically talking about the information and research submitted to EFSA or other regulatory bodies, not all research. With the research I am talking about, the papers are, I presume, already being produced by your respective companies. I am looking to know what proportion of those is published.

Dr Bushell

As I said before, the regulated resubmissions to EFSA will be subject to public scrutiny, and almost all of that, 99%—

Pamela Nash

But they are not automatically published if they go to EFSA.

Dr Bushell

No, they are not automatically published, but people can make freedom of information requests and see them and comment.

Pamela Nash

There are other bodies in the EU which do publish all submissions. Would you be comfortable if they started publishing everything you submitted?

Dr Bushell

We are pretty happy about publishing data and being as transparent as possible, provided the data protection is there to reward people who are investing, fairly, in terms of the amount of money they are putting in to bring forward these technologies. For example, when the competition-free period that a patent allows expires, is it okay for someone just to take your data and work with that invention, or should there be an element of data compensation? These are live issues that have been discussed a lot over the years.

Pamela Nash

Dr Little, in terms of other members of your body is this comparable with other companies in the sector?

Dr Little

What Mike has explained pretty much represents the rest of the industry. Our view, when it comes to regulatory dossiers, is that there is an element that is very useful to our competitors and, therefore, we would not be absolutely delighted to see everything published. However, individuals can always look at these dossiers under freedom of information. You will be aware that, even if the main assessment made of a particular dossier is at European level, all the member states have access to that. Our products do not have to succeed in their processes just in Europe; they have to do so in the country of origin and around the world, wherever they are being exported. That regulatory scrutiny is always there, and that is what should give everybody a degree of confidence that there is no issue around these products.

Pamela Nash

To be clear, your view and that of the council is that you would not want EFSA to publish all documentation submitted to them.

Dr Little

Our view has always been that Europe needs to sort out the issues surrounding competition. Whenever you do a blanket publication of all your data, you are giving away your competitive advantage. It is not a question of being worried about who might see it other than our competitors. If I am working for Bayer, I do not want Syngenta seeing the whole of our dossier because that is of use to them in producing their next best crop. We would always say that the principle of being able to publish the data is absolutely fine, but there are some issues that require some thinking. We have asked the European Commission many, many times to look at this, and so far they have refused to do so.

Dr Bushell

And don’t forget that full and frank disclosure to get a patent means you have to publish pretty early in the life cycle of any technology. We look at Bayer’s patents on the day they are published; I am sure they look at ours. We then get an early view as to whether or not they are a new and exciting area. Because there are research exemptions in Europe, we are perfectly free to look at those patents and start to work on them. Competition is not stopped by patenting; in some respects it is encouraging competition.

Stephen Metcalfe

I would like to look a little bit at what the future holds for this technology. I think it is fair to say that Europe and the UK are perhaps difficult environments in which to cultivate genetically modified crops, but there are parts of the world where the markets are more predictable. What traits are you and other companies working on that might be marketed around the world? Are any of those applicable to the UK, or would they be applicable, putting aside the regulatory framework you have to get through?

Dr Little

There is almost no area of plant science that is not being looked at in terms of its potential commercial application. It can be making things easier for farmers to grow a crop, and essentially that is where we have been for the last 10 to 15 years. For 15 to 20 years, we have been looking at the whole area of making crops more climate-resilient. Will they withstand the frost you weren’t expecting, the heatwave you weren’t expecting, the drought, the floods and everything else? It is about bringing new ideas to how you maximise your yields going forward, because we know that farmers are going to have to grow an awful lot more. We are also aware that, if you are worrying about drought, you need to think more generally about water use, because we do not have the amount of water that would be required to feed 9 million people with today’s technology. We have to find ways that plants will grow with less water and fewer nutrients. Some of those ideas have been coming into the marketplace in the last couple of years. Things like nutrient outputs are being discussed. They are quite tough ones to think about. You heard earlier about the omega 3 and omega 6 fatty acids. Their route to market is not necessarily to feed people with those crops but bizarrely, because it is more acceptable from a public perspective, you feed fish with them, and then people eat the fish to get those omega 3s. That is a bizarre way of doing things, but, hey, we will go where the market takes us. You will have heard of golden rice, but you will not necessarily have heard of golden cassava and some of the other projects going on to improve nutrients in other crops that are normally nutrient or vitamin deficient. A lot of things are going on. Which ones come to the market first depends on the ease of doing it, the chances of market acceptance and, quite simply, where the markets are that you would do that. There is no point in bringing nutrient-supplemented cassava to the US, for example.

Dr Bushell

Most of the companies are working in similar areas, so I would not want to add anything other than echoing what Julian has just said. On the traits that are in the pipeline, if you said, “Let’s unblock GM now for what’s in the European pipeline,” most of those are not particularly relevant to UK agriculture because they have not been developed with that in mind. Of course, if the regulatory framework was different, maybe that would be different. The cost of regulation globally means that the potential for genetic modification that is going to be delivered will be less than is possible. Particularly in areas where perhaps you are interested in consumer traits—taste and flavour in vegetables—mostly they will be addressed by traditional breeding rather than GM, not just because of the regulatory issues but because those polygenic traits are probably more amenable to smart breeding approaches.

Dr Mackey

We are working on nothing specifically for the European market.

Stephen Metcalfe

The question was about what is being worked on globally. Would any of those outside the European market be applicable to the UK in your view?

Dr Mackey

I think Julian covered the list—things like drought tolerance and stresses. Given the range of risks farmers and growers have to put up with, whether or not they would choose some of those products as a way of managing those risks better could be discussed, but from our perspective we are aiming nothing firmly at Europe.

Dr Little

As Mike says, when the European regulations change—because they will have to at some point—companies will come back in. You will see research institutes and SMEs coming into the marketplace and there will be traits suitable for Europe, because in the end things like drought tolerance are just as important to farmers in East Anglia as anywhere else.

Dr Bushell

From our perspective, we are interested in what our customers are interested in. You know farmers: their issues are pretty much around growing a good crop and getting a good price for it, and that is helped by getting protection from competition from pests, weeds and diseases, and increasing the quality of the crop so they get a higher price for it. I am sure that herbicide tolerance will be an effective trait that farmers in the UK would want. Virus resistance already exists in things like sugar beet, and that could be brought in fairly quickly if things changed. Our company’s approach is to look at agricultural technology as part of the total system. It is important that there are not only GM crops and good plant genetics, but also crop protection chemicals that go alongside it, and nutrients and mechanisation. By building a system based on those four technologies, we can give farmers a competitive edge in Europe. One of the issues of the precautionary principle is that it is putting enormous pressure on the other parts of the farmer’s toolbox, and perhaps this Committee might like to look at that further in the future.

Stephen Metcalfe

To go back to what Dr Little said about companies coming back in when the regulatory framework changes, would that apply to BASF?

Dr Mackey

I am sure that when things change we will have another look at it.

Stephen Metcalfe

But that is what is holding you back, or keeping you out at the moment—it is just not worth it.

Dr Mackey

At the end of the day, there is nothing here in Europe for our business in this area, and therefore there is no investment.

Dr Bushell

That is not quite true, because the crops we are growing in Brazil, Argentina and America are all being imported into Europe, so we are still making a significant amount of investment in pushing our submissions through the existing regulatory framework. In the end, cattle and people will be eating this food; it’s just that it will not be grown in Europe, it’ll be grown elsewhere.

Chair

Gentlemen, thank you very much for your attendance. It has been really enlightening. Oral evidence: GM foods and application of the precautionary principle in Europe, HC 328 27