All 1 Baroness Wilcox of Newport contributions to the Genetic Technology (Precision Breeding) Act 2023

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Mon 12th Dec 2022
Genetic Technology (Precision Breeding) Bill
Lords Chamber

Committee stage & Committee stage: Part 1

Genetic Technology (Precision Breeding) Bill

Baroness Wilcox of Newport Excerpts
Baroness Bakewell of Hardington Mandeville Portrait Baroness Bakewell of Hardington Mandeville (LD)
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My Lords, the noble Baroness, Lady Jones of Whitchurch, gave a very good introduction to these two amendments. Several of the speakers at Second Reading referred to the benefits of gene editing to enable crops to be hardier with regard to resisting drought and flood and the ability to repel insects. It is obvious to all that climate change is having a dramatic effect on crops; in many cases, it is devastating. Unlike the noble Lords, Lord Winston and Lord Krebs, my technical knowledge on gene editing is woefully inadequate. However, I will do my best.

Not only in England but in other countries as well, farmers are finding their crops destroyed by the forces of nature, which they are powerless to combat. In many cases, this has led to a shortage of crops to feed indigenous populations, resulting in food loss and, in some instances, the starvation of large numbers of populations. Attempting to ensure that crops are more resilient is important. However, at the same time, it is essential that the natural cycle of our wild plants is protected. Both the Agriculture Act and the Environment Act focused on the loss of biodiversity in our natural habitats in fields and hedgerows. The environmental land management schemes are intended to help biodiversity recover so that natural species of plants, birds and small animals recover to a sustainable level. However, if the gene editing of crops and plants affects ecosystems to such an extent that it alters their natural cycle, this will undoubtedly have an effect on wild flowers, which in turn will affect birds and small mammals.

This comes down to the precautionary principle and ensuring that action taken as a result of this Bill is closely monitored and does more good than harm. When moving forward with technology, which although tested is likely to move more quickly than traditional methods in the past, the prevention principle should also form a part of the equation.

The noble Baroness, Lady Hayman, spoke eloquently at Second Reading of the last time gene editing was debated and how the debate got bogged down to such an extent that it had to be abandoned. It is not our intention on these Benches to see this happen a second time. It is time to move on, but we are looking for safeguards for the future. Without the necessary safeguards, unintended consequences could be hard to reverse. The noble Baroness, Lady Jones, and the noble Lord, Lord Krebs, made very powerful points in their arguments, with which I agree. I hope the Minister will be able to give the reassurances which are sought around the workings of the advisory committee.

Baroness Wilcox of Newport Portrait Baroness Wilcox of Newport (Lab)
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My Lords, I apologise to the Committee for not speaking at the Second Reading of this Bill; I was not on the team at that point.

I am grateful to my noble friend Lady Jones of Whitchurch for tabling the two amendments in this group, which we understand to be probing amendments. As my noble friend said about Amendment 2, she is challenging how far technology is applied. Do we want to go beyond certain sectors? How far beyond agriculture do we want to go? Amendment 31 is about the wider environmental concerns and reporting on the potential disruption to the farming ecosystem, which could have adverse effects on other plants.

As several speakers noted at Second Reading, the use of gene-editing technologies in plants is far less contentious than in animals. There is not only a much larger body of evidence from research institutions, following years of trials, but that evidence points to the risks being substantially lower. However, even if the risks are lower and potentially easier to mitigate, we must remain mindful of them. Regardless of whether these technologies are used for plant or animal life, we are dealing with processes that accelerate natural events and which may have—we have already heard this phrase—unintended consequences. Indeed, I have heard that phrase in your Lordships’ House over and again during the process of many Bills this Session. It seems to point to an uneasiness with what is being proposed and a lack of thinking things through during the process of legislation.

One imagines that the bulk of releases and marketing authorisations under this legislation will relate to agricultural products. If we can produce certain crops in a more efficient manner, or make them less susceptible to increasingly frequent extreme weather events, that could be a good thing. But we must remember that agricultural crops live alongside wild plants—grasses, wildflowers, trees and hedgerows—all of which have their own important roles in the natural world and in the careful and precious ecosystem. These amendments allow us to consider how new gene-edited varieties of crops will live alongside and interact with other types of plant life

It may be that there is a place for these technologies beyond agriculture, such as making certain tree species less susceptible to disease. I remember well, as leader of Newport City Council, when we had to deal with the significant problem of ash dieback. Large areas of ash trees were felled, with a significant impact on local wooded areas. We had a policy of planting two trees for every tree cut down on land we were responsible for, so felled ash trees were replaced with other suitable trees. If technology could help prevent such drastic measures, that can only be a positive thing.

Regardless of the precise applications of the technologies, it is not clear that the Bill as drafted takes full account of the potential consequences of new plant varieties once they are released. The Government’s environmental land management schemes and other initiatives are trying to halt the steady decline in our biodiversity which has been caused in part by the loss of meadows and hedges and the habitats they sustain. These efforts are hugely important, and there is a role for gene-edited plant varieties as we seek to achieve that goal. However, concerns have been raised by experts in this Committee that seemingly minor changes to agricultural, forestry and other land management practices arising from the use of new plant varieties could inadvertently have significant impacts on soil quality and wildlife in the medium to long term. These amendments provide the Government with an opportunity to address these concerns and outline how they will ensure that this new regime fits into efforts to protect and enhance our natural environment. I urge the adoption of them by the Government.

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Baroness Bakewell of Hardington Mandeville Portrait Baroness Bakewell of Hardington Mandeville (LD)
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My Lords, the noble Baroness, Lady Bennett of Manor Castle, and the noble Lord, Lord Krebs, have spoken eloquently to this small group of amendments. The technical aspects of the Bill are complex and he has already mentioned the matter raised by the Royal Society. If a new seed variety is developed using GMOs, as he said, it has greater intellectual property rights than one that is developed using other breeding technologies. If some genome-edited products are not treated as GMOs, they should enjoy no greater intellectual property protection than the products of traditional breeding technologies, such as plant breeders’ rights.

The whole issue of novel foods is affected by the Bill and these amendments. The Royal Society believes that those in the plant breeding industry need to be able to breed from each other’s varieties, and it would not be in the public interest if the adoption of genome editing for crop improvement were to compromise the ability of plant breeders to make crosses with each other’s varieties. I am really sorry that the noble Lord, Lord Taylor of Holbeach, is not here because I feel he would be interested in this section. The ownership of intellectual property needs to be addressed before the Bill moves forward to Report. I agree completely with the noble Lord, Lord Krebs, and I look forward to the response of the Minister.

Baroness Wilcox of Newport Portrait Baroness Wilcox of Newport (Lab)
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I am grateful to the noble Baroness, Lady Bennett of Manor Castle, for tabling Amendment 12, and to the noble Lord, Lord Krebs, for tabling Amendment 74, which my noble friend Lady Hayman of Ullock was pleased to sign. Issues around intellectual property were not explored in any detail in another place; nor did the topic feature heavily in the Hansard report of Second Reading. Some may argue that such matters are pushing the scope of this legislation, but we believe it is vital that all interested parties understand the regimes that will apply once the Bill is passed and enacted.

For a product to make it to market, it will have been subject to research, testing, scaling up and the release and marketing processes laid out in the Bill. This will involve significant costs for those who develop the technologies and associated products. We understand that they will want to protect that work and the underlying financial investments to the best of their abilities. On the other hand, for this process to be successful, we need to see fair prices for the farmers who will utilise these technologies or the new plant and animal varieties that arise from them. At present, it is not clear what IP regimes will apply. We can make assumptions, but there is no certainty. As a result, we do not know how many players will bring these new products to market, nor how many farmers will be able to afford them. Amendment 74 offers a way forward, requiring the Secretary of State to publish guidance on these matters prior to bringing the bulk of the Bill’s provisions into force.

These matters are incredibly complex and perhaps not best dealt with through additions to the final version of the Bill. However, this is Committee, and we hope that the Minister will be able to provide an indication that this work is not only in progress, but that appropriate guidance will be in place at the earliest opportunity.

Lord Benyon Portrait Lord Benyon (Con)
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I thank noble Lords for their amendments regarding intellectual property laws. I will first take the probing amendment in the name of the noble Baroness, Lady Bennett of Manor Castle, which would prevent an organism from qualifying for precision-bred status if it was subject to a patent, either on the product itself or on the process used to produce it. This provides an opportunity for us to explore how a precision-bred organism can be patentable, and what it means for such an organism to be capable of having

“resulted from traditional processes or natural transformation”.

As I am sure she is aware from previous debates in Committee, it is the final genetic composition of an organism that we are considering when assessing whether a plant or animal meets the criteria for being “precision bred” as set out in the Bill. This is in line with the scientific advice we have received: that it is the final genetic and phenotypic characteristics of an organism that are important and not the technology or process used to produce it.

This approach differs fundamentally from the current principles used to determine whether patents are available for plants and animals whose DNA has been altered using modern biotechnology. Unlike the definition employed in the Bill to determine whether an organism is precision-bred—which, as I have said, focuses on the end result—patent principles focus on the technology or processes used to produce these plants and animals.

The definition of a “precision bred organism” should continue to be based on scientific evidence and advice. In continuation of this logic, it would be disproportionate and unscientific to prevent a qualifying precision-bred organism from having precision-bred status on the basis of the granting or not of a patent. To prevent precision-bred organisms from obtaining patent protections would go against the core principles on which the Bill is based: that regulation should be proportionate, robust and driven by the evidence.

An invention must meet a number of legal requirements if a patent is to be granted. The granting of a patent is determined not only by the nature of the invention but by other legal requirements, including whether the invention is new or non-obvious. This is not the same as asking whether an invention that did not exist previously could, in principle, have been produced through a different method. As such, the presence or absence of patent protection cannot be used to determine if a particular DNA sequence could have resulted from traditional processes or natural transformation.

Patents represent an important mechanism for innovators to gain return on their investments. As a result, preventing organisms from being classed as “precision bred” if those organisms or the processes used to create them are subject to patent protection, would likely deter uptake of the technologies that the Bill wishes to facilitate. Ultimately, the UK would lose the significant benefits that implementation of the Bill could bring.

Amendment 74 would require the Defra Secretary of State to review and publish guidance on the implications of the genetic technology Bill for intellectual property law. As I am sure that noble Lords are aware, in the UK the Intellectual Property Office is responsible for patents. I assure noble Lords that we have worked closely with the Intellectual Property Office in this area. UK patent law does not specifically exclude patents from being granted on precision-bred plants and animals. Indeed, a patent may be granted if all the requirements for a particular invention are met—novelty, utility, and non-obviousness.

The Bill does not make any changes to laws associated with obtaining a patent; nor does it alter the process by which an applicant would apply for patent protections. Breeders wishing to patent their precision-bred plant or animal should therefore undertake this process in the same manner as for all other inventions and under the guidance of the Intellectual Property Office.

Most interest in this area has revolved around the use of patents that protect precision-bred organisms. However, it is important to note that other protections for intellectual property are available. For example, a plant breeder may want to obtain protection using plant variety rights. In animals, breeders generally gain protections through contracts with buyers, which stipulate terms to ensure their trait of value is protected. Engagements with industry stakeholders have highlighted that fair access and value gains for farmers must balance with restrictions on the use of protected material in order to enable a return on investment. In plant breeding, licensing platforms which facilitate access to patented material have been borne out of the need to create this equilibrium. We envisage that a similar situation would arise should breeders decide to protect their precision-bred organisms. Ultimately, patent law strikes a balance between incentivising innovation and allowing access for farmers and breeders, precisely the point that the noble Baroness, Lady Wilcox, was making.