The UK is developing its approach to deregulating gene editing in plants

Last year, the UK enacted new legislation in the form of the Genetic Technology (Precision Breeding) Act 2023 to pursue a post-Brexit deregulatory agenda with respect to "precision breeding". New genomic techniques (NGTs) encompassed by precision breeding can produce targeted genetic changes that could have occurred through traditional breeding and natural processes. This differs from previous techniques as it does not involve the insertion of DNA from separate species and is therefore generally considered safer.

Despite taking legislative action, there are concerns that the UK's deregulatory ambitions are not being lived up to due to the lack of capacity and funding of regulators, such as the Food Standards Agency (FSA), causing a bottleneck in bringing products to market. There have not yet been any gene-edited foods placed on the market since the legislation was enacted.

The deregulatory agenda

Prior to its enactment, and while the UK was an EU member state, NGTs were stringently regulated under the EU's genetically modified organisms (GMO) legislation. Post-Brexit, the UK (or at least England) has sought to develop its own regulatory approach to regulate precision bred organisms (PBOs) "proportionately to risk", meaning that plants (and animals) produced through precision breeding techniques are no longer regulated as GMOs. This is a similar approach to other countries such as Japan, which has already concluded that PBOs should not be regulated as GMOs. The UK's new regulatory approach only applies to England as this is an area of devolved competence. The rest of the UK continues to remain aligned to the present EU GMO approach.

England's more relaxed regulatory approach seeks to enable plants, animals and food and feed products containing or consisting of PBOs to more easily make their way to market (which would include being placed on the market in Scotland and Wales under the mutual recognition principle).

What are precision bred organisms?

Under the Genetic Technology Act, an organism is considered to be "precision bred" if:

• Any feature of its genome results from the application of modern biotechnology.
• Every feature of its genome that results from the application of modern biotechnology is stable.
• Every feature of its genome could have resulted from traditional processes, whether or not in conjunction with selection techniques, or natural transformation.
• Its genome does not contain any feature that is a result of any artificial modification technique (other than modern biotechnology).

In the case of plants, "traditional processes" includes sexual fertilisation, spontaneous mutation, in vitro fertilisation, polyploidy induction, embryo rescue, grafting, induced mutagenesis, or somatic hybridisation or cell fusion of plant cells of organisms which are capable of exchanging genetic material by any of the previously mentioned processes. Transgenic GMOs are excluded and continue to be regulated under the GMO regulations.

The purpose of the legislation

The purpose of the new legislation is to allow gene editing without the need for specific complex approvals under the current GMO regime – at least in England. This will be replaced by a lighter-touch regime that is based on notification; that said, it will still be necessary to apply for a "marketing notice". The full details of the proposed application process are not currently available as it will be created through secondary legislation.

The FSA ran a consultation on proposals for the new framework for the regulation of food or feed produced from PBOs (including both plant and animal PBOs). It published its response on 5 March 2024. The response outlines that the secondary legislation is currently being drafted and will be laid before Parliament in the summer, along with technical guidance, with the aim of implementing the new process by the end of 2024 or early 2025. The response outlines how the framework will look and provides an interesting insight into how this may contrast to the EU position.

Although it is intended that the regulatory framework will apply to both plant and animal PBOs, it is anticipated that applications for regulatory approval of plant PBOs will open before applications relating to animal PBOs.

Two-tiered approach

In the recent response to its consultation, the FSA has confirmed that its proposal revolves around introducing a two-tiered regulatory approach for pre-market authorisation, meaning that those PBOs similar to traditionally bred organisms would benefit from a simpler route to market.

Tier 1 would be for those PBOs where the safety risks are understood and are not of concern, which would be determined by using a triage criteria set by FSA. Once determined, businesses would need to notify the FSA that its food or feed falls within the criteria for Tier 1. The FSA would then acknowledge receipt of the notification and place the PBO on the public register.

The Tier 2 regulatory route would be for those PBOs where the safety risks require further scrutiny, meaning the authorisation process would be more rigorous. This route would require an application to the FSA and completion of an FSA safety assessment.

Triage questions to determine whether a PBO would be Tier 1 or Tier 2 include inquiries around novelty, composition (including allergenicity) and other safety concerns.

UK-EU framework similarities

The FSA's proposed regulatory framework is similar to the proposed EU framework in that they both seek to develop a simpler and more proportionate market authorisation system for NGT plants/PBOs via a two-tiered approach. The UK approach goes further than the EU's proposal as it also covers animal PBOs.

The two regimes may also diverge in relation to the definitions applied to plants to determine which tier they fall into. The scope of plants falling within the UK's Tier 1 may well end up being broader than those falling within the EU's NGT 1 tier. In practice, this could mean that an NGT plant/PBO is considered to be similar to a traditionally bred organism in the UK and is subject to a simpler authorisation route in the UK. However, because of the proposed narrower definition in the EU, the same plant could be classed as an NGT 2 plant in the EU and, therefore, be subject to a stricter marketing authorisation process in the EU.

This could add a layer of complexity, cost and administrative burden on businesses wanting to place products on both the UK and EU markets. In this case, businesses will need to ensure that the right route for authorisation is taken to ensure products are not prohibited from being placed on the relevant market.

Product labelling

Another key difference between the FSA's proposed approach compared to the EU's proposed approach, in particular the European Parliament's position, is that there are no plans to introduce mandatory labelling for those products produced by precision breeding.

The FSA's Advisory Committee on Novel Foods and Processes previously stated that there is no scientific evidence that PBOs are "intrinsically more hazardous than traditionally bred organisms'". This has informed the UK government's position, which is that there is no justification for labelling requirements to indicate where foods have been produced as a result of precision breeding techniques.

However, the FSA's latest consultation response highlighted that respondents were concerned with the absence of mandatory labelling. The FSA reiterated that the issue of labelling is the responsibility of the government but it would pass on these concerns to the government. At time of writing, mandatory labelling requirements are not included in the FSA's proposal.

Other regulatory considerations

Although the purpose of the new legislation in the UK is to allow gene editing without the need for specific complex approvals under the current GMO regime, businesses should note that those products may still be subject to other regulatory regimes, such as being approved as a novel food.

However, the "regulated products regime", which includes novel foods, is currently undergoing a review by the FSA. Two proposals to reform the regime have been put forward:

• To remove renewal requirements for various food products, including food or feed containing, consisting of or produced from GMOs. 
• To remove the process of laying legislation after ministerial authorisation of a regulated product, which currently slows down the approval process. Instead the authorisation would be added to an official register, following a ministerial decision, which the FSA said will speed up the process.

A consultation on these new proposals was launched on 3 April  and the FSA noted that it hopes to introduce these legislative changes ahead of the general election. The consultation closes on 5 June 2024.

This recent development highlights the regulator's desire to modernise and expedite authorisation procedures. The FSA has stated that failing to take urgent action will result in an inability to cope with the increasing caseload, further underscoring the pressing need for progress in this space.

Patent rights

Unlike the European Parliament's proposed NGT plant patent ban, the UK Genetic Technology Act does not address the intellectual property position with respect to PBOs. As such, it seems that the usual European Patent Office (EPO) approach will continue to apply.

This means that plants and animals can be patented where they are not "exclusively obtained by means of an essentially biological process" and if the invention is not confined to a particular plant or animal variety. Therefore, plants or animals that are produced by a technical process, such as gene editing that modifies the genetic characteristics of the plant or animal are, in theory, patentable.

However, this position could be impacted by the European Parliament's proposed EU patent ban if the NGT plant patent ban was enacted and the EPO was to act in response to it. However, this would be a politically controversial and practically difficult move for the EPO to make.

At this stage, it seems that gene-edited plants and animals falling within the scope of the Genetic Technology Act could be patentable (subject to the usual patentability requirements). This is be good news for players seeking to make investment into developing agri-tech inventions – the ability to secure robust patent protection may well incentivise investment.

Osborne Clarke comment

Although the UK managed to enact the Genetic Technology (Precision Breeding) Act 2023 in a timely manner, its progress in making it practically easier to bring innovative food and feed products to market has been slow.

Specifically, out of the 450 regulated product applications, including novel foods and genetically modified products, submitted since January 2021, only 63 have received regulatory approval, primarily due to resource constraints within the FSA.

However, the FSA's recent activity illustrates its commitment to translating the deregulation benefits of the Genetic Technology Act into practice. The drafting of legislation for the new regulatory framework for PBOs in England is now underway. As is the FSA's consultation on the reformed regulated products regimes.

However, the potential impact an upcoming UK general election could have on progress in this area also needs to be considered. The Labour party has pledged to establish a new Regulatory Innovation Office to provide strategic direction for regulators and to set benchmarked targets aligned with international standards. While this announcement primarily focused on the life sciences sector, it does highlight the potential for the FSA to be held accountable, which could impact the authorisation of PBOs. But how quickly could any promised changes be implemented?

The suspected divergence between the EU and UK regulatory frameworks on gene-editing means that businesses operating in both regions will need to navigate different sets of rules and requirements. They will need to understand and comply with the specific regulations in each jurisdiction to ensure market access and compliance with safety and labelling requirements.

Businesses should also begin to have conversations around the proposed two-tier system and how this may affect the timeline for getting products to market. This could include considering whether there are any early-stage decisions that can be made to potentially reduce the risk profile of a PBO, and, as such, also reduce the associated regulatory burdens.

With the regulation of GMOs being a devolved issue in the UK, businesses should also be aware that the UK nations themselves could diverge on these issues. This could have a cooling effect on the marketing of PBOs in the UK due to potentially increased costs and administrative burdens.

Businesses operating in this space should continue to monitor the evolving regulatory landscapes in the UK and the EU.

This is the second Insight in our series on the deregulation of gene editing in plants. The first part of the series looked at the regulatory changes proposed in the EU.