Gene editing: A legislative update

The de-regulation of genetic technologies for food manufacturing is on the UK government’s agenda.  This as part of a wider initiative by the UK government to encourage innovation in food – particularly where it supports the development of more sustainable proteins.

Steps have been announced in line with the government’s commitment to foster agricultural innovation and accelerate the development of innovative and novel foods. This follows a consultation that took place in 2021 seeking views on the regulation of organisms (other than humans) produced using genetic technologies such as gene editing. The response, announced in September 2021, set out plans that (as widely expected) put the UK on a course to, at least temporally, diverge from the EU’s regulatory regime following the end of the Brexit transition period.

Step one

Current changes are part of step one of the government’s plans. This  aims to implement a more light-touch approach to the regulation of gene-edited plant based organisms that could have been achieved through traditional breeding practices. Draft regulations¹ were laid before Parliament in January 2022 and debated in Parliament in March 2022. As no objections have been raised, these will come into force imminently.

The regulations aim to streamline the research and development stage for these crops by making it easier to conduct field trials for certain gene-edited plant-based organisms. This will be facilitated by removing the need to (i) submit a risk assessment; or (ii) seek the secretary of state’s consent before releasing (for non-marketing purposes) genetically modified plants that could have been produced by traditional breeding methods. Instead, a simple notice to the secretary of state will be sufficient.

It is hoped that reducing the regulatory burden associated with this stage will accelerate the route to market for such crops. However, it is worth noting that the change to the regulations is limited to the development of specific types of gene-edited plants and crops that fit the tight definition of “qualifying higher plant”. Also, for the time being at least, gene-edited plants within this category will still be classified as genetically modified organisms (GMOs). What this means in practice is that the commercialisation of GMOs and any food products derived from them still require a GMO authorisation before it can be placed on the market or sold to consumers.

Draft regulation has already been put before the House of Commons

Changing the direction of travel

Nonetheless, this is indicative of the UK government’s direction of travel in regard to gene-editing technologies. Indeed, step two of the government’s plan intends to amend the regulatory definitions of a GMO to exclude organisms that have genetic changes that could have been achieved through traditional breeding or that could occur naturally.  This would mean that it may not be necessary to get a GMO authorisation before starting to sell gene edited crops. As the government has recently stated its intention to facilitate the development of innovative meat-substitute products, we anticipate that faster approvals for novel foods using gene editing or similar technologies to develop sustainable proteins such as lab grown meats, could also be announced in parallel. However, a timeline for step two has not yet been announced.

In announcing the consultation’s response, the government noted that it will also consider issues relating to the gene editing of animals as part of step two. We expect that steps towards reducing the regulatory burden will form part of the government’s plans, but this is likely to be more gradual due to the more complex ethical considerations associated with such technologies.  

As the regulatory regime develops, thought will also need to be given to how any regulatory changes will interact with the rules concerning intellectual property (IP) rights. If, as is hoped, the regulatory changes encourage a boost in research and development, it will be important for businesses to ensure that their IP is adequately protected. It is currently unclear whether patentability of gene-editing processes, or subsequent plant products that have been produced by those processes, will be affected. It also remains to be seen whether the UK government intends to widen, or even limit, the opportunity to patent plants in this context or how the interaction between plant variety rights (a form of IP right designed specifically to protect new varieties of plants that are the result of traditional breeding) and patent rights will function in relation to gene-edited plants. It is hoped that these considerations will form part of step two of the government’s approach.

Finally it is worth noting that this is not just a UK initiative.  The EU has also suggested that the regulation of gene editing for the purposes of food manufacturing is something they would consider, so in due course there may be EU developments which mirror the UK approach.

References

1. Draft Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022