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Clifford Chance

Clifford Chance
Healthtech<br />

Healthtech

Talking Tech

UK Government Proposes New Legislation for Gene-Edited Food

Healthcare & Life Sciences Intellectual Property 27 June 2022

On 25 May 2022, the Genetic Technology (Precision Breeding) Bill was introduced before the UK Parliament in a move to "cut the red tape" on the development of gene-editing technology, and to position the UK as a world-leader for investment in agri-food research and innovation.

The Bill provides for gene-edited food crops to be developed, grown and sold in England. The intention is for the legislation to eventually extend to animals (excluding humans), but only once a satisfactory regulatory regime is developed to ensure safeguarding of animal welfare.

What is "precision breeding"?

Precision breeding involves targeting specific parts of an organism's DNA in order to achieve specific breeding goals, through the use of gene-editing technologies. The edited DNA leads to new varieties of the organism which are achieved in a quicker and more efficient way than traditional breeding methods.

How does "gene-edited" differ from "genetically-modified"?

In its simplest terms, genetic modification involves taking DNA from one organism and introducing it into the DNA of another organism. In comparison, gene editing involves a specific and controlled change (such as activating or deactivating a gene) in an organism's own DNA.

Strict EU regulations, which do not distinguish between gene-edited organisms and genetically-modified organisms, prevent such organisms being placed on the market. Following Brexit, however, the UK is able, in part, to depart from these regulations, and allow new legislation which will permit gene-edited organisms to be treated differently in England from genetically-modified organisms (whose governance will remain unchanged). This will allow for gene-edited food products to be placed on the market in England, and due to the United Kingdom Internal Market Act 2020, also the markets in Wales and Scotland. Currently, however, due to the Northern Ireland Protocol, gene-edited food cannot be placed on the market in Northern Ireland, unless they undergo a full GMO authorisation in compliance with EU rules.

What is the Bill aiming to achieve?

The Government intends for the Bill to provide a range of benefits to the agri-food industry, including:

  • producing crops that require less pesticides and fertilisers, thus improving sustainability, resilience and productivity in the UK's food system and reducing costs to farmers;
  • increasing disease resistance in plants (and ultimately animals), thus reducing reliance on pesticides and antibiotics;
  • increasing climate change resistance (e.g., drought and heat tolerant crops); and
  • creating safer foods with the removal of allergens and preventing formation of harmful compounds in foods.

What issues may arise with this Bill?

Whilst the Government hopes the Bill will lead to economic growth and investment into the agri-food sector and gene-editing technologies, concerns still remain should the Bill pass into law. Through the Bill's consultation stage, and during its first MPs debate on the main principles of the Bill on 15 June 2022, the main issues that arose included:

  • Labelling – whether food products from gene-edited crops (and eventually animals) would require specific labelling, and if so, what rules on this labelling would be needed to ensure consumers could make an informed choice on their purchases. The Government have confirmed that they "will ensure that there is transparency and that any seed that is marketed is listed in a transparent way", but they have noted it is not currently their intention to have some kind of labelling requirement specifically for food.
  • Intellectual property - ownership of, and what intellectual property rights exist in gene-edited organisms, and whether gene-edited crops will infringe on farmers’ rights to harvest and resow their seeds on their own farms.
  • Trade - UK/EU trade implications for products developed using genetic technologies due to EU rules that do not allow for gene-edited or genetically-modified products to enter the Northern Ireland and EU markets.
  • Animal Welfare – the use of this technology to genetically-edit animals needs to be scrutinised and regulated to ensure that the technology is used to improve current animal welfare standards, rather than leading to poor practices (e.g., not genetically-editing animals to be resistant to diseases so that more could be kept in cramp conditions without the risk of a disease outbreak).

Next Steps

The Bill was introduced to the UK Parliament on 25 May 2022, and went through its first debate on 15 June 2022. The Bill has passed through to the next stage, and now each clause and any proposals for amendments to the Bill will be debated in the House of Commons. This debate is set for the week commencing 27 June 2022.

Should the Bill pass into legislation, the Government hopes that it will lead to new foods, businesses and technologies, leading to economic growth in the agri-food industry and increased research into gene-editing technologies.