The Gene Technology (Precision Breeding) Bill aims to simplify the regulatory regime for precisely bred plants and animals
In the 2022 Queen’s Speech, the government said it will encourage agricultural and scientific innovation and introduce new legislation, the Gene Technology (Precision Breeding) Billat “unlock the potential of new technologies to promote sustainable and efficient agriculture and food production“.
The bill is part of the government’s commitment to leave of the EU regulatory regime on gene editing to make it easier and cheaper to develop and market plant and animal products derived from gene editing.
The government previously performed gene editing consultation and, in his answerindicated that it intended to treat gene editing differently from other forms of genetic modification by introducing a lighter approach to the existing regulation of genetically modified organisms (GMOs).
The bill follows the enactment of the Genetically Modified Organisms (Deliberate) (Amendment) (England) Regulations 2022, which removed the need to submit a risk assessment and seek approval from the Secretary of State before releasing – for non-commercial purposes – genetically modified plants that could have been produced by traditional breeding methods. Instead, it requires to remark to be submitted to the Secretary of State.
The new bill
Although at this stage the details of the new bill are limited, the government has confirmed that its main elements:
- create a new, simpler regulatory regime for precisely bred plants and animals where genetic changes may have been caused by traditional breeding or natural processes;
- introduce two reporting systems for research and marketing purposes to allow breeders and researchers to notify the Department for Environment, Food and Rural Affairs (Defra) of precision bred organisms, which will then be published in a public register; and
- establish a new authorization process for food and feed products developed using precision-bred organisms.
It is expected that the bill will only apply to England.
The government said the main benefit of the bill would be that it would enable precision farming technologies to improve the sustainability, resilience and productivity of the farming system, and enable the UK to consolidate its position in as long as “scientific superpower” and meet the ambitions of 25-year environmental plan.
Effect and implications
The bill seeks to move on to what the government has called 2nd step of its genetic technology regulatory plan. It proposes removing precision plants and animals from the scope of current GMO regulations and ultimately making it easier to get these products to market.
The government has previously indicated that it would be “a few years“before genetically modified products are available on the UK market. It is not clear at this stage whether the new bill aims to speed up this period or whether the new process for the authorization of products intended for food human and animal will be phased in at a later date.
Similar to regulations passed earlier this year, the new bill proposes to move to a notification system for research and commercialization of precisely bred organisms, moving away from the current
scheme where authorization must be sought from Defra. The bill proposes to create transparency in this new system by making the notifications publicly available.
In terms of intellectual property (IP), currently the Patents Act 1977 Provides that “any animal or plant variety or any essentially biological process for obtaining animals or plants, not being a microbiological process or other technical process or the product of such a process” cannot be patented. A “predominantly biological process” is defined as “process of producing animals and plants that consists entirely of natural phenomena such as crossing and selection“. In 2020, the Enlarged Board of Appeal of the European Patent Office confirmed that plants and animals exclusively obtained by essentially biological processes are not patentable.
Gene editing encompassed in the new bill does not appear to fall under this patentability exception. The government has recognized the role that the UK’s intellectual property regime will play in achieving its Vision of life sciences. He is also keen to position the UK as a leading country in which to invest in agri-food research and innovation, an ambition which will be supported by a strong intellectual property regime. If so, that would be good news for those seeking patent protection for agri-tech innovations.
Commentary by Osborne Clarke
This year’s Queen’s Speech contained a further 37 bills, making for an extremely ambitious legislative agenda for the year ahead. How much progress will be made with this bill and how quickly is uncertain.
Although the details of how the main elements of the bill will be carried out are not yet known, the bill’s inclusion in the Queen’s Speech signifies the government’s commitment to move forward with the reduced regulatory burden surrounding gene editing. It also means moving from Stage 1 to Stage 2 of the government’s genetic technology regulatory plan, which will lay the groundwork for bringing GM products to market.
The position of patents on genetically modified plants and animals remains unclear at this stage. However, the information contained in the Queen’s Speech Lobby Folder emphasizes the government’s desire to foster innovation and be guided by a science-based approach – both backed by appropriate intellectual property protection.