Overview
Advances in biotechnology since the introduction of the current (EU-derived) legislation governing genetically modified organisms, which first came into force in 2002, has been significant. As a result, there is recognition in both the UK and the EU that legislative change is required to ensure the regime remains fit for purpose in terms of protecting human health and the environment, while also allowing society to capitalise on technological advancements in a timely manner.
Even during a particularly turbulent period in UK politics, bringing forward new legislation in this area has remained a priority for Boris Johnson's government. Following an announcement in the Queen's speech in May 2022, a ''Bill to make provision about the release and marketing of, and risk assessments relating to, precision bred plants and animals, and the marketing of food and feed produced from such plants and animals; and for connected purposes'' – titled, the 'Genetic Technology (Precision Breeding) Bill' - is currently before Parliament.
This is an important development for the industry: in the words of UK Government, ''Outside the EU we are free to follow the science. These precision technologies allow us to speed up the breeding of plants that have natural resistance to diseases and better use of soil nutrients so we can have higher yields with fewer pesticides and fertilisers.''
Recent Developments
In spring 2021, the Department for Environment, Food and Rural Affairs (DEFRA) held a public consultation on the regulation of genetic technologies in England. Following the consultation, a two-step process was developed.
'Step 1' was designed (in the words of DEFRA) to ''ease burdens on developers undertaking research and development work involving plants developed using genetic technologies, such as gene editing.'' This step was duly delivered by the 'Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022' in March 2022.
These regulations adopt a more light-touch approach to the regulation of genetically modified plants (for non-marketing purposes) that could have been produced by traditional breeding methods, removing requirements for a risk assessment and substituting a requirement for the secretary of state's consent with a notification requirement. The changes cover genome editing technologies, such as the CRISPR/Cas9 'genetic scissors', only where outcomes could have been produced by conventional breeding (known as 'cisgenesis').
Step 2 is the 'Genetic Technology (Precision Breeding) Bill', which is now working its way through Parliament.
The Genetic Technology (Precision Breeding) Bill
The stated objectives of the new Bill are as follows:
- To create a simpler regulatory framework for precision bred plants and animals;
- To introduce two notification systems for research and marketing purposes. The information collected on precision bred organisms will be published on a public register; and
- To establish a new ''science-based'' authorisation process for food and feed products developed using precision bred organisms.
The Bill is not intended to reform the law relating to organisms created by transferring genes from sexually-incompatible species (known as transgenesis). Government has also noted that ''no changes will be made to the regulation of animals until animal welfare is safeguarded.''
How Will the New Regime Diverge From That in the EU?
UK Government has emphasised that its proposed regulatory approach is intended to diverge from that of the EU, stating that the Bill ''will remove unnecessary barriers to research into new gene editing technology, which for too long has been held back by the EU's rules around gene editing, which focus on legal interpretation rather than science – hindering the UK's world leading agricultural research institutions. Outside of the EU and free to set rules that work in the best interest of the UK, this Bill will enable the development and marketing of precision bred plants and animals which will drive economic growth and attract investment into agri-food research and innovation in the UK.''
This appears to be a reference to (EU) Case C-528/16 Confédération paysanne and Others. The CJEU decision was significant as it clarified that organisms produced by targeted mutagenesis (including cisgenesis) are subject to the requirements of the current GMO legislation. The judgment had immediate consequences since those crop varieties developed by such methods could no longer be placed on the market without authorization. This was widely interpreted as a clear indication of EU scepticism for genetic engineering under the precautionary principle.
In the Queen's speech, Government asserts that around 40% of small businesses and 33% of larger companies involved in plant breeding in Europe have stopped or reduced research and development activities relating to precision breeding technologies as a result.
It should be noted that the EU is currently consulting on its own initiative for a new legal framework for plants obtained by targeted mutagenesis. In fact, early signs suggest that the EU intends to follow a similar (but distinct) trajectory to that proposed by the UK.
Divergence will not however be limited to that with the EU, since the Bill will apply in England only. Environmental policy is a devolved power, and the Scottish and Welsh Governments have to date suggested that they do not wish to pursue equivalent changes in Scotland or Wales at this stage. It should be noted however that due to the mutual recognition principle in the UK internal market, it will likely be possible to place relevant products on the market in Wales and Scotland, if they can be marketed lawfully in England. Furthermore, future changes in the EU regime may apply in Northern Ireland under the Northern Ireland protocol. It remains a complex picture.
Further Thoughts
It is noteworthy that the Bill carries a statement by the Secretary of State (George Eustice) that ''the Bill will not have the effect of reducing the level of environmental protection provided for by any existing environmental law'', a new requirement flowing from the (still relatively new) Environment Act 2021.
There is of course a legitimate debate to be had about whether the easement of regulatory burden in relation to environmental matters equates to a reduction in the level of environmental protection. Mr Eustice will clearly have his view on that. But with the debates surrounding the practical implementation of the Environment Act 2021 still fresh in parliamentary minds, it will be interesting to see how and to what extent this issue is addressed and debated by the House as the Bill moves through Parliament.
The reduction of any unnecessary regulatory burden will be welcomed by industry, as well as by farmers and consumers alike. However, the extent to which such important, cross-border issues can be appropriately managed separately by each devolved administration, and indeed separately from the EU (as the UK's biggest export market), in order to deliver an easing of the regulatory burden, but without causing additional trade complexities, remains to be seen.
This analysis was first published on Lexis®PSL on 15 June 2022
