Gene Editing: A New Era in Biotechnology

In the third episode of our regulated products series, Katrina Anderson is joined by Stephanie Caird, a partner in the Life Sciences team at Mills & Reeve, to discuss gene editing.

The field of gene editing is undergoing a significant transformation, driven by recent legislative changes and advancements in biotechnology. The Genetic Technology Precision Breeding Act 2023 (“Precision Breeding Act”), which received Royal Assent last year, marks a pivotal shift in how genetically modified organisms (GMOs) are perceived and regulated.

A Shift in Perspective   

Historically, GMOs have been met with scepticism and concern. However, the new legislation recognizes that the technology itself is not inherently problematic; rather, it is the potential impacts on people and the environment that warrant careful consideration. This shift in perspective is crucial as it acknowledges the advancements in biotechnology that have led to the development of stable plant and animal breeds through gene editing, which produce results of traditional selective breeding programs much more quickly than could be done using the traditional techniques.

Implications for the Food Industry

The Precision Breeding Act primarily focuses on plants, with provisions for animals currently on hold. The  Food Standards Agency (FSA) is empowered under this legislation to create a streamlined pathway for precision-bred organisms (PBOs) to enter the market as food products. While the exact framework is still evolving, it is clear that not all gene-edited crops will have to undergo the same approval processes as novel foods.  Provided they meet certain criteria, they will be able to be brought to market with no need to submit a dossier to the FSA for approval prior to launch.

This development is monumental for the food industry, as it opens the door for gene-edited crops to be brought to market more efficiently. The FSA will assess these crops through a series of questions to determine whether they can follow an expedited approval route or require a more comprehensive review, likely to be  similar to the novel foods process.  

Devolved Nations and Regulatory Cohesion 

One area of uncertainty is how the devolved nations within the UK will respond to this legislation. The Precision Breeding Act is specific to England, and Scotland has expressed a more cautious approach, aligning with EU regulations. The Scottish Parliament is particularly concerned about the lack of mandatory labelling for gene-edited products, which they believe is essential for consumer transparency and confidence.

Despite these differences, the United Kingdom Internal Markets Act 2020 ensures that products lawfully marketed in England can be sold in Scotland. However, this aspect remains untested, and future political agreements or labelling compromises may be necessary to achieve regulatory cohesion across the UK.

Consumer Awareness and Transparency

The debate over labelling highlights differing philosophies on consumer rights and transparency. While Westminster and the FSA argue that mandatory labelling is unnecessary for safe, gene-edited products, there is a strong consumer desire for such information. Scotland's stance reflects a belief that mandatory labelling will build consumer trust over time.

Conclusion

The Genetic Technology Precision Breeding Act represents a significant step forward in the regulation of gene editing and emphasises how far confidence in this technology has come since it was pioneered in the 1990s . By facilitating the market entry of gene-edited crops, it promises to drive innovation in the food industry while ensuring safety and transparency. As the regulatory landscape continues to evolve, it will be essential to balance technological advancements with consumer confidence and intergovernmental cooperation.

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