What governance challenges does the UK engineering biology sector face?

The Regulatory Horizon Council's (RHC) has published a report on the challenges currently faced with respect to the governance framework for complex engineering biology products.

The report, which provides impartial advice, aims to assist the government in regulatory reform. A key issue highlighted in the report is the need to strike a balance between ensuring simplicity for regulators while enhancing their ability to handle the range of innovation scales and complexities inherent in the sector. It provides six recommendations for the government to help improve the governance framework.

While the government is not obligated to implement these recommendations, given the significant interest in the engineering biology sector and its potential to assist in the government's economic growth plans, it seems likely that the government will at least consider them in future reforms.

The RHC's report follows a report from the House of Lords, which also raised issues with the sector for the government to address.

A systemic approach

The first half of the RHC's report focuses on implementing a systemic approach to regulating engineering biology products.

It advocates for regulation based on the properties of the products – such as potential benefits and hazards – rather than the production process, which can vary. This would represent a shift from the current approach used for older technologies such as genetic modification.

To successfully implement this recommendation, the report emphasises the need for decision makers, such as standards bodies and regulators, to have a detailed understanding of innovators' knowledge base. Businesses would need to provide this information to decision makers, although it would need to be carefully considered in order to avoid the disclosure of confidential information.

To facilitate the dissemination of this information across the regulatory landscape, the report recommends that the Department for Science, Innovation and Technology use the already-established Engineering Biology Regulators’ Network. This network would allow businesses to share information with regulators to ensure a comprehensive systemic understanding of their products. This process would involve preparing dossiers for innovative products, detailing aspects such as the disruptive potential of the product, anticipated benefits and hazards, which would enable decision makers to understand the appropriate governance systems required for each product.

The report also highlights problems associated with the present regulatory framework being primarily based on legally binding systems. It notes that these systems are sometimes ill-suited for innovative engineering biology products and suggests that more flexible and adaptable governance approaches, which could be achieved using standards and guidance, would be more appropriate. The report recommends that the principles of proportionality and adaptation be considered alongside creatively using standards and guidelines in sequence or in parallel with legally-based regulations.

Biosecurity concerns and responsible innovation

The second half of the report addresses governance issues that extend beyond the properties of engineering biology products. This includes biosecurity concerns such as pandemics, terrorist attacks, or antimicrobial resistance, all of which could significantly affect the engineering biology sector.

It recommends that the government develops strategies to cope with biological threats, ensuring effective communication of these issues in policy making, research, and product development, as well as a public-facing strategy. The RHC suggests that the Biosecurity Leadership Council should integrate these considerations into future biosecurity governance plans.

Beyond this, the RHC recommends that companies make a formal commitment to responsible innovation. The report refers to the requirements of BSI PAS 440, noting the benefits this can bring if implemented by companies. For example, it says it could lead to more resilient new products, better supply chain relationships, and long-term cost and risk reductions.

Access and benefits sharing

Access to genetic resources is crucial for the engineering biology sector, as is a well-functioning benefits sharing regime. The RHC report sets out stakeholder concerns with the Nagoya Protocol, an international agreement within the Convention on Biological Diversity (CBD) framework that deals with access and benefits sharing from the use of genetic resources. The protocol aims to ensure that where genetic resources have been taken by a researcher or business, the country of origin receives a share of any benefits arising from their use.

However, stakeholders have noted that the protocol – described as a twentieth century regulatory system – is difficult to adapt to new genetic technologies from the research stage, through to manufacturing and scale-up. As a consequence, stakeholders have seen a cooling effect on research falling under the protocol.

As the UK's implementation of the Nagoya Protocol forms part of assimilated law post-Brexit, the UK has greater scope to update the guidance around it to provide greater certainty to innovators and companies that they are complying with national and international requirements.

Digital sequence information

Another issue is the sharing of digital sequence information (DSI) of genetic resources. Although there is no agreed definition of DSI, it relates to digital genetic data (unlike the Nagoya Protocol which covers tangible genetic materials).

This is also dealt with under the CBD framework and it has been a contentious issue. Agreement has recently been reached to set up a voluntary fund – the Cali Fund – to pave the way for access and benefits sharing for DSI.

Issues relating to DSI may become more problematic in the future with the continued development of generative AI tools and other forms of computational biology. Where a gene sequence has been designed de novo, there may be no way of knowing if there is a basis in nature for the sequence and how it fits into the access and benefits sharing regime.

The report concludes that it is "vital" that the implementation of the Nagoya Protocol and the DSI benefit sharing mechanisms reflect the needs of the sector and that the UK continues to shape and review international agreements. This is to ensure that "access and benefit sharing can be as impactful as possible without hindering science, research and innovation in the UK".

The RHC suggests working with the Department for Food, Environment and Rural Affairs and the Department for Business and Trade to support the design and delivery of industry engagement over the first quarter of 2025 to ensure that the implementation of the Nagoya Protocol and the DSI benefit sharing mechanism is compatible with and supports the RHC's proposed governance approach.

Osborne Clarke comment

Both this report and the report from the House of Lords highlight that regulatory change is needed for the engineering biology sector in the UK to further develop and for innovative engineering biology products to come to market.

The RHC emphasises the need for clear communication between companies and decision makers, as well as for the reform of outdated and inflexible legal frameworks. However, we have seen that regulatory reform in other innovative areas, such as the novel food process, takes time. The increasing calls for reform to accelerate this sector, combined with the government's pro-innovation agenda and pro-growth ambitions, could mean that changes in this sector are prioritised – time will tell.

This is the second Insight in our series on engineering biology. In the first, we discuss the House of Lords report which calls for policy action by the government.