Regulation
Getting market authorisation is a key milestone in the life cycle of a growing biotech SME. However, as innovation outstrips regulatory agility, this milestone can feel impossible to reach for many innovators.
Biosolutions challenge conventional regulatory approaches, and span boundaries between regulators. These novel products require regulators to take a fresh look at how they assess products and how they support innovators.
We work closely with innovators, regulators and the Regulatory Innovation Office to support our members to clear regulatory hurdles and place their products on the market.
Our recommendations
Improve regulatory clarity for biosolutions products and processes
While for some companies the regulatory pathway and/or regulator is clear, this is not the case across engineering biology applications. Innovation is outpacing existing regulatory frameworks, creating significant gaps. Regulators need to work with public research funders and industry to clarify where regulation is needed for innovative products, and provide those products with a clear route to market. This includes:
- Publishing an overview of regulatory bodies and pathways for engineering biology-based products, including information on:
- how innovative engineering biology companies can approach regulators
- which teams/individuals to approach
- guidance and including case studies of innovative engineering biology products that have previously been approved.
- In line with considerations for biosecurity and responsible innovation, reviewing and updating relevant legislation and regulation to make it fit-for-purpose and future-proof to allow for engineering biology innovations to safely reach market in the UK.
Resource UK regulators appropriately, both in terms of funding and knowledge
We need regulators to have a pro-innovation, collaborative mindset and to be resourced appropriately, to be able to horizon scan and deliver effective regulation and guidance to biosolutions companies.
Regulators must have adequate funding and knowledge to be able to stay ahead of the curve, be consistent in their delivery, and provide clear and timely approvals processes, information, and guidance to companies.
Regulators must be resourced to build an adequate knowledge base to be able to appropriately and quickly understand and, where relevant, regulate engineering biology innovations.
Creating a strong regulatory knowledge base should be done with support from, and in close collaboration with, industry partners, and include early and informal engagement with start-ups and SMEs.
Strengthen regulator-industry relationships to build future-proof, enabling regulation to bring novel products to market
Regulators need to increase active and early engagement with early-stage companies and SMEs, prior to applications being filed. This can be delivered through:
- workshops and working groups
- facilitated and informal meet ups with companies of similar products and relevant regulators
- proactive engagement with industry through the Engineering BiologyRegulator’s Network (EBRN)
- regulatory sandboxes in areas of most pressing need.
The Engineering Biology Sandbox Fund must be continued and built upon to accelerate pro-innovation regulatory reform and encourage biosolutions innovation and investment in the long term.
Strong regulator-industry relationships will further support the regulatory knowledge base.
Deploy the Regulatory Innovation Office (RIO) to foster a joined-up approach to Biosolutions regulation
Create a regulatory framework that is globally competitive and attractive
The UK should aim to create a regulatory framework for biosolutions that is is globally competitive with key markets (incl.the EU and US) and attractive to companies and investors.
Close attention must also be paid to the benefits of regulatory convergence vs divergence with key markets.
A strong and supportive regulatory environment has a crowding-in effect, signalling to companies and investors alike to stay and grow here, and enabling companies to launch their products in the UK to the benefit of the UK’s society, environment and economy.
UK regulators need to work with international counterparts in key countries, including through mutual recognition agreements or MoUs and development and recognition of standards, to improve regulatory approvals and aid with opening markets to engineering biology companies.
Influencing snapshots
The EU and UK are negotiating an agreement on the Sanitary and Phytosanitary (SPS) regime, which would harmonise rules on border controls for plant and animal products. While in most respects an SPS agreement would benefit the sector, in areas where the UK has deliberately diverged from EU regulations, such as precision breeding, a deal could risk constraining innovation. BIA submitted evidence to the Environment, Food and Rural Affairs Select Committee inquiry on animal health to underline this point.
Our submission made clear that the Precision Breeding Act 2023, a landmark pro-innovation piece of legislation, must be carved out of any SPS agreement with the EU. We have been vocal on this issue in letters to new ministers following the recent reshuffle and will continue to monitor developments as negotiations progress. BIA submitted evidence to the Environment, Food and Rural Affairs Select Committee inquiry on animal health to underline this point. Our submission made clear that the Precision Breeding Act 2023, a landmark pro-innovation piece of legislation, must be carved out of any SPS agreement with the EU. We have been vocal on this issue in letters to new ministers following the recent reshuffle and will continue to monitor developments as negotiations progress.
In January, the Regulatory Horizons Council (RHC), an independent committee that monitors technological innovation and provides government with advice on the regulatory reform required to support its adoption, published a long-anticipated report on the Governance of Engineering Biology. The BIA fed into the drafting of this report, providing feedback to ensure the perspective of engineering biology SMEs was considered.
The report outlines a framework for regulating the wide variety of products derived from engineering biology as a platform technology, and makes six key recommendations. The recommendations include that regulations should focus on the merits of the products, not the process by which they were derived, and that there should be more collaboration between innovators and regulators to support regulatory understanding of the innovative potential of engineering biology. We are currently awaiting the Government’s response, which is expected in Spring.
On 20 February, BIA had the unique opportunity to present to the Engineering Biology Regulators Network (EBRN) and the Regulatory Innovation Office (RIO) on the regulatory challenges faced by innovative engineering biology SMEs. The EBRN is a unique cross-government forum bringing together 12 regulators, and stakeholders from across a wide range of Government departments, to share best practice on pro-innovation regulation, identify common challenges, and collaborate on solutions.
Structured around seven BIA member case studies spanning health, chemicals, agriculture, food, and materials, the presentation illustrated the regulatory hurdles that companies encounter, and reflected the broader challenges across the sector. The case studies were received with great interest by the regulators, who will be looking to improve the landscape for these companies.
BIA will build on the case studies to continue important industry-regulator engagement, and encourage regulators to apply for the second round of the engineering biology sandbox fund.
