Building the future with nature: Boosting biotechnology and biomanufacturing in the EU

In a display of the importance of the biotechnology industry to the European economy, the European Commission (EC) last week announced actions being taken within the EC’s strategy for boosting this industry across the continent. Details are outlined in the official EC Communication on “Building the future with nature”, linked here.

The Communication acknowledges that biotechnology is “a critical technology from the economic security perspective” and is key component to the EU’s strategy toward autonomy and resilience. Thus, the importance of supporting biotech companies is outlined in detail, with welcome acknowledgment that a “supportive” regulatory framework and more financing opportunities are needed for the industry to thrive. The EC discusses a wide range of challenges they wish to work toward addressing, ranging for the complexity of the regulatory framework and associated costs, to expertise/skill access, and even the importance of promoting public acceptance of ‘bio-manufactured’ products.

Streamlining regulatory pathways, including permitting and authorisation

Those interested in the regulatory framework will be interested to note that the Communication includes a dedicated section directed to discussing the “streamlining” of regulatory pathways. The EC recognises the need to improve conditions for moving R&D from the lab to the market, and notes “The Commission will assess how EU legislation and its implementation could be further streamlined to reduce any fragmentation, explore potential simplification, and shorten the time for biotech innovations to reach the market; as well as regulatory obstacles that arise at national or other governance levels which impede an effective single market.”  It is particularly interesting to note that “the Commission will launch a study that will map key current industrial bio-based value chains, analyse the regulatory framework and the impact of relevant legislation, and thereby lay the foundations for a possible EU Biotech Act.”

There is emphasis placed on “targeted simplifications to the regulatory framework”, as well as “streamlining/simplifying approval processes for certain product categories.”

It is helpful to note that the EC has already put some thought into how such reforms could actually be explored/tested, outlining the intention to “promote the establishment of regulatory sandboxes that allow to test novel solutions in a controlled environment for a limited amount of time under the supervision of regulators as a way of bringing more of them quickly to the market”, consistent with the observation that is has already been proposed for “breakthrough therapies under the reform of the pharmaceutical legislation.”

Artificial intelligence and use of data

Those interested in the EC’s response to growing adoption of AI tools across different industries will be interested to note that the Communication includes a dedicated section directed to discussing AI and its use in innovation within the biotech sector. After discussing advances contributed to by AI to-date, the EC goes on to outline “actions to foster the application of big data and AI in biotech and biomanufacturing companies.”   This includes discussion of the GenAI4EU initiative, and how the EC intends on supporting the accelerated “uptake” of AI.

Intellectual property

Although the Communication is not intended to be a focus-piece on biotech patents, (or IP more broadly), the EC do take the initiative to specifically point out the important of IP in the industry, including to new entrants by providing a reminder that IP is “a critical asset which emerging biotech start-up companies can offer to secure financing”. 

As part of the actions discussed in ‘stimulating’ the market, the Communication also recognises that providing “a stable, predictable, and balanced IP framework for protecting and valorising biotech innovation and facilitating access to it, especially to smaller actors across the value chain such as primary producers and SMEs, is crucial for ensuring a vibrant biotech ecosystem in the EU.”

Recognition of changes/additions with the patent system is provided: “The launch of the unitary patent (‘UP’) system in 2023, as well as the upgrade of the current EU regime for supplementary protection certificates (SPCs), proposed in the context of the Commission’s ‘patent package’ of 2023, will support ground-breaking innovation in biotechnology. Innovators across the EU, including in biotech, need to reap the full benefits of these initiatives, therefore the swift adoption of the ‘patent package’ is essential.”

The Commission provides a brief comparison of the leading territories in terms of ‘biotech patent’ filings (USA>EU>CN), indicating that the EC keeps a view on the importance of patent filings in maintaining the EU’s international competitiveness, when compared with other key international players in the biotech space.

Conclusion

It is encouraging to note the EC sees the continued importance in updating its biotech policy, and how important this industry is to society.  Policy makers in adjacent, yet important nations within biotech, (notably the UK and Switzerland), will doubtless wish to keep abreast of the EC’s plans.