Industrial biotech needs to break bureaucracy barriers

Through the advanced use of biological systems, industrial biotechnology is promising to reduce dependency on petro-chemicals and enable the creation of novel products, while contributing to a more competitive and resilient EU, as well as accelerating the green and digital transitions.

But the sector needs to scale up investment and capitalise on the upcoming political transition to become a key catalyst for European innovation, according to participants in a roundtable hosted in March by Science|Business in partnership with EuropaBio, an industry group, just a few months before the EU elections.

“Industrial biotechnology is globally right up there with AI, quantum computing and chips,” contended Claire Skentelbery, Director-General of EuropaBio. “It is not a question of whether, but how we harness its potential. The big question is how we use it to our advantage in Europe.”

Policymakers are taking notice. Earlier this year, the EU Parliament’s STEP initiative singled out biotech as a strategic technology for Europe in a move to ensure European industry remains competitive and innovative, underpinned by a €1.5 billion funding package.

Translating ambitions into action

For political ambitions to manifest themselves in targeted research, investments and innovative products that actually go to market, EuropaBio believes the EU must streamline regulatory processes. “Policymakers and legislators must recognise how bottlenecks can impact our own ambitions,” added Skentelbery. For instance, biocontrol agents can take 7-8 years to complete an assessment authorisation, she explained. “This is because of bureaucracy, not risk. We need stronger and faster guidance as well as greater cohesion between member states and EU levels.”

Coinciding with the roundtable discussion, the European Commission proposed a series of actions to boost biotechnology and biomanufacturing in the EU, recognising the sector’s potential to modernise the EU’s agriculture, forestry, energy, food and feed sectors and industry.

Among the proposed actions, the Commission will assess the EU’s position in a global context and look into streamlining regulatory pathways as well as boosting public and private investments. “We must do away with obstacles and create incentives,” stressed Kristin Schreiber, director of Ecosystems i: Chemicals, Food, Retail at DG GROW within the European Commission. “Thirty years ago, industrial biotech was already a key enabler, but the strategic aspect has changed. We have a new relevance with added environmental benefits,” as biotech could replace classic common fossil-based materials and processes. Unlocking the potential of the biotech and biomanufacturing industries will make for a more resilient, competitive and sustainable Europe, she added.

At the same time, the biotech industry itself needs to develop business models that will attract private investment, which, if successful, can make public authorities take notice.  “That can be a real litmus test of whether the company makes sense business-wise,” noted Paul Csiszár, director of basic industries, manufacturing and agriculture within the Commission’s competition directorate. “If that proves to be the case, then steps can be taken towards public funding.”

Alongside the EU, national governments can play a role in supporting the industry towards more investments, as well as nurturing future talent. To boost investment into innovations, Lithuania has established a government one-stop-shop for businesses, especially SMEs, explained Neringa Morozaitė-Rasmussen, vice-minister at the Ministry of the Economy and Innovation in Lithuania. “We need a talent pool of engineers, IT specialists, life scientists, encouraging young people through scholarships. We need EU collaboration on this,” she added.

Call for pro-entrepreneurial response

The industrial biotech sector hopes to benefit from a new modus operandi in the EU system, in the wake of handling era-defining challenges and upheavals in the form of Brexit, COVID-19, the war in Ukraine, and the climate and energy transitions. Acute crises have required action and an unprecedented degree of coordination across the Union.  The EU needs to become more pro-entrepreneurial in response to crises, noted Ana Maria Bravo-Angel, director of public affairs at International Flavors & Fragrances and chair of the Industrial Biotechnology Council at EuropaBio.

She advocated employing regulatory sandboxes, which can be used for a limited time to test innovative technologies, products, services or approaches, in a real-life environment. Several new regulations risk limiting sustainable innovations from entering – or remaining on the EU market, with some sectors particularly stuck in regulatory obstacles, added Bravo-Angel. For example, enzymes, which have long made many industrial processes more sustainable, risk being restricted under new policies because of their classification, she explained. Bravo-Angel also stressed the need to explore new policy routes that account for demonstrated sustainability benefits, in sandboxes, and to evaluate other regulatory approaches in regions, such as the US.

During the discussion, the point was made that policymakers and civil servants are not necessarily science savvy. Therefore, industrial biotech leaders and experts must drive the narrative, with the upcoming transition a good opportunity to do just that. “I feel a groundswell of change,” concluded Claire Skentelbery. “There is no better moment. If Europe is not among the global [innovation] leaders, we will be buying products from elsewhere. Let us set bold and tangible goals. Let us mobilise all actors.” The sector does not necessarily need new mechanisms, but must make better use of existing ones right now, she added.