INVENT – MAKE – APPROVE – USE
Europe is at a crossroads as a global leader. And nowhere is that more evident than in the debate around the EU Biotech Act. A history of scientific excellence is not a guarantee of success and there is an urgent need to ensure that the EU anchors and grows innovation towards resilience and security of global positioning. A worldwide biotechnology race is underway across sectors, and the winners will lead global biomanufacturing and trade.
Our food systems, healthcare, manufacturing and consumer choice must sit within a framework of competitiveness, economic security, open strategic autonomy and fair competition. Biotechnology and biomanufacturing is an essential component of this. The Biotech Act must have a scale of ambition that makes it a reality and be central to the Commission’s mandate.
Biotechnology in the spotlight for the new Commission – pain points and promise
INVENT: Europe is a scientific world leader and has provided the discovery and inventive steps in some of the founding biotechnologies that underpin many of our medicines, food and industrial processes. Today, much of biotechnology innovation originating from EU research is maturing elsewhere, delivering commercial success and support to supply chains outside Europe. There is an urgent need to ensure that our innovation anchors and grows here, if EU future economic stability and resilience is to be achieved.
MAKE: Europe has a strong track record in biomanufacturing, with capacity and skills across all sectors. As global regions rapidly pivot towards biomanufacturing for sustainability and market advantage, Europe must keep pace. It cannot rest on its laurels with current industrial process or scale, transforming existing manufacturing and growing new biomanufacturing pathways. It is the future of a skilled workforce and resilient employment in addition to securing supply chains here.
APPROVE: The regulatory landscape for biotechnology might charitably be described as ‘complex. The reality is that Europe’s principles are not matched by regulatory pathways at EU or Member State level. Most of the time novel products (or sustainable substitutes) from biotech do not reach the market in the EU at anywhere near the speed needed to serve economies or citizens. This is possibly Europe’s most profound disadvantage (and a definite own goal), driving investment for market access for our innovation into other regions. A simpler regulatory landscape, with no change to safety standards, could unlock the full power of the single market and industrial growth here rather than elsewhere.
USE: One does not simply ‘use’ biotechnology. Pathways and incentives for uptake differ across every sector and Member State, and Europe has the opportunity to ensure that citizens everywhere benefit from its advantages. Whether consumers, patients or employees, the impact of fully integrated biotechnology and biomanufacturing unlocks investment, employment, healthcare, resilience and sustainability for all Member States.
Beyond the Biotech Act
Progress and achievement with and for biotechnology does not stop with the Biotech Act. A cluster of over 20 legislations and strategies relevant to biotechnology are in the pipeline, and they will help build and strengthen the underlying economic framework for biotech product competitiveness.
These include strategy initiatives like the Lifescience Strategy, Clean Industrial Deal, Bioeconomy Strategy, EU Start Up and Scale up Strategy and Single Market Strategy. Legislations headline with the Biotech Act, however the Critical Medicines, the Circular Economy and European Innovation Acts also underpin how biotechnology is delivered to market. Finally, through economic initiatives such as the Capital Markets Union, the scale and speed of biotech growth needed for EU leadership carry equal weight.
This legislative cluster carries a significant opportunity to strengthen and amplify the impact of the Biotech Act, but it also carries substantial risk. To prevent fragmentation, legislators and stakeholders must track every interlinked policy twist and turn to ensure that a well-meaning inclusion in one text does not entirely undo a positive outcome of text elsewhere. This will require coherence and alignment across the legislative cluster and Commission services to ensure it delivers positive empowerment of the EUs most important critical technology.
However we can do this together. The responsibility lies with us to amplify the combined strengths and minimise weaknesses that arise through divergence. The increased visibility and political significance of biotechnology within a global context also makes it easier to map where biotechnology falls across the legislative spectrum, together with the opportunities and danger points that can be addressed early.
This extends beyond Brussels and into the Member States that increasingly recognise the role of biotechnology and biomanufacturing in their own competitive and societal future. The Competitiveness Council of November 28 highlighted this through the strong statements across Danish, Finnish, French, German, Irish, Latvian, Slovak and Spanish delegations towards the need for an ambitious and far-reaching action for biotechnology and biomanufacturing.
What does the Biotech Act and cluster of legislations need to achieve?
We’ve talked a good game for biotechnology, but how does this translate into impact, particularly from the Biotech Act?
- Strengthen value chains from R&D to end-users: Accelerated speed and scale of technology transfer and investment through the right incentives and pathways to match the urgency
- Simplify regulatory and market pathways: This overcomes expensive and unpredictable barriers, accelerates time to market, especially for smaller innovators, and increases the uptake of biotech products and biomanufacturing processes.
- Ensure legislative coherence: Good old-fashioned governance for this complex frontier technology. Not squeezing it into 25-year old frameworks designed for other technologies or materials but creating fit for purpose legislation that is coherent across the legislative landscape and allows for future upgrades.
Onwards together
The new Commission and Parliament start their job with challenges that didn’t exist in the innocent days of 2019. Before Covid, before the Russia invasion of Ukraine, before 5 more years of intensifying climate change impact. This unites urgency and ambition for Europe. The EU must do its job quickly, do it well and we must do it together. If we aim to lead through the tenets of INVENT – MAKE – APPROVE – USE then we must lead by example, starting today.
Dr Claire Skentelbery is the Director General at EuropaBio.
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