#VisionforEurope: Innovation, Investment, Excellence
A New European Innovation Agenda:
biotechnology will help achieve a
healthier, more sustainable, and
autonomous Europe
In 2018, the European biotechnology sector accounted for €34.5 bn, with an annual
growth of 4.1%, more than twice as fast as the overall economy, making it one of the
fastest growing innovative industries in Europe.
The EU should use its scientific and industrial excellence to drive growth in the
biotechnology industry, from SMEs to large companies. This can be done by addressing
regulatory hurdles, increasing investments, and simplifying access to finance to
facilitate scale-up in Europe. By harnessing the biotechnology industry’s potential, the
EU will continue to deliver significant benefits for people and planet.
A future-proof regulatory framework which removes barriers to innovation will allow
cutting edge technology products to be developed and launched in Europe.
Establishing regulatory sandboxes may be a relevant first step in some policy areas,
enabling more efficient regulatory pathways.
The current GMO legislation puts European patients at a relative disadvantage,
creating hurdles which result in extended timeframes, from initiation of clinical trials
through to marketing authorisation. For industrial biotechnology, inefficient regulatory
procedures have detrimental effects on the development and market access of
innovative and sustainable bio-based products and solutions. Notably, the processbased
approach of GM legislation results in unequal regulatory treatment for similar
products with equivalent risk profiles. A science-based, proportionate, and predictable
policy and regulatory approach would help leverage the full potential of biotechnology,
to benefit citizens, the economy, and the environment.
The EU should continue efforts to invest in
its scientific and industrial excellence and
bridge the innovation gap between
Member States. Initiatives aimed at
reinforcing international cooperation in
research and innovation, for example
within Horizon Europe, or in collaboration
with specific industrial sectors, such as the
Innovative Health Initiative or Circular Bio-
Based Industries Joint Undertaking, are a
key component of the EU innovation
ecosystem.
On innovation performance, there is an
urgent need to ensure fit for purpose
regulation coupled with the right incentives
for the life sciences industry. Rewarding
innovation is critical to achieve the
objectives of the EU Green Deal and the
Pharmaceutical Strategy. It will enable
development and faster market access of
bioindustrial products, as well as faster
delivery of life-changing innovative
medicines to European patients.
Innovation-friendly legislation will
empower the twin green and digital
transitions and overall EU sustainability
goals, which require a range of solutions,
including those coming from innovative
biotechnologies.
The EU needs to harness innovation
created by the biotechnology sector to
unleash its economic potential, creating,
and maintaining jobs and value for citizens.
Appropriate structures to build digital
literacy skills are vital to maximise the
impact of the digital transformation.
It is essential that we invest collectively to
build societal understanding of how data
can contribute to better healthcare
outcomes. The 2018 updated EU
Bioeconomy Strategy set out measures to
promote education, training, and skills
development which should continue to be
implemented to foster European industrial
competitiveness and innovation in key
enabling technologies such as industrial
biotechnology.
Biotechnology will help achieve a healthier,
more sustainable, and autonomous Europe
that attracts innovation and delivers for its
citizens. This will ultimately be achieved by
ensuring innovation-friendly regulation;
increased financing for cutting-edge
innovation of SMEs and maintaining strong
intellectual property rights protections;
developing the digital and science-based
skillset across society and sectors; and
improving R&D incentives to foster
advanced manufacturing for sustainable
bio-based production, and novel treatment
options for patients.