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Connecting legislation to biomanufacturing – Europe faces its future


14 Mar 2024


Science & Policymaking

Brussels, 13 March 2024 


Get legislation right to incentivise biomanufacturing investment and implement it with speed  and coherence across Member States” was the clear message from EuropaBio’s second  Biomanufacturing Policy Summit. The Biotech Association’s members, from start ups to  global actors and their national associations, discussed how legislation as vital in delivering  Europe’s biomanufacturing goals in a fast maturing global landscape. 

The Summit covered the full spectrum of applications including medicines, food, feed, fuels  and manufacturing intermediates, reflecting the expanding reach of biomanufacturing as a  next generation industrial driver. 

Within medicines, the overwhelming message was that reductions in Regulatory Data  Protection and Orphan Medicines Exclusivity damage Europe’s ability to biomanufacture  novel medicines, as investment decisions push innovators elsewhere, carrying with it a high  risk of local market failure for Europe’s biotech sector. 

For Europe’s growing fermentation and cellular industries, racing against strong global  competition to produce sustainable products and reduce petro-chemical inputs, coherence  and speed of legislative implementation between the EU and Member States is as critical as  the legislation itself. Failed or slow harmonisation prevents single market operation and with  it, the market pull of 448 million people


Claire Skentelbery, DG EuropaBio summed up Biotech and Biomanufacturing Gross Value  Added grew almost 70% faster than the European average in 2021 at €34.5bn, with an  employment growth rate seven times higher than average. Legislation needs to enable  Europe’s delivery in an intense global race for biomanufacturing, with legislations on the table  right now dictating what our future capacity will be. This is not a drill – successful regions will  influence supply chains in vital areas such as medicines and food and Europe cannot afford to  be absent.”


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