Opinion BIO Deutschland e. V. On the draft EU Biotech Act I

Introduction

BIO Deutschland e.V. welcomes the European Commission’s move towards a European Biotech Act to restore the competitiveness of the biotechnology industry, remove existing barriers for businesses and promote Europe as a location for innovation. As the Biotech Act itself rightly describes, biotechnology is one of the sectors that shapes the future. It has grown twice as fast as many other industrial sectors in recent years and generates jobs not only in its own environment but also beyond through spillover effects across the economic landscape.

However, the many innovative ideas of SMEs and start-ups are held back by regulatory hurdles. The EU occupies a weaker position than other countries when it comes to turning innovation into marketable products and producing them at the scale needed. This is mainly due to the fact that clinical trials go through too long approval processes. The current fragmented legal situation within the EU Member States also means that the full potential of biotechnology is not being harnessed. The sector also suffers from skills shortages and sufficient access to capital, as well as high energy and raw material costs. Therefore, with a view to building the EU in a resilient and independent way from other countries, the time has come for a cross-border EU Biotech Act to provide the regulatory framework for businesses to thrive more effectively. The resulting benefits are not only for the economy itself, but also for citizens, who receive innovative products, therapies, health applications and much more. Beyond this draft of the first part of the Biotech Act, we look forward to the timely publication of the subsequent second part. Biotechnology is not only limited to medicine and health, but also includes areas such as food and the bioeconomy.

In the following pages, we would like to highlight a number of selected topics of the draft that we believe can best help the biotechnology industry.