We have entered a new era of medicine with breakthrough innovation, fuelled by the convergence of biology, chemistry, data, leading to new therapy options that could potentially stop or reverse progression of a disease. Europe has extensive expertise in the biotech sector, something which became clear in the fight against the pandemic. We have a diverse research landscape, with almost half of the world’s top 100 life science universities located in Europe. However, innovation in Europe doesn’t get translated into patents and products as efficiently as it should, and it comes at a cost to patients in Europe. We want to ensure that patients and Europe don’t miss out.

The review of the Pharma Legislation can be an opportunity to future-proof Europe’s innovation ecosystem. But some of the current proposals under discussion would be detrimental to the European Innovation agenda if adopted.

The current system and regulatory conditions in Europe sometimes hinder, rather than promote success. This can be seen with advanced therapy medicinal products (ATMPs). This new era of medicines with breakthrough technologies such as Cell and Gene Therapies (CGT) is not addressed in the current proposal of the Commission. We need to scale up frameworks that enable translating European cutting-edge science into concrete innovations.