European Pharmaceutical Reform: A meaningful step, but not sufficient to boost innovation
Press Release
Halandri, 12 December 2025 – The completion of the revision of the EU pharmaceutical legislation marks a significant milestone for the pharmaceutical industry, as it sets the framework that will shape health outcomes, economic security and patients’ access to innovative therapies in the years ahead. However, the final text falls short of laying the foundations for a truly competitive Europe in the field of global pharmaceutical innovation.
While there are indications that the EU recognises the pharmaceutical industry as a key driver of competitiveness, the measures adopted are not sufficient to attract the level of investment in research and development that Europe urgently needs. Maintaining eight years of regulatory data protection, at a time when Europe is steadily losing ground to other global innovation hubs, is not enough to reverse this trend.
At the same time, positive initiatives – such as the reduction of EMA timelines – represent steps in the right direction towards a more modern and agile regulatory environment.
Michael Himonas, Director General of SFEE, stated:
“The reform lacks the level of ambition required to genuinely strengthen Europe’s global competitiveness. Over the past two decades, Europe has lost a quarter of its share of global investment, while the number of clinical trials conducted in the region has been cut in half. If Europe – and our country – truly wants to be competitive, greater investment in innovation, stronger protection of intellectual property, and faster approval processes for new medicines are essential.”
