State of the Union (SOTEU) 2026 and other news from EU’s institutions

September brought many developments on open files. The opinion of the Advocate General of the European Court of Justice, still subject to the Court’s final judgement, represents the first position against the current EPR scheme. The JURI Committee of the Parliament approved its position on the SPC extension, supporting the possibility of manufacturing and stockpiling biosimilars in Eu-rope to be ready for day-1 launch. The proposal for a Public Procurement Act introduces quality criteria alongside the sole price criteria.

Closing the gap in R&D and looking forward to new models for healthcare

The European effort to improve the competitiveness of the pharmaceutical sector is mainly focused on enhancing attractiveness to achieve the 2030 targets for clinical trials and on reforming the overall legislative framework. Meanwhile, the US has launched an aggressive reform of early development, aimed at tackling the emerging competition from China. At the HLTH 2026 experts agreed that the true challenge for Europe may be implementation, not innovation.

The EMA’s AI Observatory 2025 report

Many activities are underway to fully exploit AI's potential within regulatory processes, both at the EU and international levels. The latest report by the European Medicines Agency discusses advances in policy and guideline development, new AI applications, and collaborations with industry and other regulators to identify emerging opportunities and develop a common approach.

The current status of digital health technologies in the EU

A report published by the DG CONNECT of the European Commission provides an in-depth analysis of the current state of the EU market for digital health technologies. These frontier innovations are largely based on AI applications and aim to provide new tools to improve the efficiency of healthcare systems and the decentralised provision of care. Many barriers are still present, with the EU lagging far behind the US in terms of the number of vendors with headquarters in its territory

IDAP, the IFPMA’s vision of innovation development and access pathways

The International Federation of Pharmaceutical Manufacturers and Associations proposed the IDAP (Innovation Development and Access Pathway) framework to streamline and, as far as possible, harmonise pathways for ensuring rapid authorisation and access to innovative medicines and vaccines, taking into account the specific characteristics of different countries.