The European Parliament has adopted a revision of the general pharmaceutical legislation, repealing and amending previous legislation with a set of compromise amendments.
According to the European Commission, it has been called “the largest reform in over 20 years.”
In this POV, EVERSANA’s experts, Mike Ryan, GM, Europe and Monique Martin, SVP, Value and Evidence, share information about the revision, its meaning, implications and importance, and what the amendments could mean if they ultimately become law.
While this is not yet final legislation, the article offers best courses of action for Marketing Authorization Holders with the aim to improve equitable access to medicines, make the region more innovation-friendly and streamline processes (among other goals).
Becoming and remaining globally competitive requires a skillful understanding of the ways that approval, pricing, reimbursement and access are interlinked in the EU. As a result of the acquisition of Healthware Group in 2023, EVERSANA brings more than 25 years of experience that can help navigate a changing environment and bring innovative medicines to all EU citizens in a way that reduces risk and increases return on R&D investment. Download the full article to learn more.
Author
With more than 25 years of experience in the life science industry, Mike has held global leadership positions in both clinical development and life-sciences software companies. Given this experience, he is highly experienced in…
Monique Martin is a seasoned professional with extensive experience spanning over two decades in the pharmaceutical and healthcare industries. Before joining EVERSANA, Monique served as the Global Head of Evidence Synthesis, Modeling and Market…