Towards a Harmonised EU Assessment of the Added Therapeutic Value of Medicines

08-06-2015

TThis study, produced for the ENVI Committee by Policy Department A, investigates the possibility of a harmonised EU approach concerning the assessment of the added therapeutic value (ATV) of medicinal products. It reviews the current EU legal and policy framework and looks at the state-of-play within all 28 Member States. In addition, it presents the results of an in-depth analysis on the use of ATV in six selected EU countries. The study closes with policy recommendations on how a possible European harmonisation of the ATV assessment might be taken forward within the current legal framework.

TThis study, produced for the ENVI Committee by Policy Department A, investigates the possibility of a harmonised EU approach concerning the assessment of the added therapeutic value (ATV) of medicinal products. It reviews the current EU legal and policy framework and looks at the state-of-play within all 28 Member States. In addition, it presents the results of an in-depth analysis on the use of ATV in six selected EU countries. The study closes with policy recommendations on how a possible European harmonisation of the ATV assessment might be taken forward within the current legal framework.

Extern avdelning

VAN WILDER Philippe (Vrije Universiteit Brussel and SMART&BI), MABILIA Valentina (Milieu Ltd.), KUIPERS CAVACO Yoline (Milieu Ltd.) and MCGUINN Jennifer (Milieu Ltd.)