Quality, efficacy, safety—it is not enough!

Pharmaceutical Strategy for Europe: Reflections on Public Health-Driven Drug Development, Regulation, and Policies

“…However, there is an opportunity here to revise the current criteria for the approval of new medicines. Although "quality, efficacy and safety" are fundamental characteristics for any drug on the market, health systems, clinicians and patients need to know if a new drug is better or worse than the drugs already available for the same indications (Garattini, 2021). Including the concept of "added therapeutic value" in the legislation would boost knowledge on the actual value of new drugs, thus setting the bases for fairer prices and appropriate use in clinical practice.…”