Beate Wieseler , head of department of drug assessment , Natalie McGauran , researcher , Thomas Kaiser , head of department of drug assessment Institute for Quality and Efficiency in Health Care, Cologne, Germany Correspondence to: B Wieseler beate.wieseler{at}iqwig.de

More than half of new drugs entering the German healthcare system have not been shown to add benefit. Beate Wieseler and colleagues argue that international drug development processes and policies are responsible and must be reformed

Medicines regulators around the world are pursuing a strategy aimed at accelerating the development and approval of drugs.12 These approaches are based on the assumption that faster access to new drugs benefits patients. The rhetoric of novelty and innovation creates an assumption that new products are better than existing ones.

But although gaps in the therapeutic armamentarium undoubtedly exist, research covering drug approvals since the 1970s suggests only a limited number of new drugs provide real advances over existing drugs.3456789 Most studies put the proportion of true innovation at under 15%, with no clear improvement over time.