New Drugs to Tackle Antimicrobial Resistance: Analysis of EU Policy Options

Antimicrobial resistance (AMR) to drugs is a natural and unavoidable consequence of treating infectious diseases. A growing global public health threat, AMR reduces the chances of successfully treating patients with infectious diseases, thereby increasing the probability of complications, morbidity and mortality. The World Health Organization estimates that infectious diseases are the third leading cause of death in the European Union. In 2009, the EU emphasized the importance of encouraging the development of new antibacterials; the EU Commission has been tasked with developing comprehensive proposals by the end of 2012. In this publication, the authors provide information and recommendations that offer new insight into addressing the core issues. This monograph outlines a model that assesses the push, pull and hybrid approaches that could be applied to encourage innovation and suggest the size of the various incentives needed to make antibiotic R&D as attractive to developers as are other therapeutic drug classes. Based on these analyses, the authors express a preference for a hybrid push-pull policy similar to that used for orphan drugs. An alternative might be upfront payment for registration (rather than for volume of use) in the form of an advance market commitment ‘prize’, a priority review voucher or a transferable intellectual property extension. Each of these incentives would reward the launch of an effective drug, making actual volume of use less relevant.