Impact of antibiotic restrictions: the pharmaceutical perspective.

The development of new antibiotics is dependent on their performance in economic models that favour products with large markets, high levels of potential sales and low development risks. There is a trend toward more severe and more widespread market restrictions for the use of antibiotics, ostensibly to control resistance, though they may be enacted through the control of drug budgets. The restrictions reduce the potential earnings of new antibiotics. In addition, more stringent regulatory procedures increase development costs and risk. As a consequence, compared with drugs for other diseases, particularly chronic diseases, antibiotics perform poorly in economic decision models and are therefore less likely to be selected by pharmaceutical companies for continued development. Overall, this creates a conflict between the twin objectives of controlling resistance through antibiotic restriction and addressing resistance clinically through the introduction of new agents. Ultimately, this may lead to the accelerated loss of efficacy for currently available agents, as we become more dependent on them. Moreover, the new agents that we need to maintain our current levels of health will be lacking in pharmaceutical pipelines. Antibiotic resistance is inevitable; the development of new antibiotics is, however, under threat. Unless the market conditions can be economically rebalanced to encourage innovation and investment, or new models of pharmaceutical development can be applied to this area, the number of companies with active antibiotic research programmes will continue to fall. Just as we should not be complacent regarding the development of resistance, we should not be complacent in assuming that the antibiotics of tomorrow will be there when we need them.