The Study
An assessment of the current state of antibiotic development paints an alarming picture: of failing markets resulting from slow clinical uptake of drugs, relatively small numbers of target infections to support existing drugs economically, slow clinical uptake, and redundant drugs in the pipeline. Despite some improvement in the past decade, pharmaceutical research and development have not responded adequately to the growing need for new antibiotics.
Financial incentives and market reforms are needed but lowering regulatory hurdles to the approval of new antibiotics could also help promote the development of new drugs. To assess regulatory challenges and opportunities, One Health Trust, with support from the AMR Industry Alliance, conducted a landscape analysis of the current framework for antibiotic approval in Brazil, India, and South Africa.
The analysis was informed by organizational reports, peer-reviewed literature, press releases, and other sources. Semistructured interviews with scientists, regulators, and experts from international organizations in the three countries were conducted between November 2021 and February 2022 to obtain global and national perspectives on regulatory hurdles and the potential for innovation.
“Much remains to be done to improve how we use antibiotics globally and to reduce the need for antibiotics through vaccines, water and sanitation, and infection prevention. But these will not be sufficient. The growing burden of AMR will need to be addressed with new antibiotics. Unless we significantly rethink and revise current processes for regulatory approvals, the burden of AMR will keep increasing.”
– Dr. Ramanan Laxminarayan, Director, One Health Trust