Promoting Antibacterial Drug Development: Select Policies and Challenges

The modeled incentive corresponds to Section 805 of the Generating Antibiotic Incentives Now Act, signed into law as part of the Food and Drug Administration Safety and Innovation Act, which extends the Hatch Waxman provisions related to data exclusivity by 5 years for a Qualified Infectious Disease Product [11].

On 18 September 2014, the White House issued a series of new actions designed to incentivize efforts to combat antibiotic-resistant bacteria. One of these actions included the launch of a US$20 million prize “… sponsored by the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) to facilitate the development of a rapid diagnostic test to be used by health care providers to identify highly resistant bacterial infections at the point of patient care” [12]. The choice of US$50 million for the case study presented in the paper was loosely based on this US$20 million amount. We assumed that for antibacterial drugs, a lump-sum prize that is 2.5 times that for a rapid diagnostic test might be more appropriate.

A supplementary protection certificate is a type of incentive used in the European Union as well as Iceland, Liechtenstein, and Norway, which extends the patent life for specific pharmaceutical and plant protection products when granted.