The total market for antibiotics is about 40 billion USD each year. However, only about 12% of those sales come from patented antibiotics. As a consequence, the commercial return on R&D investment looks unattractive given the costs of taking a drug candidate through clinical trials. New antibiotics tend to have limited sales (or low value, if they are priced to compete with generics) until widespread resistance has emerged against previous generations of drugs, by which time the new antibiotic may no longer have patent protection or may soon lose it.
A new UK government review suggests a variety of ways to motivate companies to take an active role in the development of antibiotics. One suggestion is the so-called ‘pay or play’ funding scheme, in which companies would be forced to pay a charge or demonstrate that they are investing the equivalent amount or more into R&D relevant to antimicrobial resistance (AMR). Interestingly a number of ‘voucher’ schemes are also suggested, including a voucher that would provide an additional period of market exclusivity to the drug developer.
This may mitigate the problems associated with profitable products nearing patent expiry and enable drug developers to obtain the financial rewards that are commensurate to their contribution to a field that is in desperate need of new products – AMR is predicted to kill more people than cancer by 2050. Of course, the new incentives would need to be carefully balanced and central to this would be commitments from the drug developers to ensure global, affordable access to the product – either directly or through licensing arrangements such as the Medicines Patent Pool (MPP), which works to increase access to treatments in low- and middle-income countries.
So the message is clear – help to fight the rise of AMR or cough up!