Ville Kainu MD. PhD. Global Medical Affairs Director, Anti-Infectives Pfizer
How to incentivize research and development
A few years ago, the WHO developed a priority list of bacteria against which new antibiotics are needed, ranging from critical to medium priority. This list guides the focus for research and development on AMR. The urgent need for research and development on AMR is emphasized by a recent publication in the Lancet, which stated that 1.3 million deaths in 2019 were attributable to AMR globally. Another Europe-based study from 2019 estimated that there were 670,000 drug-resistant infections and 33,000 attributable AMR deaths in Europe in 2015. It also showed that the burden of AMR in Europa has substantially increased between 2007 and 2015, especially for carbapenem-resistant klebsiella pneumoniae and third generation cephalosporin resistant E. coli infections. Moreover, the burden is highest in infants and older people.
While a lot of research and development on antibiotics took place in the middle part of the 20th century, in more recent years there has been a relative lack of innovation and discovery with regard to antibiotics. Currently, there are 43 antibiotics in clinical development, of which only one third targets the critical threats regarding AMR, mentioned above. Most of the developmental studies are being conducted by small companies that have limited funding. On top of that, the development of antibiotics entails financial risks due to the fact that new discovered antibiotics tend to be used sparingly for the reason of avoiding resistancy and the fact that it takes a relatively long time for an antibiotic to become profitable.
These factors make the case for AMR problematic. For this reason new incentives and business models have been created to encourage investment in antibiotics. These incentives consist of push incentives, e.g. decreasing the costs for research and development and shortening the time to approval, and pull incentives, e.g. granting financial awards after a technology has been developed. Ville Kainu gives two examples of pull incentive pilots used in Sweden and the UK. The Swedish government has secured access to certain antibiotics for the Swedish people in exchange for a share in stock value. The UK has adopted a Netflix-like subscription model for antibiotics, in which pharmaceutical companies are paid upfront for their products in exchange for accessibility to the products. Ville emphasizes that for the UK model to work, other countries would need to follow suit.
Interestingly, the European Commission has recently stated in its Pharmaceutical Strategy that AMR is a big threat that needs to be addressed, while also pleading for innovative pilots for research and development. Ville believes that Covid-19 may have played a positive role in this development. Nevertheless, for the AMR agenda to be furthered, collective efforts remain needed both from the public and the private sector.