Reply from Kahlmeter and Giske to Brecher, ‘EUCAST and CLSI Point-Counterpoint on Susceptibility Breakpoints: Do Two “I Agree”s Miss the Point?’

REPLY

Stephen M. Brecher argues that the world at large would benefit from a merge between the systems created separately by EUCAST and CLSI. This would probably be applauded by most international colleagues, provided the merged committee were industry neutral and noncommercial, with a transparent decision process, and with breakpoint tables and other documents available free of charge. Moreover, it would be desirable if the committee had a public consultation process where all countries could have a voice, all decisions were taken in a timely manner, and where all agents available in the world would have breakpoints and methods assigned to them.

In 2001, six of seven countries (France, Germany, Norway, Sweden, The Netherlands, and the United Kingdom) decided to convert national breakpoint committees to scientific bodies of reference and to feed into a joint committee, EUCAST. Since then, EUCAST has rapidly grown in popularity and is now used not only in Europe, but in countries on all continents. EUCAST has a formal role in the determination of breakpoints for new and existing agents. CLSI has retained its status as a national committee although with international advisors. However, the influence of U.S. federal law is prominent, and breakpoints in the United States are determined not only by CLSI, but also by the FDA.

EUCAST and CLSI consult each other regularly and over the years ran joint working groups. Most certainly, all will agree that we influence each other’s work and decisions. Thus far, such joint initiatives had to be financed one by one, separately by each party, and identifying funding has frequently been challenging. Moreover, the two committees lack a common decision process, our financing is different, and the timelines for decisions are different. The financing of EUCAST is public, and the output, including background data, is in its entirety freely available on the EUCAST website. We are still a long way from a merge, and it is unclear from where the initiative should come. The urge and money to drive such a committee have not been forthcoming, and it would entail a long and challenging process.