We read the article ‘‘Procedures and methods of benefit assessments for medicines in Germany’’ by Bekkering and Kleijnen with interest [1, 2]. A discussion of this topic is of critical importance and we congratulate the authors for their attempt with summarizing what it known. The authors write ‘‘In the sections below, we will argue that, in principle, each separate outcome refers to a separate research question, and that to find the best available evidence a separate consideration of appropriate study types for each question is warranted’’. They also state that ‘‘since the benefit assessment is based on different patient-relevant outcomes, the research for each of these outcomes must also be conducted based on the principle of ‘‘best available evidence’’. The informed reader will quickly realise that the aforementioned concepts and other parts of the text, in particular in Section 4, reflect the conceptual approaches of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system and working group [3–10]. GRADE is an approach for rating quality of evidence and grading strength of recommendations that is explicit, comprehensive, transparent, and sometimes pragmatic. Since many international organizations, such as WHO, NICE, CADTH and others cited in the article use GRADE, an up-to-date description with citation of sources regarding the assessment of evidence by these various institutions would have helped the actual discussion more and would have probably lifted it to another ‘‘level’’. Unfortunately, there is no mention or citation of this initiative, which has existed since 2000, and Germany is already struggling with the lack of international knowledge uptake and generation in this area of health care research. Instead, the authors describe the recent preliminary suggestions of the United States Preventive Services Taskforce methods and a somewhat outdated version of the NICE system. GRADE also reflects a further development of the cited article by Guyatt et al. from 1995 [11]. The past 13 years, a long time frame, has brought about many revelations in evidence-based health care, just as in other fields of biomedical research. A much more important and worrisome issue is the citation of the statement from 2000 ‘‘From the perspective of EBM, a systematic review of RCTs is the most powerful and useful evidence available [35]. Therefore, this design should be the highest level of evidence.’’ Unfortunately, the second part of this statement is far from being without criticism in EBM of the current millennium. Systematic reviews do not represent a form or level of evidence, but a basis or method for identification and assessment of the evidence. Evidence in a systematic review can come from poor quality RCTs and, thus, an appraisal of the studies within a systematic review reflecting on the final quality of the evidence is required and that must be clearly said. It is not sufficient, as the cited text infers, to label evidence on the basis of having conducted a systematic review. In addition, systematic reviews should be done for observational studies when they are relevant to a question. The authors refer to other forms of evidence when RCTs are not H. Schunemann (&) R. Kunz Y. Falck-Ytter N. Santesso Department of Clinical Epidemiology and Biostatistics, McMaster University Health Sciences Centre, Room 2C10B, 1200 Main Street West, Hamilton, ON L8N 3Z5, Canada e-mail: schuneh@mcmaster.ca 1 Sackett, D.L., Straus, S.E., Richardson, W.S., Rosenberg, W., Haynes, R.B.: Evidence-based medicine. How to practice and teach EBM, 2nd edn. Churchill Livingstone, Edinburgh (2000).