There is no consensus on who might be qualified to conduct ethical analysis in the field of health technology assessment (HTA). Is there a specific expertise or skill set for doing this work? The aim of this article is to (i) clarify the concept of ethics expertise and, based on this, (ii) describe and specify the characteristics of ethics expertise in HTA.

Based on the current literature and experiences in conducting ethical analysis in HTA, a group of members of the Health Technology Assessment International (HTAi) Interest Group on Ethical Issues in HTA critically analyzed the collected information during two face-to-face workshops. On the basis of the analysis, working definitions of “ethics expertise” and “core competencies” of ethics experts in HTA were developed. This paper reports the output of the workshop and subsequent revisions and discussions online among the authors.

Expertise in a domain consists of both explicit and tacit knowledge and is acquired by formal training and social learning. There is a ubiquitous ethical expertise shared by most people in society; nevertheless, some people acquire specialist ethical expertise. To become an ethics expert in the field of HTA, one needs to acquire general knowledge about ethical issues as well as specific knowledge of the ethical domain in HTA. The core competencies of ethics experts in HTA consist of three fundamental elements: knowledge, skills, and attitudes.

The competencies described here can be used by HTA agencies and others involved in HTA to call attention to and strengthen ethical analysis in HTA.

Clinicians, epidemiologists, economists and other non-medical professions are involved in the production of Health Technology Assessment (HTA) reports. In addition, patients or representatives from patient organizations, as well as the general public, are increasingly involved. In 2015 a new proposal process of topic selection for HTA reports was initiated by German legislation with the aim of more closely involving patients and the general public. The new process has been implemented by the Institute for Quality and Efficiency in Health Care (IQWiG) under the project title “ThemenCheck Medizin” (Topic Check Medicine).

Since July 2016, patients and the general public can propose topics for HTA reports to IQWiG, excluding topics on the assessment of drugs. The proposals are submitted via the IQWiG website www.themencheck-medizin.iqwig.de (available only in German). No specific expertize is required for the submission of a topic. On the basis of the proposals a selection committee (patient representatives appointed by patient organizations legitimized in Germany) choose up to fifteen topics deemed suitable for HTA reports. In 2017 the committe will be extended to include members of the general public. IQWiG makes the final decision on the selection of up to five topics per year for HTA reports.

In the first proposal phase thirty proposals were submitted. The topics were allocated to the following categories: two for diagnostics; four for teeth; one for skin and hair; four for head and nerves; three for muscles, bones and joints; two for heart and circulation; four for cancer; two for children and adolescents; one for reproductive health and birth; and three for mental and emotional wellbeing. Four topics could not be considered because they either addressed the assessment of drugs or could not be transferred into an HTA question.

Through “ThemenCheck Medizin” patients and the general public in Germany can actively be involved in the process of collecting proposals for HTA reports as well as in topic prioritization. The prerequisites for successful implementation were in particular the easy-to-use online form and IQWiG's support of persons submitting topics in their formulation of an HTA question. The integration of a selection committee of patient representatives was shown to be constructive and productive.