Give Due Consideration …: Some Thoughts on Member States’ Obligations Under Article 13 of the HTA Regulation

The new EU Regulation on health technology assessment (htar) provides for joint clinical assessments (jca) of health technologies at EU level. When Member States carry out health technology assessments (hta) at the national level, they shall give due consideration to the results of a jca and comply with other obligations of the Regulation. This article aims to clarify what these obligations mean for the Member States and whether jca results have to be considered outside a national health technology assessment as well. In this context, the question of which processes qualify as 'national hta' and which requirements need to be fulfilled to trigger the obligations under Article 13 htar are discussed in more detail in this paper.