Section 39i(2) of the Act on Public Health Insurance stipulates the obligation of the State Institute for Drug Control (hereinafter “the Institute”) to immediately initiate ex officio proceedings to amend the determined amount and conditions of reimbursement of a medicinal product in cases where the current reimbursement or reimbursement conditions do not correspond to the basic reimbursement of the reference group or to the reimbursement conditions established in a revision procedure.
Within the ongoing proceedings initiated by the Institute pursuant to the cited provision, the Institute addressed issues related to the amount of the usual daily therapeutic dose (ODTD) and its binding nature.
According to the Institute, the purpose of this type of proceeding is not to establish a new ODTD, but to harmonize the reimbursement levels with the latest enforceable decision issued in the revision procedure.
The incorporation of the ODTD from the revision decision into individual administrative proceedings is in accordance with the law, the decree, and established administrative practice, even if the ODTD is not explicitly stated in the operative part of the decision. It constitutes an inherent component of the operative part concerning the amount of the basic reimbursement, as confirmed by relevant decisions of the Ministry of Health of the Czech Republic.
The Institute further emphasized that the ODTD forms the technical basis for calculating the basic reimbursement, and its value is legally binding for all subsequent administrative proceedings concerning changes to the amount and conditions of reimbursement until the next in-depth reimbursement revision.
The Institute therefore considered objections regarding the absence of the ODTD in the operative part of the revision decision or the request for a new determination of the ODTD within the ongoing proceedings to be unfounded.
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Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).
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The text was translated using ChatGPT 5.