The Ministry of Health (MoH) dismissed an appeal against a decision to discontinue proceedings concerning the determination of the maximum price and the amount and conditions of permanent reimbursement due to failure to pay the outstanding balance of administrative expenses. The appellant had paid the amount corresponding to the fee for an assessment without a comprehensive evaluation, whereas the State Institute for Drug Control (the Institute) required payment of the higher fee applicable to a comprehensive expert assessment. During the appeal proceedings, the MoH addressed several objections raised by the appellant.
The appellant argued that the Institute had failed to demonstrate that the conditions for applying the higher fee for a comprehensive expert assessment had been met. According to the MoH, the scope of the assessment must be determined prospectively at the beginning of the proceedings. In the case of a medicinal product with a new pharmaceutical form and intermittent dosing, entering the reimbursement system for the first time, the need for a comprehensive clinical assessment could not be ruled out.
The appellant further claimed that following the submission of additional documentation and the narrowing of its reimbursement request (acceptance of the reference group framework, withdrawal of the request for a reimbursement bonus, and reduction of the proposed reimbursement amount), a comprehensive assessment was no longer necessary. The MoH stated that even after these changes, the Institute was still required to independently assess key clinical parameters, including therapeutic interchangeability and dosing safety, to determine the product's inclusion in the reference group. Such an evaluation met the criteria for a comprehensive assessment.
The appellant also pointed to changes in the schedule of fees for administrative expenses during the proceedings. However, according to the MoH, the applicable fee is determined by the regulations in force when the payment obligation arises, i.e. on the date the application is submitted.
Finally, the appellant argued that failure to pay the outstanding balance did not constitute a material deficiency in the application and that discontinuing the proceedings was disproportionate. According to the MoH, proof of payment of the legally prescribed fee is a mandatory requirement of the application, without which the proceedings cannot continue. The Institute had also provided the appellant with the necessary assistance and sufficient time to remedy the deficiency. The MoH therefore found no procedural error on the part of the Institute.
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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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