The Ministry of Health (MoH) upheld an appeal against the rejection of an application for the abolition of the maximum price after the case had been remitted for further proceedings by the Supreme Administrative Court.
In its decision, the State Institute for Drug Control (Institute) took the view that an application for abolition of the maximum price could only be submitted on the grounds of 12 months of non-marketing. It further stated that, according to its findings, the medicinal products concerned were used only during hospitalisation and, in outpatient settings, solely as substances for individual preparation rather than as finished products.
The appellant’s
principal argument, by contrast, was that the medicinal product had become
newly usable in outpatient care. According to the appellant, the maximum price
should therefore be abolished, since under the applicable pricing regulations
medicinal products usable in outpatient care and without established
reimbursement are not subject to price regulation.
Although the Act
does not explicitly list a change in the segment of use as a ground for
abolishing the maximum price, the appellant argued that this constituted an
unintended gap in the legislation that should be bridged by analogy.
In line with the
binding opinion of the court, the MoH acknowledged the existence of an
“unintentional gap” in the legislation. If, in the further course of the
proceedings, the participant demonstrates outpatient use of the medicinal
product, this constitutes a legitimate reason for abolishing the maximum price,
even though the Act does not expressly provide for it.
At the same time,
the MoH held that the Institute must reassess the issue of the product’s actual
usability in outpatient care in a more thorough manner.
The contested decision of the Institute was therefore annulled and the case was remitted for reconsideration.
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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).
A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.
The text was translated using ChatGPT 5.5.