The State
Institute for Drug Control (the Institute) received an application from the
General Health Insurance Company of the Czech Republic (VZP) for a change in
the amount and conditions of reimbursement from public health insurance for
selected orphan medicinal products, based on the following statutory provision:
“In the
event of a significant change in the price references of an orphan
medicinal product, the Institute shall, upon application by a health insurance
fund, initiate proceedings pursuant to Section 39i to change the amount and
conditions of reimbursement of the orphan medicinal product.”
This provision
has been effective since 1 January 2026 following the amendment to the Act.
VZP’s
application specified price references indicating a change in the price
references and, consequently, a change in the reimbursement amount.
The Institute
subsequently issued a decision in the proceedings changing the reimbursement of
the medicinal product concerned.
During the
proceedings, price references were identified that could potentially support
the conclusion that a significant change in price references had occurred.
However, in its decision, the Institute did not address whether it actually
considered the identified change in price references to be significant, nor did
it indicate the percentage change in price references that would be required
for a change to be considered significant.
Although the
Institute granted VZP’s application in full, VZP appealed against the decision
after it had been issued in order to withdraw its application in its entirety.
Following the withdrawal of the application, the proceedings were discontinued.
The Institute addressed
the interpretation of the term “significant change in price references” in
another proceeding concerning a change in the reimbursement of an orphan
medicinal product on the same grounds. A party to the proceedings argued that,
according to the explanatory memorandum, a significant change in price
references should be in the range of tens of percent, which was not the case in
the proceedings concerned, and that the Institute had failed to address whether
or not a significant change in price references had occurred.
The Institute
stated that the term “significant change in price references” is not defined
by law and that the law does not require the Institute to define this
term in abstract terms beyond the wording of the Act. Although the
Institute acknowledged the reference to the explanatory memorandum, it
emphasised that the explanatory memorandum is not a legally binding document
for decision-making purposes and cannot substitute for the law. According to
the Institute, the fact that the explanatory memorandum mentioned a potential
decrease in the range of tens of percent does not mean that only a price
reduction of such magnitude can constitute grounds for initiating proceedings.
The Institute
also pointed out that proceedings in the event of a significant change in price
references are initiated upon application by a health insurance fund.
According to the Institute, it is the health insurance fund that, by submitting
its application, implies that the change in price references in the
particular case is sufficiently relevant to warrant consideration by the
Institute in administrative proceedings.
The Institute entirely refrained from assessing whether the statutory condition of a significant change in price references had been met, even though this condition is essential for the initiation of the proceedings.
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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 English translation was prepared using the latest available ChatGPT model.