The State
Institute for Drug Control (the Institute) initiated ex officio proceedings
to change the maximum price of an orphan medicinal product pursuant to
Section 39da(10) of Act No. 48/1997 Coll., on Public Health Insurance.
According to the provision in force on the date the proceedings were initiated:
“No later
than 3 years from the date on which the decision establishing the amount and
conditions of reimbursement of an orphan medicinal product becomes enforceable,
the Institute shall initiate ex officio administrative proceedings to change
the maximum price pursuant to Section 39i. Sections 39l and 39p shall apply
mutatis mutandis.”
The marketing
authorisation holder (MAH) argued that the proceedings should not have been
initiated “automatically”, but only “where necessary”. According
to the MAH, the Institute should have assessed whether the proceedings served a
meaningful purpose and would result in actual savings; otherwise, the
proceedings should have been discontinued.
The Institute
stated that the law imposes an unconditional obligation to initiate
proceedings to change the maximum price within 3 years of the date on which the
orphan reimbursement decision becomes enforceable. According to the
Institute, the condition “where necessary” does not apply to the
initiation of proceedings to change the maximum price of an orphan medicinal
product itself. In this case, the three-year requirement for initiating the
proceedings was therefore met.
The MAH further
argued that the statutory requirement of annual savings of CZK 30 million,
applicable to the review proceedings referred to in Section 39da(10), had not
been demonstrated. In the MAH’s view, the Institute should have demonstrated
the expected savings to the public health insurance system; without doing so,
the proceedings were unlawful or not subject to proper review.
The Institute
maintained that demonstrating such savings is not a statutory requirement
for this type of proceeding. The requirement that the relevant provisions
apply mutatis mutandis does not mean that the conditions governing the
initiation of a reimbursement review are transferred to these individual
proceedings concerning a change in the maximum price of an orphan medicinal
product. The purpose of these proceedings is not to generate reimbursement
savings, but to change the maximum price.
The MAH also
argued that the maximum price of the medicinal product concerned had already
been changed previously and that there was therefore no justification for
further ex officio proceedings.
The Institute
stated that the earlier proceedings cannot be regarded as fulfilling the
obligation under Section 39da(10), as the law requires these specific
proceedings to be initiated no later than 3 years after the orphan
reimbursement decision becomes enforceable, irrespective of whether another
change in the maximum price has taken place in the meantime.
The Institute rejected all the objections and issued a decision in the matter, against which the MAH filed an appeal.
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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.