The State Institute for Drug Control (SÚKL) has launched the Innovation Office for Medical Devices, a new service designed to support innovation in the Czech healthcare sector.
The Innovation Office for Medical Devices will provide expert consultations to entities developing innovative medical devices, in vitro diagnostic medical devices (IVDs), and medical software.
The new service has been established in cooperation with the Ministry of Health as part of broader initiatives aimed at fostering innovation in the healthcare sector and creating a predictable regulatory environment for the development of new medical technologies.
The objective of the Innovation Office is to help developers gain an early understanding of regulatory requirements and identify, at an early stage of their projects, any issues or risks that may affect further product development. Early consultation can contribute to more efficient development planning, an appropriate regulatory strategy, and a smoother route to market.
Expert consultations may cover topics such as the intended purpose of a medical device, its regulatory status, qualification and classification, clinical evaluation or performance evaluation, conformity assessment procedures, and the need to involve a notified body.
At the same time, SÚKL has published the Guidance of the Innovation Office for Medical Devices, which sets out the conditions for submitting applications, the scope of expert consultations, and the procedures for providing them. The guidance also includes a triage form, which serves as the basis for the preliminary assessment of applications and the preparation of expert consultations.
In its initial phase, the Innovation Office is being implemented as a pilot project. Its purpose is to validate the established processes in practice and to gather feedback from both applicants and SÚKL experts. Based on the experience gained during the pilot phase, both the methodology and the scope of consultations may be further refined to better meet the needs of innovators and regulatory practice.
This article is based on information published on the SÚKL website, where the full version is available.
The English translation was prepared using the latest available ChatGPT model.
The State
Institute for Drug Control (the Institute) received a joint request from medical
societies to establish increased reimbursement for medicinal products
containing a selected active substance for the treatment of paraphilic
disorders, an indication that falls outside the approved marketing
authorisation (i.e. an off-label indication). In their statement, the medical
societies explained that the request was supported by clinical experience,
scientific evidence, and safety considerations.
The
Institute concluded that the therapy represents the only available treatment
option. Consequently, it did not require the submission of a cost-effectiveness
analysis; a budget impact analysis based on the number of patients reported by
the medical societies was considered sufficient.
Based on the
submitted documentation, the Institute concluded that reimbursement in this
off-label indication is adequately supported by current scientific evidence and
that the therapy constitutes the only available treatment option. It therefore
proposed granting increased reimbursement for this indication as well.
According to
Section 39b(3) of the Public Health Insurance Act: “…The
Institute may establish reimbursement for an unregistered medicinal product
where its use is sufficiently justified by current scientific knowledge and it
represents the only available treatment option, or where its use is
cost-effective compared with available treatment, for the duration of an
approved specific treatment programme. The Institute may also establish
reimbursement for a registered medicinal product for indications not included
in the Summary of Product Characteristics, provided that the use of the
medicinal product is sufficiently justified by current scientific knowledge and
represents the only available treatment option, or where it is cost-effective
compared with existing treatment.”
Are you interested in reading regular commentaries on decisions by
Pharmeca a.s.? Feel free to contact us.
At Pharmeca, we help you navigate the complex landscape of
pharmaceutical and medical device information. We also offer flexible services
that can be tailored to your needs at any time.
Our market position and experience allow us to support you whenever you
need expert guidance.
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.
As of 1 January
2026, an amendment to the Public Health Insurance Act has entered into force,
introducing, among other changes, new rules for determining the prices of
strategically important medicines. The aim is to prevent supply shortages
in the Czech Republic through a more flexible approach to setting maximum
prices.
For medicinal
products deemed to be in the public interest, the State Institute for
Drug Control (the Institute) now determines the maximum price based on:
·
the average of prices in up to seven of the
lowest-priced countries within the EU reference basket;
·
if the medicinal product is not available in at
least two reference basket countries, prices are compared across the entire EU,
or alternatively against therapeutically comparable medicines in the Czech
Republic or within the reference basket.
To prevent Czech
prices from being driven down by isolated price anomalies, the Institute applies
a number of exclusion rules:
·
if the lowest price in the EU is more than
20% lower than the average of the second and third lowest prices, it is
excluded from the calculation;
·
prices from countries experiencing significant
currency depreciation are excluded where three or more reference prices are
available;
·
prices distorted by government crisis
interventions in other countries are disregarded, provided that the Institute
has received official information about such measures.
The Institute
has already issued a number of decisions establishing maximum prices for
strategically important medicines. However, a concerning trend can be
observed in its decision-making practice. Although this “special regime” is
intended to enhance market stability, many decisions lack sufficiently
detailed reasoning clearly demonstrating that the statutory conditions for
applying this approach have been met.
The new framework
provides the state with a powerful tool for safeguarding the availability of
medicines. Its effectiveness, however, will depend on the transparency and
reviewability of decisions, ensuring that marketing authorisation holders
clearly understand how and why the final price was determined.
Are you interested in reading regular commentaries on decisions by
Pharmeca a.s.? Feel free to contact us.
At Pharmeca, we help you navigate the complex landscape of
pharmaceutical and medical device information. We also offer flexible services
that can be tailored to your needs at any time.
Our market position and experience allow us to support you whenever you
need expert guidance.
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.
In
administrative proceedings concerning a change in the amount and conditions of
reimbursement, the marketing authorisation holder applied for an extension of
the prescribing restriction to one additional medical specialty. Together with
the application, the holder paid only the administrative fee applicable to
cases that do not require a full clinical and pharmacoeconomic assessment. However,
during the proceedings, the State Institute for Drug Control (the Institute)
subsequently requested payment of an additional amount, taking the view that
the case required a comprehensive expert assessment. The
applicant appealed against this approach.
In the
appeal proceedings, the Ministry of Health (MoH) upheld the Institute’s
position, confirming that the administrative fee applicable to proceedings
involving a full expert assessment was appropriate. According to
the MoH, any relaxation of prescribing restrictions facilitates patient access
to treatment, which in itself creates the potential for increased expenditure
from the public health insurance system. This applies even where the absolute
number of patients in the indication does not increase, as treatment patterns
may shift internally in favour of the medicinal product concerned. From the
Ministry’s perspective, such shifts may also result in increased expenditure
from the system. The MoH
therefore concluded that the Institute has a legitimate obligation to properly
assess any potential impact on public health insurance funds and that the
requested administrative fee corresponds to the scope of the assessment being
carried out.
Are you interested in reading regular commentaries on decisions by
Pharmeca a.s.? Feel free to contact us.
At Pharmeca, we help you navigate the complex landscape of
pharmaceutical and medical device information. We also offer flexible services
that can be tailored to your needs at any time. Our market position and experience allow us to support you whenever you
need expert guidance.
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.
A medicinal
product entered the reimbursement system as the first similar medicinal product
to the reference product, even without submitting the confidential agreements
that ensure the cost-effectiveness of the reference product.
During the
proceedings, health insurance funds pointed out that, in practice, a situation
may arise where, even after the statutory 40% price reduction of the first
similar medicinal product, its price would still remain higher than the actual
(contractual) price of the originator product. According to the insurers, such
a situation would result in a breach of the requirement for an efficient
therapeutic intervention. From the payer’s
perspective, this approach is considered unacceptable in terms of budget
stability and contrary to the public interest.
The State
Institute for Drug Control rejected the insurers’ objections
with reference to the amendment to the Public Health Insurance Act effective
from 1 January 2026. Under this amendment, a similar medicinal product is
deemed cost-effective even where the reimbursement of the reference medicinal
product of another marketing authorisation holder was influenced by an
agreement concluded between that holder and health insurance funds, while no
comparable agreement was concluded for the assessed medicinal product.
Part of the
amended statutory provision states: “Similar medicinal
products shall be deemed to fulfil the conditions of an efficient therapeutic
intervention pursuant to Section 15(6)(d), and the Institute shall not assess
them, except for similar medicinal products of the same marketing authorisation
holder who concluded an agreement with health insurance funds, where such
agreement was decisive for granting reimbursement to the originally reimbursed
medicinal product.”
Are you interested in reading regular commentaries on decisions by
Pharmeca a.s.? Feel free to contact us.
At Pharmeca, we help you navigate the complex landscape of
pharmaceutical and medical device information. We also offer flexible services
that can be tailored to your needs at any time. Our market position and experience allow us to support you whenever you
need expert guidance.
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 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.
Are you interested in reading regular commentaries on decisions by
Pharmeca a.s.? Feel free to contact us.
At Pharmeca, we help you navigate the complex landscape of
pharmaceutical and medical device information. We also offer flexible services
that can be tailored to your needs at any time.
Our market position and experience allow us to support you whenever you
need expert guidance.
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 Ministry of Health (MoH)
assessed whether the maximum price of the so-called “first similar medicinal
product” may be increased after an abbreviated reimbursement review, or only
after an abbreviated review of maximum prices. The key issue in dispute was
therefore the interpretation of the term “the first subsequent abbreviated
review”, which is set out in the Public Health Insurance Act as a condition for
a potential increase in the maximum price.
In the proceedings, the State
Institute for Drug Control (the Institute) argued that this must refer
exclusively to a review of maximum prices. As only a reimbursement review—and
not a price review—had been conducted in the relevant group, the Institute rejected
the application as inadmissible. The appellant, by contrast,
argued that the Act does not distinguish between a price review and a
reimbursement review.
In its decision, the MoH
stated that the Act refers generally to “an abbreviated review under Section
39p”, which covers both price reviews and reimbursement reviews. In its view,
the Institute’s interpretation was overly restrictive. The original purpose of the
reduction in price and reimbursement for the first generic was to prevent high
patient co-payments upon its market entry. Once the Institute had carried out
an abbreviated reimbursement review, reimbursement levels were aligned across
all products within the relevant group, thereby eliminating the risk of
inequality in patient co-payments.
For these reasons, the MoH concluded that the completion of
an abbreviated reimbursement review is sufficient to allow the submission of an
application for a price increase and, on that basis, annulled the Institute’s
decision by which the proceedings had been discontinued.
Are you interested in reading regular commentaries on decisions by
Pharmeca a.s.? Feel free to contact us.
At Pharmeca, we help you navigate the complex landscape of
pharmaceutical and medical device information. We also offer flexible services
that can be tailored to your needs at any time.
Our market position and experience allow us to support you whenever you
need expert guidance.
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 Ministry of Health (MoH)
assessed an appeal against a decision on a change in reimbursement based on the
fixed base reimbursement established in a review.
The appellant argued that the
Institute had incorrectly classified the comparator product as a generic within
the meaning of a first similar medicinal product. According to the appellant,
for medicinal products authorised on the basis of bibliographic data
(bibliographic applications), the provisions on reimbursement reduction
applicable to the entry of generic products cannot be applied automatically, as
such products are not generics. The appellant referred to a
prior judgment of the Municipal Court in Prague, which annulled the Institute’s
decision on reimbursement determination due to its unlawfulness, where the
Institute had classified the product as a generic—although, according to the
court, a product authorised on the basis of a bibliographic application does
not qualify as a generic. The appellant therefore
maintained that the court’s conclusions on the unlawfulness of the Institute’s
approach to the assessment of bibliographic registrations were directly
applicable to the present proceedings.
The Ministry acknowledged the
shift in the case law of the Municipal Court in Prague but emphasised that
administrative authorities cannot arbitrarily disregard their own final
decisions unless and until they are annulled by a competent court. The current
situation, in which a legal action has been brought against the review
decision, does not entitle the authority to depart from that decision, even if
it has been challenged. At the same time, the MoH
concluded that in the present case the nature of the authorisation
(bibliographic vs. generic) was not relevant, as the subject of the proceedings
was limited to a technical recalculation of reimbursement.
For these reasons, the MoH upheld the Institute’s decision.
Are you interested in reading regular commentaries on decisions by
Pharmeca a.s.? Feel free to contact us.
At Pharmeca, we help you navigate the complex landscape of
pharmaceutical and medical device information. We also offer flexible services
that can be tailored to your needs at any time.
Our market position and experience allow us to support you whenever you
need expert guidance.
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.
