The amendment
introduced a new type of reimbursement procedure for products intended for
immunisation (vaccines), designed primarily for non-mandatory vaccination. As
of 1 May 2026, according to information from the State Institute for
Drug Control (the Institute), 10 administrative proceedings had been
initiated and are currently at various stages of progress.
This type of
procedure is intended to apply the principle of multi-criteria assessment,
placing emphasis not only on economic but primarily on non-economic criteria
reflecting broader societal needs and interests. In addition to
the standard reimbursement criteria (safety, efficacy and, in the case of
vaccines, immunogenicity), the criteria assessed also include, for example:
the severity of the disease targeted by the
vaccine,
the broader societal importance of prevention,
the public health benefit, including increased herd
immunity, prevention of threats to public health, and support for and
improvement of population health,
recommendations issued by professional societies
and institutions.
A different
approach also applies tobudget impact, where a high budget impact may
reflect high vaccination uptake, which is desirable in this context. Budget
impact is therefore assessed as the difference between the costs of prevention
and the costs of treatment, diagnostics and broader societal costs that would
arise in the absence of immunisation.
The Institute’s
assessment report will also include an opinion of theNational Institute of
Public Health (SZÚ). SZÚ has already provided opinions in the first two
administrative proceedings, focusing in detail on the epidemiology of the
diseases concerned. It also addresses the health, societal and economic impacts
of the diseases and the extent to which these may be mitigated through
vaccination. The opinion further includes a recommended time horizon for the
budget impact analysis, taking into account the characteristics of the disease,
as well as an overview of currently applicable vaccination recommendations.
As in the case
of orphans, the assessment report will subsequently be reviewed by the advisory
body of the Ministry of Health (MoH) during a closed session, in which a
conciliation procedure will take place.
The
subsequently issued binding opinion of the MoH will then be incorporated into
the final decision issued by the Institute.
Our knowledge, your opportunity.
The article is based on publicly available information concerning administrative proceedings conducted by SÚKL in the area of pricing and reimbursement.
The amendment to the Public Health Insurance Act, effective from the beginning of 2026, introduced a dedicated reimbursement procedure for selected vaccines. The first proceedings are already...
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.
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At
the beginning of April, a draft amendment to the Act on the Regulation of
Advertising and the Act on Medical Devices and In Vitro Diagnostic Medical
Devices was circulated to Members of Parliament. Among other things, it focuses
on advertising of selected sensitive commodities, including human medicinal
products and medical devices. The
scope of the Act is not limited to B2C relationships, i.e. advertising
directed at the general public, but also extends to B2B relationships,
including advertising targeted at healthcare professionals and employees of
healthcare providers. The
expected effective date of the amendment is 1 January 2027.
In
the following article, we present selected areas of the proposal in relation to
specific product categories.
Medicinal
Products
The
draft expands the definition of advertising, under which all forms of
information, market research or incentives intended to promote prescribing,
sale, dispensing or consumption will newly be considered advertising.
The
amendment also sets out strict conditions under which patient programmesmay be conducted so that they are not regarded as impermissible advertising.
Changes
will also affect advertising targeted at healthcare professionals. Commercial
representatives will newly be allowed to provideSummaries of Product
Characteristics (SPC) and reimbursement information also in the form of a
link to a source enabling remote access.
Conversely,
stricter rules will apply to the provision offree samples, including
limits related to the duration of treatment.
The
amendment also introduces exemptions from regulation, particularly for
incentive programmes run by health insurance funds and for educational
programmes aimed at non-physician healthcare professionals.
Medical
Devices (MD) and In Vitro Diagnostic Medical Devices (IVD)
For
medical devices and in vitro diagnostic medical devices, the definition of
advertising is both expanded and clarified. Advertising will explicitly
include, for example, lotteries, similar games, or consumer experience-based
testing.
A
more precise definition is also introduced for therecipients of comparative
advertising, replacing the previously used general term “professionals”.
As
with medicinal products, certain exemptions from regulation are defined.
A
separate section is dedicated to patient programmes, which aim to
improve awareness of diseases, diagnosis and treatment, as well as to support
patient cooperation in healthcare provision and to provide training and
guidance on the proper use of prescribed medical devices.
Fines
The
amendment introduces new obligations and therefore significantly expands the
list of actions(administrative offences) subject to penalties.
A fine of
up to CZK 500,000 may newly be imposed, for example, for conducting
patient programmes in breach of the law—whether due to violation of their
intended purpose, content, or the provision of prohibited benefits to
patients. The same fine applies to failure to meet notification
obligations towards SÚKL, breaches of hospitality rules in online
professional meetings, and similar cases.
Fines of
up to CZK 2,000,000 are newly expressly applicable to organising
prohibited competitions, lotteries and user tests for medicinal products
and medical devices, for missing or outdated information in advertising
directed at professionals, or for exceeding limits on the number of
samples.
Fines of
up to CZK 5,000,000 may be imposed for suggesting that the safety
of a medicinal product is guaranteed by its natural origin, for using
inappropriate depictions of bodily changes, or for providing gifts and
benefits to healthcare professionals that are unrelated to their professional
activities, among other violations.
Healthcare
professionals themselves may newly face fines of up to CZK 100,000 if
they actively request prohibited benefits or excessive hospitality, rather than
merely accepting them.
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Our market position and experience allow us to support you whenever you
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As of January next year, the currently discussed draft amendment to the Act on the Regulation of Advertising may come into force. It introduces a number of new regulatory requirements and...
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.
In proceedings concerning the determination or modification of the
amount and conditions of permanent reimbursement of medicinal products, where
pharmacoeconomic evidence is submitted, comparative clinical efficacy and
safety must be demonstrated against all relevant comparators. According to
the methodology of the State Institute for Drug Control (SÚKL), relevant
comparators may include therapies that are commonly or routinely used and
reimbursed from public health insurance. These are not limited to medicinal
products.
The requirement for relevant comparators was modified in 2022 for
proceedings on the reimbursement of orphan medicinal products (Section 39da),
when the advisory body of the Ministry of Health introduced the following
requirement for this specific type of proceedings: “…that any future application for reimbursement of an orphan
medicinal product for which comparators reimbursed from public health insurance
exist (whether with reimbursement determined by the Institute in administrative
proceedings or under Section 16 of Act No. 48/1997 Coll.) must include a
cost-effectiveness analysis against such comparators.” As a result, in reimbursement proceedings for orphan medicinal
products conducted under Section 39da, therapies reimbursed not routinely but
under exceptional reimbursement pursuant to Section 16 are commonly
included among comparators—even in cases where their use is off-label
within the given indication.
This approach has also been identified in proceedings concerning
the determination of permanent reimbursement for a non-orphan medicinal
product, where SÚKL likewise accepted as a comparator a product reimbursed
under Section 16. However, in another case involving the use of a comparator
reimbursed under Section 16, SÚKL argued in its assessment report, for example,
as follows: “…treatment provided under Section 16 of the Public Health
Insurance Act is, by its nature, exceptional and cannot be considered the least costly standard option for the purposes of general reimbursement
setting…’”
It remains to be seen whether, in the future, the approach to the
use of Section 16 comparators will become harmonised across different
groups of medicinal products, and whether the position of Section 16–reimbursed
treatments will gain greater importance even in standard reimbursement
proceedings.
Section 16 of Act No. 48/1997 Coll., on Public Health Insurance The competent health insurance fund shall reimburse, pursuant to
Section 19(1)(a), in exceptional cases healthcare services otherwise not
covered by health insurance, provided that the provision of such healthcare
services constitutes the only option in view of the insured person’s health
condition.
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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.
In the case of rare diseases, it is not uncommon in practice that reimbursement is granted under Section 16. However, a medicinal product reimbursed in this way may also play a significant role in...
The Ministry of Health (MoH)
assessed whether the medicinal product under review met the criteria for being
designated as a highly innovative medicinal product (VILP). In the proceedings
on the determination of the amount and conditions of price and reimbursement,
the Institute for Drug Control (SÚKL) had refused to grant initial temporary reimbursement, as it
concluded that the product did not meet the VILP criteria.
The main reasons cited were:
Insufficient therapeutic benefit
Issues related to the selection and positioning of
comparators
Failure to meet VILP criteria across all proposed indications
Insufficient evidence on survival outcomes
Methodological concerns in comparative analyses
According to the SÚKL,
unless the VILP criteria are met against all relevant comparators under
assessment, the product cannot be granted temporary reimbursement, even under
modified conditions.
The MoH upheld the SÚKL’s
decision and additionally highlighted the inappropriateness of relying on
abstracts, which are condensed summaries and do not provide sufficient detail
on the underlying data. On this basis, the administrative authority cannot
responsibly assess the presented evidence. Furthermore, the MoH recommends not submitting key scientific
data under confidentialityrestrictions if a detailed evaluation
is expected, as any public assessment of such protected data can only remain of
a general nature.
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
Public Health Insurance Act No. 48/1997 Coll. provides in Section 16:
“The
competent health insurance fund shall reimburse, pursuant to Section 19(1)(a),
in exceptional cases healthcare services otherwise not covered by health
insurance, provided that the provision of such healthcare services constitutes
the only option in view of the insured person’s health condition.”
That
such requests are not rare is evidenced, for example, by statistics published
by the General Health Insurance Company of the Czech Republic.
In cases of non-reimbursed treatment, its use pursuant to Section 16—which allows reimbursement in justified cases—is not uncommon in practice. The complexity of such assessments is also reflected...
Under the previous wording of
the Public Health Insurance Act, abbreviated proceedings for similar medicinal
products allowed the selection of even the most expensive product in the group
as the reference product, which led to inequalities within the reference group
and disadvantaged other medicinal products. As of 1 January 2026, it now
applies that the applicant may not request a reimbursement level higher than
that established for the first similar medicinal product or higher than that
derived from the base reimbursement of the reference group.
Pursuant to Section 39b(5),
the Institute determines the amount and conditions of reimbursement of the
assessed similar medicinal product based on the amount and conditions of
reimbursement of the medicinal product to which it is similar. Where more than
one such reference product exists, or where an application for reimbursement
has already been submitted by another marketing authorisation holder, the
applicant may not request a reimbursement level higher than that established
for the first similar medicinal product pursuant to Section 39b(6), or higher
than that derived from the base reimbursement of the reference group pursuant
to Section 39b(8).
In the first months of this
year, this rule was applied in two proceedings. In both cases, the applicant
selected a reference medicinal product whose reimbursement level did not
correspond to the base reimbursement of the reference group (RS) within the meaning
of Sections 39b(5) and (8) of the Act. In other words, the selected reference
product had a base reimbursement (and thus also a core reimbursement) higher
than the base reimbursement of the reference group. As a result, one proceeding was terminated following the
withdrawal of the application, while in the other case, after the modification
of the submission, reimbursement was successfully 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.
