In a previously conducted in-depth reimbursement review, the medicine containing budesonide in tablet form was assessed as generally therapeutically interchangeable with rectal formulations in the reference indication of treatment of acute ulcerative colitis affecting the rectum and sigmoid colon. This conclusion was primarily based on the results of the CORE I and CORE II studies in a subgroup of patients with proctosigmoiditis.

However, following the entry of another budesonide-based medicine in suppository form into the reimbursement system during an ongoing review procedure, the Institute (SÚKL) decided to narrow the reference indication to the treatment of acute ulcerative colitis affecting the rectum only.

In the issued assessment report, the Institute responded to objections raised by one of the parties, pointing out that patients with ulcerative colitis limited to the rectum were not included in the registration studies for the tablet formulation. Therefore, it is not possible to draw conclusions regarding the efficacy and safety of the tablet form for this specific patient group based on those studies, nor to conduct a direct comparison with rectal formulations of budesonide.

Given the different clinical uses, the Institute proposes dividing the assessed medicines into two separate groups:

• a) Budesonide for the treatment of ulcerative colitis affecting the rectum (rectal formulations) – reference indication: treatment of acute ulcerative colitis affecting the rectum.
• b) Budesonide for the treatment of ulcerative colitis (oral formulations) – reference indication: treatment of acute ulcerative colitis affecting the rectum and sigmoid colon.

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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 4o. 

In one such proceeding, the Ministry of Health (MoH) expressed the legal opinion that replacing the symbol “S” with a prescribing restriction “E/DER” (i.e., extending prescribing rights from a limited number of specialized centers to all physicians with defined specializations) generally presumes an increase in the budget impact.

Specifically, the MoH stated in its decision: “The reimbursed medicinal products in question will now be dispensed to insured persons at pharmacies—potentially without any link to a specialized center—based on a prescription, and the dispensing pharmacy will routinely invoice the relevant health insurance company the amount corresponding to the set reimbursement. This change has certain economic consequences—at a minimum, in terms of co-payments and pharmacy markups. These are not the only economic implications: medicinal products with the ‘S’ symbol are reimbursed by the health insurance fund only to providers with whom they have a special agreement to ensure the economical use of such products, whereas no such legal obligation applies to products without the ‘S’ symbol.”

For these reasons, the MoH concluded that a cost-effectiveness and budget impact analysis was necessary, which the Institute failed to conduct during the procedure.
Although the Czech Dermatovenerology Society, when consulted by the Institute, confirmed the Institute’s assumption that the number of patients would not increase, the MoH noted that budget impact can still rise even without an increase in patient numbers. It also highlighted that the medical society did not comment at all on the actual budget impact.
As a result, the MoH annulled the Institute’s decision.

Definitions of the Symbols:

• Symbol “S” – Used for medicinal products that, in the public interest, should be concentrated in specialized centers (as per Section 15(10) of the Act). Only these specialized centers may invoice such products to health insurance companies, and only based on a special agreement between the provider and the insurance company.
• Symbol “E“ – Used when, due to the medicine’s efficacy and safety profile, prescribing should remain limited to physicians with a specific specialty qualification listed in the prescribing restriction.
• Symbol “DER” – Refers to the specialties of dermatovenerology, pediatric dermatovenerology, and corrective dermatology.

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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.

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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 4o. 

Okruh semináře: Revize 3 pokynu ICH R6 R3 správné klinické praxe

Podrobný program semináře bude k dispozici nejpozději den před konáním semináře.

Cílovou skupinou jsou monitoři, zkoušející, členové studijních týmů (studijní sestra, koordinátoři,… ), zástupci zadavatelů, CRO, výzkumníci.

Okruh semináře: Revize 3 pokynu ICH R6 R3 správné klinické praxe

Podrobný program semináře bude k dispozici nejpozději den před konáním semináře.

Cílovou skupinou jsou monitoři, zkoušející, členové studijních týmů (studijní sestra, koordinátoři,… ), zástupci zadavatelů, CRO, výzkumníci.

Okruh semináře: Revize 3 pokynu ICH R6 R3 správné klinické praxe

Podrobný program semináře bude k dispozici nejpozději den před konáním semináře.

Cílovou skupinou jsou monitoři, zkoušející, členové studijních týmů (studijní sestra, koordinátoři,… ), zástupci zadavatelů, CRO, výzkumníci.

The Act, in the referenced paragraph, requires the Institute—in cases where another Highly Innovative Medicinal Product with similar clinical use and comparable or close efficacy has already been granted temporary reimbursement—to set the temporary reimbursement amount of the assessed product at most to the level of that other product, taking into account differences in dosing and pack size.

The Institute is responsible for demonstrating the existence of another VILP with similar clinical use and comparable or close efficacy, which is temporarily reimbursed under public health insurance. In particular, it must prove the condition of comparable or close efficacy. If it fails to gather the necessary evidence, it is not authorized to reduce the reimbursement on these grounds.

The Institute also examines the possibility of reducing reimbursement for a Highly Innovative Medicinal Product in cases where the product is reimbursed in a different therapeutic indication and is not included in a group of interchangeable products together with other medicinal products.

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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 4o. 

According to the Ministry of Health, this condition follows from Section 39da(1): “If it is in the public interest under Section 17(2) and no application has been submitted for the same indication for temporary reimbursement under Section 39d or for determination of the amount and conditions of reimbursement in proceedings under Section 39g, the Institute shall decide on the amount and conditions of reimbursement for a medicinal product intended for the treatment of a rare disease…”

The Ministry stated that this provision must be applied not only to parallel administrative proceedings concerning the same indication but also to proceedings that have already taken place and have been lawfully concluded for the same indication of the given medicinal product.

An amendment to the Act on Public Health Insurance, scheduled to enter into force on 1 January 2026, explicitly establishes the rule that reimbursement for an LPVO cannot be requested if the product already has temporary reimbursement set for the same indication.

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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 4o. 

This requirement follows a request from the Ministry of Health in connection with forthcoming legislation. The inclusion of EMDN codes, in accordance with Article 26 of the MDR / Article 23 of the IVDR, is essential for setting clear, transparent, and predictable rules, both within the legislative process and for the inclusion, modification, or price/reimbursement adjustment of medical devices in the ÚK VZP – ZP.

According to the current wording of the MDR / IVDR, manufacturers must assign an EMDN code to their device, which will be used for registration in the EUDAMED database and linked to the device’s Unique Device Identifier (UDI-DI).

Using the EMDN hierarchical structure, manufacturers must always assign the code at the lowest applicable level available (i.e., the most specific level of the categorisation tree).

If one ZÚM item includes multiple devices (catalogue numbers) with different EMDN codes, list each EMDN code in the corresponding “EMDN” column.

If a single device (catalogue number) has multiple intended purposes and therefore multiple potential EMDN codes, select and submit only one EMDN code.

A single submission may contain up to 5,000 ZÚM items.

The template and submission instructions are available on the VZP website.

The text of the opinion was translated using ChatGPT 4o.  

The foundation of this approach is the comparison of the ex-factory prices of a given medicinal product across EU countries, with the final maximum price in the Czech Republic derived based on these references. It is important to note that EPR conditions and methodologies vary across the EU and a uniform approach has not yet been adopted. Each country has its own specific rules and lists of countries it references in its EPR system.

To support understanding, we have created an interactive map that visualizes the countries involved in the EPR system as applied in the Czech Republic. This tool provides a quick overview of which countries are considered when determining the maximum price and the reimbursement level of medicinal products in the Czech setting.

🔍 Map features:

• Display of countries used as reference when determining reimbursement levels
• Overview of national price databases
• Distinction between countries used in the reference basket for the manufacturer’s maximum price
• Clear color coding for easy navigation

This map is a useful tool for:

• Professionals in the pharmaceutical industry
• Health policy analysts
• Pricing and reimbursement regulators
• And anyone interested in the dynamics of European pharmaceutical pricing strategies

👉 The interactive map is available here     

Although the LPVO under assessment will be reimbursed, it will still be necessary to submit an application for an exceptional individual reimbursement under Section 16 of the Act on Public Health Insurance. This is because the LPVO is used in the given indication in combination with another medicinal product that is not covered by public health insurance. For this second product, an application for exceptional reimbursement will therefore need to be submitted, as stated by the Ministry in its opinion.

The Ministry agrees to the reimbursement terms particularly with regard to the age of the patients for whom the treatment is indicated, the seriousness of the disease, and after careful review of the evidence on the efficacy and safety of the LPVO in question.

Since the entry into force of the new legislation on pricing and reimbursement of rare disease medicines in 2023, the Ministry of Health has issued a total of 35 binding opinions. Of these, in 11 cases reimbursement was not approved, in 2 cases the Ministry proposed a change in the reimbursement conditions compared to the SUKL’s proposal, and in 1 case it proposed a change in the reimbursement amount.

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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 4o. 

Act No. 48/1997 Coll., on Public Health Insurance and on Amendments and Supplements to Certain Related Acts, as amended (hereinafter referred to as the "Act"), does not regulate a special procedure for the entry into the reimbursement system for a medicinal product intended for the treatment of a rare disease that has not been granted so-called orphan designation under the relevant Regulation. Such a medicinal product cannot be classified as an orphan medicinal product (LPVO) under the Act, as the second sentence of Section 39da(1) stipulates: “An orphan medicinal product shall mean a medicinal product designated as such under directly applicable EU legislation on orphan medicinal products.” This means that a medicinal product not designated as an orphan under Regulation (EC) No 141/2000 cannot apply for reimbursement under Section 39da, even if it is authorized for a rare disease.

It is worth noting that submitting a reimbursement application under Section 39da is a right, not an obligation, of the marketing authorization holder. Entry into the reimbursement system is also possible via the procedures set out in Sections 39g or 39d of the Act.

Thus, medicinal products that cannot be considered LPVOs under the Act can only enter the reimbursement system via procedures under Sections 39g, 39i, or 39d. In proceedings under Sections 39g or 39i, resulting in permanent reimbursement of a non-orphan medicinal product for a rare disease indication, it is necessary, among other things, to meet the condition of a purposeful therapeutic intervention under the second sentence of Section 15(7) of the Act. However, during cost-effectiveness assessment in such procedures, it is not appropriate to use LPVOs reimbursed under Section 39da as comparators in the base-case scenario, as clarified in the Ministry's statement from 7 April 2025.

Therefore, the more suitable route for non-orphan designated products for rare diseases is through temporary reimbursement under Section 39d, as the features of this procedure are better suited to the nature of such medicinal products than the process for permanent reimbursement.

The first specific feature of the Section 39d procedure is the requirement to demonstrate at least one criterion for granting Highly Innovative Medicinal Product (VILP) status under Section 39d(2), which ensures that the product brings a degree of innovation that significantly impacts the treatment of a serious disease and plays a role in recommended treatment guidelines either in the Czech Republic or abroad. The applicant should specify in the submission, based on the principle of disposition, under which paragraph of Section 39d(2) the product fulfills the VILP criteria.

Fulfilment of at least one criterion for granting VILP status to a non-orphan designated medicinal product for which the first or second temporary reimbursement is requested in therapeutic indications for a condition meeting the definition of a rare disease is then assessed in comparison to therapies with reimbursement established under Section 39g of the Act, i.e., in a manner analogous to the procedure before 1 January 2022, when the amendment introducing the legal framework for the third reimbursement pathway under Section 39da for LPVOs entered into force. Given that the procedure under Section 39da is intended solely for a clearly defined group of LPVOs and applies specific requirements and criteria, where an LPVO reimbursed under Section 39da already exists in the reimbursement system at the time of the application for temporary reimbursement of a non-orphan medicinal product for a rare disease indication, the VILP criteria for such a product should not be assessed in comparison to the LPVO. This preserves the principle of assessing VILP criteria against therapies reimbursed under Section 39g, as is also the case when a temporary reimbursement is requested and a VILP is already reimbursed for the same indication. Otherwise, it would lead to an unjustified cumulative increase in entry requirements for newly entering medicinal products.

The relevant comparator for assessing the VILP criteria under Section 39d(2) and comparative effectiveness should thus be a reimbursed therapeutic intervention with reimbursement under Section 39g or Section 39i, or, if unavailable, another treatment alternative such as best supportive care (BSC). Nonetheless, even a reimbursed LPVO under Section 39da constitutes a therapeutic option, and thus in the clinical evaluation submitted by the applicant, a comparison with the LPVO in the given indication should be made. The entering VILP must meet the requirement of comparable or superior efficacy versus the LPVO in the assessed therapeutic indication—since setting reimbursement for a product with lower efficacy than a reimbursed LPVO cannot be considered in the public interest. Such a product would likely not bring patient benefit over the existing LPVO treatment. Regarding the evaluation of the VILP criterion for the non-orphan designated product, it is appropriate to note that where direct evidence is insufficient, indirect evidence or methodologically appropriate indirect comparisons may be accepted.

The second specific feature of the Section 39d procedure is the approach to assessing the purposefulness of therapeutic intervention, as under the third sentence of Section 39d(3) of the Act, “For temporary reimbursement, it is not required to fulfil the cost-effectiveness condition as one of the conditions for purposeful therapeutic intervention under Section 15(7).” This addresses cases where highly innovative medicines are not cost-effective due, for example, to a lack of sufficient data for a methodologically acceptable cost-effectiveness analysis, yet are reasonably expected to become cost-effective over time and clearly provide innovation.

Although failure to meet the cost-effectiveness condition under Section 15(7), second sentence, is not grounds to reject temporary reimbursement for a product eligible for VILP status, pharmacoeconomic evaluations—cost-effectiveness and budget impact analyses—must still be submitted. As per Section 15(8), fourth sentence, “The budget impact must align with the public interest under Section 17(2),” meaning an unacceptable budget impact may justify denial of temporary reimbursement.

Since the relevant clinical comparator for VILP assessment of a non-orphan medicinal product in a rare disease indication is therapy reimbursed under Section 39g or Section 39i or other alternatives, these should be used in the base-case scenario of the pharmacoeconomic assessment.

However, the alternative cost-effectiveness analysis scenario should include a comparator consisting of the LPVO reimbursed under Section 39da, provided that the analysis is methodologically sound and reviewable. Conversely, the LPVO must be used as the base-case comparator in the budget impact analysis under Section 39d(6), to ensure that estimated budget impacts reflect actual clinical practice and do not overestimate costs by omitting the LPVO as a comparator.

A product not designated as an orphan under Regulation (EC) No 141/2000 but intended for a rare disease indication may enter the reimbursement system under Section 39d if it demonstrates at least one VILP criterion compared to therapies reimbursed under Sections 39g or 39i and shows comparable efficacy to an LPVO reimbursed under Section 39da. The pharmacoeconomic base-case analysis should be performed using comparators reimbursed under Sections 39g or 39i, and the LPVO reimbursed under Section 39da must be included as a comparator in the base-case budget impact analysis and the alternative cost-effectiveness analysis.

This text was fully taken from the website of the Ministry of Health of the Czech Republic.

Sufficient scientific knowledge is evaluated based on the evidence related to the specific indication. Recently, the State Institute for Drug Control (SÚKL) reached different conclusions on this condition for two indications of the same product: the treatment of high-grade squamous intraepithelial lesions of the vulva (HSIL) and extramammary Paget’s disease of the vulva (EMPD). Both proposed indications, HSIL and EMPD, are off-label.
The Institute determined that, based on available evidence, the use of the product in the treatment of vulvar HSIL is sufficiently supported by current scientific knowledge. Additionally, the product was found to be cost-effective, and therefore the reimbursement conditions for this off-label indication can be established.
In contrast, for EMPD, the use of the product was deemed insufficiently justified. The studies provided exhibited several methodological limitations, such as small patient samples, lack of a control arm, and observational design. As a result, the Institute proposes not to grant reimbursement for the EMPD indication.

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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 4o. 

The appellant maintained that under the provision in question, full reimbursement must be increased within the group of interchangeable products. According to the appellant, it is not sufficient that a fully reimbursed product exists within the same Annex No. 2 group if it is not therapeutically interchangeable and cannot be used in patients requiring the evaluated active substance under the established reimbursement conditions. Therefore, the appellant argued that the requirement for full reimbursement of at least one product under Section 39c(5) of the Act had not been met.

The Ministry of Health (MoH) responded by stating that the assessed active substances fall under the cytostatic tyrosine kinase inhibitors group—Group No. 116 of Annex No. 2. The medicinal products under review, as well as the fully reimbursed product within the same group, are used and reimbursed for the same disease type—chronic myeloid leukemia (CML). The Ministry noted that the condition of ensuring full reimbursement for at least one product within Annex No. 2 must be assessed in relation to the reference indication (i.e., the broader patient population), not to a specific subpopulation of CML patients. For these reasons, the MoH confirmed that SÚKL had acted correctly, as a reimbursed product was ensured for patients with CML within Group 116 of Annex No. 2 of the Act on Public Health Insurance.

The issue of fully reimbursed medicinal products under Annex No. 2 has also been addressed by the Constitutional Court of the Czech Republic. A landmark ruling concerned the full reimbursement of therapy for prostate and breast cancer.
In decision ref. no. III. ÚS 2332/16, the Court focused on whether it is constitutionally acceptable for no fully reimbursed product to be available for patients with prostate cancer, while such a product exists for breast cancer—even though the relevant products are categorized in the same Annex No. 2 group under the Act on Public Health Insurance.
The Constitutional Court held that interpreting the law in a way that denies full reimbursement of a medicinal product simply because another fully reimbursed product exists for a different disease (in this case, breast cancer) undermines the essence of the constitutionally guaranteed right to health protection under Article 31 of the Charter of Fundamental Rights and Freedoms. The Court emphasized that the administrative courts had acted too formalistically and failed to consider the merits of the claimant’s argument that no fully reimbursed treatment existed for prostate cancer.
As a result, it followed that if products contain active substances listed in the same Annex No. 2 group but are intended to treat categorically different diseases (e.g., one for breast cancer and another for prostate cancer), then full reimbursement must be ensured not only within the Annex No. 2 group but also specifically for each individual disease (i.e., for both breast and prostate cancer).
In a recent appeal review concerning the expedited reassessment of a reference group, the Ministry interpreted the Constitutional Court’s ruling to mean that if full reimbursement is ensured for a product from Annex No. 2 for the treatment of a specific disease type, and other products from the same group are indicated for entirely different diseases, then it is not necessary to ensure full reimbursement for those other products—provided that treatment for the different disease type is already fully reimbursed by a product outside the same Annex No. 2 group. No court has yet ruled on this interpretation.

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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 4o. 

Following this MoH decision, another ministerial ruling was issued concerning the reimbursement of a product included in the same reimbursement group as in the aforementioned case.
Again, SÚKL justified its decision not to consider the existence of agreements in setting the reimbursement for the comparably effective therapy in a similar manner to the previous case.
The MoH confirmed this approach as well, reasoning that essential parts of the agreements—specifically the agreed manufacturer’s maximum price—were confidential. As such, these agreements could not be taken into consideration during the procedure.

The Ministry of Health’s reasoning may influence SÚKL’s approach in cases involving confidential agreements affecting the reimbursement of a comparator/reference product/comparably effective therapy.

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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.

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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 4o. 

In addition to listing the legal requirements related to orphan drugs and a comprehensive overview of all proceedings within the reviewed period, one chapter focuses on the key lessons learned from the advisory board's experience.

The full summary report is available on the Ministry of Health’s website. 

Gliflozins are used in the treatment of T2DM, contributing to improved glycaemic control and offering additional benefits for comorbidities such as heart failure and chronic kidney disease.
The proceeding evaluated medicinal products containing the following active substances from the group of sodium-glucose co-transporter 2 (SGLT2) inhibitors: dapagliflozin, empagliflozin, and ertugliflozin.

The core question was whether gliflozin-containing products can be deemed essentially therapeutically interchangeable within the reference indication "treatment of type 2 diabetes mellitus."
In its objections to the therapeutic interchangeability of dapagliflozin-containing products, the appellant presented the following key arguments:

1. Different Approved Indications – The company claimed that dapagliflozin has broader approved indications (e.g., heart failure with reduced and preserved ejection fraction) that are not approved for all other gliflozins.
2. Differences in Efficacy and Safety – The argument was based on variations in clinical study outcomes and differences in dapagliflozin’s safety profile compared to other gliflozins.
3. Varying Availability of Clinical Data – More robust clinical evidence is available for dapagliflozin in multiple indications, whereas for other gliflozins data is either incomplete or lacking.
4. Irreplaceability in Specific Indications – In clinical practice, dapagliflozin is irreplaceable in certain indications due to the lack of alternative treatments with comparable efficacy and safety evidence.

Despite the objections, the MoH confirmed that SÚKL correctly assessed gliflozins as essentially therapeutically interchangeable based on similar efficacy, safety, and clinical use in the reference indication. The rationale was that while individual gliflozins may offer different benefits for specific patient subpopulations, their overall effects in T2DM treatment are comparable.

The MoH also confirmed that classification into a group of essentially therapeutically interchangeable medicines is not based on market share or prevalence of use, but rather on expert considerations such as efficacy, safety, and clinical application. Therefore, the limited use of one substance in T2DM therapy was not a valid reason to exclude it from the group.

The MoH cited a judgment of the Prague Municipal Court dated 22 May 2015, Case No. 5 Ad 11/2010-164, which concluded that terms such as "essentially therapeutically interchangeable," "similar or close efficacy and safety," and "similar clinical use" under Section 39c(1) of Act No. 48/1997 Coll. should not be interpreted narrowly. The law deliberately uses modifiers such as "similar," "close," and "essentially" to indicate that products do not need to be completely identical in all aspects, including safety profiles.
This interpretation was subsequently reaffirmed by the same court in its judgment dated 23 September 2015, Case No. 7 Ad 19/2011-98. Further support comes from the Supreme Administrative Court’s ruling (Case No. 2 As 388/2017–66, para. 24), which stated: "There is no reason to equate the terms 'essentially therapeutically interchangeable with similar or close efficacy and safety and similar clinical use' for reimbursement purposes with 'interchangeability' of medicinal products for healthcare provision purposes. The objectives of these administrative proceedings differ, and the criteria considered cannot be compared with those evaluated by physicians in selecting appropriate therapy (...)."

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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 4o. 

The Association’s calculations were based on a comparison of per-patient treatment costs – CZK 1,509,429 for the evaluated intervention versus CZK 151,503 for the reimbursed comparator, representing nearly a tenfold increase. However, SÚKL concluded that this merely reflects a multiple increase in unit costs, not the total budget impact. According to SÚKL, such an argument does not sufficiently reflect the capacity or planning of the public health insurance system.

Both the Association’s and VZP’s calculations were based on internal data from the years 2017–2023 (Association) and 2014–2023 (VZP), and in both cases the projected budget impacts were compared against figures from the first (older) version of the assessment report.
SÚKL considered the projected cost increase presented by the insurers to be irrelevant, as the conclusions were based on outdated data. Current costs are lower due to updated external reference pricing and cost-capping agreements submitted by the applicant in cooperation with health insurance companies. Therefore, SÚKL did not accept the insurers’ conclusions as valid for the present decision-making process.

What Should a Statement on Unacceptable Budget Impact Look Like?

In an updated 2023 article, SÚKL based on a decision by the Ministry of Health outlined new requirements regarding how health insurance funds should submit statements concerning the unacceptability of budget impact.

SÚKL emphasized, among other things, that it is not acceptable to apply a universal threshold for all therapies that would automatically indicate the boundary between acceptable and unacceptable budget impact.
Furthermore, it stated that budget impact assessments must not be limited to pharmaceutical costs alone, but must reflect the overall budget impact, including other non-pharmaceutical segments of healthcare provision.

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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 4o. 

A similar product is, in simplified terms, a medicinal product with the same active substance(s) and an identical or similar pharmaceutical form as the reimbursed product (similarly applicable to biological products).

The court addressed the question of whether an application could be considered first in line, even if another product had already been granted reimbursement under legislation valid until 31 December 2007.
The court held that the definition of a “first similar product” does not require the application to have been submitted after the effective date of the amendment to the Public Health Insurance Act.

Furthermore, the court assessed whether an application for reimbursement modification is equivalent to an application for reimbursement determination.
In the case of a first similar product, the applicant is required to submit a commitment to market the product. However, this obligation does not apply to applications for reimbursement of the second or subsequent similar products.
SÚKL had interpreted the law in such a way that, for determining the order of applications (i.e. whether the product is the first or not), only the existence of a previous reimbursement determination application for a similar product was relevant, while applications for modification of reimbursement were not considered.
The court disagreed, accepting the plaintiff’s argument that both types of applications (determination and modification) are materially equivalent and should be taken into account when assessing the order. Thus, if an application for reimbursement modification for a similar product was submitted before the application for reimbursement determination, the latter cannot be considered an application for the first similar product, and therefore the marketing commitment does not need to be submitted.

The court also considered whether the medicinal product in question could be regarded as a generic.
The court stated that in order to deny reimbursement due to non-submission of the marketing commitment for 12 months, it is not sufficient for the product to be the first similar product—the law also requires that the product must be registered as either a biological medicinal product or a generic. Since the product under review was not registered as a generic, it cannot be considered one.

Following the City Court’s ruling, SÚKL re-evaluated the application for the maximum price and reimbursement determination of the medicinal product in question and did not classify it as the first similar product. Instead, it recognized another product as the first similar one.

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In a new application, the same product was submitted for permanent reimbursement as an orphan drug under Section 39da, this time proposing reimbursement for a broader population than previously approved. The request aimed to extend reimbursement to post-transplant AML patients and to remove the first relapse condition.

The Ministry of Health (MoH) agreed with SÚKL’s conclusion that the application must be rejected due to the overlap in indications with the original temporary reimbursement. According to Section 39da of the Public Health Insurance Act, it is not legally permissible to apply for reimbursement for an indication already covered by a previous reimbursement decision. Although the relevant medical society opposed SÚKL’s decision, citing concerns about potential negative impacts on patient care and treatment quality, the Ministry upheld the rejection, stating that rules are consistent and the perceived medical need for the drug cannot override legal requirements.
The appeal was dismissed by the Ministry of Health, and SÚKL’s original decision was confirmed.

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Under the Public Health Insurance Act, if, during the validity of a decision granting temporary reimbursement for a VILP, SÚKL subsequently grants reimbursement under Section 39g to another medicinal product with comparable clinical use, the Institute must promptly initiate ex officio administrative proceedings. The purpose of these proceedings is to assess whether the VILP still fulfils the criteria for a highly innovative medicinal product. This obligation does not apply if the temporary reimbursement would expire in less than 12 months.

Such a situation has now occurred. The reason for initiating the proceeding was a decision effective from 1 November 2024, which granted permanent reimbursement to a new relevant comparator for a similar indication—namely, maintenance monotherapy in adult patients with BRCA1/2-mutated (FIGO stage III or IV) advanced high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response following first-line platinum-based chemotherapy.

SÚKL has now issued a final assessment report regarding the reimbursement of a medicinal product for patients with advanced ovarian cancer, recommending that the second temporary reimbursement of the product remain in force.
In its assessment, the Institute compared the efficacy and safety of niraparib versus olaparib in patients with and without BRCA mutations. It concluded that comparable efficacy was demonstrated only in patients with BRCA mutations, and not in BRCA wild-type (BRCAwt) or unknown-status patients. Due to a lack of clinical evidence, no efficacy comparison was possible for the BRCAwt/unknown subgroup. For this subpopulation, the Institute found that the criteria for high innovativeness continue to be met, and that the appropriate comparator remains best supportive care (i.e., watch and wait approach).

SÚKL emphasized that within the scope of this administrative proceeding, it cannot modify the existing reimbursement conditions by limiting coverage to only part of the patient population. The decision to revoke or maintain reimbursement must therefore be based on whether the VILP criteria are met overall.

Given that the VILP criteria remain fulfilled for a subpopulation of patients (BRCAwt/unknown), and that the product demonstrated at least a 30% improvement in the primary endpoint of progression-free survival (PFS) versus the relevant comparator in the overall population, SÚKL has decided to maintain the temporary reimbursement.

Timeline:

• 03/2024 – Medicinal product containing niraparib: second temporary reimbursement granted in SCAU
• 11/2024 – Medicinal product containing olaparib: permanent reimbursement granted in SCAU
• 11/2024 – Ex officio proceeding initiated to reassess fulfilment of high innovativeness criteria

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The Ministry of Health issued a binding opinion for the OMP stating that the SÚKL is not allowed to grant reimbursement for the given OMP. The MAH disagreed with the negative binding opinion and submitted a request for its review. At the same time, the MAH asked the SÚKL to suspend the reimbursement proceedings for the OMP until the review of the opinion is completed.

The SÚKL argues that it is bound by the binding opinion of the Ministry and is obliged to issue a decision. According to SÚKL, the submission of a review request is not a valid reason for suspension because the outcome of the review is not determinative for this proceeding. The SÚKL holds a binding opinion from the Ministry, which is key for the decision, and must act in accordance with it, also considering the legitimate expectations of other parties to the proceeding. Therefore, the SÚKL will not suspend the reimbursement proceedings.

Since the new legislation concerning pricing and reimbursement of orphan drugs came into effect in 2023, the Ministry of Health has issued a total of 31 binding opinions. In 10 of these cases, the Ministry did not agree with the granting of reimbursement, in 2 cases it proposed changes to the reimbursement conditions compared to SÚKL’s proposal, and in 1 case it suggested a change in the reimbursement amount compared to SÚKL’s proposal.

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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).

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Subjective Parameter in Reimbursement Indication Restriction

The Ministry of Health upheld SÚKL’s approach of including the MSWS-12 questionnaire—a subjective parameter—in the reimbursement indication restriction for a particular medicinal product.
The Ministry justified the correctness of this procedure by referencing the wording of the Summary of Product Characteristics (SmPC), which allows the prescribing physician, already at the initiation of treatment, to evaluate efficacy using the MSWS-12 questionnaire instead of the objective T25FW test.
For this reason, the Ministry dismissed the appellant’s objection, which questioned the demonstration of efficacy through a subjective questionnaire. The Ministry stated that efficacy proven by such a tool is sufficiently supported by the conditions established during the marketing authorization process.
Moreover, the Ministry emphasized that the inclusion of subjective parameters in cost-effectiveness analyses is not considered a flaw or deficiency of such analyses in general.

Subjective Parameter in Clinical Evaluation

In certain cases, the use of a subjectively assessed primary efficacy endpoint in the evaluation of therapeutic appropriateness for reimbursement purposes has been accepted by SÚKL:

The primary efficacy endpoint assessed in clinical trials was based on purely subjective patient assessment. Considering that the MG-ADL score is more sensitive to changes in condition than the QMG score, and given the observed correlation between changes in MG-ADL and QMG scores, this benefit parameter is deemed acceptable. The treatment’s efficacy compared to placebo can be considered statistically significant, even though the difference in the primary endpoint was not clinically significant.

In contrast, in other proceedings, the subjective nature of the primary study endpoint has been labeled an unacceptable limitation for the purpose of reimbursement determination:

SÚKL proposes not to grant reimbursement for the medicinal product in the indication of symptomatic treatment of myotonia. In view of the study’s limitations and other concerns (e.g., potential overestimation of efficacy, the dose used, and the subjective nature of the primary endpoint)...
The study’s primary endpoint had a subjective character (VAS scale based on patient evaluation). The secondary endpoint (chair test) was objectively measurable. Even so, variability exists between different types of NDM, with some types affecting upper limbs and facial muscles more, and others affecting the legs. EMA also stated that direct measurement of muscle strength would have been more appropriate.

These examples illustrate that the subjective nature of a study’s primary endpoint may in some cases be a limitation for reimbursement purposes. However, if the parameter is embedded in the indication restriction in accordance with the product’s SmPC, it should be accepted by SÚKL for the purpose of reimbursement determination.

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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).

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Opinion of the Ministry of Health of the Czech Republic on the Selection of a Medicinal Product Intended for the Treatment of a Rare Disease with Reimbursement Granted under Section 39da as a Comparator in Cost-Effectiveness Assessment in Proceedings for the Determination or Modification of Reimbursement in the So-Called Permanent Reimbursement Regime Conducted under Section 39g or Section 39i of Act No. 48/1997 Coll., on Public Health Insurance and on Amendments to Certain Related Acts, as Amended

Cost-effectiveness assessment, as part of evaluating the appropriateness of a therapeutic intervention, is a necessary element of administrative proceedings for the determination or modification of the amount and conditions of reimbursement of a medicinal product conducted under Section 39g or 39i of Act No. 48/1997 Coll., on Public Health Insurance and on Amendments to Certain Related Acts, as amended (hereinafter referred to as "Act No. 48/1997 Coll." or the "Public Health Insurance Act"), in cases enumerated in Section 15(9) of this Act. Fulfilment of the condition of an appropriate therapeutic intervention is one of the basic conditions for granting reimbursement for a medicinal product for a given indication (regardless of whether this indication is defined by a specific formulation of the reimbursement restriction or by the summary of product characteristics), as Section 15(6)(d) of Act No. 48/1997 Coll. stipulates that "The Institute shall not grant reimbursement for medicinal products and foods for special medical purposes that do not meet the conditions of an appropriate therapeutic intervention."

According to the second sentence of Section 15(7) of Act No. 48/1997 Coll., "An appropriate therapeutic intervention shall mean healthcare services provided for the prevention or treatment of disease with the aim of achieving the most effective and safest treatment while maintaining cost-effectiveness." Thus, cost-effectiveness is one of the cumulative conditions of an appropriate therapeutic intervention within the meaning of Section 15(7).

However, the definition of an appropriate therapeutic intervention for a medicinal product intended for the treatment of a rare disease (hereinafter also referred to as "LPVO") with reimbursement granted under Section 39da differs from the definition applicable to a medicinal product in the so-called permanent reimbursement regime, i.e., with reimbursement from public health insurance granted in proceedings conducted under Section 39g or Section 39i of Act No. 48/1997 Coll. According to the third sentence of Section 15(7) of Act No. 48/1997 Coll., "In the case of medicinal products intended for the treatment of a rare disease under Section 39da, an appropriate therapeutic intervention shall mean healthcare services provided for the prevention or treatment of a rare disease with the aim of achieving the most effective and safest treatment, provided that the pharmacotherapeutic impact of this disease has a societal significance and the financial impact on the health insurance system (hereinafter the 'budget impact') is in accordance with the public interest pursuant to Section 17(2)."

This different approach to the requirement of appropriate therapeutic intervention in proceedings for the determination or modification of reimbursement for LPVOs under Section 39da as compared to medicinal products in the so-called permanent reimbursement regime is further expressed in Section 39da(3)(i) of Act No. 48/1997 Coll., which states that "In the proceedings for determining the amount and conditions of reimbursement of a medicinal product intended for the treatment of a rare disease, the following shall be assessed..., (i) cost-effectiveness analysis, however, without taking into account its result in the form of the incremental cost-effectiveness ratio..."

A medicinal product intended for the treatment of a rare disease for which reimbursement has been granted under Section 39da of the Public Health Insurance Act thus does not necessarily meet the condition of an appropriate therapeutic intervention as defined by the requirements of the law for medicinal products under the so-called permanent reimbursement regime. An LPVO reimbursed under Section 39da does not have to meet the condition of maintaining cost-effectiveness and therefore may not qualify as an appropriate therapeutic intervention within the meaning of the second sentence of Section 15(7) of the Act (although it does qualify under the third sentence of Section 15(7)). The anticipated inability of LPVOs to demonstrate their cost-effectiveness as required in proceedings under Section 39g is one of the reasons why LPVOs are granted a different procedure for determining reimbursement under Section 39da.

For the above reasons, when proving the appropriate therapeutic intervention of a medicinal product entering the so-called permanent reimbursement system under Section 39g, or in proceedings for modifying reimbursement under Section 39i of the Act, it is not possible to rely on the appropriate therapeutic intervention demonstrated by an LPVO that entered the reimbursement system under Section 39da. These are two different types of appropriate therapeutic intervention, requiring the demonstration of different circumstances and applicable in different types of proceedings. Therefore, it is not valid to equate them or assume that if an LPVO reimbursed under Section 39da meets the condition of appropriate therapeutic intervention pursuant to the third sentence of Section 15(7) of the Act, it also meets the condition pursuant to the second sentence of that same provision.

Using an LPVO reimbursed under Section 39da as a comparator in the base-case scenario of a cost-effectiveness analysis in proceedings for the determination or modification of reimbursement in the so-called permanent reimbursement regime would lead to methodological inconsistencies in the cost-effectiveness assessment submitted by the applicant and subsequently to inequalities in the Institute's assessment compared to other medicinal products in the permanent reimbursement regime.

Based on the above, it is clear that an assessed intervention in proceedings for the determination or modification of reimbursement in the so-called permanent reimbursement regime cannot be considered to meet the condition of appropriate therapeutic intervention if a medicinal product reimbursed under Section 39da is used as a comparator in the base-case scenario of the cost-effectiveness analysis.

The Ministry is therefore convinced that the use of a medicinal product intended for the treatment of a rare disease reimbursed under Section 39da as a comparator in the base-case scenario of the cost-effectiveness assessment in proceedings for the determination or modification of reimbursement in the so-called permanent reimbursement regime cannot in any way prove that the assessed intervention meets the condition of appropriate therapeutic intervention within the meaning of the second sentence of Section 15(7) of Act No. 48/1997 Coll. Failure to demonstrate appropriate therapeutic intervention under the second sentence of Section 15(7) of Act No. 48/1997 Coll. in reimbursement proceedings under the so-called permanent reimbursement regime constitutes a legal reason for denying reimbursement pursuant to Section 15(6)(d) of the same Act.

This is an unofficial translation generated with the assistance of ChatGPT-4o. It is provided for informational purposes only and does not constitute an official or legally binding translation.

The Institute argued that if all products in a given group serve the same purpose and can be administered by patients, there is no reason for them to be subject to different reimbursement conditions. Previously, some products required immediate administration by a physician (marked with the “A” symbol), while others—therapeutically interchangeable—were not subject to such restriction.

The appeal body agreed with this reasoning and described the previous arrangement as inefficient.

The Institute had already reached the same conclusion in 2022, stating that if the accompanying texts (SPC/PIL) allow for patient self-administration after proper training instead of administration in ambulatory care, the “A” prescription restriction (ZULP for ambulatory care) may be removed without requiring a pharmacoeconomic assessment, as no expansion in the number of treated patients occurs.

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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.

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Full Reimbursement in Inpatient and Outpatient Care 

Act No. 48/1997 Coll. stipulates that, during the provision of inpatient care, the following are fully reimbursed:

·        medicinal products and foods for special medical purposes,

·        individually prepared medicinal products,

·        radiopharmaceuticals,

·        transfusion products,

·        medical devices,

·        medicinal products for advanced therapy,

·        tissues and cells.

These items are reimbursed in the least economically demanding version, and the insured person does not contribute to their payment.

In outpatient care, Annex No. 2 of the Act plays a crucial role in ensuring that at least one medicinal product in each therapeutic group is fully reimbursed by public health insurance. This guarantees patient access to treatment without co-payments, especially for chronic and severe diseases.

Full Reimbursement and Real Availability of Medicinal Products

However, full reimbursement of a medicinal product does not automatically mean its actual availability on the market. Data shows that only a portion of fully reimbursed medicines are genuinely available to patients, influenced by factors such as manufacturers’ supply decisions, demand fluctuations, and regulatory measures.

The list of medicinal products and foods for special medical purposes reimbursed by health insurance (SCAU250401) includes a total of 8,873 items, of which 987 are fully reimbursed. Out of this number, 748 products are available. The full reimbursement guarantee under Annex No. 2 of the Act applies to 467 of them, while 281 products are not included in Annex No. 2.

• Fully reimbursed products make up 11.12% of all items in the reimbursed medicines list.
• Available fully reimbursed products represent 75.79% of the total number of fully reimbursed products.
• Of the fully reimbursed items, 47.32% fall under Annex No. 2 of the Act.
• Outside Annex No. 2, 28.47% of fully reimbursed products exist.
• Available fully reimbursed products constitute only 8.43% of the total number of items in the list.
• Of the available fully reimbursed ones, 62.42% are from Annex No. 2.
• Outside Annex No. 2, 37.58% of the available fully reimbursed products remain.

In 2021, the Association of Health Insurance Companies (Svaz ZP) appealed against the extension of reimbursement conditions for products containing inosine pranobex as part of a comprehensive reimbursement review. The Institute had approved the extension without assessing the cost-effectiveness and budget impact of the proposed change.

The Ministry stated that the removal of reimbursement conditions, such as prescription and indication restrictions, constitutes an expansion of reimbursement that leads to an increase in the number of treated patients. Following the change, all medical specialists could prescribe these products for reimbursement from public health insurance within the approved therapeutic indications listed in the SPC. However, the Ministry emphasized that the prevalence of the relevant conditions in the general Czech population was likely much higher than the number of patients covered under the prior reimbursement restrictions. The contested decision would thus logically lead to increased use and higher reimbursement costs.

By extending reimbursement without a proper assessment of cost-effectiveness and budget impact, the Institute acted unlawfully.

In the further course of the administrative proceedings, the Institute was not allowed to change the reimbursement conditions in a way that would increase the number of treated patients without the submission and assessment of the relevant pharmacoeconomic analyses from the parties to the proceedings. However, after the participants failed to provide the requested analyses, the Institute performed its own calculations and again extended the reimbursement conditions. This decision was again challenged — all payers filed an appeal.

Following further review, the Ministry of Health reiterated that the Institute may not create its own pharmacoeconomic analyses for the purpose of changing reimbursement conditions in the absence of such analyses submitted by the parties. The Institute is only authorized to perform corrective recalculations or similar adjustments within the scope of analyses provided by the parties.

For these reasons, the Ministry annulled the Institute’s decision once again.

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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).

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This typically applies to contractual arrangements between marketing authorization holders and health insurance companies, which include a binding commitment to ensure availability of the respective medicinal products.

On the other hand, the right to free medicinal products cannot be ensured through products that are not present on the Czech market or are available only in negligible quantities.

Furthermore, according to the Ministry of Health of the Czech Republic, SÚKL is not obliged to verify whether a product has been reported as temporarily unavailable on the domestic market, since such a temporary unavailability concerns only a transitional period, unlike permanent discontinuation of supply.

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. 

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Rejecting the statement of one insurance company solely because other insurers remain silent or their statements are less convincing (or not sufficiently substantiated) is, in the Ministry’s view, irrational. If the presented budget impact poses an economic risk to even one health insurance company, this is clearly a factor indicating the unacceptability of the proposed budget impact.

The requirement by SÚKL for statements from all health insurance companies regarding the acceptability of the budget impact has no legal basis, according to the Ministry of Health.

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. 

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Cost-effectiveness assessment is a crucial element of the administrative process for determining drug reimbursement, not only in the Czech Republic. A well-prepared cost-effectiveness analysis, including budget impact assessment, not only supports the applicant's arguments but also minimizes requests for additional documentation from the State Institute for Drug Control (SÚKL/Institute) via cooperation requests, which have become standard practice.

This article presents a selection of key questions that applicants seeking drug reimbursement (where cost-effectiveness assessment is required) should be able to answer within their submitted evaluation.

Upon reviewing the documentation, the Institute identified several problematic aspects. Pharmaceutical costs had increased compared to the originally submitted data. Uncertainties regarding dosage—the method of dose determination was unverifiable, and it was impossible to clearly establish the considered dosage for individual patients. Serious discrepancies in total cost presentation—different values appeared in various sections of the documentation.

All these inconsistencies prevented a proper assessment of cost-effectiveness.

Given these findings, the Institute concluded that the submitted analysis did not meet the minimum quality requirements, and therefore, the medicinal product could not be considered a cost-effective intervention.

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. 

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How Does the New Approach Work? In a recent reimbursement revision decision regarding JAK inhibitors (Ref. No. SUKLS274309/2022), SUKL determined the reimbursement for certain indications based on the daily costs of comparably effective therapy. This means that medicinal products were not necessarily placed in the same reference group as the compared therapies, yet their reimbursement was set according to cheaper alternatives from another reference group, which included, for instance, generic drugs. In the case of filgotinib, the reference product, a head-to-head clinical study (Combe, B. et al.) comparing its efficacy with the TNF-alpha inhibitor adalimumab confirmed direct clinical equivalence between these therapies.

This approach has several critical consequences:

• Reduction in the reimbursement of innovative medicines – if the reimbursement of a medicinal product is set according to another reference group that includes generics, it automatically decreases regardless of the original therapeutic value.
• Domino effect on other groups – once reimbursement is lowered in one group, this decrease can reflect in reimbursement revisions across other reference groups, leading to a gradual overall reduction in reimbursements.
• Unpredictability for pharmaceutical manufacturers – companies bringing new medicinal products to market lack certainty about how their reimbursement will be determined, as it may be derived from different reference groups without formal inclusion in them.

Long-Term Impacts This new approach has not only short-term effects on the reimbursement of specific medicines but also long-term consequences for the entire pharmaceutical sector:

1. Reduced attractiveness of the Czech market – if innovative medicines are systematically undervalued, pharmaceutical companies may be discouraged from introducing new medicines to the Czech market.
2. Impact on patients – lower reimbursements may lead to reduced availability of innovative therapies and fewer treatment options for both patients and physicians.
3. Disruption of reimbursement policy transparency – linking reimbursements across different reference groups may complicate predictability and planning in the field of pharmaco-economics.

Open Question: Where is the Boundary Between Efficiency and Innovation Regulation? How might the domino effect manifest in non-referential indications in the future? This case represents a breakthrough in setting more than one additional increased reimbursement, meaning the barrier of "only one increased reimbursement" is eliminated. On the other hand, this new trend may lead to an intricate network of interconnected reference groups with generic-based reimbursements, discouraging marketing authorization holders from including their products in such groups.

The text was translated using ChatGPT 4o.

Given that such an expansion of reimbursement conditions would result in an increase in the number of treated patients, it is necessary to evaluate the cost-effectiveness and the budget impact. Since SÚKL did not receive a pharmacoeconomic evaluation from the participants in the required scope, the expansion of reimbursement for rheumatoid arthritis with moderate disease activity was carried out by setting the reimbursement for JAKi at the cost level of another therapy that is (at least) equally effective and already reimbursed for the target group of patients with RA and moderate disease activity. The approach chosen by SÚKL in the ongoing reimbursement review, therefore, by setting two reimbursement levels, ensures that JAKi remain reimbursed for RA with high disease activity in the second and subsequent lines of treatment with higher reimbursement, while JAKi are also newly reimbursed for moderate disease activity, though at a lower reimbursement amount.

The participant argued that a medicinal product may only have one additional increased reimbursement level set, alongside the basic reimbursement (not multiple increased reimbursement levels, as SÚKL did). SÚKL refers to Section 39b, paragraph 11 of the Health Insurance Act, which does not exclude the possibility of applying it based on the evaluation of a medicinal substance, product, or pharmaceutical form for several selected indications or for multiple patient groups.

SÚKL also states that during the ongoing reimbursement review, no statements were received from payers regarding any difficulties in reporting healthcare when establishing multiple reimbursement levels.

Articles from decision-making practice are based on publicly available texts from decisions by the Ministry of Health of the Czech Republic and decisions by SÚKL.

On the website of Pharmeca a.s., you can continuously follow an overview of the pricing and reimbursement decisions issued by SÚKL and the Ministry of Health of the Czech Republic. 

Articles on decision-making practice are based on publicly available texts of the Ministry of Health and SÚKL decisions.  

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"The Department of Medicinal Products and Medical Devices of the Ministry of Health of the Czech Republic (hereinafter referred to as "the Ministry"), in view of the wording of the applicable Act No. 338/2024 Coll., amending Act No. 48/1997 Coll., on Public Health Insurance and on Amendments and Supplements to Certain Related Acts, as amended, Act No. 592/1992 Coll., on Insurance Contributions for Public Health Insurance, as amended, and Act No. 378/2007 Coll., on Medicinal Products and on Amendments to Certain Related Acts (the Medicinal Products Act), as amended, which, with effect from January 1, 2025, changes the principles in the area of monitoring limits of deductible co-payments for partially reimbursed medicinal products and foods for special medical purposes (the protective limit) and the subsequent reimbursement of deductible co-payments exceeding the protective limit under Act No. 48/1997 Coll., on Public Health Insurance and on Amendments and Supplements to Certain Related Acts, as amended (hereinafter referred to as "the Public Health Insurance Act"), hereby issues its opinion on the procedure for assessing the financial impact on the health insurance system when determining or changing the amount and conditions of reimbursement for medicinal products or foods for special medical purposes.

The method of assessing the financial impact on the health insurance system (hereinafter referred to as "budget impact") is expressed in the third and fourth sentences of Section 15(8) of the Public Health Insurance Act, which state that "The budget impact is determined as the difference between the costs of treating a given disease associated with the use of a medicinal product or food for special medical purposes that would be reimbursed from health insurance funds, and the costs of treatment using another medicinal product, food for special medical purposes, or treatment method that is already reimbursed from health insurance funds. The budget impact must be in accordance with the public interest pursuant to Section 17(2)."

If, under Section 15(9) of the Public Health Insurance Act, the anticipated budget impact associated with determining reimbursement for a medicinal product or food for special medical purposes shows an increase in expenditures from the health insurance system, the budget impact assessment must be conducted through a budget impact analysis submitted by the applicant, which the State Institute for Drug Control assesses during the proceedings [see Section 39b(2)(c) of the Public Health Insurance Act].

The requirements of the third and fourth sentences of Section 15(8) of the Public Health Insurance Act for the applicant-submitted budget impact analysis and the procedure of the State Institute for Drug Control in its assessment are elaborated in the methodology SP-CAU-27 (hereinafter referred to as "the methodology") as of the date of this opinion. For the purpose of quantifying the budget impact, the methodology allows only the perspective of health insurance expenditures (for completeness, it should be noted that this applies outside of proceedings conducted under Section 39da of the Public Health Insurance Act).

The Ministry is aware from its own official activities that the State Institute for Drug Control currently considers only direct costs (both pharmaceutical and non-pharmaceutical) demonstrably incurred from health insurance in connection with the therapy of the given disease as relevant costs in the budget impact assessment, whereby the State Institute for Drug Control considers only the costs at the level of reimbursement from health insurance, or costs corresponding to the maximum consumer price if this price is lower than the reimbursement amount, as direct pharmaceutical costs for both the evaluated intervention and the comparator.

However, as the Public Health Insurance Act stipulates that the budget impact is determined as the difference in treatment costs for the given disease (from the perspective of health insurance) associated with the use of medicinal products, the Ministry considers it necessary to include in the relevant direct costs for the evaluated intervention and the comparator also the amounts of deductible co-payments reimbursed by health insurance funds above the protective limit of the insured, which, in connection with the amendment to the Public Health Insurance Act, will be a direct expenditure of health insurance funds paid to pharmacy service providers related to the treatment of the given disease.

For this reason, it is necessary that the applicant, within the submitted application, consider the anticipated budget impact, taking into account any deductible co-payments for the evaluated and comparator intervention.

If, in the assessment of the anticipated budget impact under Section 39b(2)(j) of the Public Health Insurance Act in proceedings on determining or changing the amount and conditions of reimbursement for a medicinal product, it becomes apparent that this anticipated reimbursement impact on health insurance funds, taking into account the anticipated amount of deductible co-payments (representing the cost of treating the given disease), shows an increase in expenditures from the health insurance system, in such a case, the applicant must submit a budget impact analysis that also considers the amount of the anticipated deductible co-payment.

According to the Ministry, in order to fulfill the purpose of the aforementioned legal provisions concerning the new protective limit rules, it is necessary that, in the budget impact assessment by the applicant and the budget impact evaluation by the State Institute for Drug Control, the deductible co-payment amounts applied in practice are considered, rather than the highest possible deductible co-payment amounts calculated according to the second sentence of Section 16b(1) of the Public Health Insurance Act.

The Ministry further emphasizes that the deductible co-payments for partially reimbursed medicinal products and foods for special medical purposes, which count towards the insured person's protective limit, are known to the State Institute for Drug Control from its own official activities, as well as to health insurance funds, and marketing authorization holders can also determine the actually applied amounts of deductible co-payments from the publicly available data on the website of the State Institute for Drug Control at https://prehledy.sukl.cz/prehled_leciv.html#/ or calculate them from data on already reimbursed medicinal products (comparators) published at regular intervals on https://opendata.sukl.cz/?q=katalog/lek-13 (note: link valid as of the date of this opinion).

For practical implementation, the Ministry believes that the above-mentioned change in the procedure for budget impact assessment can be realized as follows. The budget impact analysis will, in addition to the currently expressed budget impact, also include a separately calculated budget impact incorporating the costs of deductible co-payments for partially reimbursed medicinal products and foods for special medical purposes that would arise for health insurance funds when exceeding the annual protective limit. However, presenting a separately calculated budget impact with applied deductible co-payments will not be entirely necessary (or would be redundant) in cases where no deductible co-payment arises in the determination or change of the reimbursement amount and conditions for the evaluated intervention.

In conclusion, the Ministry states that this opinion does not interfere with the current practice of assessing cost-effectiveness analyses."   

The original document is available on the website of the Ministry of Health of the Czech Republic.

This is an unofficial translation generated with the assistance of ChatGPT-4o. It is provided for informational purposes only and does not constitute an official or legally binding translation.

Key Points:

• Platform Availability: The European Shortages Monitoring Platform (ESMP) is now accessible online.
• Mandatory Usage: Starting from February 2, 2025, all Marketing Authorization Holders (MAHs) with centrally authorized products will be required to use the ESMP.
• Early Familiarity: EMA encourages MAHs to familiarize themselves with the platform before the mandatory deadline.
• Data Submission: Until February 2, 2025, MAHs and National Competent Authorities (NCAs) can submit data on supply, demand, and availability of both centrally and nationally authorized medicines to the EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG).
• Medicine Monitoring: The platform will be used for routine monitoring of all centrally authorized medicines and may also be used for monitoring nationally authorized medicines under special circumstances.

Additional Resources:

• Frequently Asked Questions

For marketing authorization holders, knowledge of SÚKL and MZ ČR decisions in the area of pricing and reimbursement is essential. The outcomes of individual proceedings shape decision-making practices that influence future decisions.

To address this need, Pharmeca a.s. now offers an interactive overview of decisions issued in the past five weeks.

Act No. 48/1997 Coll., on Public Health Insurance and on Amendments to Some Related Acts, as amended.  

Implementing Regulation:

• Decree No. 376/2011 Coll., which implements certain provisions of the Public Health Insurance Act, as amended,
• Decree No  384/2007 Coll., on the list of reference groups, as amended,
• Decree No  385/2007 Coll., on the list of active substances for adjunct or add-on therapy;
• Decree No. 63/2007 Coll., on the reimbursement of medicinal products and foods for special medical purposes, as amended.
• Decree No. 618/2006 Coll., which issues framework agreements, as amended,
• Decree No. 134/1998 Coll., which issues a list of medical services with point values, as amended,
• Decree No. 527/2021 Coll., on determination of the amount of reimbursement of expenses for professional acts and the method of determination of the amount of compensation of expenses for professional consultations carried out by the State Institute for Drug Control under the Public Health Insurance Act, as amended,
• Decree on the determination of point values, the amount of payments for paid services and regulatory restrictions - always issued for the current year,
• Government Regulation No. 307/2012 Coll., on local and temporal availability of health services, as amended.

Act No. 551/1991 Coll., on the General Health Insurance Company of the Czech Republic, as amended.

Act No. 280/1992 Coll., on departmental, branch, corporate and other insurance companies, as amended.

Act No. 592/1992 Coll., on public health insurance premiums, as amended.

Implementing Regulation:

• Decree No. 351/2022 Coll., on the transmission of data on the consumption of medicinal products by insured persons of the public health insurance when changing the health insurance company, as amended

Act No. 526/1990  Coll., on Prices, as amended.

Price Regulations – Medicinal Products:

• Price Regulation of the Ministry of Health No. 4/2024/OLZP, on the determination of a special distribution surcharge for medicinal products released from the reserve stock system,
• Price Decision of the Ministry of Health No. 3/2024/OLZP, dated November 29, 2023, setting out lists of ATC groups with the relevant route of administration, for which the ex-factory price of the medicinal product is not subject to price regulation or maximum price regulation,
• Price Regulation of the Ministry of Health No. 2/2024/OLZP, dated November 29, 2023, on the price regulation of medicinal products and foods for special medical purposes,
• Price Regulation of the Ministry of Health No. 11/2023/OLZP, dated October 25, 2023, on the determination of the distribution and dispensing surcharge for medicinal products reimbursed under Section 32c of Act No. 48/1997 Coll.,
• Price Regulation No. 3/2022/OLZP, on the price regulation of individually prepared medicinal products containing cannabis for medical use.

Price Regulations – Medical Devices:

• Price Regulation of the Ministry of Health No. 1/2024/OLZP, dated October 25, 2023, on the price regulation of medical devices and in vitro diagnostic medical devices,
• Price Regulation of the Ministry of Health No. 2/2022/OLZP, dated January 7, 2022, amending Price Regulation No. 1/2019/CAU, dated May 22, 2019, on the price regulation of medical devices,
• Price Decision 2/13-FAR, establishing a list of medical devices with deregulated manufacturer prices.

Act No. 378/2007 Coll., on Pharmaceuticals, as amended.

Implementing Regulation:

·         Decree No. 457/2023 Coll., establishing a list of human medicinal products exempt from the obligation of the marketing authorization holder to ensure their supply after the announced date of supply interruption or discontinuation, as amended.

• Decree No. 84/2008 Coll., on good pharmaceutical practice, detailed conditions of handling pharmaceuticals in pharmacies, healthcare facilities and other operators and facilities supplying medicinal products, as amended,
• Decree No. 85/2008 Coll., which lays down a list of active substances and excipients which may be used in the preparation of medicinal products, as amended,
• Decree No 226/2008 Coll., on good clinical practice and detailed conditions of clinical trials on medicinal products, as amended,
• Decree No. 228/2008 Coll., on the marketing authorisation of medicinal products, as amended,
• Decree No. 229/2008 Coll., on the manufacture and distribution of pharmaceuticals, as amended,
• Decree No. 236/2015 Coll., on the determination of conditions for prescription, preparation, distribution, dispense and use of individually prepared medicinal products containing cannabis for medical use, as amended,
• Decree No. 329/2019 Coll., on prescribing medicinal products in the provision of health services, as amended,
• Decree No. 463/2021 Coll., on the detailed conditions for conducting a clinical trial of medicinal products for human use, as amended.

Act No 167/1998 Coll, on addictive substances and amending certain other acts, as amended

Implementing Regulation:

• Decree No. 53/2014 Coll., on forms under the Addictive Substances Act, as amended,
• Decree No. 123/2006 Coll., on evidence and documentation of addictive substances and preparations, as amended,
• Decree No. 243/2009 Coll., on establishing a list of persons indicating their workplaces for their work is not required permit to treatment of addictive substances and preparations containing them, as amended,
• Government Regulation No. 463/2013 Coll., on lists of addictive substances, as amended,
• Decree No. 235/2022 Coll., on the cultivation and processing of cannabis plants for medicinal use, as amended,
• Decree No 53/2022 Coll., on the determination of the amount of compensation of expenses for professional acts performed by the State Institute for Drug Control pursuant to the Act on Addictive Substances, as amended.

Act No. 375/2022 Coll., on medical devices and in vitro diagnostic medical devices, as amended. 

Implementing Regulation:

• Decree No 377/2022 Coll., on the implementation of certain provisions of the Act on medical devices and in vitro diagnostic medical devices, as amended, 

·         Decree No. 378/2022 Coll., on the template of the inspector's identification card of the State Institute for Drug Control under the Act on Medical Devices and In Vitro Diagnostic Medical Devices, as amended.

• Decree No 379/2022 Coll., on the determination of the amount of compensation of expenses for professional acts performed by the State Institute for Drug Control pursuant to the Act on Medical Devices and In Vitro Diagnostic Medical Devices, as amended. 

Act No 376/2022 Coll. amending certain acts in connection with the adoption of the Act on medical devices and in vitro diagnostic medical devices, as amended.

Act No. 268/2014 Coll., on medical devices and amending Act No. 634/2004 Coll., on administrative fees, as amended.

Act No. 89/2021 Coll., on medical devices and amending Act No. 378/2007 Coll., on pharmaceuticals and on amendments to certain related acts (Act on pharmaceuticals), as amended.

Implementing Regulation:

·         Notification of the Ministry of Health No. 54/2022 Coll., on the commissioning of the central repository of electronic vouchers.

Act No. 22/1997 Coll., on Technical Requirements for Products and amendments to some related acts, as amended.  

Act No. 90/2016 Coll., on the assessment of the conformity of specified products when they are placed on the market, as amended.

Act No. 372/2011 Coll., on health services and conditions for their provision (the Health Services Act), as amended.  

Decree No. 373/2016 Coll., on the transfer of data to the National Health Information System, as amended.

Act No. 40/1995 Coll., on the regulation of advertising and on amending and supplementing Act No. 468/1991 Coll., on the operation of radio and television broadcasting, as amended. 

Act No 242/2022 Coll., on the services of video sharing platforms and amending certain related acts (Act on the services of video sharing platforms), as amended.

Act No. 387/2024 Coll., on General Product Safety and Amendments to Certain Related Acts, as amended.

Act No. 500/2004 Coll., Administrative Code, as amended.

Current price decisions, opinions and methodological instructions or regulations of the Ministry of Health of the Czech Republic.

Instructions and methodologies of SÚKL.

Key Points:

• Platform Availability: The European Shortages Monitoring Platform (ESMP) is now accessible online.
• Mandatory Usage: Starting from February 2, 2025, all Marketing Authorization Holders (MAHs) with centrally authorized products will be required to use the ESMP.
• Early Familiarity: EMA encourages MAHs to familiarize themselves with the platform before the mandatory deadline.
• Data Submission: Until February 2, 2025, MAHs and National Competent Authorities (NCAs) can submit data on supply, demand, and availability of both centrally and nationally authorized medicines to the EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG).
• Medicine Monitoring: The platform will be used for routine monitoring of all centrally authorized medicines and may also be used for monitoring nationally authorized medicines under special circumstances.

Additional Resources:

• Frequently Asked Questions

This change contrasts with developments in the Czech Republic, where, as of January 1, 2024, the VAT rate on medicines increased from the original 10% to 12%, as we mentioned in our previous article Changes in VAT Rate for Pharmaceuticals.

What Impact Will the Reduced VAT Rate Have in Slovakia?

The lower VAT rate is expected to significantly reduce costs for patients in Slovakia for medical devices and medicines, both in outpatient and hospital care. The direct financial impact on individuals will depend on specific measures and pricing policies. For comparison, Slovakia’s VAT on medicines has dropped from 10% to 5%, which could lead to a more noticeable impact on final prices than in the Czech Republic, where the rate was increased.

Impact on External Price Referencing for Medicines

The reduced VAT rate in Slovakia, however, will not affect the external price referencing (EPR) of medicines, used by some countries to set maximum prices and reimbursement levels in their markets. The VAT change does not reflect in EPR because the reference price is almost universally based on the manufacturer’s price.

At the same time, this change offers an opportunity to compare tax policies across the EU, where VAT rates on medicines and medical devices vary significantly. For example, according to data from EFPIA (European Federation of Pharmaceutical Industries and Associations) as of January 1, 2024, Spain applies a 4% VAT rate on medicines, while Denmark has a standard rate of 25%.

Stay tuned to our website for more updates on legislative changes and their impact on healthcare in the EU.

EU residents will have more control over their health data, being able to access it electronically and share it across borders. This is particularly beneficial for cross-border healthcare, allowing individuals to access medical records and receive care seamlessly throughout the EU.

The EHDS promotes the secondary use of health data for research, innovation, and policy-making. Researchers and innovators will be able to access health data more easily and securely, which could drive the development of new treatments, medical devices, and AI applications.

The main objectives of the European Health Data Space (source: excerpt from the Communication from the Commission to the European Parliament and the Council: The European Health Data Space: Harnessing the power of health data for people, patients, and innovation):  

Evropská léková agentura (EMA) průběžně publikuje zprávy, jak proces přechodu na nový systém pokračuje.

V předchozím článku jsme ukazovali, jaká byla situace v únoru 2024, v tomto článku jsme informace o počtu podání a rozhodnutí o přechodu aktualizovali ke konci srpna 2024.

Obr. č. 1 – Změny v počtu podaných žádostí, resp. v počtu podání, kde již bylo rozhodnuto, v porovnání s předchozím měsícem

CTIS is guaranteed by European Medicines agency (EMA) and works in a secured workspace.

The important milestones for clinical trials:

• CT starts after 30^th January 2023 – the submission must be completed through CTIS
• CT ends before 30^th January 2025 – CT is maintained in EudraCT or national systems
• CT is expected to continue after 30^th January 2025 – transition from the EudraCT or national systems to the CTIS is necessary.

While the standard VAT rate remains at 21 percent, the original reduced rates of 15 percent (for medical devices) and 10 percent (for medicinal products) have been unified into a single 12 percent rate. The newly introduced zero rate applies exclusively to books, although the inclusion of medicinal products could have been possible in line with European legislation.

The infographics provides an overview of the changes in rates as follows:

Our new online overview provides:
✔ The required average exchange rate from the previous quarter
✔ The exchange rate development in the current quarter
✔ A monitoring focus on the 7 most commonly used European exchange rates in administrative proceedings

And all of this at a click!

• the remainder of the appeal is dismissed and the decision under appeal is upheld.

More information: MZCR.cz.

• the remainder of the appeal is dismissed and the decision under appeal is upheld.

More information: MZCR.cz.

• the remainder of the appeal is dismissed and the decision under appeal is upheld.

More information: MZCR.cz.

• the decision under appeal is reversed and the issue is referred back to the State Institute for Drug Control for reappraisal.
  

More information: MZCR.cz.

• the remainder of the appeal is dismissed and the decision under appeal is upheld.

More information: MZCR.cz.

Act No. 48/1997 Coll., on Public Health Insurance and on Amendments to Some Related Acts, as amended.  

Implementing legislations:  

• Decree No. 376/2011 Coll., which implements certain provisions of the Public Health Insurance Act, as amended,
  
• Decree No  384/2007 Coll., on the list of reference groups, as amended,
  
• Decree No  385/2007 Coll., on the list of active substances for adjunct or add-on therapy;
• Decree No. 618/2006 Coll., which issues framework agreements, as amended,
  
• Decree No. 134/1998 Coll., which issues a list of medical services with point values, as amended,
• Decree No. 527/2021 Coll., on determination of the amount of reimbursement of expenses for professional acts and the method of determination of the amount of compensation of expenses for professional consultations carried out by the State Institute for Drug Control under the Public Health Insurance Act, as amended,
  
• Decree on the determination of point values, the amount of payments for paid services and regulatory restrictions - always issued for the current year,
• Government Regulation No. 307/2012 Coll., on local and temporal availability of health services, as amended.

Act No. 551/1991 Coll., on the General Health Insurance Company of the Czech Republic, as amended.

Act No. 280/1992 Coll., on departmental, branch, corporate and other insurance companies, as amended.

Act No. 592/1992 Coll., on public health insurance premiums, as amended.

Implementing legislations:  

• Decree No. 351/2022 Coll., on the transmission of data on the consumption of medicinal products by insured persons of the public health insurance when changing the health insurance company, as amended

Act No. 526/1990  Coll., on Prices, as amended.

Act No. 378/2007 Coll., on Pharmaceuticals, as amended.

Implementing legislations:  

• Decree No. 228/2008 Coll., on the marketing authorisation of medicinal products, as amended,  
• Decree No. 84/2008 Coll., on good pharmaceutical practice, detailed conditions of handling pharmaceuticals in pharmacies, healthcare facilities and other operators and facilities supplying medicinal products, as amended,
• Decree No. 85/2008 Coll., which lays down a list of active substances and excipients which may be used in the preparation of medicinal products, as amended,
• Decree No 226/2008 Coll., on good clinical practice and detailed conditions of clinical trials on medicinal products, as amended,
  
• Decree No. 228/2008 Coll., on the marketing authorisation of medicinal products, as amended,
  
• Decree No. 229/2008 Coll., on the manufacture and distribution of pharmaceuticals, as amended,
  
• Decree No. 236/2015 Coll., on the determination of conditions for prescription, preparation, distribution, dispense and use of individually prepared medicinal products containing cannabis for medical use, as amended,
• Decree No. 329/2019 Coll., on prescribing medicinal products in the provision of health services, as amended,
• Decree No. 463/2021 Coll., on the detailed conditions for conducting a clinical trial of medicinal products for human use, as amended.

Act No 167/1998 Coll, on addictive substances and amending certain other acts, as amended

Implementing legislations:

• Decree No. 53/2014 Coll., on forms under the Addictive Substances Act, as amended,
• Decree No. 123/2006 Coll., on evidence and documentation of addictive substances and preparations, as amended,
• Decree No. 243/2009 Coll., on establishing a list of persons indicating their workplaces for their work is not required permit to treatment of addictive substances and preparations containing them, as amended,
• Government Regulation No. 463/2013 Coll., on lists of addictive substances, as amended,
• Decree No. 235/2022 Coll., on the cultivation and processing of cannabis plants for medicinal use, as amended,
• Decree No 53/2022 Coll., on the determination of the amount of compensation of expenses for professional acts performed by the State Institute for Drug Control pursuant to the Act on Addictive Substances, as amended.
  

Act No. 375/2022 Coll., on medical devices and in vitro diagnostic medical devices, as amended. 

Implementing legislations:

• Decree No 377/2022 Coll., on the implementation of certain provisions of the Act on medical devices and in vitro diagnostic medical devices, as amended, 
• Decree No 379/2022 Coll., on the determination of the amount of compensation of expenses for professional acts performed by the State Institute for Drug Control pursuant to the Act on Medical Devices and In Vitro Diagnostic Medical Devices, as amended. 
  

Act No 376/2022 Coll. amending certain acts in connection with the adoption of the Act on medical devices and in vitro diagnostic medical devices, as amended.

Act No. 268/2014 Coll., on medical devices and amending Act No. 634/2004 Coll., on administrative fees, as amended.

Act No. 89/2021 Coll., on medical devices and amending Act No. 378/2007 Coll., on pharmaceuticals and on amendments to certain related acts (Act on pharmaceuticals), as amended.

Act No. 22/1997 Coll., on Technical Requirements for Products and amendments to some related acts, as amended.  

Act No. 90/2016 Coll., on the assessment of the conformity of specified products when they are placed on the market, as amended.

Act No. 372/2011 Coll., on health services and conditions for their provision (the Health Services Act), as amended.  

Decree No. 373/2016 Coll., on the transfer of data to the National Health Information System, as amended.

Act No. 40/1995 Coll., on the regulation of advertising and on amending and supplementing Act No. 468/1991 Coll., on the operation of radio and television broadcasting, as amended. 

Act No 242/2022 Coll., on the services of video sharing platforms and amending certain related acts (Act on the services of video sharing platforms), as amended.

Act No. 500/2004 Coll., Administrative Code, as amended.

Current price decisions, opinions and methodological instructions or regulations of the Ministry of Health of the Czech Republic.

Instructions and methodologies of SÚKL.